Trial Outcomes & Findings for The CANTATA-MSU Trial (CANagliflozin Treatment And Trial Analysis - Metformin and SUlphonylurea) (NCT NCT01106625)
NCT ID: NCT01106625
Last Updated: 2013-06-20
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
469 participants
Primary outcome timeframe
Day 1 (Baseline) and Week 26
Results posted on
2013-06-20
Participant Flow
This study evaluated the efficacy and safety of canagliflozin in patients with type 2 diabetes mellitus with inadequate control despite treatment with metformin and sulphonylurea therapy. The study was conducted between 07 April 2010 and 17 April 2012 and recruited patients from 85 study centers in 11 countries worldwide.
A total of 469 patients were randomly allocated to the 3 treatment arms in the study. All 469 patients received at least 1 dose of study drug and were included in the modified intent-to-treat analysis set (used for the week 26 efficacy analyses). All 469 patients were included in the week 26 and week 52 safety analysis sets.
Participant milestones
| Measure |
Placebo
Each patient received matching placebo once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
|
Canagliflozin 100 mg
Each patient received 100 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
|
Canagliflozin 300 mg
Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
|
|---|---|---|---|
|
Core Period: Baseline to Week 26
STARTED
|
156
|
157
|
156
|
|
Core Period: Baseline to Week 26
COMPLETED
|
123
|
129
|
129
|
|
Core Period: Baseline to Week 26
NOT COMPLETED
|
33
|
28
|
27
|
|
Extension Period: Week 26 to Week 52
STARTED
|
119
|
127
|
128
|
|
Extension Period: Week 26 to Week 52
COMPLETED
|
90
|
109
|
111
|
|
Extension Period: Week 26 to Week 52
NOT COMPLETED
|
29
|
18
|
17
|
Reasons for withdrawal
| Measure |
Placebo
Each patient received matching placebo once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
|
Canagliflozin 100 mg
Each patient received 100 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
|
Canagliflozin 300 mg
Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
|
|---|---|---|---|
|
Core Period: Baseline to Week 26
Adverse Event
|
6
|
8
|
8
|
|
Core Period: Baseline to Week 26
Lost to Follow-up
|
5
|
0
|
4
|
|
Core Period: Baseline to Week 26
Physician Decision
|
1
|
0
|
0
|
|
Core Period: Baseline to Week 26
Protocol Violation
|
2
|
1
|
3
|
|
Core Period: Baseline to Week 26
Withdrawal by Subject
|
6
|
9
|
7
|
|
Core Period: Baseline to Week 26
Unable to take rescue therapy
|
4
|
1
|
0
|
|
Core Period: Baseline to Week 26
Creatinine, or eGFR withdrawal criteria
|
0
|
1
|
1
|
|
Core Period: Baseline to Week 26
Noncompliance with study drug
|
1
|
1
|
0
|
|
Core Period: Baseline to Week 26
Other
|
8
|
7
|
4
|
|
Extension Period: Week 26 to Week 52
Adverse Event
|
2
|
2
|
3
|
|
Extension Period: Week 26 to Week 52
Lost to Follow-up
|
1
|
3
|
2
|
|
Extension Period: Week 26 to Week 52
Physician Decision
|
2
|
0
|
1
|
|
Extension Period: Week 26 to Week 52
Protocol Violation
|
0
|
1
|
0
|
|
Extension Period: Week 26 to Week 52
Withdrawal by Subject
|
4
|
1
|
1
|
|
Extension Period: Week 26 to Week 52
Unable to take rescue therapy
|
14
|
5
|
4
|
|
Extension Period: Week 26 to Week 52
Creatinine or eGFR withdrawal criteria
|
1
|
1
|
2
|
|
Extension Period: Week 26 to Week 52
Other
|
5
|
5
|
4
|
Baseline Characteristics
The CANTATA-MSU Trial (CANagliflozin Treatment And Trial Analysis - Metformin and SUlphonylurea)
Baseline characteristics by cohort
| Measure |
Placebo
n=156 Participants
Each patient received matching placebo once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
|
Canagliflozin 100 mg
n=157 Participants
Each patient received 100 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
|
Canagliflozin 300 mg
n=156 Participants
Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
|
Total
n=469 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
|
|
Sex: Female, Male
Female
|
80 Participants
n=5 Participants
|
81 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
230 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
130 Participants
n=5 Participants
|
121 Participants
n=7 Participants
|
134 Participants
n=5 Participants
|
385 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
26 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
84 Participants
n=4 Participants
|
|
Age Continuous
|
56.7 years
STANDARD_DEVIATION 8.36 • n=5 Participants
|
57.3 years
STANDARD_DEVIATION 10.47 • n=7 Participants
|
56 years
STANDARD_DEVIATION 8.95 • n=5 Participants
|
56.7 years
