Trial Outcomes & Findings for Evaluating PCSK9 Binding antiBody Influence oN coGnitive HeAlth in High cardiovascUlar Risk Subjects (NCT NCT02207634)
NCT ID: NCT02207634
Last Updated: 2018-01-16
Results Overview
Assessments were performed with the Cambridge Neuropsychological Test Automated Battery (CANTAB), a language-independent battery of computerized tests that is used to assess cognitive function. The Spatial Working Memory (SWM) test assesses the cognitive domain of executive function (high-level thinking and decision making). Patients search for colored tokens hidden inside boxes on the screen by touching them. The critical instruction is that once a token has been found inside a box, there will never be a token hidden inside that box again, so patients must not return to a box where a token has been found. The SWM strategy index of executive function represented the number of times a subject began a search with a different box. The Z score represents the standardized measure of how far an individual subject deviates from the study cohort average at baseline. A higher Z score reflects better performance. The mean change from baseline averaged across all the visits is reported.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1974 participants
Primary outcome timeframe
Assessments were conducted at Baseline and at weeks 24, 48, 96, 144 and end of study visit (median time on study was 19.4 months).
Results posted on
2018-01-16
Participant Flow
Participants enrolled in Study 20110118 (FOURIER; NCT01764633) at select sites in select countries (based on study start-up timelines) were invited to participate in this cognitive function study. Participants were enrolled at 340 centers in 29 countries in Europe, North America, and Asia Pacific from September 2014 to July 2015.
There was no separate randomization in this study; each participant received their assigned treatment per Protocol 20110118. Data were analyzed according to Study 20110118 randomized treatment arm.
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. Participants continued with their background statin therapy during the course of the study.
|
Evolocumab
Participants received evolocumab 140 mg Q2W or 420 mg QM subcutaneous injections according to their own preference. Participants continued with their background statin therapy during the course of the study.
|
|---|---|---|
|
Overall Study
STARTED
|
990
|
984
|
|
Overall Study
Received Treatment
|
990
|
983
|
|
Overall Study
COMPLETED
|
968
|
953
|
|
Overall Study
NOT COMPLETED
|
22
|
31
|
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. Participants continued with their background statin therapy during the course of the study.
|
Evolocumab
Participants received evolocumab 140 mg Q2W or 420 mg QM subcutaneous injections according to their own preference. Participants continued with their background statin therapy during the course of the study.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
21
|
31
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
All enrolled and dosed participants who completed a baseline cognitive functional assessment prior to or on the first date of administration of study drug and who have at least one post-baseline cognitive measure.
Baseline characteristics by cohort
| Measure |
Placebo
n=990 Participants
Participants received placebo subcutaneous injections either once every 2 weeks (Q2W) or once a month (QM) according to their own preference. Participants continued with their background statin therapy during the course of the study.
|
Evolocumab
n=984 Participants
Participants received evolocumab 140 mg Q2W or 420 mg QM subcutaneous injections according to their own preference. Participants continued with their background statin therapy during the course of the study.
|
Total
n=1974 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.7 years
STANDARD_DEVIATION 8.7 • n=990 Participants
|
62.9 years
STANDARD_DEVIATION 8.7 • n=984 Participants
|
62.8 years
STANDARD_DEVIATION 8.7 • n=1974 Participants
|
|
Sex: Female, Male
Female
|
274 Participants
n=990 Participants
|
269 Participants
n=984 Participants
|
543 Participants
n=1974 Participants
|
|
Sex: Female, Male
Male
|
716 Participants
n=990 Participants
|
715 Participants
n=984 Participants
|
1431 Participants
n=1974 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
14 Participants
n=990 Participants
|
9 Participants
n=984 Participants
|
23 Participants
n=1974 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
976 Participants
n=990 Participants
|
975 Participants
n=984 Participants
|
1951 Participants
n=1974 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=990 Participants
|
0 Participants
n=984 Participants
|
0 Participants
n=1974 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
2 Participants
n=990 Participants
|
1 Participants
n=984 Participants
|
3 Participants
n=1974 Participants
|
|
Race/Ethnicity, Customized
Asian
|
28 Participants
n=990 Participants
|
31 Participants
n=984 Participants
|
59 Participants
n=1974 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
32 Participants
n=990 Participants
|
28 Participants
n=984 Participants
|
60 Participants
n=1974 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=990 Participants
|
3 Participants
n=984 Participants
|
3 Participants
n=1974 Participants
|
|
Race/Ethnicity, Customized
White
|
910 Participants
n=990 Participants
|
908 Participants
n=984 Participants
|
1818 Participants
n=1974 Participants
|
|
Race/Ethnicity, Customized
Multiple
|
1 Participants
n=990 Participants
|
1 Participants
n=984 Participants
|
2 Participants
n=1974 Participants
|
|
Race/Ethnicity, Customized
Other
|
17 Participants
n=990 Participants
|
12 Participants
n=984 Participants
|
29 Participants
n=1974 Participants
|
|
Spatial Working Memory (SWM) Strategy Index of Executive Function Raw Score
|
17.8 units on a scale
STANDARD_DEVIATION 3.4 • n=618 Participants • All enrolled and dosed participants who completed a baseline cognitive functional assessment prior to or on the first date of administration of study drug and who have at least one post-baseline cognitive measure.
