Trial Outcomes & Findings for An Efficacy, Safety, and Tolerability Study of Canagliflozin in Patients With Type 2 Diabetes Mellitus Who Have Moderate Renal Impairment (NCT NCT01064414)
NCT ID: NCT01064414
Last Updated: 2013-08-14
Results Overview
The table below shows the least-squares (LS) mean change in HbA1c from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
272 participants
Primary outcome timeframe
Day 1 (Baseline) and Week 26
Results posted on
2013-08-14
Participant Flow
This study evaluated the efficacy and safety of canagliflozin in patients with type 2 diabetes mellitus and moderate renal impairment. The study was conducted between 02 March 2010 and 19 January 2012 and recruited patients from 89 study centers located in 19 countries worldwide.
272 patients were randomly allocated to the 3 treatment arms. 269 patients received at least 1 dose of study drug and were included in the modified intent-to-treat (mITT) analysis set and safety analysis set. Participant flow is presented in two parts: for Baseline to Week 26 as "Core Period", and for Week 26 to Week 52 as "Extension Period".
Participant milestones
| Measure |
Placebo
Each patient received matching placebo once daily for 52 weeks. Data are presented for Baseline to Week 26 (Core Period) and for Week 26 to 52 (Extension Period).
|
Canagliflozin 100 mg
Each patient received 100 mg of canagliflozin once daily for 52 weeks. Data are presented for Baseline to Week 26 (Core Period) and for Week 26 to 52 (Extension Period).
|
Canagliflozin 300 mg
Each patient received 300 mg of canagliflozin once daily for 52 weeks.Data are presented for Baseline to Week 26 (Core Period) and for Week 26 to 52 (Extension Period).
|
|---|---|---|---|
|
Core Period: Baseline to Week 26
STARTED
|
90
|
90
|
89
|
|
Core Period: Baseline to Week 26
COMPLETED
|
77
|
75
|
82
|
|
Core Period: Baseline to Week 26
NOT COMPLETED
|
13
|
15
|
7
|
|
Extension Period: Week 26 to Week 52
STARTED
|
76
|
72
|
81
|
|
Extension Period: Week 26 to Week 52
COMPLETED
|
64
|
67
|
76
|
|
Extension Period: Week 26 to Week 52
NOT COMPLETED
|
12
|
5
|
5
|
Reasons for withdrawal
| Measure |
Placebo
Each patient received matching placebo once daily for 52 weeks. Data are presented for Baseline to Week 26 (Core Period) and for Week 26 to 52 (Extension Period).
|
Canagliflozin 100 mg
Each patient received 100 mg of canagliflozin once daily for 52 weeks. Data are presented for Baseline to Week 26 (Core Period) and for Week 26 to 52 (Extension Period).
|
Canagliflozin 300 mg
Each patient received 300 mg of canagliflozin once daily for 52 weeks.Data are presented for Baseline to Week 26 (Core Period) and for Week 26 to 52 (Extension Period).
|
|---|---|---|---|
|
Core Period: Baseline to Week 26
Adverse Event
|
4
|
4
|
2
|
|
Core Period: Baseline to Week 26
Death
|
0
|
1
|
0
|
|
Core Period: Baseline to Week 26
Protocol Violation
|
1
|
0
|
1
|
|
Core Period: Baseline to Week 26
Withdrawal by Subject
|
4
|
2
|
2
|
|
Core Period: Baseline to Week 26
Noncompliance with study drug
|
0
|
1
|
0
|
|
Core Period: Baseline to Week 26
Other
|
4
|
7
|
2
|
|
Extension Period: Week 26 to Week 52
Adverse Event
|
2
|
1
|
2
|
|
Extension Period: Week 26 to Week 52
Death
|
0
|
1
|
0
|
|
Extension Period: Week 26 to Week 52
Lost to Follow-up
|
1
|
0
|
0
|
|
Extension Period: Week 26 to Week 52
Physician Decision
|
1
|
0
|
0
|
|
Extension Period: Week 26 to Week 52
Withdrawal by Subject
|
1
|
0
|
1
|
|
Extension Period: Week 26 to Week 52
Noncompliance with study drug
|
1
|
0
|
0
|
|
Extension Period: Week 26 to Week 52
Protocol Violation
|
1
|
1
|
1
|
|
Extension Period: Week 26 to Week 52
Other
|
5
|
2
|
1
|
Baseline Characteristics
An Efficacy, Safety, and Tolerability Study of Canagliflozin in Patients With Type 2 Diabetes Mellitus Who Have Moderate Renal Impairment
Baseline characteristics by cohort
| Measure |
Placebo
n=90 Participants
Each patient received matching placebo once daily for 52 weeks.
