Trial Outcomes & Findings for Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk (NCT NCT01764633)
NCT ID: NCT01764633
Last Updated: 2024-05-28
Results Overview
All deaths and potential endpoint events were adjudicated by an independent external Clinical Events Committee (CEC) led by the Thrombolysis in Myocardial Infarction (TIMI) Study Group, using standardized definitions based on the "Standardized Definitions for Cardiovascular and Stroke End Point Events in Clinical Trials and the Third Universal Definition of Myocardial Infarction". Time to cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization was defined as the time from randomization to the first occurrence of any component of the composite endpoint and was analyzed using Kaplan-Meier (KM) survival analysis. KM estimates of the percentage of participants with an event are reported. Participants with no event were censored based on last non-fatal potential endpoint collection date.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
27564 participants
Primary outcome timeframe
Events that occurred from randomization to the last confirmed survival status date; the median duration of follow-up was 26 months. KM estimates at 6, 12, 18, 24, 30 and 36 months are reported.
Results posted on
2024-05-28
Participant Flow
Participants were enrolled at 1242 clinical centers in 49 countries in the regions of Europe (62.9%), North America (16.6%), Asia Pacific (13.9%), and Latin America (6.6%) from 08 February 2013 to 05 June 2015.
Eligible participants were randomized in a 1:1 ratio to receive either subcutaneous (SC) evolocumab or placebo. Randomization was stratified by the final screening low-density lipoprotein cholesterol (LDL-C) level (\< 85 mg/dL vs ≥ 85 mg/dL) and by geographical region.
Participant milestones
| Measure |
Placebo
Participants received placebo subcutaneous injections either once every 2 weeks (Q2W) or once a month (QM) according to their own preference.
|
Evolocumab
Participants received evolocumab subcutaneous injections either 140 mg Q2W or 420 mg QM according to their own preference.
|
|---|---|---|
|
Overall Study
STARTED
|
13780
|
13784
|
|
Overall Study
Received Treatment
|
13756
|
13769
|
|
Overall Study
COMPLETED
|
13662
|
13691
|
|
Overall Study
NOT COMPLETED
|
118
|
93
|
Reasons for withdrawal
| Measure |
Placebo
Participants received placebo subcutaneous injections either once every 2 weeks (Q2W) or once a month (QM) according to their own preference.
|
Evolocumab
Participants received evolocumab subcutaneous injections either 140 mg Q2W or 420 mg QM according to their own preference.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
105
|
88
|
|
Overall Study
Lost to Follow-up
|
13
|
5
|
Baseline Characteristics
Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk
Baseline characteristics by cohort
| Measure |
Placebo
n=13780 Participants
Participants received placebo subcutaneous injections either once every 2 weeks (Q2W) or once a month (QM) according to their own preference.
|
Evolocumab
n=13784 Participants
Participants received evolocumab subcutaneous injections either 140 mg Q2W or 420 mg QM according to their own preference.
|
Total
n=27564 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.5 years
STANDARD_DEVIATION 8.9 • n=93 Participants
|
62.5 years
STANDARD_DEVIATION 9.1 • n=4 Participants
|
62.5 years
STANDARD_DEVIATION 9.0 • n=27 Participants
|
|
Age, Customized
< 65 years
|
7687 Participants
n=93 Participants
|
7623 Participants
n=4 Participants
|
15310 Participants
n=27 Participants
|
|
Age, Customized
≥ 65 years
|
6093 Participants
n=93 Participants
|
6161 Participants
n=4 Participants
|
12254 Participants
n=27 Participants
|
|
Sex: Female, Male
Female
|
3382 Participants
n=93 Participants
|
3387 Participants
n=4 Participants
|
6769 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
10398 Participants
n=93 Participants
|
10397 Participants
n=4 Participants
|
20795 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1084 Participants
n=93 Participants
|
1093 Participants
n=4 Participants
|
2177 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12694 Participants
n=93 Participants
|
12688 Participants
n=4 Participants
|
25382 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
80 Participants
n=93 Participants
|
60 Participants
n=4 Participants
|
140 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1349 Participants
n=93 Participants
|
1374 Participants
n=4 Participants
|
2723 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
352 Participants
n=93 Participants
|
317 Participants
n=4 Participants
|
669 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
11 Participants
n=93 Participants
|
15 Participants
n=4 Participants
|
26 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
White
|
11710 Participants
n=93 Participants
|
11748 Participants
n=4 Participants
|
23458 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Multiple
|
12 Participants
n=93 Participants
|
19 Participants
n=4 Participants
|
31 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Other
|
266 Participants
n=93 Participants
|
251 Participants
n=4 Participants
|
517 Participants
n=27 Participants
|
|
Low-density Lipoprotein Cholesterol
< 85 mg/dL
|
4803 Participants
n=93 Participants
|
4809 Participants
n=4 Participants
|
9612 Participants
n=27 Participants
|
|
Low-density Lipoprotein Cholesterol
≥ 85 mg/dL
|
8977 Participants
n=93 Participants
|
8975 Participants
n=4 Participants
|
17952 Participants
n=27 Participants
|
|
Geographical Region
Europe
|
8669 Participants
n=93 Participants
|
8667 Participants
n=4 Participants
|
17336 Participants
n=27 Participants
|
|
Geographical Region
North America
|
2284 Participants
n=93 Participants
|
2286 Participants
n=4 Participants
|
4570 Participants
n=27 Participants
|
|
Geographical Region
Latin America
|
910 Participants
n=93 Participants
|
913 Participants
n=4 Participants
|
1823 Participants
n=27 Participants
|
|
Geographical Region
Asia Pacific
|
1917 Participants
n=93 Participants
|
1918 Participants
n=4 Participants
|
3835 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Events that occurred from randomization to the last confirmed survival status date; the median duration of follow-up was 26 months. KM estimates at 6, 12, 18, 24, 30 and 36 months are reported.Population: All randomized participants; The number of participants entered at each time point represents the number of participants at risk.
All deaths and potential endpoint events were adjudicated by an independent external Clinical Events Committee (CEC) led by the Thrombolysis in Myocardial Infarction (TIMI) Study Group, using standardized definitions based on the "Standardized Definitions for Cardiovascular and Stroke End Point Events in Clinical Trials and the Third Universal Definition of Myocardial Infarction". Time to cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization was defined as the time from randomization to the first occurrence of any component of the composite endpoint and was analyzed using Kaplan-Meier (KM) survival analysis. KM estimates of the percentage of participants with an event are reported. Participants with no event were censored based on last non-fatal potential endpoint collection date.
Outcome measures
| Measure |
Placebo
n=13780 Participants
Participants received placebo subcutaneous injections either once every 2 weeks (Q2W) or once a month (QM) according to their own preference.
|
Evolocumab
n=13784 Participants
Participants received evolocumab subcutaneous injections either 140 mg Q2W or 420 mg QM according to their own preference.
|
|---|---|---|
|
Time to Cardiovascular Death, Myocardial Infarction, Hospitalization for Unstable Angina, Stroke, or Coronary Revascularization
KM estimate at 24 months
|
10.66 percentage of participants
Interval 10.12 to 11.19
|
9.13 percentage of participants
Interval 8.63 to 9.63
|
|
Time to Cardiovascular Death, Myocardial Infarction, Hospitalization for Unstable Angina, Stroke, or Coronary Revascularization
KM estimate at 30 months
|
12.72 percentage of participants
Interval 12.08 to 13.35
|
10.91 percentage of participants
Interval 10.31 to 11.5
|
|
Time to Cardiovascular Death, Myocardial Infarction, Hospitalization for Unstable Angina, Stroke, or Coronary Revascularization
KM estimate at 36 months
|
14.64 percentage of participants
Interval 13.76 to 15.5
|
12.57 percentage of participants
Interval 11.7 to 13.42
|
|
Time to Cardiovascular Death, Myocardial Infarction, Hospitalization for Unstable Angina, Stroke, or Coronary Revascularization
KM estimate at 6 months
|
3.11 percentage of participants
Interval 2.82 to 3.4
|
2.74 percentage of participants
Interval 2.47 to 3.01
|
|
Time to Cardiovascular Death, Myocardial Infarction, Hospitalization for Unstable Angina, Stroke, or Coronary Revascularization
KM estimate at 18 months
|
8.32 percentage of participants
Interval 7.86 to 8.78
|
7.25 percentage of participants
Interval 6.81 to 7.68
|
|
Time to Cardiovascular Death, Myocardial Infarction, Hospitalization for Unstable Angina, Stroke, or Coronary Revascularization
KM estimate at 12 months
|
6.01 percentage of participants
Interval 5.61 to 6.41
|
5.31 percentage of participants
Interval 4.93 to 5.68
|
SECONDARY outcome
Timeframe: Events that occurred from randomization to the last confirmed survival status date; the median duration of follow-up was 26 months. KM estimates at 6, 12, 18, 24, 30 and 36 months are reported.Population: All randomized participants; The number of participants entered at each time point represents the number of participants at risk.
All deaths and potential endpoint events were adjudicated by an independent external CEC led by the TIMI Study Group, using standardized definitions based on the "Standardized Definitions for Cardiovascular and Stroke End Point Events in Clinical Trials and the Third Universal Definition of Myocardial Infarction". Time to cardiovascular death, myocardial infarction, or stroke was defined as the time from randomization to the first occurrence of any component of the composite endpoint and was analyzed using Kaplan-Meier (KM) survival analysis. KM estimates of the percentage of participants with an event are reported. Participants with no event were censored based on last non-fatal potential endpoint collection date.
Outcome measures
| Measure |
Placebo
n=13780 Participants
Participants received placebo subcutaneous injections either once every 2 weeks (Q2W) or once a month (QM) according to their own preference.
|
Evolocumab
n=13784 Participants
Participants received evolocumab subcutaneous injections either 140 mg Q2W or 420 mg QM according to their own preference.
|
|---|---|---|
|
Time to Cardiovascular Death, Myocardial Infarction, or Stroke
KM estimate at 24 months
|
6.83 percentage of participants
Interval 6.39 to 7.26
|
5.47 percentage of participants
Interval 5.08 to 5.86
|
|
Time to Cardiovascular Death, Myocardial Infarction, or Stroke
KM estimate at 30 months
|
8.31 percentage of participants
Interval 7.78 to 8.84
|
6.66 percentage of participants
Interval 6.19 to 7.14
|
|
Time to Cardiovascular Death, Myocardial Infarction, or Stroke
KM estimate at 6 months
|
1.86 percentage of participants
Interval 1.63 to 2.08
|
1.65 percentage of participants
Interval 1.44 to 1.86
|
|
Time to Cardiovascular Death, Myocardial Infarction, or Stroke
KM estimate at 12 months
|
3.68 percentage of participants
Interval 3.36 to 3.99
|
3.10 percentage of participants
Interval 2.81 to 3.38
|
|
Time to Cardiovascular Death, Myocardial Infarction, or Stroke
KM estimate at 18 months
|
5.18 percentage of participants
Interval 4.81 to 5.55
|
4.29 percentage of participants
Interval 3.95 to 4.62
|
|
Time to Cardiovascular Death, Myocardial Infarction, or Stroke
KM estimate at 36 months
|
9.93 percentage of participants
Interval 9.16 to 10.69
|
7.90 percentage of participants
Interval 7.17 to 8.63
|
SECONDARY outcome
Timeframe: Events that occurred from randomization to the last confirmed survival status date; the median duration of follow-up was 26 months. KM estimates at 6, 12, 18, 24, 30 and 36 months are reported.Population: All randomized participants; The number of participants entered at each time point represents the number of participants at risk.
