Trial Outcomes & Findings for Ranolazine for Incomplete Vessel Revascularization Post-Percutaneous Coronary Intervention (PCI) (NCT NCT01442038)
NCT ID: NCT01442038
Last Updated: 2016-07-15
Results Overview
Time to event distributions were estimated by the Kaplan-Meier (KM) method. 1 month = 28 days; 1 calendar year = 365 days.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
2651 participants
Primary outcome timeframe
Baseline through end of study (average 90 weeks)
Results posted on
2016-07-15
Participant Flow
Participants were enrolled at study sites in the United States, Canada, Europe, Russia, and Israel. The first participant was screened on 03 November 2011. The last study visit occurred on 09 February 2015.
2734 participants were screened.
Participant milestones
| Measure |
Ranolazine
Ranolazine 500 mg (1 x 500 mg tablet) twice daily for 7 days, followed by ranolazine 1000 mg (2 x 500 mg tablet) twice daily for the duration of the study (participants receiving a moderate CYP3A4 inhibitor continued to receive ranolazine 500 mg (1 x 500 mg tablet) twice daily for the duration of the study)
|
Placebo
Ranolazine placebo (1 tablet) for 7 days, followed by ranolazine placebo (2 tablets) twice daily for the duration of the study (participants receiving a moderate CYP3A4 inhibitor continued to receive ranolazine placebo (1 tablet) twice daily for the duration of the study)
|
|---|---|---|
|
Overall Study
STARTED
|
1332
|
1319
|
|
Overall Study
COMPLETED
|
1029
|
1040
|
|
Overall Study
NOT COMPLETED
|
303
|
279
|
Reasons for withdrawal
| Measure |
Ranolazine
Ranolazine 500 mg (1 x 500 mg tablet) twice daily for 7 days, followed by ranolazine 1000 mg (2 x 500 mg tablet) twice daily for the duration of the study (participants receiving a moderate CYP3A4 inhibitor continued to receive ranolazine 500 mg (1 x 500 mg tablet) twice daily for the duration of the study)
|
Placebo
Ranolazine placebo (1 tablet) for 7 days, followed by ranolazine placebo (2 tablets) twice daily for the duration of the study (participants receiving a moderate CYP3A4 inhibitor continued to receive ranolazine placebo (1 tablet) twice daily for the duration of the study)
|
|---|---|---|
|
Overall Study
Death
|
35
|
29
|
|
Overall Study
Investigator-Initiated Early Closure
|
44
|
43
|
|
Overall Study
Participant Withdrew Consent
|
137
|
102
|
|
Overall Study
Lost to Follow-up
|
37
|
51
|
|
Overall Study
Adverse Event
|
26
|
15
|
|
Overall Study
Protocol Deviation
|
9
|
20
|
|
Overall Study
Investigator's Discretion
|
13
|
16
|
|
Overall Study
Study Terminated By Sponsor
|
2
|
3
|
Baseline Characteristics
Ranolazine for Incomplete Vessel Revascularization Post-Percutaneous Coronary Intervention (PCI)
Baseline characteristics by cohort
| Measure |
Ranolazine
n=1322 Participants
Ranolazine 500 mg (1 x 500 mg tablet) twice daily for 7 days, followed by ranolazine 1000 mg (2 x 500 mg tablet) twice daily for the duration of the study (participants receiving a moderate CYP3A4 inhibitor continued to receive ranolazine 500 mg (1 x 500 mg tablet) twice daily for the duration of the study)
|
Placebo
n=1297 Participants
Ranolazine placebo (1 tablet) twice daily for 7 days, followed by ranolazine placebo (2 tablets) twice daily for the duration of the study (participants receiving a moderate CYP3A4 inhibitor continued to receive ranolazine placebo (1 tablet) twice daily for the duration of the study)
|
Total
n=2619 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.4 years
STANDARD_DEVIATION 10.51 • n=5 Participants
|
63.4 years
STANDARD_DEVIATION 10.06 • n=7 Participants
|
63.4 years
STANDARD_DEVIATION 10.29 • n=5 Participants
|
|
Age, Customized
< 65 Years
|
714 participants
n=5 Participants
|
719 participants
n=7 Participants
|
1433 participants
n=5 Participants
|
|
Age, Customized
65-74 Years
|
402 participants
n=5 Participants
|
383 participants
n=7 Participants
|
785 participants
n=5 Participants
|
|
Age, Customized
≥ 75 Years
|
206 participants
n=5 Participants
|
195 participants
n=7 Participants
|
401 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
276 Participants
n=5 Participants
|
260 Participants
n=7 Participants
|
536 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1046 Participants
n=5 Participants
|
1037 Participants
n=7 Participants
|
2083 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 participants
n=5 Participants
|
3 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
16 participants
n=5 Participants
|
10 participants
n=7 Participants
|
26 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
49 participants
n=5 Participants
|
43 participants
n=7 Participants
|
92 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Pacific Islander
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
1203 participants
n=5 Participants
|
1196 participants
n=7 Participants
|
2399 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
29 participants
n=5 Participants
|
28 participants
n=7 Participants
|
57 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Permitted
|
23 participants
n=5 Participants
|
16 participants
n=7 Participants
|
39 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
72 participants
n=5 Participants
|
64 participants
n=7 Participants
|
136 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
1219 participants
n=5 Participants
|
1208 participants
n=7 Participants
|
2427 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
28 participants
n=5 Participants
|
24 participants
n=7 Participants
|
52 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
3 participants
n=5 Participants
|
1 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Region of Enrollment
Russian Federation
|
154 participants
n=5 Participants
|
168 participants
n=7 Participants
|
322 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
499 participants
n=5 Participants
|
466 participants
n=7 Participants
|