|
Canagliflozin 100 mg
n=90 Participants
Each patient received 100 mg of canagliflozin once daily for 52 weeks.
|
Canagliflozin 300 mg
n=89 Participants
Each patient received 300 mg of canagliflozin once daily for 52 weeks.
|
Total
n=269 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
27 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
83 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
63 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
186 Participants
n=4 Participants
|
|
Age Continuous
|
68.2 years
STANDARD_DEVIATION 8.4 • n=5 Participants
|
69.5 years
STANDARD_DEVIATION 8.2 • n=7 Participants
|
67.9 years
STANDARD_DEVIATION 8.24 • n=5 Participants
|
68.5 years
STANDARD_DEVIATION 8.28 • n=4 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
106 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
57 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
163 Participants
n=4 Participants
|
|
Region of Enrollment
AUSTRALIA
|
3 participants
n=5 Participants
|
6 participants
n=7 Participants
|
5 participants
n=5 Participants
|
14 participants
n=4 Participants
|
|
Region of Enrollment
BELGIUM
|
5 participants
n=5 Participants
|
1 participants
n=7 Participants
|
6 participants
n=5 Participants
|
12 participants
n=4 Participants
|
|
Region of Enrollment
BRAZIL
|
4 participants
n=5 Participants
|
4 participants
n=7 Participants
|
5 participants
n=5 Participants
|
13 participants
n=4 Participants
|
|
Region of Enrollment
CANADA
|
7 participants
n=5 Participants
|
11 participants
n=7 Participants
|
3 participants
n=5 Participants
|
21 participants
n=4 Participants
|
|
Region of Enrollment
FRANCE
|
7 participants
n=5 Participants
|
5 participants
n=7 Participants
|
4 participants
n=5 Participants
|
16 participants
n=4 Participants
|
|
Region of Enrollment
GERMANY
|
6 participants
n=5 Participants
|
10 participants
n=7 Participants
|
2 participants
n=5 Participants
|
18 participants
n=4 Participants
|
|
Region of Enrollment
INDIA
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
3 participants
n=5 Participants
|
9 participants
n=4 Participants
|
|
Region of Enrollment
ITALY
|
4 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
6 participants
n=4 Participants
|
|
Region of Enrollment
LATVIA
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
4 participants
n=5 Participants
|
7 participants
n=4 Participants
|
|
Region of Enrollment
MALAYSIA
|
2 participants
n=5 Participants
|
4 participants
n=7 Participants
|
8 participants
n=5 Participants
|
14 participants
n=4 Participants
|
|
Region of Enrollment
MEXICO
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
4 participants
n=4 Participants
|
|
Region of Enrollment
NEW ZEALAND
|
7 participants
n=5 Participants
|
2 participants
n=7 Participants
|
5 participants
n=5 Participants
|
14 participants
n=4 Participants
|
|
Region of Enrollment
POLAND
|
5 participants
n=5 Participants
|
5 participants
n=7 Participants
|
4 participants
n=5 Participants
|
14 participants
n=4 Participants
|
|
Region of Enrollment
ROMANIA
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
5 participants
n=4 Participants
|
|
Region of Enrollment
RUSSIAN FEDERATION
|
10 participants
n=5 Participants
|
11 participants
n=7 Participants
|
9 participants
n=5 Participants
|
30 participants
n=4 Participants
|
|
Region of Enrollment
SOUTH AFRICA
|
2 participants
n=5 Participants
|
3 participants
n=7 Participants
|
1 participants
n=5 Participants
|
6 participants
n=4 Participants
|
|
Region of Enrollment
SOUTH KOREA
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
2 participants
n=4 Participants
|
|
Region of Enrollment
SPAIN
|
4 participants
n=5 Participants
|
5 participants
n=7 Participants
|
8 participants
n=5 Participants
|
17 participants
n=4 Participants
|
|
Region of Enrollment
UNITED STATES
|
16 participants
n=5 Participants
|
14 participants
n=7 Participants
|
17 participants
n=5 Participants
|
47 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Day 1 (Baseline) and Week 26Population: Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.