All deaths and potential endpoint events were adjudicated by an independent external CEC led by the TIMI Study Group, using standardized definitions based on the "Standardized Definitions for Cardiovascular and Stroke End Point Events in Clinical Trials and the Third Universal Definition of Myocardial Infarction". Cardiovascular death includes death resulting from an acute myocardial infarction (MI), sudden cardiac death, death due to heart failure (HF), death due to stroke, death due to cardiovascular (CV) procedures, death due to CV hemorrhage, and death due to other CV causes. Time to cardiovascular death was defined as the time from randomization to the date of cardiovascular death and was analyzed using Kaplan-Meier (KM) survival analysis. KM estimates of the percentage of participants with an event are reported. Participants with no event were censored based on the last confirmed survival status date.
Outcome measures
| Measure |
Placebo
n=13780 Participants
Participants received placebo subcutaneous injections either once every 2 weeks (Q2W) or once a month (QM) according to their own preference.
|
Evolocumab
n=13784 Participants
Participants received evolocumab subcutaneous injections either 140 mg Q2W or 420 mg QM according to their own preference.
|
|---|---|---|
|
Time to Cardiovascular Death
KM estimate at 36 months
|
2.39 percentage of participants
Interval 1.98 to 2.8
|
2.49 percentage of participants
Interval 2.09 to 2.88
|
|
Time to Cardiovascular Death
KM estimate at 6 months
|
0.40 percentage of participants
Interval 0.29 to 0.5
|
0.39 percentage of participants
Interval 0.29 to 0.5
|
|
Time to Cardiovascular Death
KM estimate at 12 months
|
0.82 percentage of participants
Interval 0.67 to 0.97
|
0.79 percentage of participants
Interval 0.64 to 0.94
|
|
Time to Cardiovascular Death
KM estimate at 18 months
|
1.19 percentage of participants
Interval 1.01 to 1.37
|
1.20 percentage of participants
Interval 1.01 to 1.38
|
|
Time to Cardiovascular Death
KM estimate at 24 months
|
1.57 percentage of participants
Interval 1.36 to 1.79
|
1.64 percentage of participants
Interval 1.42 to 1.85
|
|
Time to Cardiovascular Death
KM estimate at 30 months
|
1.99 percentage of participants
Interval 1.72 to 2.26
|
2.11 percentage of participants
Interval 1.83 to 2.39
|
SECONDARY outcome
Timeframe: Events that occurred from randomization to the last confirmed survival status date; the median duration of follow-up was 26 months. KM estimates at 6, 12, 18, 24, 30 and 36 months are reported.Population: All randomized participants; The number of participants entered at each time point represents the number of participants at risk.
Time to all-cause death was defined as the time from randomization to the date of death and was analyzed using Kaplan-Meier (KM) survival analysis. KM estimates of the percentage of participants with an event are reported. Participants with no event were censored based on the last confirmed survival status date.
Outcome measures
| Measure |
Placebo
n=13780 Participants
Participants received placebo subcutaneous injections either once every 2 weeks (Q2W) or once a month (QM) according to their own preference.
|
Evolocumab
n=13784 Participants
Participants received evolocumab subcutaneous injections either 140 mg Q2W or 420 mg QM according to their own preference.
|
|---|---|---|
|
Time to All Cause Death
KM estimate at 6 months
|
0.62 percentage of participants
Interval 0.49 to 0.75
|
0.55 percentage of participants
Interval 0.43 to 0.68
|
|
Time to All Cause Death
KM estimate at 12 months
|
1.29 percentage of participants
Interval 1.1 to 1.47
|
1.26 percentage of participants
Interval 1.07 to 1.44
|
|
Time to All Cause Death
KM estimate at 18 months
|
1.96 percentage of participants
Interval 1.73 to 2.19
|
1.94 percentage of participants
Interval 1.71 to 2.17
|
|
Time to All Cause Death
KM estimate at 24 months
|
2.78 percentage of participants
Interval 2.49 to 3.06
|
2.81 percentage of participants
Interval 2.52 to 3.1
|
|
Time to All Cause Death
KM estimate at 30 months
|
3.48 percentage of participants
Interval 3.12 to 3.83
|
3.63 percentage of participants
Interval 3.27 to 3.98
|
|
Time to All Cause Death
KM estimate at 36 months
|
4.28 percentage of participants
Interval 3.74 to 4.82
|
4.75 percentage of participants
Interval 4.16 to 5.34
|
SECONDARY outcome
Timeframe: Events that occurred from randomization to the last confirmed survival status date; the median duration of follow-up was 26 months. KM estimates at 6, 12, 18, 24, 30 and 36 months are reported.Population: All randomized participants; The number of participants entered at each time point represents the number of participants at risk.
All deaths and potential endpoint events were adjudicated by an independent external CEC led by the TIMI Study Group, using standardized definitions based on the "Standardized Definitions for Cardiovascular and Stroke End Point Events in Clinical Trials and the Third Universal Definition of Myocardial Infarction". The diagnosis of myocardial infarction required the combination of: * Evidence of myocardial necrosis (either changes in cardiac biomarkers or post-mortem pathological findings); and * Supporting information derived from the clinical presentation, electrocardiographic changes, or the results of myocardial or coronary artery Imaging. Time to first myocardial infarction was defined as the time from randomization to the date of the first MI and was analyzed using Kaplan-Meier survival analysis. KM estimates of the percentage of participants with an event are reported. Participants with no event were censored based on last non-fatal potential endpoint collection date.
Outcome measures
| Measure |
Placebo
n=13780 Participants
Participants received placebo subcutaneous injections either once every 2 weeks (Q2W) or once a month (QM) according to their own preference.
|
Evolocumab
n=13784 Participants
Participants received evolocumab subcutaneous injections either 140 mg Q2W or 420 mg QM according to their own preference.
|
|---|---|---|
|
Time to First Myocardial Infarction
KM estimate at 6 months
|
1.14 percentage of participants
Interval 0.97 to 1.32
|
1.06 percentage of participants
Interval 0.88 to 1.23
|
|
Time to First Myocardial Infarction
KM estimate at 12 months
|
2.39 percentage of participants
Interval 2.13 to 2.64
|
1.90 percentage of participants
Interval 1.67 to 2.13
|
|
Time to First Myocardial Infarction
KM estimate at 18 months
|
3.33 percentage of participants
Interval 3.03 to 3.63
|
2.55 percentage of participants
Interval 2.28 to 2.81
|
|
Time to First Myocardial Infarction
KM estimate at 24 months
|
4.30 percentage of participants
Interval 3.95 to 4.65
|
3.21 percentage of participants
Interval 2.9 to 3.51
|
|
Time to First Myocardial Infarction
KM estimate at 30 months
|
5.25 percentage of participants
Interval 4.82 to 5.67
|
3.83 percentage of participants
Interval 3.47 to 4.19
|
|
Time to First Myocardial Infarction
KM estimate at 36 months
|
6.28 percentage of participants
Interval 5.67 to 6.89
|
4.41 percentage of participants
Interval 3.85 to 4.96
|
SECONDARY outcome
Timeframe: Events that occurred from randomization to the last confirmed survival status date; the median duration of follow-up was 26 months. KM estimates at 6, 12, 18, 24, 30 and 36 months are reported.Population: All randomized participants; The number of participants entered at each time point represents the number of participants at risk.
All deaths and potential endpoint events were adjudicated by an independent external CEC led by the TIMI Study Group, using standardized definitions based on the "Standardized Definitions for Cardiovascular and Stroke End Point Events in Clinical Trials and the Third Universal Definition of Myocardial Infarction". Stroke was defined as an acute episode of focal or global neurological dysfunction caused by brain, spinal cord, or retinal vascular injury as a result of hemorrhage or infarction. Time to first stroke was defined as the time from randomization to the date of the stroke and was analyzed using Kaplan-Meier (KM) survival analysis. KM estimates of the percentage of participants with an event are reported. Participants with no event were censored based on last non-fatal potential endpoint collection date.
Outcome measures
| Measure |
Placebo
n=13780 Participants
Participants received placebo subcutaneous injections either once every 2 weeks (Q2W) or once a month (QM) according to their own preference.
|
Evolocumab
n=13784 Participants
Participants received evolocumab subcutaneous injections either 140 mg Q2W or 420 mg QM according to their own preference.
|
|---|---|---|
|
Time to First Stroke
KM estimate at 6 months
|
0.50 percentage of participants
Interval 0.38 to 0.61
|
0.31 percentage of participants
Interval 0.22 to 0.41
|
|
Time to First Stroke
KM estimate at 12 months
|
0.85 percentage of participants
Interval 0.69 to 1.0
|
0.70 percentage of participants
Interval 0.56 to 0.84
|
|
Time to First Stroke
KM estimate at 18 months
|
1.30 percentage of participants
Interval 1.11 to 1.5
|
1.05 percentage of participants
Interval 0.88 to 1.22
|
|
Time to First Stroke
KM estimate at 24 months
|
1.80 percentage of participants
Interval 1.57 to 2.04
|
1.36 percentage of participants
Interval 1.16 to 1.56
|
|
Time to First Stroke
KM estimate at 30 months
|
2.15 percentage of participants
Interval 1.88 to 2.43
|
1.71 percentage of participants
Interval 1.46 to 1.96
|
|
Time to First Stroke
KM estimate at 36 months
|
2.60 percentage of participants
Interval 2.2 to 3.0
|
2.18 percentage of participants
Interval 1.76 to 2.59
|
SECONDARY outcome
Timeframe: Events that occurred from randomization to the last confirmed survival status date; the median duration of follow-up was 26 months. KM estimates at 6, 12, 18, 24, 30 and 36 months are reported.Population: All randomized participants; the number of participants entered at each time point represents the number of participants at risk.
All deaths and potential endpoint events were adjudicated by an independent external CEC led by the TIMI Study Group, using standardized definitions based on the "Standardized Definitions for Cardiovascular and Stroke End Point Events in Clinical Trials and the Third Universal Definition of Myocardial Infarction". Time to first coronary revascularization was defined as the time from randomization to the date of the coronary revascularization and was analyzed using Kaplan-Meier (KM) survival analysis. KM estimates of the percentage of participants with an event are reported. Participants with no event were censored based on last non-fatal potential endpoint collection date.