965 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
16 participants
n=5 Participants
|
17 participants
n=7 Participants
|
33 participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
80 participants
n=5 Participants
|
87 participants
n=7 Participants
|
167 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
80 participants
n=5 Participants
|
85 participants
n=7 Participants
|
165 participants
n=5 Participants
|
|
Region of Enrollment
Austria
|
12 participants
n=5 Participants
|
15 participants
n=7 Participants
|
27 participants
n=5 Participants
|
|
Region of Enrollment
Czech Republic
|
31 participants
n=5 Participants
|
44 participants
n=7 Participants
|
75 participants
n=5 Participants
|
|
Region of Enrollment
Netherlands
|
13 participants
n=5 Participants
|
13 participants
n=7 Participants
|
26 participants
n=5 Participants
|
|
Region of Enrollment
Sweden
|
19 participants
n=5 Participants
|
25 participants
n=7 Participants
|
44 participants
n=5 Participants
|
|
Region of Enrollment
Belgium
|
20 participants
n=5 Participants
|
21 participants
n=7 Participants
|
41 participants
n=5 Participants
|
|
Region of Enrollment
Poland
|
203 participants
n=5 Participants
|
172 participants
n=7 Participants
|
375 participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
28 participants
n=5 Participants
|
33 participants
n=7 Participants
|
61 participants
n=5 Participants
|
|
Region of Enrollment
Israel
|
111 participants
n=5 Participants
|
109 participants
n=7 Participants
|
220 participants
n=5 Participants
|
|
Region of Enrollment
France
|
22 participants
n=5 Participants
|
15 participants
n=7 Participants
|
37 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
34 participants
n=5 Participants
|
27 participants
n=7 Participants
|
61 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline through end of study (average 90 weeks)Population: Full Analysis Set: all participants in the Safety Analysis Set (randomized and received at least one dose of study drug), except participants with no qualifying percutaneous coronary intervention (PCI; formerly known as angioplasty with stent))
Time to event distributions were estimated by the Kaplan-Meier (KM) method. 1 month = 28 days; 1 calendar year = 365 days.
Outcome measures
| Measure |
Ranolazine
n=1317 Participants
Ranolazine 500 mg (1 x 500 mg tablet) twice daily for 7 days, followed by ranolazine 1000 mg (2 x 500 mg tablet) twice daily for the duration of the study (participants receiving a moderate CYP3A4 inhibitor continued to receive ranolazine 500 mg (1 x 500 mg tablet) twice daily for the duration of the study)
|
Placebo
n=1287 Participants
Ranolazine placebo (1 tablet) twice daily for 7 days, followed by ranolazine placebo (2 tablets) twice daily for the duration of the study (participants receiving a moderate CYP3A4 inhibitor continued to receive ranolazine placebo (1 tablet) twice daily for the duration of the study)
|
|---|---|---|
|
Kaplan-Meier Estimates for Time From Randomization to First Occurrence of Ischemia-driven Revascularization or Ischemia-driven Hospitalization Without Revascularization
KM Estimate: 1 Month
|
3.4 percentage of participants
|
2.3 percentage of participants
|
|
Kaplan-Meier Estimates for Time From Randomization to First Occurrence of Ischemia-driven Revascularization or Ischemia-driven Hospitalization Without Revascularization
KM Estimate: 6 Months
|
11.3 percentage of participants
|
10.0 percentage of participants
|
|
Kaplan-Meier Estimates for Time From Randomization to First Occurrence of Ischemia-driven Revascularization or Ischemia-driven Hospitalization Without Revascularization
KM Estimate: 12 Months
|
19.1 percentage of participants
|
17.3 percentage of participants
|
|
Kaplan-Meier Estimates for Time From Randomization to First Occurrence of Ischemia-driven Revascularization or Ischemia-driven Hospitalization Without Revascularization
KM Estimate: 1 Calendar Year
|
20.2 percentage of participants
|
18.9 percentage of participants
|
|
Kaplan-Meier Estimates for Time From Randomization to First Occurrence of Ischemia-driven Revascularization or Ischemia-driven Hospitalization Without Revascularization
KM Estimate: 18 Months
|
23.8 percentage of participants
|
25.3 percentage of participants
|
|
Kaplan-Meier Estimates for Time From Randomization to First Occurrence of Ischemia-driven Revascularization or Ischemia-driven Hospitalization Without Revascularization
KM Estimate: 24 Months
|
27.6 percentage of participants
|
29.4 percentage of participants
|
|
Kaplan-Meier Estimates for Time From Randomization to First Occurrence of Ischemia-driven Revascularization or Ischemia-driven Hospitalization Without Revascularization
KM Estimate: 2 Calendar Years
|
30.7 percentage of participants
|
31.0 percentage of participants
|
|
Kaplan-Meier Estimates for Time From Randomization to First Occurrence of Ischemia-driven Revascularization or Ischemia-driven Hospitalization Without Revascularization
KM Estimate: 30 months
|
31.1 percentage of participants
|
33.8 percentage of participants
|
|
Kaplan-Meier Estimates for Time From Randomization to First Occurrence of Ischemia-driven Revascularization or Ischemia-driven Hospitalization Without Revascularization
KM Estimate: 36 Months
|
32.2 percentage of participants
|
37.8 percentage of participants
|
|
Kaplan-Meier Estimates for Time From Randomization to First Occurrence of Ischemia-driven Revascularization or Ischemia-driven Hospitalization Without Revascularization
KM Estimate: 3 Calendar Years
|
NA percentage of participants
NA = not calculable: all participants had an event or were censored prior to the Year 3 time point
|
37.8 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline through end of study (average 90 weeks)Population: Full Analysis Set
Time to event distributions were estimated by the Kaplan-Meier method. 1 month = 28 days; 1 calendar year = 365 days.