The table below shows the least-squares (LS) mean change in HbA1c from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.
Outcome measures
| Measure |
Placebo
n=87 Participants
Each patient received matching placebo once daily for 52 weeks.
|
Canagliflozin 100 mg
n=88 Participants
Each patient received canagliflozin 100 mg once daily for 52 weeks.
|
Canagliflozin 300 mg
n=89 Participants
Each patient received canagliflozin 300 mg once daily for 52 weeks.
|
|---|---|---|---|
|
Change in HbA1c From Baseline to Week 26
|
-0.03 Percent
Standard Error 0.090
|
-0.33 Percent
Standard Error 0.090
|
-0.44 Percent
Standard Error 0.089
|
SECONDARY outcome
Timeframe: Week 26Population: Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.
The table below shows the percentage of patients with HbA1c \<7% at Week 26 in each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the percentage.
Outcome measures
| Measure |
Placebo
n=87 Participants
Each patient received matching placebo once daily for 52 weeks.
|
Canagliflozin 100 mg
n=88 Participants
Each patient received canagliflozin 100 mg once daily for 52 weeks.
|
Canagliflozin 300 mg
n=89 Participants
Each patient received canagliflozin 300 mg once daily for 52 weeks.
|
|---|---|---|---|
|
Percentage of Patients With HbA1c <7% at Week 26
|
17.2 Percentage of patients
|
27.3 Percentage of patients
|
32.6 Percentage of patients
|
SECONDARY outcome
Timeframe: Day 1 (Baseline) and Week 26Population: Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.
The table below shows the least-squares (LS) mean change in FPG from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.
Outcome measures
| Measure |
Placebo
n=88 Participants
Each patient received matching placebo once daily for 52 weeks.
|
Canagliflozin 100 mg
n=90 Participants
Each patient received canagliflozin 100 mg once daily for 52 weeks.
|
Canagliflozin 300 mg
n=88 Participants
Each patient received canagliflozin 300 mg once daily for 52 weeks.
|
|---|---|---|---|
|
Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26
|
0.49 mg/dL
Standard Error 5.089
|
-14.9 mg/dL
Standard Error 5.089
|
-11.7 mg/dL
Standard Error 5.099
|
Adverse Events
Placebo: Baseline to Week 26
Serious events: 16 serious events
Other events: 27 other events
Deaths: 0 deaths
Canagliflozin 100 mg: Baseline to Week 26
Serious events: 10 serious events
Other events: 21 other events
Deaths: 0 deaths
Canagliflozin 300 mg: Baseline to Week 26
Serious events: 10 serious events
Other events: 33 other events
Deaths: 0 deaths
Placebo: Baseline to Week 52
Serious events: 24 serious events
Other events: 46 other events
Deaths: 0 deaths
Canagliflozin 100 mg: Baseline to Week 52
Serious events: 18 serious events
Other events: 46 other events
Deaths: 0 deaths
Canagliflozin 300 mg: Baseline to Week 52
Serious events: 21 serious events
Other events: 48 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo: Baseline to Week 26
n=90 participants at risk
Each patient received matching placebo once daily for 52 weeks. Data are presented for Baseline to Week 26.
|
Canagliflozin 100 mg: Baseline to Week 26
n=90 participants at risk
Each patient received 100 mg of canagliflozin once daily for 52 weeks. Data are presented for Baseline to Week 26.
|
Canagliflozin 300 mg: Baseline to Week 26
n=89 participants at risk
Each patient received 300 mg of canagliflozin once daily for 52 weeks. Data are presented for Baseline to Week 26.
|
Placebo: Baseline to Week 52
n=90 participants at risk
Each patient received matching placebo once daily for 52 weeks. Data are presented for Baseline to Week 52.
|
Canagliflozin 100 mg: Baseline to Week 52
n=90 participants at risk
Each patient received 100 mg of canagliflozin once daily for 52 weeks. Data are presented for Baseline to Week 52.
|
Canagliflozin 300 mg: Baseline to Week 52
n=89 participants at risk
Each patient received 300 mg of canagliflozin once daily for 52 weeks. Data are presented for Baseline to Week 52.