Outcome measures
| Measure |
Placebo
n=13780 Participants
Participants received placebo subcutaneous injections either once every 2 weeks (Q2W) or once a month (QM) according to their own preference.
|
Evolocumab
n=13784 Participants
Participants received evolocumab subcutaneous injections either 140 mg Q2W or 420 mg QM according to their own preference.
|
|---|---|---|
|
Time to First Coronary Revascularization
KM estimate at 24 months
|
6.57 percentage of participants
Interval 6.14 to 7.0
|
5.22 percentage of participants
Interval 4.84 to 5.61
|
|
Time to First Coronary Revascularization
KM estimate at 6 months
|
1.87 percentage of participants
Interval 1.65 to 2.1
|
1.60 percentage of participants
Interval 1.39 to 1.81
|
|
Time to First Coronary Revascularization
KM estimate at 12 months
|
3.71 percentage of participants
Interval 3.39 to 4.02
|
3.13 percentage of participants
Interval 2.84 to 3.42
|
|
Time to First Coronary Revascularization
KM estimate at 18 months
|
5.20 percentage of participants
Interval 4.82 to 5.57
|
4.16 percentage of participants
Interval 3.83 to 4.5
|
|
Time to First Coronary Revascularization
KM estimate at 30 months
|
7.91 percentage of participants
Interval 7.39 to 8.42
|
6.13 percentage of participants
Interval 5.68 to 6.58
|
|
Time to First Coronary Revascularization
KM estimate at 36 months
|
9.17 percentage of participants
Interval 8.46 to 9.87
|
7.01 percentage of participants
Interval 6.36 to 7.65
|
SECONDARY outcome
Timeframe: Events that occurred from randomization to the last confirmed survival status date; the median duration of follow-up was 26 months. KM estimates at 6, 12, 18, 24, 30 and 36 months are reported.Population: All randomized participants; the number of participants entered at each time point represents the number of participants at risk.
All events were adjudicated by an independent external CEC led by the TIMI Study Group, using standardized definitions. HF hospitalization was defined as an event that met all of the following criteria: 1. Admitted to hospital with a primary diagnosis of HF 2. In hospital for at least 24 hours 3. Documented new or worsening symptoms due to HF, including at least 1 of the following: * Dyspnea * Decreased exercise tolerance * Fatigue * Other symptoms of worsened end-organ perfusion or volume overload 4. Evidence of new or worsening HF consisting of at least 2 physical exam findings or 1 physical exam finding and at least 1 laboratory criterion 5. Received new or increased treatment for HF. Time to CV death or first hospitalization for worsening HF was defined as the time from randomization to the first occurrence of any component of the endpoint analyzed using KM survival analysis. Participants with no event were censored based on last non-fatal potential endpoint collection date.
Outcome measures
| Measure |
Placebo
n=13780 Participants
Participants received placebo subcutaneous injections either once every 2 weeks (Q2W) or once a month (QM) according to their own preference.
|
Evolocumab
n=13784 Participants
Participants received evolocumab subcutaneous injections either 140 mg Q2W or 420 mg QM according to their own preference.
|
|---|---|---|
|
Time to Cardiovascular Death or First Hospitalization for Worsening Heart Failure
KM estimate at 6 months
|
0.79 percentage of participants
Interval 0.64 to 0.93
|
0.64 percentage of participants
Interval 0.51 to 0.77
|
|
Time to Cardiovascular Death or First Hospitalization for Worsening Heart Failure
KM estimate at 12 months
|
1.35 percentage of participants
Interval 1.16 to 1.54
|
1.29 percentage of participants
Interval 1.1 to 1.48
|
|
Time to Cardiovascular Death or First Hospitalization for Worsening Heart Failure
KM estimate at 18 months
|
1.99 percentage of participants
Interval 1.75 to 2.22
|
1.99 percentage of participants
Interval 1.76 to 2.22
|
|
Time to Cardiovascular Death or First Hospitalization for Worsening Heart Failure
KM estimate at 24 months
|
2.70 percentage of participants
Interval 2.41 to 2.98
|
2.64 percentage of participants
Interval 2.36 to 2.92
|
|
Time to Cardiovascular Death or First Hospitalization for Worsening Heart Failure
KM estimate at 30 months
|
3.45 percentage of participants
Interval 3.09 to 3.81
|
3.31 percentage of participants
Interval 2.97 to 3.65
|
|
Time to Cardiovascular Death or First Hospitalization for Worsening Heart Failure
KM estimate at 36 months
|
4.03 percentage of participants
Interval 3.5 to 4.55
|
4.13 percentage of participants
Interval 3.57 to 4.68
|
SECONDARY outcome
Timeframe: Events that occurred from randomization to the last confirmed survival status date; the median duration of follow-up was 26 months. KM estimates at 6, 12, 18, 24, 30 and 36 months are reported.Population: All randomized participants; the number of participants entered at each time point represents the number of participants at risk.
All deaths and potential endpoint events were adjudicated by an independent external CEC led by the TIMI Study Group, using standardized definitions. Ischemic stroke was defined as an acute episode of focal cerebral, spinal, or retinal dysfunction caused by infarction of central nervous system tissue. Transient ischemic attack (TIA) was defined as a transient episode of focal neurological dysfunction caused by brain, spinal cord, or retinal ischemia, without acute infarction. Time to first ischemic fatal or non-fatal stroke or TIA was defined as the time from randomization to the first occurrence of any component of the composite endpoint and was analyzed using KM analysis. KM estimates of the percentage of participants with an event are reported. Participants with no event were censored based on last non-fatal potential endpoint collection date.
Outcome measures
| Measure |
Placebo
n=13780 Participants
Participants received placebo subcutaneous injections either once every 2 weeks (Q2W) or once a month (QM) according to their own preference.
|
Evolocumab
n=13784 Participants
Participants received evolocumab subcutaneous injections either 140 mg Q2W or 420 mg QM according to their own preference.
|
|---|---|---|
|
Time to First Ischemic Fatal or Non-Fatal Stroke or Transient Ischemic Attack
KM estimate at 6 months
|
0.61 percentage of participants
Interval 0.48 to 0.73
|
0.42 percentage of participants
Interval 0.31 to 0.53
|
|
Time to First Ischemic Fatal or Non-Fatal Stroke or Transient Ischemic Attack
KM estimate at 12 months
|
1.05 percentage of participants
Interval 0.88 to 1.22
|
0.83 percentage of participants
Interval 0.67 to 0.98
|
|
Time to First Ischemic Fatal or Non-Fatal Stroke or Transient Ischemic Attack
KM estimate at 18 months
|
1.52 percentage of participants
Interval 1.32 to 1.73
|
1.18 percentage of participants
Interval 1.0 to 1.37
|
|
Time to First Ischemic Fatal or Non-Fatal Stroke or Transient Ischemic Attack
KM estimate at 24 months
|
2.05 percentage of participants
Interval 1.81 to 2.3
|
1.46 percentage of participants
Interval 1.25 to 1.66
|
|
Time to First Ischemic Fatal or Non-Fatal Stroke or Transient Ischemic Attack
KM estimate at 30 months
|
2.40 percentage of participants
Interval 2.11 to 2.68
|
1.92 percentage of participants
Interval 1.65 to 2.19
|
|
Time to First Ischemic Fatal or Non-Fatal Stroke or Transient Ischemic Attack
KM estimate at 36 months
|
2.81 percentage of participants
Interval 2.41 to 3.21
|
2.48 percentage of participants
Interval 2.01 to 2.95
|
Adverse Events
Placebo
Serious events: 3404 serious events
Other events: 3438 other events
Deaths: 0 deaths
Evolocumab
Serious events: 3410 serious events
Other events: 3500 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=13756 participants at risk
Participants received placebo subcutaneous injections either once every 2 weeks (Q2W) or once a month (QM) according to their own preference.
|
Evolocumab
n=13769 participants at risk
Participants received evolocumab subcutaneous injections either 140 mg Q2W or 420 mg QM according to their own preference.