Outcome measures
| Measure |
Ranolazine
n=1317 Participants
Ranolazine 500 mg (1 x 500 mg tablet) twice daily for 7 days, followed by ranolazine 1000 mg (2 x 500 mg tablet) twice daily for the duration of the study (participants receiving a moderate CYP3A4 inhibitor continued to receive ranolazine 500 mg (1 x 500 mg tablet) twice daily for the duration of the study)
|
Placebo
n=1287 Participants
Ranolazine placebo (1 tablet) twice daily for 7 days, followed by ranolazine placebo (2 tablets) twice daily for the duration of the study (participants receiving a moderate CYP3A4 inhibitor continued to receive ranolazine placebo (1 tablet) twice daily for the duration of the study)
|
|---|---|---|
|
Kaplan-Meier Estimates for Time From Randomization to Sudden Cardiac Death
KM Estimate: 1 Month
|
0.2 percentage of participants
|
0.1 percentage of participants
|
|
Kaplan-Meier Estimates for Time From Randomization to Sudden Cardiac Death
KM Estimate: 6 Months
|
0.5 percentage of participants
|
0.2 percentage of participants
|
|
Kaplan-Meier Estimates for Time From Randomization to Sudden Cardiac Death
KM Estimate: 12 Months
|
0.5 percentage of participants
|
0.5 percentage of participants
|
|
Kaplan-Meier Estimates for Time From Randomization to Sudden Cardiac Death
KM Estimate: 1 Calendar Year
|
0.5 percentage of participants
|
0.5 percentage of participants
|
|
Kaplan-Meier Estimates for Time From Randomization to Sudden Cardiac Death
KM Estimate: 18 Months
|
0.5 percentage of participants
|
0.8 percentage of participants
|
|
Kaplan-Meier Estimates for Time From Randomization to Sudden Cardiac Death
KM Estimate: 24 Months
|
0.5 percentage of participants
|
0.9 percentage of participants
|
|
Kaplan-Meier Estimates for Time From Randomization to Sudden Cardiac Death
KM Estimate: 2 Calendar Years
|
0.7 percentage of participants
|
0.9 percentage of participants
|
|
Kaplan-Meier Estimates for Time From Randomization to Sudden Cardiac Death
KM Estimate: 30 months
|
0.7 percentage of participants
|
0.9 percentage of participants
|
|
Kaplan-Meier Estimates for Time From Randomization to Sudden Cardiac Death
KM Estimate: 36 Months
|
0.7 percentage of participants
|
0.9 percentage of participants
|
|
Kaplan-Meier Estimates for Time From Randomization to Sudden Cardiac Death
KM Estimate: 3 Calendar Years
|
0.7 percentage of participants
|
0.9 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline through end of study (average 90 weeks)Population: Full Analysis Set
Time to event distributions were estimated by the Kaplan-Meier method. 1 month = 28 days; 1 calendar year = 365 days.