|
17.8 units on a scale
STANDARD_DEVIATION 3.5 • n=586 Participants • All enrolled and dosed participants who completed a baseline cognitive functional assessment prior to or on the first date of administration of study drug and who have at least one post-baseline cognitive measure.
|
17.8 units on a scale
STANDARD_DEVIATION 3.4 • n=1204 Participants • All enrolled and dosed participants who completed a baseline cognitive functional assessment prior to or on the first date of administration of study drug and who have at least one post-baseline cognitive measure.
|
|
Spatial Working Memory (SWM) Strategy Index of Executive Function Z Score
|
-0.0106 Z score
STANDARD_DEVIATION 0.9910 • n=618 Participants • All enrolled and dosed participants who completed a baseline cognitive functional assessment prior to or on the first date of administration of study drug and who have at least one post-baseline cognitive measure.
|
0.0166 Z score
STANDARD_DEVIATION 1.0066 • n=586 Participants • All enrolled and dosed participants who completed a baseline cognitive functional assessment prior to or on the first date of administration of study drug and who have at least one post-baseline cognitive measure.
|
0.0026 Z score
STANDARD_DEVIATION 0.9983 • n=1204 Participants • All enrolled and dosed participants who completed a baseline cognitive functional assessment prior to or on the first date of administration of study drug and who have at least one post-baseline cognitive measure.
|
|
Spatial Working Memory Between Errors Raw Score
|
21.0 units on a scale
STANDARD_DEVIATION 10.6 • n=618 Participants • All enrolled and dosed participants who completed a baseline cognitive functional assessment prior to or on the first date of administration of study drug and who have at least one post-baseline cognitive measure.
|
20.9 units on a scale
STANDARD_DEVIATION 10.2 • n=586 Participants • All enrolled and dosed participants who completed a baseline cognitive functional assessment prior to or on the first date of administration of study drug and who have at least one post-baseline cognitive measure.
|
21.0 units on a scale
STANDARD_DEVIATION 10.4 • n=1204 Participants • All enrolled and dosed participants who completed a baseline cognitive functional assessment prior to or on the first date of administration of study drug and who have at least one post-baseline cognitive measure.
|
|
Spatial Working Memory Between Errors Z Score
|
-0.0130 Z score
STANDARD_DEVIATION 1.0075 • n=618 Participants • All enrolled and dosed participants who completed a baseline cognitive functional assessment prior to or on the first date of administration of study drug and who have at least one post-baseline cognitive measure.
|
0.0024 Z score
STANDARD_DEVIATION 0.9675 • n=586 Participants • All enrolled and dosed participants who completed a baseline cognitive functional assessment prior to or on the first date of administration of study drug and who have at least one post-baseline cognitive measure.
|
-0.0055 Z score
STANDARD_DEVIATION 0.9879 • n=1204 Participants • All enrolled and dosed participants who completed a baseline cognitive functional assessment prior to or on the first date of administration of study drug and who have at least one post-baseline cognitive measure.
|
|
Paired Associates Learning (PAL) Total Errors Adjusted Raw Score
|
25.2 units on a scale
STANDARD_DEVIATION 18.4 • n=618 Participants • All enrolled and dosed participants who completed a baseline cognitive functional assessment prior to or on the first date of administration of study drug and who have at least one post-baseline cognitive measure.
|
26.5 units on a scale
STANDARD_DEVIATION 19.3 • n=586 Participants • All enrolled and dosed participants who completed a baseline cognitive functional assessment prior to or on the first date of administration of study drug and who have at least one post-baseline cognitive measure.
|
25.8 units on a scale
STANDARD_DEVIATION 18.9 • n=1204 Participants • All enrolled and dosed participants who completed a baseline cognitive functional assessment prior to or on the first date of administration of study drug and who have at least one post-baseline cognitive measure.
|
|
Paired Associates Learning Total Errors Adjusted Z Score
|
0.0442 Z score
STANDARD_DEVIATION 0.9834 • n=618 Participants • All enrolled and dosed participants who completed a baseline cognitive functional assessment prior to or on the first date of administration of study drug and who have at least one post-baseline cognitive measure.