|
|---|---|---|
|
Cardiac disorders
Coronary artery stenosis
|
0.03%
4/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.04%
5/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Coronary artery thrombosis
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Diastolic dysfunction
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Dressler's syndrome
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Extrasystoles
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Heart alternation
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Heart valve incompetence
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Hypertensive cardiomyopathy
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Hypertensive heart disease
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Intracardiac thrombus
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Ischaemic cardiomyopathy
|
0.04%
6/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.05%
7/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.05%
7/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Left ventricular failure
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Microvascular coronary artery disease
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Mitral valve incompetence
|
0.02%
3/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.08%
11/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Mitral valve stenosis
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Myocardial infarction
|
0.23%
31/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.23%
31/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.15%
21/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.19%
26/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Myocardial necrosis
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Myocarditis
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Palpitations
|
0.06%
8/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.05%
7/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Pericardial effusion
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.02%
3/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Pericarditis
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.03%
4/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Prinzmetal angina
|
0.02%
3/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Pulseless electrical activity
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Rhythm idioventricular
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Silent myocardial infarction
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Sinus arrest
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Sinus bradycardia
|
0.03%
4/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.03%
4/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Sinus node dysfunction
|
0.13%
18/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.12%
17/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Stress cardiomyopathy
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.07%
9/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.07%
9/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Tachycardia
|
0.03%
4/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.02%
3/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Torsade de pointes
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.04%
6/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.03%
4/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.04%
5/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.05%
7/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Ventricular fibrillation
|
0.06%
8/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.09%
12/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Ventricular hypertrophy
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Ventricular tachyarrhythmia
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.20%
27/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.17%
23/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Congenital, familial and genetic disorders
Adenomatous polyposis coli
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Endocrine disorders
Adrenal mass
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Endocrine disorders
Basedow's disease
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Congenital, familial and genetic disorders
Arteriovenous malformation
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Congenital, familial and genetic disorders
Atrial septal defect
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Congenital, familial and genetic disorders
Carbohydrate metabolism disorder
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Congenital, familial and genetic disorders
Corneal dystrophy
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Congenital, familial and genetic disorders
Exomphalos
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Congenital, familial and genetic disorders
Gastrointestinal arteriovenous malformation
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Congenital, familial and genetic disorders
Hereditary motor and sensory neuropathy
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Endocrine disorders
Goitre
|
0.02%
3/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.02%
3/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Congenital, familial and genetic disorders
Hydrocele
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Congenital, familial and genetic disorders
Hypertrophic cardiomyopathy
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Congenital, familial and genetic disorders
Intracranial lipoma
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Congenital, familial and genetic disorders
Subependymal nodular heterotopia
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Ear and labyrinth disorders
Acute vestibular syndrome
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Ear and labyrinth disorders
Deafness
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Ear and labyrinth disorders
Deafness neurosensory
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Ear and labyrinth disorders
Deafness unilateral
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Ear and labyrinth disorders
Inner ear inflammation
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Ear and labyrinth disorders
Meniere's disease
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Ear and labyrinth disorders
Otorrhoea
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Ear and labyrinth disorders
Sudden hearing loss
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Ear and labyrinth disorders
Vertigo
|
0.09%
13/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.07%
9/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.05%
7/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Ear and labyrinth disorders
Vestibular disorder
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Ear and labyrinth disorders
Vestibular ischaemia
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.20%
27/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.20%
27/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Blood and lymphatic system disorders
Anaemia of chronic disease
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Blood and lymphatic system disorders
Autoimmune haemolytic anaemia
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.02%
3/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Blood and lymphatic system disorders
Haemorrhagic anaemia
|
0.04%
5/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Blood and lymphatic system disorders
Haemorrhagic disorder
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Blood and lymphatic system disorders
Hypochromic anaemia
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Blood and lymphatic system disorders
Immune thrombocytopenic purpura
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.04%
6/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.07%
9/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.03%
4/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Blood and lymphatic system disorders
Lymphadenitis
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.02%
3/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Blood and lymphatic system disorders
Lymphadenopathy mediastinal
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Blood and lymphatic system disorders
Microcytic anaemia
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Blood and lymphatic system disorders
Normochromic normocytic anaemia
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.03%
4/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Blood and lymphatic system disorders
Pernicious anaemia
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Blood and lymphatic system disorders
Polycythaemia
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Blood and lymphatic system disorders
Spleen disorder
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.08%
11/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.04%
6/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Acute left ventricular failure
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.17%
23/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.08%
11/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Angina pectoris
|
1.6%
221/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.5%
208/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Angina unstable
|
2.0%
278/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.7%
233/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Aortic valve disease
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Aortic valve incompetence
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Aortic valve stenosis
|
0.06%
8/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.07%
10/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Arrhythmia
|
0.03%
4/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Arrhythmia supraventricular
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.02%
3/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.02%
3/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Arteritis coronary
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Atrial fibrillation
|
0.96%
132/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.86%
119/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Atrial flutter
|
0.12%
17/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.18%
25/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Atrial tachycardia
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Atrial thrombosis
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Atrioventricular block
|
0.04%
5/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.03%
4/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.09%
13/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.12%
16/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.02%
3/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.05%
7/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.05%
7/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Bifascicular block
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Bradyarrhythmia
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Bradycardia
|
0.09%
13/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.07%
10/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Bundle branch block bilateral
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Bundle branch block left
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.02%
3/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Bundle branch block right
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Cardiac aneurysm
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Cardiac arrest
|
0.04%
5/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.02%
3/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Cardiac asthma
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Cardiac disorder
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Cardiac failure
|
0.48%
66/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.48%
66/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Cardiac failure acute
|
0.07%
10/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.09%
13/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Cardiac failure chronic
|
0.34%
47/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.36%
50/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.27%
37/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.33%
46/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Cardiac flutter
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Cardiac tamponade
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Cardiac ventricular thrombosis
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Cardiogenic shock
|
0.02%
3/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Cardiomyopathy
|
0.03%
4/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Cardiorenal syndrome
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Cardiotoxicity
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Cardiovascular disorder
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Congestive cardiomyopathy
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Coronary artery disease
|
0.33%
46/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.23%
32/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Coronary artery occlusion
|
0.03%
4/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Endocrine disorders
Hyperparathyroidism
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Endocrine disorders
Hyperparathyroidism primary
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Endocrine disorders
Hyperthyroidism
|
0.02%
3/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.03%
4/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Endocrine disorders
Hypoaldosteronism
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Endocrine disorders
Inappropriate antidiuretic hormone secretion
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Endocrine disorders
Thyroid mass
|
0.03%
4/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Eye disorders
Angle closure glaucoma
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Eye disorders
Blepharochalasis
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Eye disorders
Cataract
|
0.16%
22/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.11%
15/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Eye disorders
Cataract nuclear
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Eye disorders
Dacryoadenitis acquired
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Eye disorders
Diabetic retinopathy
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Eye disorders
Ectropion
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Eye disorders
Eyelid ptosis
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Eye disorders
Glaucoma
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Eye disorders
Iridocyclitis
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Eye disorders
Macular degeneration
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Eye disorders
Macular fibrosis
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.02%
3/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Eye disorders
Ocular myasthenia
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Eye disorders
Ophthalmoplegia
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Eye disorders
Pterygium
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Eye disorders
Retinal artery occlusion
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Eye disorders
Retinal artery thrombosis
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Eye disorders
Retinal detachment
|
0.04%
5/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.02%
3/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Eye disorders
Retinal tear
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Eye disorders
Retinal vascular disorder
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Eye disorders
Retinal vein thrombosis
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Eye disorders
Strabismus
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Eye disorders
Uveitis
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Eye disorders
Visual acuity reduced
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Eye disorders
Visual impairment
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Eye disorders
Vitreous floaters
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Eye disorders
Vitreous haemorrhage
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Abdominal adhesions
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.06%
8/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.08%
11/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.14%
19/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.09%
12/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.09%
13/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.09%
12/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Abdominal wall haematoma
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Alcoholic pancreatitis
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Anal fissure
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Anal fistula
|
0.03%
4/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Anal incontinence
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Anastomotic ulcer perforation
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Ascites
|
0.02%
3/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Barrett's oesophagus
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Chronic gastritis
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.02%
3/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Coeliac artery stenosis
|
0.02%
3/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Colitis
|
0.06%
8/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.04%
6/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.07%
10/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.04%
5/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Colonic fistula
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Constipation
|
0.07%
9/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.07%
9/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Crohn's disease
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.03%
4/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.07%
9/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Diverticulum
|
0.03%
4/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.03%
4/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.02%
3/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.02%
3/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Diverticulum intestinal haemorrhagic
|
0.03%
4/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.04%
5/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.04%
5/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.04%
5/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.04%
5/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Duodenitis
|
0.04%
5/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.03%
4/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.05%
7/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Dysphagia
|
0.03%
4/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Enteritis
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Epiploic appendagitis
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Erosive oesophagitis
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Faecaloma
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.03%
4/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Food poisoning
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.03%
4/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Gastric cyst
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Gastric disorder
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.06%
8/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.07%
9/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.04%
6/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.05%
7/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Gastric ulcer perforation
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Gastritis
|
0.12%
17/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
19/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Gastritis alcoholic
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.02%
3/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.02%
3/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Gastritis haemorrhagic
|
0.02%
3/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Gastroduodenal haemorrhage
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Gastroduodenitis
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Gastrointestinal angiodysplasia
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Gastrointestinal angiodysplasia haemorrhagic
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.12%
16/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.20%
27/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Gastrointestinal polyp haemorrhage
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Gastrointestinal ulcer
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Gastrointestinal ulcer haemorrhage
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.11%
15/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.10%
14/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Haematemesis
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.03%
4/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Haematochezia
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.03%
4/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Haemorrhagic erosive gastritis
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.04%
5/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.02%
3/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.07%
10/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.04%
6/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Haemorrhoids thrombosed
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Hernial eventration
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.02%
3/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.07%
9/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Ileus
|
0.05%
7/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.04%
6/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Ileus paralytic
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.02%
3/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Incarcerated inguinal hernia
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Incarcerated umbilical hernia
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Inflammatory bowel disease
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.16%
22/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.23%
32/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Intestinal dilatation
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Intestinal fistula
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Intestinal haemorrhage
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.04%
5/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.02%
3/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Intestinal polyp
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Intestinal prolapse
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Intra-abdominal fluid collection
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Intra-abdominal haematoma
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Intra-abdominal haemorrhage
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Intussusception
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Large intestinal haemorrhage
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
0.02%
3/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Large intestinal ulcer
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.12%
16/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.07%
10/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Leukoplakia oral
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.02%
3/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Mallory-Weiss syndrome
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Mechanical ileus
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Melaena
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Mesenteric arterial occlusion
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Mesenteric artery stenosis
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Mesenteric artery thrombosis
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Mesenteric vein thrombosis
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Nausea
|
0.03%
4/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.04%
5/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Odynophagia
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Oesophageal achalasia
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Oesophageal food impaction
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Oesophageal obstruction
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Oesophageal spasm
|
0.02%
3/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Oesophageal stenosis
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Oesophageal ulcer
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Oesophageal varices haemorrhage
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.03%
4/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Oesophagitis ulcerative
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Palatal swelling
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Pancreatic cyst
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Pancreatic disorder
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Pancreatic necrosis
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Pancreatic phlegmon
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Pancreatic pseudocyst
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.12%
16/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.07%
10/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.16%
22/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.10%
14/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Pancreatitis chronic
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Pancreatitis necrotising
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.02%
3/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Pancreatolithiasis
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Peptic ulcer
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Peptic ulcer haemorrhage
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Periodontal disease
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Peritoneal haematoma
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Proctitis
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.07%
9/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.04%
6/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Rectal polyp
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Reflux gastritis
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Retching
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Retroperitoneal fibrosis
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Retroperitoneal haematoma
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Retroperitoneal haemorrhage
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Salivary gland enlargement
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Small intestinal haemorrhage
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.04%
6/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.03%
4/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Small intestine ulcer
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Strangulated umbilical hernia
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Stress ulcer
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Thrombosis mesenteric vessel
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Tongue cyst
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Tongue oedema
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Tooth disorder
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Tooth impacted
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.10%
14/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.07%
10/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.07%
9/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.09%
13/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Varices oesophageal
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Volvulus