Outcome measures
| Measure |
Ranolazine
n=1317 Participants
Ranolazine 500 mg (1 x 500 mg tablet) twice daily for 7 days, followed by ranolazine 1000 mg (2 x 500 mg tablet) twice daily for the duration of the study (participants receiving a moderate CYP3A4 inhibitor continued to receive ranolazine 500 mg (1 x 500 mg tablet) twice daily for the duration of the study)
|
Placebo
n=1287 Participants
Ranolazine placebo (1 tablet) twice daily for 7 days, followed by ranolazine placebo (2 tablets) twice daily for the duration of the study (participants receiving a moderate CYP3A4 inhibitor continued to receive ranolazine placebo (1 tablet) twice daily for the duration of the study)
|
|---|---|---|
|
Kaplan-Meier Estimates for Time From Randomization to Cardiovascular Death
KM Estimate: 1 Month
|
0.2 percentage of participants
|
0.1 percentage of participants
|
|
Kaplan-Meier Estimates for Time From Randomization to Cardiovascular Death
KM Estimate: 6 Months
|
0.6 percentage of participants
|
0.4 percentage of participants
|
|
Kaplan-Meier Estimates for Time From Randomization to Cardiovascular Death
KM Estimate: 12 Months
|
1.0 percentage of participants
|
0.9 percentage of participants
|
|
Kaplan-Meier Estimates for Time From Randomization to Cardiovascular Death
KM Estimate: 1 Calendar Year
|
1.1 percentage of participants
|
1.0 percentage of participants
|
|
Kaplan-Meier Estimates for Time From Randomization to Cardiovascular Death
KM Estimate: 18 Months
|
1.5 percentage of participants
|
1.4 percentage of participants
|
|
Kaplan-Meier Estimates for Time From Randomization to Cardiovascular Death
KM Estimate: 24 Months
|
1.7 percentage of participants
|
1.7 percentage of participants
|
|
Kaplan-Meier Estimates for Time From Randomization to Cardiovascular Death
KM Estimate: 2 Calendar Years
|
1.9 percentage of participants
|
1.7 percentage of participants
|
|
Kaplan-Meier Estimates for Time From Randomization to Cardiovascular Death
KM Estimate: 30 months
|
1.9 percentage of participants
|
1.7 percentage of participants
|
|
Kaplan-Meier Estimates for Time From Randomization to Cardiovascular Death
KM Estimate: 36 Months
|
1.9 percentage of participants
|
1.7 percentage of participants
|
|
Kaplan-Meier Estimates for Time From Randomization to Cardiovascular Death
KM Estimate: 3 Calendar Years
|
1.9 percentage of participants
|
1.7 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline through end of study (average 90 weeks)Population: Full Analysis Set
Time to event distributions were estimated by the Kaplan-Meier method. 1 month = 28 days; 1 calendar year = 365 days.
Outcome measures
| Measure |
Ranolazine
n=1317 Participants
Ranolazine 500 mg (1 x 500 mg tablet) twice daily for 7 days, followed by ranolazine 1000 mg (2 x 500 mg tablet) twice daily for the duration of the study (participants receiving a moderate CYP3A4 inhibitor continued to receive ranolazine 500 mg (1 x 500 mg tablet) twice daily for the duration of the study)
|
Placebo
n=1287 Participants
Ranolazine placebo (1 tablet) twice daily for 7 days, followed by ranolazine placebo (2 tablets) twice daily for the duration of the study (participants receiving a moderate CYP3A4 inhibitor continued to receive ranolazine placebo (1 tablet) twice daily for the duration of the study)
|
|---|---|---|
|
Kaplan-Meier Estimates for Time From Randomization to Myocardial Infarction
KM Estimate: 12 Months
|
5.8 percentage of participants
|
5.7 percentage of participants
|
|
Kaplan-Meier Estimates for Time From Randomization to Myocardial Infarction
KM Estimate: 1 Month
|
1.2 percentage of participants
|
0.6 percentage of participants
|
|
Kaplan-Meier Estimates for Time From Randomization to Myocardial Infarction
KM Estimate: 6 Months
|
3.8 percentage of participants
|
3.3 percentage of participants
|
|
Kaplan-Meier Estimates for Time From Randomization to Myocardial Infarction
KM Estimate: 1 Calendar Year
|
6.2 percentage of participants
|
6.2 percentage of participants
|
|
Kaplan-Meier Estimates for Time From Randomization to Myocardial Infarction
KM Estimate: 18 Months
|
7.3 percentage of participants
|
8.5 percentage of participants
|
|
Kaplan-Meier Estimates for Time From Randomization to Myocardial Infarction
KM Estimate: 24 Months
|
8.7 percentage of participants
|
9.4 percentage of participants
|
|
Kaplan-Meier Estimates for Time From Randomization to Myocardial Infarction
KM Estimate: 2 Calendar Years
|
10.0 percentage of participants
|
9.4 percentage of participants
|
|
Kaplan-Meier Estimates for Time From Randomization to Myocardial Infarction
KM Estimate: 30 months
|
10.9 percentage of participants
|
10.1 percentage of participants
|
|
Kaplan-Meier Estimates for Time From Randomization to Myocardial Infarction
KM Estimate: 36 Months
|
10.9 percentage of participants
|
13.4 percentage of participants
|
|
Kaplan-Meier Estimates for Time From Randomization to Myocardial Infarction
KM Estimate: 3 Calendar Years
|
10.9 percentage of participants
|
13.4 percentage of participants
|
Adverse Events
Ranolazine
Serious events: 516 serious events
Other events: 665 other events
Deaths: 0 deaths
Placebo
Serious events: 485 serious events
Other events: 531 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ranolazine
n=1322 participants at risk
Ranolazine 500 mg (1 x 500 mg tablet) twice daily for 7 days, followed by ranolazine 1000 mg (2 x 500 mg tablet) twice daily for the duration of the study (participants receiving a moderate CYP3A4 inhibitor continued to receive ranolazine 500 mg (1 x 500 mg tablet) twice daily for the duration of the study)
|
Placebo
n=1297 participants at risk
Ranolazine placebo (1 tablet) twice daily for 7 days, followed by ranolazine placebo (2 tablets) twice daily for the duration of the study (participants receiving a moderate CYP3A4 inhibitor continued to receive ranolazine placebo (1 tablet) twice daily for the duration of the study)
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.76%
10/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.23%
3/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.15%
2/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Blood and lymphatic system disorders
Normochromic normocytic anaemia
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Blood and lymphatic system disorders
Platelet dysfunction
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Cardiac disorders
Acute coronary syndrome
|
0.15%
2/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.69%
9/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Cardiac disorders
Acute myocardial infarction
|
2.1%
28/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
2.2%
29/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Cardiac disorders
Angina pectoris
|
9.5%
125/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
8.8%
114/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Cardiac disorders
Angina unstable
|
4.4%
58/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
5.5%
71/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Cardiac disorders
Arrhythmia
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Cardiac disorders
Arrhythmia supraventricular
|
0.15%
2/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.00%
0/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.15%
2/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Cardiac disorders
Atrial fibrillation
|
0.91%
12/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
1.1%
14/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Cardiac disorders
Atrial flutter
|
0.38%
5/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Cardiac disorders
Atrioventricular block
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Cardiac disorders
Atrioventricular block complete
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.00%
0/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.00%
0/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.15%
2/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Cardiac disorders
Bradycardia
|
0.38%
5/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.23%
3/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Cardiac disorders
Cardiac arrest
|
0.38%
5/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.23%
3/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Cardiac disorders
Cardiac failure
|
0.83%
11/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.93%
12/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Cardiac disorders
Cardiac failure acute
|
0.15%
2/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.15%
2/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Cardiac disorders
Cardiac failure chronic
|
0.00%
0/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.15%
2/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Cardiac disorders
Cardiac failure congestive
|
1.5%
20/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.46%