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
1.1%
1/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
1.1%
1/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Cardiac disorders
Acute coronary syndrome
|
1.1%
1/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
1.1%
1/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
1.1%
1/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
1.1%
1/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Cardiac disorders
Cardiac failure congestive
|
1.1%
1/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
1.1%
1/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
1.1%
1/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
2.2%
2/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Cardiac disorders
Coronary artery disease
|
1.1%
1/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
1.1%
1/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
1.1%
1/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Cardiac disorders
Myocardial infarction
|
1.1%
1/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
2.2%
2/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
2.2%
2/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
1.1%
1/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
1.1%
1/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
1.1%
1/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Cardiac disorders
Ventricular fibrillation
|
1.1%
1/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
1.1%
1/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Eye disorders
Glaucoma
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
1.1%
1/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
1.1%
1/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.1%
1/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
1.1%
1/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
1.1%
1/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
1.1%
1/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Infections and infestations
Appendicitis perforated
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
1.1%
1/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
1.1%
1/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Infections and infestations
Campylobacter intestinal infection
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
1.1%
1/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Infections and infestations
Infected skin ulcer
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
1.1%
1/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
1.1%
1/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Infections and infestations
Infective exacerbation of chronic obstructive airways disease
|
1.1%
1/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
1.1%
1/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
1.1%
1/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
1.1%
1/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Infections and infestations
Pneumonia
|
2.2%
2/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
2.2%
2/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Infections and infestations
Sepsis
|
1.1%
1/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
1.1%
1/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Infections and infestations
Septic shock
|
1.1%
1/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
1.1%
1/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
1.1%
1/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
1.1%
1/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
1.1%
1/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
1.1%
1/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Injury, poisoning and procedural complications
Splenic rupture
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
1.1%
1/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
1.1%
1/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
1.1%
1/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
1.1%
1/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Injury, poisoning and procedural complications
Wound complication
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
1.1%
1/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
1.1%
1/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
1.1%
1/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
1.1%
1/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Investigations
Troponin increased
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
1.1%
1/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
1.1%
1/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
1.1%
1/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
1.1%
1/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
1.1%
1/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
1.1%
1/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
1.1%
1/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer metastatic
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
1.1%
1/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
1.1%
1/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Nervous system disorders
Carotid artery stenosis
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
1.1%
1/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
1.1%
1/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Nervous system disorders
Transient ischaemic attack
|
1.1%
1/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
1.1%
1/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
1.1%
1/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
1.1%
1/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Renal and urinary disorders
Bladder neck obstruction
|
1.1%
1/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
1.1%
1/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Renal and urinary disorders
Renal artery stenosis
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
1.1%
1/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
1.1%
1/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Renal and urinary disorders
Renal failure
|
1.1%
1/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
2.2%
2/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
1.1%
1/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
1.1%
1/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
1.1%
1/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
1.1%
1/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
1.1%
1/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Renal and urinary disorders
Renal impairment
|
1.1%
1/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
1.1%
1/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
1.1%
1/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
1.1%
1/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
1.1%
1/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
1.1%
1/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
1.1%
1/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
1.1%
1/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
1.1%
1/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
1.1%
1/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
1.1%
1/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
1.1%
1/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Vascular disorders
Arteritis
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
1.1%
1/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
1.1%
1/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
1.1%
1/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
1.1%
1/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
1.1%
1/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Vascular disorders
Femoral arterial stenosis
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
1.1%
1/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
1.1%
1/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Vascular disorders
Hypertension
|
1.1%
1/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
1.1%
1/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Vascular disorders
Hypotension
|
1.1%
1/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
1.1%
1/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Cardiac disorders
Coronary artery insufficiency
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
1.1%
1/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Cardiac disorders
Cor pulmonale
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
1.1%
1/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Cardiac disorders
Cardiac failure acute
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
1.1%
1/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
1.1%
1/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
1.1%
1/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
1.1%
1/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
1.1%
1/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Cardiac disorders
Atrial fibrilation
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
2.2%
2/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Eye disorders
Cataract
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
1.1%
1/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
1.1%
1/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
1.1%
1/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
General disorders
Oedema peripheral
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
1.1%
1/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
1.1%
1/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
1.1%
1/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
1.1%
1/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Infections and infestations
Lobar pneumonia
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
1.1%
1/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
1.1%
1/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
1.1%
1/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Renal and urinary disorders
Neophrolithiasis
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
1.1%
1/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
1.1%
1/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
1.1%
1/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
1.1%
1/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
1.1%
1/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
1.1%
1/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
1.1%
1/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
1.1%
1/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
1.1%
1/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
1.1%
1/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Skin and subcutaneous tissue disorders
Skin necrosis
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
1.1%
1/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Infections and infestations
Campylobacter gastroenteritis
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
1.1%
1/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Metabolism and nutrition disorders
Diabetic complications
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
1.1%
1/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
Other adverse events
| Measure |
Placebo: Baseline to Week 26
n=90 participants at risk
Each patient received matching placebo once daily for 52 weeks. Data are presented for Baseline to Week 26.