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Vomiting
|
0.07%
10/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.03%
4/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Asthenia
|
0.04%
6/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.06%
8/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Breakthrough pain
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Catheter site extravasation
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Chest discomfort
|
0.04%
5/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.03%
4/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Chest pain
|
0.36%
49/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.31%
42/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Complication associated with device
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Cyst rupture
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Drug intolerance
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Drug withdrawal syndrome
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Exercise tolerance decreased
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Fat necrosis
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Fatigue
|
0.03%
4/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Gait disturbance
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.04%
5/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
General physical health deterioration
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Generalised oedema
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Hernia
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Impaired healing
|
0.04%
5/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.03%
4/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Implant site inflammation
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Incarcerated hernia
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Inflammation
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Malaise
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.02%
3/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Mass
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Medical device discomfort
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Mucosal inflammation
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.03%
4/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Non-cardiac chest pain
|
0.97%
133/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.79%
109/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Oedema peripheral
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.03%
4/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Pacemaker generated arrhythmia
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Pain
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Peripheral swelling
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Pyrexia
|
0.07%
9/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.04%
5/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Sensation of foreign body
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Soft tissue inflammation
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Strangulated hernia
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Sudden cardiac death
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Surgical failure
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Systemic inflammatory response syndrome
|
0.02%
3/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Vascular stent occlusion
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Vascular stent restenosis
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Vascular stent stenosis
|
0.02%
3/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Vascular stent thrombosis
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Hepatobiliary disorders
Acute hepatic failure
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Hepatobiliary disorders
Ampulla of Vater stenosis
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Hepatobiliary disorders
Autoimmune hepatitis
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Hepatobiliary disorders
Bile duct obstruction
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Hepatobiliary disorders
Bile duct stenosis
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.04%
5/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.04%
6/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Hepatobiliary disorders
Biliary colic
|
0.04%
5/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.03%
4/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Hepatobiliary disorders
Biliary cyst
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Hepatobiliary disorders
Cholangitis
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.04%
5/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Hepatobiliary disorders
Cholangitis acute
|
0.04%
6/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.05%
7/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.10%
14/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.23%
31/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.29%
40/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.04%
5/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.04%
5/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Hepatobiliary disorders
Cholecystocholangitis
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.17%
23/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.20%
27/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Hepatobiliary disorders
Cholelithiasis migration
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Hepatobiliary disorders
Cholelithiasis obstructive
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Hepatobiliary disorders
Cholestasis
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Hepatobiliary disorders
Cirrhosis alcoholic
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.02%
3/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Hepatobiliary disorders
Gallbladder perforation
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Hepatobiliary disorders
Gallbladder polyp
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Hepatobiliary disorders
Hepatic cyst
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Hepatobiliary disorders
Hepatic fibrosis
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Hepatobiliary disorders
Hepatic pain
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Hepatobiliary disorders
Hepatitis acute
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Hepatobiliary disorders
Hepatitis alcoholic
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Hepatobiliary disorders
Hepatitis toxic
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Hepatobiliary disorders
Hepatorenal syndrome
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Hepatobiliary disorders
Hepatotoxicity
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Bronchitis
|
0.22%
30/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.12%
17/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Hepatobiliary disorders
Liver disorder
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Hepatobiliary disorders
Porcelain gallbladder
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Hepatobiliary disorders
Subacute hepatic failure
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Immune system disorders
Allergy to arthropod sting
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Immune system disorders
Anaphylactic reaction
|
0.02%
3/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Immune system disorders
Anaphylactic shock
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Immune system disorders
Food allergy
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Immune system disorders
Hypersensitivity
|
0.02%
3/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Immune system disorders
Mite allergy
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Immune system disorders
Sarcoidosis
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Immune system disorders
Transplant rejection
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Abdominal abscess
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Abdominal sepsis
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Abdominal wall abscess
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Abscess
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Abscess bacterial
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Abscess limb
|
0.03%
4/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.07%
10/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Abscess of eyelid
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Abscess of salivary gland
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Abscess soft tissue
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Acute sinusitis
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Amoebic dysentery
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Anal abscess
|
0.04%
5/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Anal fistula infection
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Appendiceal abscess
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Appendicitis
|
0.10%
14/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.15%
20/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Appendicitis perforated
|
0.04%
5/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Arteritis infective
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Arthritis bacterial
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Atypical pneumonia
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Bacteraemia
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Bacterial pericarditis
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Bacterial prostatitis
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Bacterial pyelonephritis
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Bacterial sepsis
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Bacteroides bacteraemia
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Beta haemolytic streptococcal infection
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Bone abscess
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Breast abscess
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Bronchitis bacterial
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Burkholderia cepacia complex infection
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Burkholderia pseudomallei infection
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Bursitis infective
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Campylobacter gastroenteritis
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Carbuncle
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Catheter site infection
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Cellulitis
|
0.20%
28/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.28%
39/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Cellulitis gangrenous
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Cervicitis
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Cholecystitis infective
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Chronic hepatitis B
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Chronic sinusitis
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.04%
6/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Clostridium difficile infection
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.02%
3/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Colonic abscess
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Creutzfeldt-Jakob disease
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Cystitis
|
0.04%
5/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.02%
3/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Cystitis escherichia
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Dengue fever
|
0.03%
4/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Device related infection
|
0.02%
3/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Device related sepsis
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Diabetic foot infection
|
0.04%
6/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Diabetic gangrene
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Diarrhoea infectious
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Diverticulitis
|
0.19%
26/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.12%
16/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Diverticulitis intestinal haemorrhagic
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Eczema infected
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Embolic pneumonia
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Empyema
|
0.02%
3/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Encephalitis viral
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Endocarditis
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Endocarditis bacterial
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Endocarditis haemophilus
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Endophthalmitis
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Enteritis infectious
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Enterobacter bacteraemia
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Enterococcal bacteraemia
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Enterococcal sepsis
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Epididymitis
|
0.02%
3/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Epiglottitis
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Erysipelas
|
0.14%
19/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.12%
16/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Erysipeloid
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Escherichia bacteraemia
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Escherichia sepsis
|
0.02%
3/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.03%
4/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Febrile infection
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Fungal peritonitis
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Furuncle
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Gallbladder empyema
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Gangrene
|
0.09%
12/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.04%
6/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Gastritis viral
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Gastroenteritis
|
0.10%
14/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
19/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Gastroenteritis adenovirus
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Gastroenteritis bacterial
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Gastroenteritis clostridial
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Gastroenteritis rotavirus
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Gastroenteritis salmonella
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Gastroenteritis viral
|
0.02%
3/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.02%
3/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Gastrointestinal infection
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Gingival abscess
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Graft infection
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Groin abscess
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
H1N1 influenza
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Haematoma infection
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Helicobacter infection
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Hepatitis A
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Hepatitis B
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Hepatitis C
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.02%
3/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Hepatitis E
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.02%
3/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Herpes zoster
|
0.02%
3/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.04%
5/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Implant site infection
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Incision site infection
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Infected bite
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Infected cyst
|
0.02%
3/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Infected skin ulcer
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Infection
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Infection in an immunocompromised host
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Infectious colitis
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Infectious pleural effusion
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Infective exacerbation of chronic obstructive airways disease
|
0.04%
5/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.02%
3/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Infective tenosynovitis
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Influenza
|
0.04%
6/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.07%
9/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Intervertebral discitis
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Kidney infection
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Laryngitis
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Liver abscess
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Localised infection
|
0.04%
6/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.04%
6/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.11%
15/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.10%
14/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Lower respiratory tract infection viral
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Lung abscess
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Lung infection
|
0.02%
3/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.04%
5/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Mastoiditis
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Mediastinitis
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Medical device site infection
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Meningitis
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Meningitis bacterial
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Meningitis pneumococcal
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Muscle abscess
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Necrotising fasciitis
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Neurosyphilis
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Neutropenic infection
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Nosocomial infection
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Ophthalmic herpes zoster
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Oral fungal infection
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Orchitis
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Osteomyelitis
|
0.05%
7/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.12%
16/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Osteomyelitis acute
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Osteomyelitis chronic
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Otitis externa
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Otitis externa bacterial
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Otitis media
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Pancreas infection
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Paronychia
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Parotitis
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Pelvic abscess
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Perineal abscess
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Periodontitis
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Perirectal abscess
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Peritonitis
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.03%
4/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Peritonitis bacterial
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Pharyngeal abscess
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Pneumococcal sepsis
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Pneumonia
|
1.1%
152/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.1%
147/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Pneumonia adenoviral
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Pneumonia bacterial
|
0.08%
11/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.13%
18/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Pneumonia influenzal
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Pneumonia legionella
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Pneumonia pneumococcal
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Pneumonia staphylococcal
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Arterial bypass thrombosis
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Pneumonia viral
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Post procedural infection
|
0.02%
3/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.03%
4/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Post procedural pneumonia
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Post procedural sepsis
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Postoperative abscess
|
0.03%
4/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Postoperative wound infection
|
0.06%
8/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.02%
3/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Prostate infection
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Prostatic abscess
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Pseudomembranous colitis
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Psoas abscess
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Pulmonary sepsis
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.02%
3/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Pyelonephritis
|
0.03%
4/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.07%
10/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Pyelonephritis acute
|
0.04%
6/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.04%
6/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Pyelonephritis chronic
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Pyonephrosis
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Rectal abscess
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Respiratory tract infection
|
0.06%
8/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.06%
8/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Respiratory tract infection bacterial
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Rhinovirus infection
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Salmonellosis
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Salpingitis
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Scrotal abscess
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Scrotal infection
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Sepsis
|
0.23%
31/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.15%
21/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Septic shock
|
0.07%
9/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.04%
6/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Sinusitis
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Skin bacterial infection
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Skin infection
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Soft tissue infection
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Spermatic cord funiculitis
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Splenic abscess
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Staphylococcal abscess
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.02%
3/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Staphylococcal infection
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Staphylococcal sepsis
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Streptococcal sepsis
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Subcutaneous abscess
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Testicular abscess
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Tick-borne viral encephalitis
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Tonsillitis
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Tooth abscess
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.02%
3/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Tracheitis
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Tracheobronchitis
|
0.02%
3/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Tuberculosis
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.04%
6/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.04%
6/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Upper respiratory tract infection bacterial
|
0.02%
3/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Ureteritis
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Urinary tract infection
|
0.27%
37/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.30%
41/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Urinary tract infection bacterial
|
0.05%
7/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.05%
7/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Urosepsis
|
0.11%
15/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.09%
12/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Vestibular neuronitis
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Viral infection
|
0.02%
3/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.03%
4/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Viral myocarditis
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Viral pericarditis
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Vulval abscess
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Wound abscess
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Wound infection
|
0.08%
11/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.04%
6/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Wound infection bacterial
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Wound infection staphylococcal
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Wound sepsis
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Abdominal injury
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.02%
3/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Acetabulum fracture
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.02%
3/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.02%
3/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Anaemia postoperative
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Anastomotic fistula
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Anastomotic leak
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Anastomotic stenosis
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Animal scratch
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.09%
12/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.06%
8/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Aortic injury
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Arterial bypass occlusion
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Arterial injury
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Arterial restenosis
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula site complication
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Avulsion fracture
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Back injury
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Carbon monoxide poisoning
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Carotid artery restenosis
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Cartilage injury
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.03%
4/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Chemical burn of gastrointestinal tract
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Chemical poisoning
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Chest injury
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.02%
3/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Comminuted fracture
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.02%
3/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.04%
5/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.02%
3/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.04%