6/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Cardiac disorders
Cardiac tamponade
|
0.00%
0/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Cardiac disorders
Cardiogenic shock
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Cardiac disorders
Cardiorenal syndrome
|
0.00%
0/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Cardiac disorders
Conduction disorder
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Cardiac disorders
Cor pulmonale
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Cardiac disorders
Coronary artery disease
|
1.1%
14/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.85%
11/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Cardiac disorders
Coronary artery insufficiency
|
0.00%
0/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Cardiac disorders
Coronary artery occlusion
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Cardiac disorders
Coronary artery stenosis
|
0.15%
2/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.15%
2/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Cardiac disorders
Ischaemic cardiomyopathy
|
0.15%
2/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.31%
4/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Cardiac disorders
Mitral valve incompetence
|
0.23%
3/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Cardiac disorders
Myocardial infarction
|
1.4%
18/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
1.4%
18/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Cardiac disorders
Myocardial ischaemia
|
0.61%
8/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.93%
12/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Cardiac disorders
Myocardial rupture
|
0.00%
0/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Cardiac disorders
Palpitations
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Cardiac disorders
Pericarditis
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Cardiac disorders
Postinfarction angina
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Cardiac disorders
Right ventricular dysfunction
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Cardiac disorders
Sinus arrest
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Cardiac disorders
Sinus arrhythmia
|
0.00%
0/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Cardiac disorders
Sinus bradycardia
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Cardiac disorders
Sinus tachycardia
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Cardiac disorders
Tachycardia
|
0.15%
2/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.00%
0/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.15%
2/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Cardiac disorders
Ventricular dysfunction
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Cardiac disorders
Ventricular fibrillation
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.15%
2/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Cardiac disorders
Ventricular tachyarrhythmia
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Cardiac disorders
Ventricular tachycardia
|
0.38%
5/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.31%
4/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Cardiac disorders
Wolff-Parkinson-White syndrome
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Congenital, familial and genetic disorders
Atrial septal defect
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Ear and labyrinth disorders
Vertigo
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.23%
3/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Ear and labyrinth disorders
Vestibular disorder
|
0.00%
0/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Endocrine disorders
Adrenal insufficiency
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Endocrine disorders
Hyperthyroidism
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Eye disorders
Cataract
|
0.00%
0/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Eye disorders
Hyphaema
|
0.00%
0/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Eye disorders
Retinal detachment
|
0.00%
0/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.00%
0/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Gastrointestinal disorders
Abdominal pain
|
0.23%
3/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.15%
2/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.15%
2/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Gastrointestinal disorders
Anal fissure
|
0.00%
0/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Gastrointestinal disorders
Chronic gastrointestinal bleeding
|
0.00%
0/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Gastrointestinal disorders
Colitis
|
0.15%
2/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.23%
3/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Gastrointestinal disorders
Constipation
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Gastrointestinal disorders
Crohn's disease
|
0.00%
0/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Gastrointestinal disorders
Diarrhoea
|
0.23%
3/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Gastrointestinal disorders
Diverticular perforation
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Gastrointestinal disorders
Diverticulum
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.00%
0/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.15%
2/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Gastrointestinal disorders
Duodenitis
|
0.15%
2/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Gastrointestinal disorders
Dysphagia
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Gastrointestinal disorders
Gastritis
|
0.15%
2/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.00%
0/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.61%
8/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
1.0%
13/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Gastrointestinal disorders
Gastrointestinal perforation
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Gastrointestinal disorders
Gastrointestinal polyp haemorrhage
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Gastrointestinal disorders
Haematemesis
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Gastrointestinal disorders
Haematochezia
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Gastrointestinal disorders
Ileus
|
0.15%
2/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Gastrointestinal disorders
Ileus paralytic
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.15%
2/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.15%
2/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Gastrointestinal disorders
Intestinal angina
|
0.00%
0/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Gastrointestinal disorders
Intestinal haemorrhage
|
0.00%
0/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Gastrointestinal disorders
Intestinal mass
|
0.00%
0/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.15%
2/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Gastrointestinal disorders
Intra-abdominal haemorrhage
|
0.00%
0/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Gastrointestinal disorders
Lip disorder
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.15%
2/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Gastrointestinal disorders
Mesenteric artery thrombosis
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Gastrointestinal disorders
Nausea
|
0.30%
4/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Gastrointestinal disorders
Pancreatitis
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Gastrointestinal disorders
Pancreatitis chronic
|
0.00%
0/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Gastrointestinal disorders
Proctitis
|
0.00%
0/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Gastrointestinal disorders
Radicular cyst
|
0.00%
0/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.45%
6/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Gastrointestinal disorders
Retroperitoneal haematoma
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Gastrointestinal disorders
Small intestinal ulcer haemorrhage
|
0.00%
0/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Gastrointestinal disorders
Vomiting
|
0.30%
4/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.23%
3/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
General disorders
Arterial restenosis
|
0.00%
0/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.15%
2/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
General disorders
Asthenia
|
0.23%
3/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
General disorders
Carotid artery restenosis
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
General disorders
Chest discomfort
|
0.15%
2/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.23%
3/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
General disorders
Chest pain
|
2.8%
37/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
1.9%