|
-0.0272 Z score
STANDARD_DEVIATION 1.0294 • n=586 Participants • All enrolled and dosed participants who completed a baseline cognitive functional assessment prior to or on the first date of administration of study drug and who have at least one post-baseline cognitive measure.
|
0.0095 Z score
STANDARD_DEVIATION 1.0063 • n=1204 Participants • All enrolled and dosed participants who completed a baseline cognitive functional assessment prior to or on the first date of administration of study drug and who have at least one post-baseline cognitive measure.
|
|
Reaction Time Median 5-Choice Reaction Time Raw Score
|
355.10 msec
STANDARD_DEVIATION 77.60 • n=614 Participants • All enrolled and dosed participants who completed a baseline cognitive functional assessment prior to or on the first date of administration of study drug and who have at least one post-baseline cognitive measure.
|
356.74 msec
STANDARD_DEVIATION 65.01 • n=585 Participants • All enrolled and dosed participants who completed a baseline cognitive functional assessment prior to or on the first date of administration of study drug and who have at least one post-baseline cognitive measure.
|
355.90 msec
STANDARD_DEVIATION 71.71 • n=1199 Participants • All enrolled and dosed participants who completed a baseline cognitive functional assessment prior to or on the first date of administration of study drug and who have at least one post-baseline cognitive measure.
|
|
Reaction Time Median 5-Choice Reaction Time Z Score
|
-0.0271 Z-score
STANDARD_DEVIATION 1.0829 • n=614 Participants • All enrolled and dosed participants who completed a baseline cognitive functional assessment prior to or on the first date of administration of study drug and who have at least one post-baseline cognitive measure.
|
-0.0500 Z-score
STANDARD_DEVIATION 0.9072 • n=585 Participants • All enrolled and dosed participants who completed a baseline cognitive functional assessment prior to or on the first date of administration of study drug and who have at least one post-baseline cognitive measure.
|
-0.0383 Z-score
STANDARD_DEVIATION 1.0007 • n=1199 Participants • All enrolled and dosed participants who completed a baseline cognitive functional assessment prior to or on the first date of administration of study drug and who have at least one post-baseline cognitive measure.
|
PRIMARY outcome
Timeframe: Assessments were conducted at Baseline and at weeks 24, 48, 96, 144 and end of study visit (median time on study was 19.4 months).Population: All enrolled and dosed participants who completed a baseline cognitive functional assessment prior to or on the first date of administration of study drug and who have at least one post-baseline cognitive measure. Cognitive function assessments after an on-study stroke event were excluded from the analysis.
Assessments were performed with the Cambridge Neuropsychological Test Automated Battery (CANTAB), a language-independent battery of computerized tests that is used to assess cognitive function. The Spatial Working Memory (SWM) test assesses the cognitive domain of executive function (high-level thinking and decision making). Patients search for colored tokens hidden inside boxes on the screen by touching them. The critical instruction is that once a token has been found inside a box, there will never be a token hidden inside that box again, so patients must not return to a box where a token has been found. The SWM strategy index of executive function represented the number of times a subject began a search with a different box. The Z score represents the standardized measure of how far an individual subject deviates from the study cohort average at baseline. A higher Z score reflects better performance. The mean change from baseline averaged across all the visits is reported.
Outcome measures
| Measure |
Placebo
n=616 Participants
Participants received placebo subcutaneous injections either once every 2 weeks (Q2W) or once a month (QM) according to their own preference. Participants continued with their background statin therapy during the course of the study.
|
Evolocumab
n=586 Participants
Participants received evolocumab 140 mg Q2W or 420 mg QM subcutaneous injections according to their own preference. Participants continued with their background statin therapy during the course of the study.
|
|---|---|---|
|
Mean Change From Baseline in Spatial Working Memory Strategy Index of Executive Function (6-8 Boxes) Z Score
|
0.1206 Z score
Interval 0.0535 to 0.1877
|
0.1134 Z score
Interval 0.0449 to 0.182
|
SECONDARY outcome
Timeframe: Assessments were conducted at Baseline and at weeks 24, 48, 96, 144 and end of study visit (median time on study was 19.4 months).Population: All enrolled and dosed participants who completed a baseline cognitive functional assessment prior to or on the first date of administration of study drug and who have at least one post-baseline cognitive measure. Cognitive function assessments after an on-study stroke event were excluded from the analysis.
Assessments were performed with the CANTAB, a language-independent battery of computerized tests that is used to assess cognitive function. The Spatial Working Memory (SWM) between-errors test assesses the cognitive domain of working memory (holding material in mind while that material is being actively processed). Patients search for colored tokens hidden inside boxes on the screen by touching them. The critical instruction is that once a token has been found inside a box, there will never be a token hidden inside that box again, so patients must not return to a box where a token has been found. The SWM between-errors score is the number of times that a patient revisited a box in which a token had previously been found. The Z score represents the standardized measure of how far an individual participant deviates from the study cohort average at baseline. A higher Z score reflects better performance. The mean change from baseline averaged across all the visits is reported.