6/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Coronary artery restenosis
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Cranial nerve injury
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.02%
3/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.04%
6/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Diffuse axonal injury
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Dislocation of sternum
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Dislocation of vertebra
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Endotracheal intubation complication
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Extradural haematoma
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Eye contusion
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Eye injury
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Eye operation complication
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Face injury
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.03%
4/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.02%
3/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Fall
|
0.09%
13/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.12%
17/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.05%
7/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.03%
4/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.07%
9/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.15%
20/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.03%
4/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.04%
5/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Forearm fracture
|
0.02%
3/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.03%
4/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Foreign body aspiration
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Fracture
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Fracture displacement
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Fractured ischium
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Fractured sacrum
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Graft complication
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Graft thrombosis
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.02%
3/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.06%
8/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.04%
6/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Heat exhaustion
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Heat stroke
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.08%
11/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.08%
11/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.06%
8/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.04%
6/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Ilium fracture
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
0.03%
4/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.04%
5/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Incomplete spinal fusion
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Inflammation of wound
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Injury
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.04%
5/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Intentional overdose
|
0.04%
5/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Jaw fracture
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.04%
5/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.03%
4/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Joint dislocation postoperative
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Kidney contusion
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.03%
4/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.03%
4/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.02%
3/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Limb crushing injury
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Limb fracture
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.02%
3/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Limb traumatic amputation
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.03%
4/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.02%
3/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.02%
3/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.03%
4/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.05%
7/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Medication error
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.03%
4/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.06%
8/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Metal poisoning
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Multiple fractures
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Multiple injuries
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Muscle contusion
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Muscle rupture
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Neck injury
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Open globe injury
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.02%
3/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.03%
4/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Peripheral arterial reocclusion
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Peripheral artery restenosis
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Perirenal haematoma
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Peroneal nerve palsy postoperative
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Pneumoconiosis
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Pneumonitis chemical
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Pneumothorax traumatic
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Poisoning
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Post concussion syndrome
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Post laminectomy syndrome
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Post procedural constipation
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
0.02%
3/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.02%
3/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Post procedural haematuria
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.05%
7/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.04%
6/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Post procedural myocardial infarction
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Post procedural swelling
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Post-traumatic neck syndrome
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Post-traumatic pain
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Postoperative respiratory failure
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Postoperative thoracic procedure complication
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Postoperative wound complication
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Procedural complication
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Procedural haemorrhage
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Procedural hypotension
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Procedural pneumothorax
|
0.02%
3/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Pubis fracture
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Radial head dislocation
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Radiation mucositis
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Radiation oesophagitis
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.03%
4/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.08%
11/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.05%
7/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.04%
6/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.03%
4/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Sacroiliac fracture
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Scapula fracture
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Seroma
|
0.02%
3/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Skeletal injury
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Skull fracture
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.02%
3/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Skull fractured base
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Snake bite
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Spinal column injury
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.03%
4/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.04%
5/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Spinal cord injury
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Spinal cord injury lumbar
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.02%
3/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Splenic injury
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Stab wound
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Sternal fracture
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Subarachnoid haemorrhage
|
0.02%
3/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.02%
3/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Subcutaneous haematoma
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.08%
11/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.04%
6/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Subdural haemorrhage
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.02%
3/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Tendon injury
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.06%
8/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.04%
6/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.02%
3/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.02%
3/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.05%
7/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.03%
4/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Transplant failure
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Traumatic arthritis
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Traumatic fracture
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Traumatic haematoma
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Traumatic haemothorax
|
0.02%
3/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Traumatic intracranial haemorrhage
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Traumatic shock
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Traumatic ulcer
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Ulnar nerve injury
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.04%
5/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Urethral stricture postoperative
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Vascular bypass dysfunction
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Vascular graft complication
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Vascular graft occlusion
|
0.04%
5/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Vascular graft thrombosis
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.02%
3/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Vascular procedure complication
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.02%
3/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Wound
|
0.02%
3/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.03%
4/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Wound evisceration
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Wound haemorrhage
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Wound necrosis
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Wound secretion
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.02%
3/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Alanine aminotransferase increased
|
0.11%
15/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.08%
11/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Arteriogram coronary
|
0.02%
3/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.04%
5/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Arteriogram coronary abnormal
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Arteriogram coronary normal
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Aspartate aminotransferase increased
|
0.08%
11/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.04%
6/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Blood bilirubin increased
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.04%
6/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.05%
7/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Blood creatinine increased
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Blood glucose decreased
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Blood glucose fluctuation
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Blood glucose increased
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Blood potassium increased
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Blood pressure increased
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Cardiac stress test abnormal
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Ejection fraction decreased
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.03%
4/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Electrocardiogram ST segment depression
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Electrocardiogram abnormal
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Exercise electrocardiogram abnormal
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
False positive investigation result
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Heart rate increased
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Heart rate irregular
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Hepatic enzyme increased
|
0.06%
8/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.17%
24/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Hepatitis A antibody positive
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Hepatitis A virus test positive
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Hepatitis B antibody positive
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Hepatitis C virus test positive
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Influenza A virus test positive
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Influenza B virus test positive
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
International normalised ratio abnormal
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
International normalised ratio increased
|
0.03%
4/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Investigation
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Lipase increased
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Liver function test abnormal
|
0.03%
4/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.05%
7/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Liver function test increased
|
0.05%
7/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Medical observation
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Myocardial necrosis marker increased
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Oxygen saturation decreased
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Precancerous cells present
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Stress echocardiogram
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Thyroid function test abnormal
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Transaminases increased
|
0.04%
5/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.04%
6/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Troponin I increased
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Troponin T increased
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Troponin increased
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.02%
3/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Weight decreased
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Weight increased
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Abnormal loss of weight
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Cachexia
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.13%
18/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.12%
16/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.41%
56/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.44%
61/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.08%
11/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.04%
6/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.06%
8/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.07%
10/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Diabetic metabolic decompensation
|
0.02%
3/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.02%
3/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Fluid retention
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Glucose tolerance impaired
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Gout
|
0.04%
5/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.04%
6/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Hyperammonaemia
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.06%
8/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.06%
8/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Hyperinsulinaemic hypoglycaemia
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.05%
7/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.07%
10/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Hyperosmolar hyperglycaemic state
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.08%
11/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.12%
17/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Hypoglycaemia unawareness
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.05%
7/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.04%
6/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.04%
5/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.04%
5/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Hypovitaminosis
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Ketoacidosis
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Obesity
|
0.04%
6/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.02%
3/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Type 1 diabetes mellitus
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.03%
4/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.09%
12/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Vitamin B12 deficiency
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.13%
18/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.12%
16/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.09%
13/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.08%
11/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Arthropathy
|
0.02%
3/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.03%
4/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.22%
30/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.22%
30/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Bone deformity
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.02%
3/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.02%
3/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Chondrocalcinosis pyrophosphate
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Chondropathy
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
0.02%
3/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Diabetic amyotrophy
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Dupuytren's contracture
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Enthesopathy
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Exostosis
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Exostosis of jaw
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Facet joint syndrome
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Femoroacetabular impingement
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Fibromyalgia
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Foot deformity
|
0.04%
5/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.05%
7/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Fracture nonunion
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Gouty arthritis
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.02%
3/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.06%
8/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc disorder
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.03%
4/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc displacement
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.17%
24/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.16%
22/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Jaw cyst
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Joint adhesion
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Joint instability
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.12%
17/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.15%
21/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Mobility decreased
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Monarthritis
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.27%
37/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.36%
49/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.04%
5/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.04%
5/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.06%
8/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Myalgia intercostal
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Myofascitis
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Myopathy
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.03%
4/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Neuropathic arthropathy
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Nodal osteoarthritis
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Osteitis
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.73%
100/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.66%
91/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Osteochondritis
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Osteochondrosis
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Osteolysis
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.04%
5/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.03%
4/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Osteoporotic fracture
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.03%
4/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.06%
8/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Patellofemoral pain syndrome
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Polyarthritis
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Polymyalgia rheumatica
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Polymyositis
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Pseudarthrosis
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Psoriatic arthropathy
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.05%
7/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.03%
4/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.02%
3/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.07%
9/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.06%
8/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Seronegative arthritis
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.04%
5/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.04%
6/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Spinal instability
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.09%
12/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.07%
9/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.04%
5/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.06%
8/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Spondylitis
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Spondyloarthropathy
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.02%
3/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Spondylolysis
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Sympathetic posterior cervical syndrome
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Symphysiolysis
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.04%
5/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Temporomandibular joint syndrome
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Tendon necrosis
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Trigger finger
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Vertebral foraminal stenosis
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Vertebral osteophyte
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute leukaemia
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma gastric
|
0.03%
4/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.03%
4/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of appendix
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.09%
12/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.12%
17/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma pancreas
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adrenal adenoma
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adrenal gland cancer
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adrenal neoplasm
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anal cancer stage III
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anal neoplasm
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anogenital warts
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell lymphoma
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell lymphoma stage I
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell prolymphocytic leukaemia
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.08%
11/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.03%
4/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basosquamous carcinoma
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign gastric neoplasm
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign gastrointestinal neoplasm
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign lung neoplasm
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of adrenal gland
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of bladder
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of prostate
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of spinal cord
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign pancreatic neoplasm
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign renal neoplasm
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bile duct cancer
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Biliary adenoma
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder adenocarcinoma stage III
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder adenocarcinoma stage unspecified
|
0.03%
4/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.06%
8/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.09%
12/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer recurrent
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer stage 0, with cancer in situ
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer stage I, with cancer in situ
|
0.02%
3/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer stage III
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder neoplasm
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.02%
3/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder papilloma
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma
|
0.04%
6/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.07%
9/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma recurrent
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma stage I
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma stage II
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma stage III
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma stage IV
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bowen's disease
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain cancer metastatic
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm malignant
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.04%
6/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.04%
6/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer female
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer in situ
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer recurrent
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bronchial carcinoma
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.03%
4/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bronchial neoplasm