24/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
General disorders
Coronary artery restenosis
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.15%
2/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
General disorders
Death
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
General disorders
Device extrusion
|
0.00%
0/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
General disorders
Device malfunction
|
0.00%
0/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
General disorders
Face oedema
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
General disorders
Fatigue
|
0.15%
2/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
General disorders
Impaired healing
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
General disorders
Multi-organ disorder
|
0.00%
0/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
General disorders
Multi-organ failure
|
0.00%
0/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.23%
3/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
General disorders
Non-cardiac chest pain
|
1.4%
19/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
1.5%
19/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
General disorders
Oedema peripheral
|
0.00%
0/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
General disorders
Peripheral artery restenosis
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
General disorders
Pyrexia
|
0.15%
2/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.15%
2/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
General disorders
Sudden cardiac death
|
0.15%
2/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
General disorders
Thrombosis in device
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
General disorders
Ulcer haemorrhage
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Hepatobiliary disorders
Biliary colic
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.15%
2/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.15%
2/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.00%
0/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Immune system disorders
Drug hypersensitivity
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Infections and infestations
Abdominal wall abscess
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Infections and infestations
Abscess limb
|
0.15%
2/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Infections and infestations
Abscess neck
|
0.00%
0/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Infections and infestations
Appendicitis
|
0.23%
3/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.23%
3/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Infections and infestations
Appendicitis perforated
|
0.00%
0/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Infections and infestations
Bronchitis
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.31%
4/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Infections and infestations
Bronchitis bacterial
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Infections and infestations
Bronchopneumonia
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Infections and infestations
Bursitis infective
|
0.00%
0/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.15%
2/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Infections and infestations
Cellulitis
|
0.38%
5/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.15%
2/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Infections and infestations
Cholangitis infective
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Infections and infestations
Clostridium difficile colitis
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Infections and infestations
Creutzfeldt-Jakob disease
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Infections and infestations
Cystitis
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Infections and infestations
Device related infection
|
0.00%
0/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.15%
2/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Infections and infestations
Diarrhoea infectious
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Infections and infestations
Diverticulitis
|
0.30%
4/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Infections and infestations
Endocarditis bacterial
|
0.00%
0/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Infections and infestations
Enterocolitis bacterial
|
0.00%
0/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Infections and infestations
Erysipelas
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Infections and infestations
Gastroenteritis
|
0.23%
3/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.15%
2/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.15%
2/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Infections and infestations
Gingival abscess
|
0.00%
0/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Infections and infestations
Groin abscess
|
0.00%
0/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Infections and infestations
Herpes zoster oticus
|
0.00%
0/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Infections and infestations
Infection
|
0.00%
0/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Infections and infestations
Influenza
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Infections and infestations
Localised infection
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Infections and infestations
Orchitis
|
0.00%
0/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Infections and infestations
Osteomyelitis
|
0.15%
2/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Infections and infestations
Osteomyelitis acute
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Infections and infestations
Otitis externa
|
0.00%
0/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Infections and infestations
Pneumonia
|
1.1%
14/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.93%
12/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Infections and infestations
Postoperative abscess
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Infections and infestations
Postoperative wound infection
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Infections and infestations
Pyelonephritis acute
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.23%
3/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Infections and infestations
Respiratory tract infection viral
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Infections and infestations
Sepsis
|
0.45%
6/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Infections and infestations
Sepsis syndrome
|
0.00%
0/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Infections and infestations
Septic shock
|
0.23%
3/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Infections and infestations
Skin infection
|
0.00%
0/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Infections and infestations
Subcutaneous abscess
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Infections and infestations
Tuberculosis
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Infections and infestations
Urinary tract infection
|
0.15%
2/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.46%
6/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Infections and infestations
Urinary tract infection bacterial
|
0.00%
0/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Infections and infestations
Urosepsis
|
0.15%
2/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Infections and infestations
Wound infection
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.15%
2/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Injury, poisoning and procedural complications
Anaemia postoperative
|
0.00%
0/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Injury, poisoning and procedural complications
Chest injury
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.00%
0/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Injury, poisoning and procedural complications
Graft thrombosis
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Injury, poisoning and procedural complications
Head injury
|
0.23%
3/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Injury, poisoning and procedural complications
Laceration
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.15%
2/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Injury, poisoning and procedural complications
Muscle rupture
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Injury, poisoning and procedural complications
Overdose
|
0.15%
2/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Injury, poisoning and procedural complications
Periorbital haematoma
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Injury, poisoning and procedural complications
Peripheral arterial reocclusion
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Injury, poisoning and procedural complications
Post procedural fistula