Outcome measures
| Measure |
Placebo
n=616 Participants
Participants received placebo subcutaneous injections either once every 2 weeks (Q2W) or once a month (QM) according to their own preference. Participants continued with their background statin therapy during the course of the study.
|
Evolocumab
n=586 Participants
Participants received evolocumab 140 mg Q2W or 420 mg QM subcutaneous injections according to their own preference. Participants continued with their background statin therapy during the course of the study.
|
|---|---|---|
|
Mean Change From Baseline in Spatial Working Memory (SWM) Between-errors Z Score
|
0.1024 Z score
Interval 0.0373 to 0.1675
|
0.0691 Z score
Interval 0.0026 to 0.1355
|
SECONDARY outcome
Timeframe: Assessments were conducted at Baseline and at weeks 24, 48, 96, 144 and end of study visit (median time on study was 19.4 months).Population: All enrolled and dosed participants who completed a baseline cognitive functional assessment prior to or on the first date of administration of study drug and who have at least one post-baseline cognitive measure. Cognitive function assessments after an on-study stroke event were excluded from the analysis.
The CANTAB PAL test assesses visuospatial episodic memory (storing/retrieving information by associating an event with a time and place). Boxes on the screen opened up one at a time to reveal a number of patterns. Participants were asked to remember the location of each pattern. After all the boxes had been opened, each pattern was then shown in the center of the screen in a randomized order, and the patient should touch the box where they think each pattern was hidden. The PAL total errors adjusted comprised the number of errors committed by a patient plus an adjustment for the estimated number of errors the patient would have made on any stages that were not reached. Z score represents the standardized measure of how far an individual patient deviates from the study cohort average at baseline. A higher Z score indicated better performance. The mean change from baseline averaged across all the visits is reported.
Outcome measures
| Measure |
Placebo
n=615 Participants
Participants received placebo subcutaneous injections either once every 2 weeks (Q2W) or once a month (QM) according to their own preference. Participants continued with their background statin therapy during the course of the study.
|
Evolocumab
n=585 Participants
Participants received evolocumab 140 mg Q2W or 420 mg QM subcutaneous injections according to their own preference. Participants continued with their background statin therapy during the course of the study.
|
|---|---|---|
|
Mean Change From Baseline in Paired Associated Learning (PAL) Total Errors Adjusted Z Score
|
0.1098 Z score
Interval 0.0511 to 0.1686
|
0.0873 Z score
Interval 0.0273 to 0.1472
|
SECONDARY outcome
Timeframe: Assessments were conducted at Baseline and at weeks 24, 48, 96, 144 and end of study visit (median time on study was 19.4 months).Population: All enrolled and dosed participants who completed a baseline cognitive functional assessment prior to or on the first date of administration of study drug and who have at least one post-baseline cognitive measure. Cognitive function assessments after an on-study stroke event were excluded from the analysis.
Assessments were performed with the CANTAB, a language-independent battery of computerized tests that is used to assess cognitive function. The Reaction Time (RTI) test assessed the cognitive domain of psychomotor speed (detecting and responding to a stimulus). Participants held down a button until a spot appeared in 1 of 5 circles on the screen. As soon as possible after the spot flashed up, the patient lifted their finger from the button and touched the circle in which the spot appeared. The RTI median 5-choice reaction time was the median duration between the onset of the stimulus and the release of the button. Z score represents the standardized measure of how far an individual participant deviates from the study cohort average at baseline. A higher Z score reflects better performance. The mean change from baseline averaged across all the visits is reported.
Outcome measures
| Measure |
Placebo
n=611 Participants
Participants received placebo subcutaneous injections either once every 2 weeks (Q2W) or once a month (QM) according to their own preference. Participants continued with their background statin therapy during the course of the study.
|
Evolocumab
n=584 Participants
Participants received evolocumab 140 mg Q2W or 420 mg QM subcutaneous injections according to their own preference. Participants continued with their background statin therapy during the course of the study.
|
|---|---|---|
|
Mean Change From Baseline in Reaction Time (RTI) Median 5-choice Reaction Time Z Score
|
0.0153 Z score
Interval -0.0529 to 0.0834
|
-0.0575 Z score
Interval -0.127 to 0.0121
|
Adverse Events
Placebo
Serious events: 204 serious events
Other events: 257 other events
Deaths: 0 deaths
Evolocumab
Serious events: 212 serious events
Other events: 272 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=990 participants at risk
Participants received placebo subcutaneous injections either once every 2 weeks (Q2W) or once a month (QM) according to their own preference. Participants continued with their background statin therapy during the course of the study.