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Burkitt's lymphoma
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carcinoid tumour pulmonary
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix carcinoma
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cholangiocarcinoma
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cholesteatoma
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Choroid melanoma
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic lymphocytic leukaemia
|
0.02%
3/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic myeloid leukaemia
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Clear cell renal cell carcinoma
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.02%
3/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon adenoma
|
0.04%
5/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.03%
4/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.04%
5/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.08%
11/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer metastatic
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer stage I
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer stage III
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon neoplasm
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal adenocarcinoma
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal cancer
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal cancer metastatic
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Dermatofibrosarcoma protuberans
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Diffuse large B-cell lymphoma
|
0.02%
3/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ductal adenocarcinoma of pancreas
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial adenocarcinoma
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial adenoma
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Fallopian tube cancer
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Fibroma
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Follicular thyroid cancer
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gallbladder neoplasm
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric adenoma
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.03%
4/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.04%
5/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer stage 0
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer stage IV
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal carcinoma
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal neoplasm
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal stromal tumour
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioblastoma
|
0.03%
4/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioblastoma multiforme
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangiopericytoma
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic cancer
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic neoplasm
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular carcinoma
|
0.02%
3/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hodgkin's disease
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intraductal papillary mucinous neoplasm
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intraductal papillary-mucinous carcinoma of pancreas
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intraductal proliferative breast lesion
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive breast carcinoma
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.04%
6/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Large cell lung cancer stage III
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal cancer
|
0.02%
3/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.04%
6/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal cancer metastatic
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal cancer stage 0
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal cancer stage IV
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal squamous cell carcinoma
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lip and/or oral cavity cancer
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lip and/or oral cavity cancer stage III
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lip squamous cell carcinoma
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to pleura
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Liposarcoma
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.03%
4/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.09%
13/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma metastatic
|
0.02%
3/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma stage I
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.03%
4/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma stage III
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma stage IV
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metastatic
|
0.02%
3/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.02%
3/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung carcinoma cell type unspecified stage I
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung carcinoma cell type unspecified stage II
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung carcinoma cell type unspecified stage III
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung carcinoma cell type unspecified stage IV
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
0.03%
4/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.11%
15/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
19/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung squamous cell carcinoma metastatic
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung squamous cell carcinoma stage I
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung squamous cell carcinoma stage III
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoproliferative disorder
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant anorectal neoplasm
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant ascites
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.04%
5/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.04%
5/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma in situ
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma of sites other than skin
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant mesenteric neoplasm
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm of pleura
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm of renal pelvis
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant peritoneal neoplasm
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant urinary tract neoplasm
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma benign
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mesothelioma
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mesothelioma malignant
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to adrenals
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.02%
3/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.03%
4/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.02%
3/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.03%
4/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lung
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lymph nodes
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to spine
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastasis
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal adenoma
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic bronchial carcinoma
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic malignant melanoma
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic squamous cell carcinoma
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelofibrosis
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm progression
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm prostate
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroendocrine carcinoma
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroendocrine carcinoma metastatic
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroendocrine tumour
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's lymphoma
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
0.03%
4/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.02%
3/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer metastatic
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal adenocarcinoma
|
0.02%
3/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal adenocarcinoma metastatic
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal squamous cell carcinoma
|
0.02%
3/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oral cavity cancer metastatic
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oral neoplasm
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oral papilloma
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oropharyngeal cancer
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oropharyngeal squamous cell carcinoma
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian adenoma
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer stage II
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian epithelial cancer
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.04%
6/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.04%
5/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma metastatic
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary cystadenoma lymphomatosum
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary thyroid cancer
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Parathyroid tumour benign
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Penile cancer
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Phaeochromocytoma
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pharyngeal cancer
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pharyngeal cancer stage IV
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pharyngeal neoplasm benign
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma cell myeloma
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.03%
4/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasmacytoma
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pleural mesothelioma malignant
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Polycythaemia vera
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.29%
40/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.30%
41/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer metastatic
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.03%
4/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer stage I
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer stage II
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer stage IV
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostatic adenoma
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.04%
6/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal adenocarcinoma
|
0.05%
7/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.02%
3/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer stage III
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer stage IV
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.07%
9/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer metastatic
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer stage I
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.03%
4/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.03%
4/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma stage I
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma stage II
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma stage III
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal neoplasm
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal oncocytoma
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Retroperitoneal neoplasm
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Salivary gland adenoma
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Sarcoma
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Sarcoma metastatic
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Schwannoma
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin cancer
|
0.02%
3/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.04%
5/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer limited stage
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer metastatic
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small intestine carcinoma
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Soft tissue sarcoma
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Spindle cell sarcoma
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.03%
4/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of head and neck
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of lung
|
0.02%
3/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.02%
3/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.04%
5/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of the oral cavity
|
0.03%
4/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of the tongue
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of the vulva
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer metastatic
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tongue neoplasm malignant stage unspecified
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tonsil cancer
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell cancer of the renal pelvis and ureter
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.02%
3/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Undifferentiated sarcoma
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ureteral neoplasm
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine cancer
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Vocal cord neoplasm
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Vulval cancer recurrent
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Altered state of consciousness
|
0.03%
4/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Amnesia
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Amputation stump pain
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Amyotrophic lateral sclerosis
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Aphasia
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Apraxia
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Arachnoid cyst
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Ataxia
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Balance disorder
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Basal ganglia infarction
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Basilar artery aneurysm
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Basilar artery stenosis
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Carotid arteriosclerosis
|
0.04%
6/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.04%
5/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Carotid artery disease
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.02%
3/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Carotid artery occlusion
|
0.05%
7/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.02%
3/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Carotid artery stenosis
|
0.28%
39/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.27%
37/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.02%
3/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.04%
6/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Cauda equina syndrome
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Cerebellar ataxia
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Cerebellar infarction
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Cerebral arteriosclerosis
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Cerebral artery occlusion
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Cerebral artery stenosis
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Cerebral atrophy
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Cerebral haematoma
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Cerebral infarction
|
0.02%
3/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.04%
5/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Cerebral ischaemia
|
0.04%
6/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Cerebral thrombosis
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Cerebral vasoconstriction
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.15%
21/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.18%
25/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Cerebrovascular disorder
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Cerebrovascular insufficiency
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Cervical cord compression
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Cervical myelopathy
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Cervical radiculopathy
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Cervicobrachial syndrome
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.02%
3/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Cervicogenic headache
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Complex partial seizures
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Dementia Alzheimer's type
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Demyelinating polyneuropathy
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Diabetic neuropathy
|
0.04%
6/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.03%
4/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Dizziness
|
0.14%
19/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.11%
15/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Dizziness postural
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Dystonia
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Encephalitis autoimmune
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Encephalopathy
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Epilepsy
|
0.05%
7/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.04%
5/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Facial paralysis
|
0.03%
4/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Generalised tonic-clonic seizure
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Guillain-Barre syndrome
|
0.02%
3/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Headache
|
0.12%
17/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.07%
9/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Hemiparesis
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.03%
4/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Hemiplegic migraine
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Hydrocephalus
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Hypertensive encephalopathy
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Hypertonia
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Hypoaesthesia
|
0.02%
3/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.02%
3/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Hypoglycaemic coma
|
0.02%
3/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Hypoglycaemic encephalopathy
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Hypoglycaemic unconsciousness
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
IIIrd nerve paralysis
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Intracranial aneurysm
|
0.04%
6/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.02%
3/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Intracranial mass
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Ischaemic cerebral infarction
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Ischaemic stroke
|
0.04%
5/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.04%
6/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Lacunar infarction
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Lacunar stroke
|
0.02%
3/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Loss of consciousness
|
0.05%
7/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Lumbar radiculopathy
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.02%
3/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Lumbosacral radiculopathy
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Meralgia paraesthetica
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Migraine
|
0.02%
3/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.02%
3/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Migraine with aura
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Monoparesis
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Motor neurone disease
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Myelopathy
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Nerve compression
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Nervous system disorder
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Neuralgia
|
0.02%
3/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Neuritis
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Neuroglycopenia
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Neuromuscular pain
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.02%
3/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.04%
5/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Paraesthesia
|
0.03%
4/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.02%
3/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Paraparesis
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Paresis
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Parkinson's disease
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Parkinsonism
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Partial seizures
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Peroneal nerve palsy
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Petit mal epilepsy
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Polyneuropathy
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Polyneuropathy idiopathic progressive
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Postictal state
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Presyncope
|
0.03%
4/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.07%
9/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Pseudoradicular syndrome
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Psychomotor hyperactivity
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Quadriplegia
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Radicular syndrome
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Radiculopathy
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.04%
6/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Retrograde amnesia
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Sciatica
|
0.07%
10/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.10%
14/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Sedation
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Seizure
|
0.09%
13/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.06%
8/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Speech disorder
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Spinal claudication
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Spinal cord compression
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Status epilepticus
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Stroke in evolution
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Subdural effusion
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Syncope
|
0.41%
56/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.46%
63/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Tarsal tunnel syndrome
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Tension headache
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.02%
3/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Thoracic outlet syndrome
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Toxic encephalopathy
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Transient global amnesia
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.26%
36/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.31%
42/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Unresponsive to stimuli
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Vascular encephalopathy
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.02%
3/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Vertebral artery occlusion
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Vertebrobasilar insufficiency
|
0.04%
5/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.03%
4/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Vertigo CNS origin
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Visual field defect
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Vocal cord paralysis
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Product Issues
Device battery issue
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Product Issues
Device breakage
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Product Issues
Device dislocation
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Product Issues
Device failure
|
0.02%
3/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Product Issues
Device ineffective
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Product Issues
Device leakage
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Product Issues
Device loosening
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Product Issues
Device malfunction
|
0.04%
5/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.04%
5/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Product Issues
Device occlusion
|
0.02%
3/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Product Issues
Lead dislodgement
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Product Issues
Thrombosis in device
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Psychiatric disorders
Acute psychosis
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Psychiatric disorders
Affective disorder
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Psychiatric disorders
Alcohol abuse
|
0.03%
4/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Psychiatric disorders
Alcohol withdrawal syndrome
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.02%
3/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Psychiatric disorders
Alcoholism
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Psychiatric disorders
Anxiety
|
0.05%
7/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.03%
4/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Psychiatric disorders
Anxiety disorder
|
0.03%
4/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Psychiatric disorders
Anxiety disorder due to a general medical condition
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Psychiatric disorders
Burnout syndrome
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Psychiatric disorders
Confusional state
|
0.02%
3/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.03%
4/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Psychiatric disorders
Conversion disorder
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.02%
3/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Psychiatric disorders
Delirium
|
0.02%
3/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Psychiatric disorders
Delirium tremens
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Psychiatric disorders
Depressed mood
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Psychiatric disorders
Depression
|
0.15%
20/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.11%
15/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Psychiatric disorders
Depression suicidal
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Psychiatric disorders
Drug abuse
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Psychiatric disorders
Drug dependence
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Psychiatric disorders
Hallucination
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Psychiatric disorders
Hallucination, visual
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Psychiatric disorders
Major depression
|
0.03%
4/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Psychiatric disorders
Mania
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Psychiatric disorders
Mental disorder
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Psychiatric disorders
Mental status changes
|
0.03%
4/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.04%