|
0.00%
0/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
0.00%
0/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Injury, poisoning and procedural complications
Postoperative hernia
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Injury, poisoning and procedural complications
Postoperative wound complication
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Injury, poisoning and procedural complications
Postpericardiotomy syndrome
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Injury, poisoning and procedural complications
Pubis fracture
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.15%
2/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Injury, poisoning and procedural complications
Subcutaneous haematoma
|
0.00%
0/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Injury, poisoning and procedural complications
Subdural haemorrhage
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Injury, poisoning and procedural complications
Vascular graft complication
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Investigations
Cardiac stress test abnormal
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Investigations
Ejection fraction decreased
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Investigations
Electrocardiogram ST segment depression
|
0.00%
0/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Metabolism and nutrition disorders
Dehydration
|
0.15%
2/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.00%
0/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.15%
2/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.30%
4/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.30%
4/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.15%
2/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.15%
2/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.30%
4/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.15%
2/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.15%
2/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.15%
2/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis
|
0.00%
0/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.15%
2/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.15%
2/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Neck mass
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.38%
5/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Osteochondrosis
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Polyarthritis
|
0.00%
0/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Psoriatic arthropathy
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.15%
2/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.15%
2/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.00%
0/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.23%
3/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Spinal disorder
|
0.00%
0/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adrenal adenoma
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder adenocarcinoma stage unspecified
|
0.15%
2/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.00%
0/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer stage 0, with cancer in situ
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder neoplasm
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma
|
0.00%
0/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.15%
2/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bronchial carcinoma
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cholangiocarcinoma
|
0.00%
0/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon neoplasm
|
0.00%
0/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer
|
0.00%
0/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer stage I
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Fibrous histiocytoma
|
0.00%
0/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioblastoma
|
0.00%
0/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leukaemia
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
0.00%
0/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to peritoneum
|
0.00%
0/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm
|
0.00%
0/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal adenocarcinoma
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma metastatic
|
0.00%
0/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma cell myeloma
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.23%
3/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.00%
0/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Salivary gland neoplasm
|
0.00%
0/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.15%
2/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Testis cancer
|
0.00%
0/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid neoplasm
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.00%
0/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine cancer
|
0.15%
2/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Nervous system disorders
Brain oedema
|
0.00%
0/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Nervous system disorders
Carotid artery aneurysm
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Nervous system disorders
Carotid artery dissection
|
0.00%
0/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Nervous system disorders
Carotid artery occlusion
|
0.00%
0/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Nervous system disorders
Carotid artery stenosis
|
0.61%
8/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.15%
2/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Nervous system disorders
Cerebellar infarction
|
0.00%
0/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Nervous system disorders
Cerebral haematoma
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Nervous system disorders
Cerebral infarction
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Nervous system disorders
Cerebrovascular accident
|
0.91%
12/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.69%
9/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Nervous system disorders
Dizziness
|
0.38%
5/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Nervous system disorders
Dysarthria
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Nervous system disorders
Generalised tonic-clonic seizure
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Nervous system disorders
Guillain-Barre syndrome
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Nervous system disorders
Haemorrhagic transformation stroke
|
0.00%
0/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Nervous system disorders
Headache
|
0.15%
2/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.15%
2/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Nervous system disorders
Intracranial pressure increased
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Nervous system disorders
Ischaemic stroke
|
0.38%
5/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Nervous system disorders
Lacunar infarction
|
0.00%
0/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.15%
2/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Nervous system disorders
Lateral medullary syndrome
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Nervous system disorders
Loss of consciousness
|
0.15%
2/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Nervous system disorders
Lumbar radiculopathy
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Nervous system disorders
Mononeuropathy
|
0.00%
0/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Nervous system disorders
Muscle contractions involuntary
|
0.00%
0/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Nervous system disorders
Myasthenia gravis
|
0.00%
0/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Nervous system disorders
Myelopathy
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Nervous system disorders
Paraesthesia
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Nervous system disorders
Presyncope
|
0.68%
9/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.15%
2/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Nervous system disorders
Radicular pain
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Nervous system disorders
Sciatica
|
0.00%
0/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Nervous system disorders
Syncope
|
1.9%
25/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
1.0%
13/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Nervous system disorders
Toxic encephalopathy
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Nervous system disorders
Transient ischaemic attack
|
0.91%
12/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.23%
3/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Nervous system disorders
Tremor
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Nervous system disorders
Vertebral artery stenosis
|
0.00%
0/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Psychiatric disorders