|
Evolocumab
n=983 participants at risk
Participants received evolocumab 140 mg Q2W or 420 mg QM subcutaneous injections according to their own preference. Participants continued with their background statin therapy during the course of the study.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.61%
6/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.20%
2/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Blood and lymphatic system disorders
Autoimmune haemolytic anaemia
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.00%
0/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.10%
1/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Blood and lymphatic system disorders
Haemorrhagic anaemia
|
0.00%
0/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.10%
1/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Blood and lymphatic system disorders
Immune thrombocytopenic purpura
|
0.00%
0/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.10%
1/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.10%
1/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Blood and lymphatic system disorders
Spleen disorder
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.00%
0/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.10%
1/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.10%
1/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Cardiac disorders
Angina pectoris
|
1.6%
16/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
1.5%
15/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Cardiac disorders
Angina unstable
|
1.5%
15/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
1.1%
11/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Cardiac disorders
Arrhythmia
|
0.20%
2/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.00%
0/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Cardiac disorders
Atrial fibrillation
|
0.71%
7/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
1.3%
13/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Cardiac disorders
Atrial flutter
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.10%
1/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Cardiac disorders
Atrioventricular block
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.00%
0/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.00%
0/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.10%
1/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.00%
0/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Cardiac disorders
Bradycardia
|
0.30%
3/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.00%
0/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Cardiac disorders
Bundle branch block left
|
0.00%
0/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.10%
1/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Cardiac disorders
Cardiac failure
|
0.40%
4/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.10%
1/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Cardiac disorders
Cardiac failure acute
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.10%
1/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Cardiac disorders
Cardiac failure chronic
|
0.40%
4/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.20%
2/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.51%
5/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.41%
4/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Cardiac disorders
Cardiac tamponade
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.00%
0/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Cardiac disorders
Cardiomyopathy
|
0.00%
0/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.10%
1/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Cardiac disorders
Congestive cardiomyopathy
|
0.00%
0/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.10%
1/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Cardiac disorders
Coronary artery disease
|
0.30%
3/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.20%
2/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Cardiac disorders
Dressler's syndrome
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.00%
0/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Cardiac disorders
Heart alternation
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.00%
0/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.00%
0/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Cardiac disorders
Left ventricular failure
|
0.00%
0/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.10%
1/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Cardiac disorders
Mitral valve incompetence
|
0.00%
0/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.31%
3/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Cardiac disorders
Mitral valve stenosis
|
0.00%
0/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.10%
1/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Cardiac disorders
Myocardial infarction
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.00%
0/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Cardiac disorders
Myocarditis
|
0.00%
0/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.10%
1/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.10%
1/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Cardiac disorders
Sinus arrest
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.00%
0/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.10%
1/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Cardiac disorders
Sinus node dysfunction
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.10%
1/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.00%
0/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Cardiac disorders
Ventricular fibrillation
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.00%
0/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.30%
3/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.10%
1/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Congenital, familial and genetic disorders
Intracranial lipoma
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.00%
0/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Ear and labyrinth disorders
Vertigo
|
0.20%
2/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.10%
1/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Eye disorders
Cataract
|
0.20%
2/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.00%
0/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Eye disorders
Iridocyclitis
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.00%
0/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Eye disorders
Retinal detachment
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.00%
0/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Eye disorders
Strabismus
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.00%
0/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Eye disorders
Uveitis
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.00%
0/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Eye disorders
Visual impairment
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.00%
0/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.20%
2/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.20%
2/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.20%
2/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.10%
1/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.10%
1/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Gastrointestinal disorders
Coeliac artery stenosis
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.00%
0/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Gastrointestinal disorders
Colitis
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.00%
0/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.00%
0/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.00%
0/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.10%
1/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Gastrointestinal disorders
Constipation
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.10%
1/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.10%
1/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Gastrointestinal disorders
Diverticulum
|
0.00%
0/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.10%
1/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.00%
0/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.00%
0/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Gastrointestinal disorders
Faecaloma
|
0.00%
0/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.10%
1/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Gastrointestinal disorders
Gastric disorder
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.00%
0/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.10%
1/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Gastrointestinal disorders
Gastric ulcer perforation
|
0.00%
0/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.10%
1/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Gastrointestinal disorders
Gastritis
|
0.20%
2/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.20%
2/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.00%
0/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.10%
1/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Gastrointestinal disorders
Gastritis haemorrhagic
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.00%
0/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.00%
0/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Gastrointestinal disorders
Gastrointestinal polyp haemorrhage
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.00%
0/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.20%
2/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.10%
1/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.10%
1/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.10%
1/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.10%
1/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Gastrointestinal disorders
Ileus
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.00%
0/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.31%
3/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.00%
0/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Gastrointestinal disorders
Mesenteric artery stenosis
|
0.00%
0/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.10%
1/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Gastrointestinal disorders
Oesophageal ulcer
|
0.00%
0/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.10%
1/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Gastrointestinal disorders
Pancreatic cyst
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.00%
0/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.20%
2/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.00%