6/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Psychiatric disorders
Mood disorder due to a general medical condition
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Psychiatric disorders
Neurosis
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Psychiatric disorders
Panic attack
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.02%
3/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Psychiatric disorders
Personality disorder
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Psychiatric disorders
Psychiatric decompensation
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Psychiatric disorders
Psychogenic seizure
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Psychiatric disorders
Psychotic disorder
|
0.02%
3/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Psychiatric disorders
Somatic symptom disorder
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Psychiatric disorders
Suicidal ideation
|
0.02%
3/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.02%
3/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Psychiatric disorders
Suicide attempt
|
0.04%
6/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.04%
6/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.47%
64/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.46%
64/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Acute prerenal failure
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Azotaemia
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Bladder dilatation
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Bladder diverticulum
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Bladder neck obstruction
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Bladder obstruction
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Bladder outlet obstruction
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Bladder spasm
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Bladder tamponade
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Calculus bladder
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Calculus urethral
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.02%
3/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Calculus urinary
|
0.04%
6/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.02%
3/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.11%
15/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.12%
17/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Cystitis haemorrhagic
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Diabetic nephropathy
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
End stage renal disease
|
0.03%
4/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Glomerulonephritis chronic
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Glomerulonephritis membranous
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Haematuria
|
0.09%
12/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.12%
17/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Haemorrhage urinary tract
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.03%
4/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.02%
3/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.21%
29/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.12%
16/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Nephropathy toxic
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Nephrotic syndrome
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Neurogenic bladder
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Nocturia
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Obstructive uropathy
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Prerenal failure
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Pyelocaliectasis
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Renal artery stenosis
|
0.04%
6/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Renal colic
|
0.03%
4/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.02%
3/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Renal cyst
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Renal cyst haemorrhage
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Renal failure
|
0.03%
4/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.04%
5/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Renal impairment
|
0.03%
4/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.03%
4/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Renal infarct
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Renal mass
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Renal pain
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Stress urinary incontinence
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.02%
3/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Tubulointerstitial nephritis
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Ureteric rupture
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Ureteric stenosis
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.04%
5/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.07%
9/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Urethral stenosis
|
0.03%
4/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.04%
5/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.04%
6/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Urinary retention
|
0.03%
4/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.10%
14/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.02%
3/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.02%
3/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Urinoma
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Reproductive system and breast disorders
Adnexa uteri mass
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.19%
26/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.22%
30/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Reproductive system and breast disorders
Breast dysplasia
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Reproductive system and breast disorders
Breast enlargement
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Reproductive system and breast disorders
Breast pain
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Reproductive system and breast disorders
Cervical dysplasia
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Reproductive system and breast disorders
Cervical polyp
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Reproductive system and breast disorders
Cervix disorder
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Reproductive system and breast disorders
Cystocele
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Reproductive system and breast disorders
Endometrial hyperplasia
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Reproductive system and breast disorders
Endometrial thickening
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Reproductive system and breast disorders
Genital haemorrhage
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Reproductive system and breast disorders
Male genital tract fistula
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.02%
3/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Reproductive system and breast disorders
Metrorrhagia
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Reproductive system and breast disorders
Postmenopausal haemorrhage
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Reproductive system and breast disorders
Priapism
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Reproductive system and breast disorders
Prostatitis
|
0.04%
5/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Reproductive system and breast disorders
Prostatomegaly
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Reproductive system and breast disorders
Reproductive tract disorder
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Reproductive system and breast disorders
Scrotal cyst
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Reproductive system and breast disorders
Scrotal oedema
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Reproductive system and breast disorders
Spermatic cord inflammation
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Reproductive system and breast disorders
Uterine atony
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Reproductive system and breast disorders
Uterine enlargement
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Reproductive system and breast disorders
Uterine haemorrhage
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Reproductive system and breast disorders
Uterine polyp
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Reproductive system and breast disorders
Uterine prolapse
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.02%
3/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.02%
3/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Reproductive system and breast disorders
Vaginal prolapse
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Reproductive system and breast disorders
Vulval disorder
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Reproductive system and breast disorders
Vulvar dysplasia
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Reproductive system and breast disorders
Vulvovaginal pruritus
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Acquired diaphragmatic eventration
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.02%
3/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.09%
13/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.08%
11/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Apnoea
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.08%
11/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.06%
8/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma-chronic obstructive pulmonary disease overlap syndrome
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial fistula
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchiectasis
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis chronic
|
0.03%
4/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.47%
64/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.46%
64/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic respiratory failure
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Combined pulmonary fibrosis and emphysema
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.02%
3/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Diaphragmatic paralysis
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.13%
18/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.20%
28/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea at rest
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.08%
11/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.04%
6/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Epiglottic cyst
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.06%
8/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.07%
10/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.03%
4/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.05%
7/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Hyperventilation
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Idiopathic pulmonary fibrosis
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.02%
3/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal oedema
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal cyst
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal obstruction
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal polyps
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.03%
4/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal septum deviation
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal turbinate hypertrophy
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Nocturnal dyspnoea
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Orthopnoea
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal cyst
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Pickwickian syndrome
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural adhesion
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural disorder
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.08%
11/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.04%
5/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.03%
4/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.02%
3/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.05%
7/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.06%
8/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.04%
5/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.07%
10/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.04%
5/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary alveolar haemorrhage
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary arterial hypertension
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.20%
28/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.15%
20/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.02%
3/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.02%
3/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.02%
3/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary pain
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.06%
8/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.12%
16/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.09%
13/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.04%
6/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Stridor
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Vocal cord leukoplakia
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.02%
3/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Dermatitis exfoliative
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Dermatomyositis
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
0.05%
7/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.04%
6/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.02%
3/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Eczema nummular
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Excessive granulation tissue
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Excessive skin
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Henoch-Schonlein purpura
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Lichen myxoedematosus
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Lichen planus
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Papulopustular rosacea
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Pemphigoid
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.03%
4/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.02%
3/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Scar pain
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.04%
6/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.04%
5/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Stasis dermatitis
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Subcutaneous emphysema
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.02%
3/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Social circumstances
Abstains from alcohol
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Social circumstances
Disability
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Social circumstances
Social stay hospitalisation
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Social circumstances
Substance abuser
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Surgical and medical procedures
Abscess drainage
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Surgical and medical procedures
Aortic valve replacement
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Surgical and medical procedures
Arrhythmia prophylaxis
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Surgical and medical procedures
Arterial catheterisation
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Surgical and medical procedures
Arteriovenous fistula operation
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Surgical and medical procedures
Asthma prophylaxis
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Surgical and medical procedures
Cardiac ablation
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Surgical and medical procedures
Cardiac pacemaker insertion
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Surgical and medical procedures
Cardiac rehabilitation therapy
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Surgical and medical procedures
Cardiac resynchronisation therapy
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Surgical and medical procedures
Coronary arterial stent insertion
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Surgical and medical procedures
Coronary artery bypass
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Surgical and medical procedures
Coronary revascularisation
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Surgical and medical procedures
Elective procedure
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Surgical and medical procedures
Enterostomy
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Surgical and medical procedures
Finger amputation
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Surgical and medical procedures
Fracture treatment
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Surgical and medical procedures
Gastric banding reversal
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Surgical and medical procedures
Haemostasis
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Surgical and medical procedures
Hospitalisation
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Surgical and medical procedures
Implantable defibrillator insertion
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Surgical and medical procedures
Incisional hernia repair
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Surgical and medical procedures
Inguinal hernia repair
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.02%
3/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Surgical and medical procedures
Knee arthroplasty
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.02%
3/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Surgical and medical procedures
Large intestinal polypectomy
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Surgical and medical procedures
Large intestine anastomosis
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Surgical and medical procedures
Leg amputation
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Surgical and medical procedures
Open reduction of fracture
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Surgical and medical procedures
Percutaneous coronary intervention
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.02%
3/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Surgical and medical procedures
Peripheral artery bypass
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Surgical and medical procedures
Plastic surgery to the face
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Surgical and medical procedures
Preoperative care
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Surgical and medical procedures
Proctectomy
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Surgical and medical procedures
Rehabilitation therapy
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Surgical and medical procedures
Spinal anaesthesia
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Surgical and medical procedures
Stent placement
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Surgical and medical procedures
Therapy cessation
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Surgical and medical procedures
Toe amputation
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Surgical and medical procedures
Transcatheter aortic valve implantation
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Surgical and medical procedures
Transurethral prostatectomy
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Surgical and medical procedures
Umbilical hernia repair
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Surgical and medical procedures
Urethral operation
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Accelerated hypertension
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.02%
3/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Aneurysm
|
0.03%
4/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Angiopathy
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Angiosclerosis
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Aortic aneurysm
|
0.20%
27/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.20%
27/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Aortic aneurysm rupture
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Aortic occlusion
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Aortic stenosis
|
0.06%
8/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.05%
7/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Aortic thrombosis
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Arterial occlusive disease
|
0.04%
5/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Arterial thrombosis
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Arteriosclerosis
|
0.03%
4/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Arteriovenous fistula
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Blood pressure fluctuation
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Circulatory collapse
|
0.04%
6/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.04%
5/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Cryoglobulinaemia
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Deep vein thrombosis
|
0.10%
14/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.05%
7/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Diabetic vascular disorder
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Dry gangrene
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.03%
4/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Embolism
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Embolism arterial
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Embolism venous
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Extremity necrosis
|
0.03%
4/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Granulomatosis with polyangiitis
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Haematoma
|
0.04%
5/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Haemorrhage
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Hypertension
|
0.30%
41/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.41%
56/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Hypertensive crisis
|
0.09%
12/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.11%
15/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Hypertensive emergency
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Hypotension
|
0.09%
13/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.07%
9/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Hypovolaemic shock
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Iliac artery occlusion
|
0.02%
3/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.04%
5/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Intermittent claudication
|
0.16%
22/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.23%
31/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Internal haemorrhage
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Leriche syndrome
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Lymphocele
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Lymphoedema
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Malignant hypertension
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Neurogenic shock
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Orthostatic hypotension
|
0.05%
7/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.07%
9/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Pelvic venous thrombosis
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.60%
82/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.68%
94/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Peripheral artery aneurysm
|
0.05%
7/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.04%
5/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Peripheral artery dissection
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Peripheral artery occlusion
|
0.12%
16/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.15%
20/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Peripheral artery stenosis
|
0.24%
33/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.20%
27/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Peripheral artery thrombosis
|
0.04%
5/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.04%
5/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Peripheral circulatory failure
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Peripheral embolism
|
0.02%
3/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Peripheral ischaemia
|
0.28%
39/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.25%
35/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Peripheral vascular disorder
|
0.07%
9/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.12%
16/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Peripheral venous disease
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Poor peripheral circulation
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Renovascular hypertension
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Shock
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Shock haemorrhagic
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Subclavian artery embolism
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Subclavian artery occlusion
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Subclavian artery stenosis
|
0.04%
5/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.03%
4/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Subclavian steal syndrome
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Superior vena cava syndrome
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Takayasu's arteritis
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Temporal arteritis
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Thromboangiitis obliterans
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Thrombophlebitis
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Thrombophlebitis superficial
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Thrombosis
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Varicose ulceration
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Varicose vein
|
0.03%
4/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.02%
3/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Vascular insufficiency
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Vascular occlusion
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Vascular stenosis
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
2/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Vasodilatation
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Vena cava thrombosis
|
0.00%
0/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Venous thrombosis
|
0.01%
1/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Venous thrombosis limb
|
0.01%
2/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.01%
1/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
Other adverse events
| Measure |
Placebo
n=13756 participants at risk
Participants received placebo subcutaneous injections either once every 2 weeks (Q2W) or once a month (QM) according to their own preference.
|
Evolocumab
n=13769 participants at risk
Participants received evolocumab subcutaneous injections either 140 mg Q2W or 420 mg QM according to their own preference.
|
|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
7.4%
1021/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
7.7%
1067/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Upper respiratory tract infection
|
4.7%
649/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.0%
692/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
8.0%
1096/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.4%
1156/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Hypertension
|
8.4%
1157/13756 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
7.8%
1069/13769 • From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
Additional Information
Study Director
Amgen Inc.
Phone: 866-572-6436
Results disclosure agreements
- Principal investigator is a sponsor employee The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
- Publication restrictions are in place
Restriction type: OTHER