Delusional disorder, unspecified type
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Psychiatric disorders
Depression
|
0.23%
3/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Psychiatric disorders
Major depression
|
0.00%
0/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Psychiatric disorders
Mental status changes
|
0.15%
2/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.31%
4/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Psychiatric disorders
Suicidal ideation
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Renal and urinary disorders
Bladder outlet obstruction
|
0.00%
0/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Renal and urinary disorders
Diabetic nephropathy
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Renal and urinary disorders
Haematuria
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.31%
4/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Renal and urinary disorders
Nephropathy
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Renal and urinary disorders
Nephrotic syndrome
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Renal and urinary disorders
Renal artery stenosis
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Renal and urinary disorders
Renal failure
|
0.30%
4/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Renal and urinary disorders
Renal failure acute
|
0.38%
5/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.46%
6/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Renal and urinary disorders
Renal failure chronic
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Renal and urinary disorders
Renal infarct
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.15%
2/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.31%
4/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Reproductive system and breast disorders
Epididymal cyst
|
0.00%
0/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Reproductive system and breast disorders
Prostatitis
|
0.15%
2/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis chronic
|
0.00%
0/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.38%
5/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.54%
7/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.98%
13/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
1.0%
13/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.15%
2/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.31%
4/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.15%
2/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal stenosis
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Lung consolidation
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal haemorrhage
|
0.00%
0/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.15%
2/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.15%
2/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax spontaneous
|
0.00%
0/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.15%
2/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.00%
0/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.15%
2/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.31%
4/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.15%
2/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillar hypertrophy
|
0.00%
0/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Tracheal stenosis
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Skin and subcutaneous tissue disorders
Dry gangrene
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
0.00%
0/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Vascular disorders
Aortic aneurysm
|
0.38%
5/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.15%
2/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Vascular disorders
Aortic stenosis
|
0.23%
3/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Vascular disorders
Arterial stenosis
|
0.00%
0/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Vascular disorders
Arteriosclerosis
|
0.00%
0/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Vascular disorders
Deep vein thrombosis
|
0.30%
4/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Vascular disorders
Extremity necrosis
|
0.00%
0/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Vascular disorders
Femoral artery occlusion
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Vascular disorders
Hypertension
|
0.68%
9/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.23%
3/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Vascular disorders
Hypertensive crisis
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.15%
2/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Vascular disorders
Hypertensive emergency
|
0.15%
2/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Vascular disorders
Hypotension
|
0.53%
7/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Vascular disorders
Hypovolaemic shock
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Vascular disorders
Intermittent claudication
|
0.23%
3/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Vascular disorders
Ischaemia
|
0.00%
0/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Vascular disorders
Lymphorrhoea
|
0.00%
0/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Vascular disorders
Malignant hypertension
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Vascular disorders
Orthostatic hypotension
|
0.30%
4/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.30%
4/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.54%
7/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Vascular disorders
Peripheral artery stenosis
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.15%
2/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Vascular disorders
Peripheral artery thrombosis
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Vascular disorders
Peripheral ischaemia
|
0.45%
6/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.54%
7/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Vascular disorders
Peripheral vascular disorder
|
0.30%
4/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.39%
5/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Vascular disorders
Renovascular hypertension
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Vascular disorders
Subclavian vein thrombosis
|
0.08%
1/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Vascular disorders
Thrombosis
|
0.15%
2/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Vascular disorders
Varicose vein
|
0.00%
0/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.08%
1/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
Other adverse events
| Measure |
Ranolazine
n=1322 participants at risk
Ranolazine 500 mg (1 x 500 mg tablet) twice daily for 7 days, followed by ranolazine 1000 mg (2 x 500 mg tablet) twice daily for the duration of the study (participants receiving a moderate CYP3A4 inhibitor continued to receive ranolazine 500 mg (1 x 500 mg tablet) twice daily for the duration of the study)
|
Placebo
n=1297 participants at risk
Ranolazine placebo (1 tablet) twice daily for 7 days, followed by ranolazine placebo (2 tablets) twice daily for the duration of the study (participants receiving a moderate CYP3A4 inhibitor continued to receive ranolazine placebo (1 tablet) twice daily for the duration of the study)
|
|---|---|---|
|
Cardiac disorders
Angina pectoris
|
12.2%
161/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
12.0%
156/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Gastrointestinal disorders
Constipation
|
12.6%
167/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
5.5%
71/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Gastrointestinal disorders
Nausea
|
9.3%
123/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
4.9%
63/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
General disorders
Chest pain
|
7.3%
97/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
7.1%
92/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
General disorders
Fatigue
|
7.5%
99/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
5.7%
74/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Nervous system disorders
Dizziness
|
18.2%
240/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
9.2%
119/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Nervous system disorders
Headache
|
7.4%
98/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
6.9%
89/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.2%
69/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
3.9%
51/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
6.7%
89/1322 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
6.9%
89/1297 • Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met: * The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or * The study has been completed at all study sites for at least 2 years
- Publication restrictions are in place
Restriction type: OTHER