0/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Gastrointestinal disorders
Peptic ulcer
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.00%
0/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Gastrointestinal disorders
Reflux gastritis
|
0.00%
0/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.10%
1/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Gastrointestinal disorders
Retroperitoneal haemorrhage
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.00%
0/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.10%
1/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.00%
0/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.10%
1/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.10%
1/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
General disorders
Asthenia
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.00%
0/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
General disorders
Chest discomfort
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.00%
0/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
General disorders
Chest pain
|
0.40%
4/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.20%
2/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
General disorders
Non-cardiac chest pain
|
1.2%
12/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.61%
6/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
General disorders
Oedema peripheral
|
0.00%
0/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.10%
1/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
General disorders
Pyrexia
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.00%
0/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
General disorders
Soft tissue inflammation
|
0.00%
0/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.10%
1/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
General disorders
Systemic inflammatory response syndrome
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.00%
0/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.10%
1/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Hepatobiliary disorders
Cholangitis acute
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.00%
0/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.10%
1/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.10%
1/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.00%
0/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.20%
2/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.10%
1/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Hepatobiliary disorders
Cholelithiasis obstructive
|
0.00%
0/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.10%
1/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Hepatobiliary disorders
Liver disorder
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.00%
0/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Immune system disorders
Hypersensitivity
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.00%
0/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Infections and infestations
Appendiceal abscess
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.00%
0/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Infections and infestations
Appendicitis
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.10%
1/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Infections and infestations
Bronchitis
|
0.20%
2/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.00%
0/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Infections and infestations
Burkholderia cepacia complex infection
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.00%
0/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Infections and infestations
Cellulitis
|
0.20%
2/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.10%
1/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Infections and infestations
Clostridium difficile infection
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.10%
1/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Infections and infestations
Cystitis
|
0.00%
0/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.10%
1/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Infections and infestations
Device related sepsis
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.00%
0/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.10%
1/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Infections and infestations
Escherichia sepsis
|
0.00%
0/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.10%
1/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.00%
0/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.10%
1/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Infections and infestations
Gastroenteritis
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.10%
1/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Infections and infestations
Hepatitis C
|
0.00%
0/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.10%
1/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Infections and infestations
Hepatitis E
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.10%
1/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Infections and infestations
Infectious pleural effusion
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.00%
0/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Infections and infestations
Influenza
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.00%
0/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.20%
2/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.00%
0/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Infections and infestations
Lung infection
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.00%
0/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Infections and infestations
Mastoiditis
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.00%
0/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Infections and infestations
Orchitis
|
0.00%
0/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.10%
1/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Infections and infestations
Osteomyelitis
|
0.20%
2/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.31%
3/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Infections and infestations
Peritonitis
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.00%
0/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Infections and infestations
Pneumonia
|
0.71%
7/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
1.0%
10/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Infections and infestations
Pneumonia bacterial
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.20%
2/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Infections and infestations
Post procedural sepsis
|
0.00%
0/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.10%
1/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Infections and infestations
Pyelonephritis
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.00%
0/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Infections and infestations
Sepsis
|
0.40%
4/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.00%
0/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Infections and infestations
Septic shock
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.00%
0/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Infections and infestations
Streptococcal sepsis
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.00%
0/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Infections and infestations
Upper respiratory tract infection bacterial
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.00%
0/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.20%
2/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Infections and infestations
Urinary tract infection bacterial
|
0.00%
0/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.10%
1/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Infections and infestations
Urosepsis
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.00%
0/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Infections and infestations
Wound infection
|
0.20%
2/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.00%
0/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.20%
2/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.00%
0/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Injury, poisoning and procedural complications
Arterial bypass occlusion
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.00%
0/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.20%
2/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Injury, poisoning and procedural complications
Coronary artery restenosis
|
0.00%
0/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.10%
1/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Injury, poisoning and procedural complications
Dislocation of sternum
|
0.00%
0/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.10%
1/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Injury, poisoning and procedural complications
Eye injury
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.00%
0/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.20%
2/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.00%
0/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.10%
1/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.10%
1/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
0.00%
0/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.10%
1/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Injury, poisoning and procedural complications
Intentional overdose
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.00%
0/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.00%
0/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.10%
1/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Injury, poisoning and procedural complications
Peripheral arterial reocclusion
|
0.00%
0/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.10%
1/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Injury, poisoning and procedural complications
Peripheral artery restenosis
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.10%
1/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Injury, poisoning and procedural complications
Pneumoconiosis
|
0.00%
0/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.10%
1/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Injury, poisoning and procedural complications
Pneumonitis chemical
|
0.00%
0/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.10%
1/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Injury, poisoning and procedural complications
Post concussion syndrome
|
0.00%
0/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.10%
1/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Injury, poisoning and procedural complications