|
Canagliflozin 100 mg: Baseline to Week 26
n=90 participants at risk
Each patient received 100 mg of canagliflozin once daily for 52 weeks. Data are presented for Baseline to Week 26.
|
Canagliflozin 300 mg: Baseline to Week 26
n=89 participants at risk
Each patient received 300 mg of canagliflozin once daily for 52 weeks. Data are presented for Baseline to Week 26.
|
Placebo: Baseline to Week 52
n=90 participants at risk
Each patient received matching placebo once daily for 52 weeks. Data are presented for Baseline to Week 52.
|
Canagliflozin 100 mg: Baseline to Week 52
n=90 participants at risk
Each patient received 100 mg of canagliflozin once daily for 52 weeks. Data are presented for Baseline to Week 52.
|
Canagliflozin 300 mg: Baseline to Week 52
n=89 participants at risk
Each patient received 300 mg of canagliflozin once daily for 52 weeks. Data are presented for Baseline to Week 52.
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
5.6%
5/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
3.3%
3/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
4.5%
4/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
10.0%
9/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
4.4%
4/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
4.5%
4/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Infections and infestations
Nasopharyngitis
|
11.1%
10/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
3.3%
3/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
7.9%
7/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
14.4%
13/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
5.6%
5/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
10.1%
9/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Infections and infestations
Urinary tract infection
|
5.6%
5/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
4.4%
4/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
7.9%
7/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
6.7%
6/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
4.4%
4/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
13.5%
12/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
4.4%
4/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
14.4%
13/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
11.2%
10/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
4.4%
4/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
20.0%
18/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
22.5%
20/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
5.6%
5/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
1.1%
1/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
4.4%
4/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
2.2%
2/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
1.1%
1/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.6%
5/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
2.2%
2/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
5.6%
5/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
1.1%
1/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
4.5%
4/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
1.1%
1/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
5.6%
5/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
2.2%
2/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
1.1%
1/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
5.6%
5/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Vascular disorders
Hypotension
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
1.1%
1/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
6.7%
6/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
3.3%
3/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
1.1%
1/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
6.7%
6/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
General disorders
Fatigue
|
4.4%
4/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
4.5%
4/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
5.6%
5/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
1.1%
1/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
5.6%
5/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
General disorders
Oedema peripheral
|
4.4%
4/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
2.2%
2/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
3.4%
3/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
6.7%
6/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
5.6%
5/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
6.7%
6/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Infections and infestations
Bronchitis
|
3.3%
3/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
4.4%
4/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
3.4%
3/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
1.1%
1/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
5.6%
5/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
5.6%
5/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Infections and infestations
Influenza
|
3.3%
3/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
3.3%
3/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
2.2%
2/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
6.7%
6/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
3.3%
3/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
3.4%
3/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Infections and infestations
Upper respiratory tract
|
1.1%
1/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
3.3%
3/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
1.1%
1/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
1.1%
1/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
5.6%
5/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
4.5%
4/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
3.3%
3/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
2.2%
2/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
1.1%
1/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
5.6%
5/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
3.3%
3/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
1.1%
1/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
4.4%
4/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
2.2%
2/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
2.2%
2/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
5.6%
5/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
2.2%
2/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
2.2%
2/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.2%
2/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
4.4%
4/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
2.2%
2/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
3.3%
3/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
5.6%
5/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
3.4%
3/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Nervous system disorders
Headache
|
3.3%
3/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
2.2%
2/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
2.2%
2/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
5.6%
5/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
3.3%
3/90 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
3.4%
3/89 • Adverse events data were collected for the duration of study (52 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
Additional Information
Vice President, Franchise Medical Leader, Cardiovascular & Metabolism Franchise
Janssen Research & Development, LLC
Phone: 1-800-526-7736
Results disclosure agreements
- Principal investigator is a sponsor employee A copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested in writing, such publication will be withheld for up to an additional 60 days.
- Publication restrictions are in place
Restriction type: OTHER