Post procedural constipation
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.00%
0/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.10%
1/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Injury, poisoning and procedural complications
Post procedural swelling
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.00%
0/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.00%
0/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Injury, poisoning and procedural complications
Spinal column injury
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.00%
0/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.00%
0/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.10%
1/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.10%
1/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Investigations
Alanine aminotransferase increased
|
0.20%
2/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.00%
0/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Investigations
Arteriogram coronary
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.10%
1/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Investigations
Aspartate aminotransferase increased
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.00%
0/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.30%
3/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.00%
0/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Investigations
Blood potassium increased
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.00%
0/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.20%
2/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Investigations
Liver function test abnormal
|
0.00%
0/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.10%
1/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Investigations
Myocardial necrosis marker increased
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.00%
0/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Investigations
Thyroid function test abnormal
|
0.00%
0/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.10%
1/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Metabolism and nutrition disorders
Cachexia
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.00%
0/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.10%
1/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.20%
2/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.00%
0/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.10%
1/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Metabolism and nutrition disorders
Fluid retention
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.00%
0/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.20%
2/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.00%
0/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.00%
0/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.10%
1/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.20%
2/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.10%
1/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.10%
1/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.00%
0/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.00%
0/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.51%
5/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.00%
0/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Exostosis
|
0.00%
0/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.10%
1/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Foot deformity
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.20%
2/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Gouty arthritis
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.00%
0/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.00%
0/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.10%
1/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.20%
2/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.10%
1/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Myalgia intercostal
|
0.00%
0/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.10%
1/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.30%
3/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.31%
3/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.10%
1/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.10%
1/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Polyarthritis
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.10%
1/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Polymyalgia rheumatica
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.00%
0/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.00%
0/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.00%
0/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.00%
0/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.00%
0/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma gastric
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.00%
0/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.00%
0/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.10%
1/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign pancreatic neoplasm
|
0.00%
0/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.10%
1/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.00%
0/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.20%
2/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma
|
0.00%
0/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.10%
1/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma stage III
|
0.00%
0/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.10%
1/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bronchial carcinoma
|
0.00%
0/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.10%
1/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon adenoma
|
0.20%
2/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.00%
0/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.10%
1/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Diffuse large B-cell lymphoma
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.00%
0/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.00%
0/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.00%
0/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal cancer stage 0
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.00%
0/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lip and/or oral cavity cancer stage III
|
0.00%
0/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.10%
1/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.20%
2/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma metastatic
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.00%
0/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.00%
0/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.40%
4/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.10%
1/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung squamous cell carcinoma stage III
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.00%
0/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoproliferative disorder
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.00%
0/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma benign
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.00%
0/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.00%
0/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic malignant melanoma
|
0.00%
0/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.10%
1/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic squamous cell carcinoma
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.00%
0/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.00%
0/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.00%
0/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary thyroid cancer
|
0.00%
0/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.10%
1/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.10%
1/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer metastatic
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.00%
0/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.10%
1/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer
|
0.00%
0/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.10%
1/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of lung
|
0.00%
0/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.10%
1/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tonsil cancer
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.00%
0/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.00%
0/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.10%
1/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.10%
1/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Nervous system disorders
Arachnoid cyst
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.00%
0/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.10%
1/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Nervous system disorders
Carotid artery disease
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.00%
0/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Nervous system disorders
Carotid artery stenosis
|
0.51%
5/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.61%
6/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.00%
0/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Nervous system disorders
Cerebral ischaemia
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.00%
0/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.00%
0/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Nervous system disorders
Cervical myelopathy
|
0.00%
0/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.10%
1/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Nervous system disorders
Cervicobrachial syndrome
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.00%
0/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.10%
1/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.20%
2/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Nervous system disorders
Facial paralysis
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.00%
0/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Nervous system disorders
Generalised tonic-clonic seizure
|
0.00%
0/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.10%
1/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Nervous system disorders
Guillain-Barre syndrome
|
0.00%
0/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.10%
1/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Nervous system disorders
Headache
|
0.30%
3/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.00%
0/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.10%
1/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Nervous system disorders
Meralgia paraesthetica
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.00%
0/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Nervous system disorders
Neuralgia
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.10%
1/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.10%
1/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Nervous system disorders
Paraparesis
|
0.00%
0/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.10%
1/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Nervous system disorders
Parkinsonism
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.00%
0/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Nervous system disorders
Radiculopathy
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.10%
1/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Nervous system disorders
Sciatica
|
0.20%
2/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.00%
0/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Nervous system disorders
Seizure
|
0.00%
0/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.10%
1/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Nervous system disorders
Syncope
|
0.40%
4/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.31%
3/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.20%
2/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Product Issues
Device malfunction
|
0.20%
2/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.00%
0/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Product Issues
Device occlusion
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.00%
0/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Psychiatric disorders
Depression
|
0.00%
0/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.10%
1/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Psychiatric disorders
Major depression
|
0.00%
0/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.10%
1/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.10%
1/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.61%
6/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.20%
2/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Renal and urinary disorders
Calculus urethral
|
0.00%
0/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.10%
1/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.20%
2/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.00%
0/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Renal and urinary disorders
End stage renal disease
|
0.20%
2/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.00%
0/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Renal and urinary disorders
Haematuria
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.20%
2/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.00%
0/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.00%
0/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.10%
1/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Renal and urinary disorders
Tubulointerstitial nephritis
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.00%
0/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.00%
0/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.10%
1/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Renal and urinary disorders
Urethral stenosis
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.10%
1/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.20%
2/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.00%
0/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Renal and urinary disorders
Urinary retention
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.00%
0/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.20%
2/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.10%
1/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Reproductive system and breast disorders
Metrorrhagia
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.00%
0/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Reproductive system and breast disorders
Postmenopausal haemorrhage
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.00%
0/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.30%
3/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.10%
1/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.00%
0/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma-chronic obstructive pulmonary disease overlap syndrome
|
0.00%
0/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.10%
1/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.51%
5/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.41%
4/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.00%
0/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.20%
2/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.10%
1/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.00%
0/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.10%
1/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.00%
0/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.00%
0/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.00%
0/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.00%
0/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.10%
1/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.00%
0/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.10%
1/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.20%
2/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.10%
1/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.00%
0/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
0.20%
2/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.10%
1/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.10%
1/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Eczema nummular
|
0.00%
0/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.10%
1/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.10%
1/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.10%
1/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.20%
2/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Surgical and medical procedures
Fracture treatment
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.00%
0/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Surgical and medical procedures
Gastric banding reversal
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.00%
0/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Vascular disorders
Accelerated hypertension
|
0.00%
0/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.10%
1/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Vascular disorders
Aortic aneurysm
|
0.40%
4/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.10%
1/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Vascular disorders
Aortic aneurysm rupture
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.00%
0/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Vascular disorders
Aortic stenosis
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.00%
0/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Vascular disorders
Arterial occlusive disease
|
0.00%
0/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.10%
1/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Vascular disorders
Circulatory collapse
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.00%
0/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.20%
2/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Vascular disorders
Hypertension
|
0.51%
5/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.71%
7/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.10%
1/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Vascular disorders
Hypotension
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.31%
3/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Vascular disorders
Iliac artery occlusion
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.00%
0/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Vascular disorders
Intermittent claudication
|
0.20%
2/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.20%
2/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Vascular disorders
Leriche syndrome
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.00%
0/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.51%
5/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
1.0%
10/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Vascular disorders
Peripheral artery occlusion
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.00%
0/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Vascular disorders
Peripheral artery stenosis
|
0.40%
4/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.20%
2/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Vascular disorders
Peripheral artery thrombosis
|
0.00%
0/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.10%
1/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Vascular disorders
Peripheral ischaemia
|
0.40%
4/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.61%
6/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Vascular disorders
Peripheral vascular disorder
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.10%
1/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Vascular disorders
Subclavian artery stenosis
|
0.10%
1/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.00%
0/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Vascular disorders
Thrombosis
|
0.20%
2/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
0.10%
1/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
Other adverse events
| Measure |
Placebo
n=990 participants at risk
Participants received placebo subcutaneous injections either once every 2 weeks (Q2W) or once a month (QM) according to their own preference. Participants continued with their background statin therapy during the course of the study.
|
Evolocumab
n=983 participants at risk
Participants received evolocumab 140 mg Q2W or 420 mg QM subcutaneous injections according to their own preference. Participants continued with their background statin therapy during the course of the study.
|
|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
7.5%
74/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
10.3%
101/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Infections and infestations
Upper respiratory tract infection
|
6.4%
63/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
5.4%
53/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
6.0%
59/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
4.6%
45/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.6%
36/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
5.9%
58/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
|
Vascular disorders
Hypertension
|
6.7%
66/990 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
|
6.2%
61/983 • From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here. Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% 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