STANDARD_DEVIATION 9.3 • n=4 Participants
|
|
Sex: Female, Male
Male
|
76 Participants
n=5 Participants
|
76 Participants
n=7 Participants
|
87 Participants
n=5 Participants
|
239 Participants
n=4 Participants
|
|
Region of Enrollment
AUSTRALIA
|
3 participants
n=5 Participants
|
6 participants
n=7 Participants
|
4 participants
n=5 Participants
|
13 participants
n=4 Participants
|
|
Region of Enrollment
BELGIUM
|
3 participants
n=5 Participants
|
1 participants
n=7 Participants
|
6 participants
n=5 Participants
|
10 participants
n=4 Participants
|
|
Region of Enrollment
FRANCE
|
4 participants
n=5 Participants
|
7 participants
n=7 Participants
|
9 participants
n=5 Participants
|
20 participants
n=4 Participants
|
|
Region of Enrollment
GUATEMALA
|
15 participants
n=5 Participants
|
12 participants
n=7 Participants
|
16 participants
n=5 Participants
|
43 participants
n=4 Participants
|
|
Region of Enrollment
HUNGARY
|
11 participants
n=5 Participants
|
14 participants
n=7 Participants
|
11 participants
n=5 Participants
|
36 participants
n=4 Participants
|
|
Region of Enrollment
ISRAEL
|
1 participants
n=5 Participants
|
6 participants
n=7 Participants
|
8 participants
n=5 Participants
|
15 participants
n=4 Participants
|
|
Region of Enrollment
MEXICO
|
11 participants
n=5 Participants
|
11 participants
n=7 Participants
|
11 participants
n=5 Participants
|
33 participants
n=4 Participants
|
|
Region of Enrollment
RUSSIAN FEDERATION
|
14 participants
n=5 Participants
|
13 participants
n=7 Participants
|
8 participants
n=5 Participants
|
35 participants
n=4 Participants
|
|
Region of Enrollment
SPAIN
|
5 participants
n=5 Participants
|
7 participants
n=7 Participants
|
8 participants
n=5 Participants
|
20 participants
n=4 Participants
|
|
Region of Enrollment
UNITED KINGDOM
|
8 participants
n=5 Participants
|
6 participants
n=7 Participants
|
5 participants
n=5 Participants
|
19 participants
n=4 Participants
|
|
Region of Enrollment
UNITED STATES
|
81 participants
n=5 Participants
|
74 participants
n=7 Participants
|
70 participants
n=5 Participants
|
225 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=150 Participants
Each patient received matching placebo once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
|
Canagliflozin 100 mg
n=155 Participants
Each patient received 100 mg of canagliflozin once daily for for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
|
Canagliflozin 300 mg
n=152 Participants
Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
|
|---|---|---|---|
|
Change in HbA1c From Baseline to Week 26
|
-0.13 Percent
Standard Error 0.075
|
-0.85 Percent
Standard Error 0.075
|
-1.06 Percent
Standard Error 0.076
|
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=150 Participants
Each patient received matching placebo once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
|
Canagliflozin 100 mg
n=155 Participants
Each patient received 100 mg of canagliflozin once daily for for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
|
Canagliflozin 300 mg
n=152 Participants
Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
|
|---|---|---|---|
|
Percentage of Patients With HbA1c <7% at Week 26
|
18 Percentage of patients
|
43.2 Percentage of patients
|
56.6 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=150 Participants
Each patient received matching placebo once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
|
Canagliflozin 100 mg
n=155 Participants
Each patient received 100 mg of canagliflozin once daily for for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
|
Canagliflozin 300 mg
n=152 Participants
Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
|
|---|---|---|---|
|
Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26
|
4.11 mg/dL
Standard Error 3.629
|
-18.2 mg/dL
Standard Error 3.629
|
-30.5 mg/dL
Standard Error 3.650
|
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 percent change in body weight 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 percent change.
Outcome measures
| Measure |
Placebo
n=150 Participants
Each patient received matching placebo once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
|
Canagliflozin 100 mg
n=156 Participants
Each patient received 100 mg of canagliflozin once daily for for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
|
Canagliflozin 300 mg
n=154 Participants
Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
|
|---|---|---|---|
|
Percent Change in Body Weight From Baseline to Week 26
|
-0.7 Percent change
Standard Error 0.3
|
-2.1 Percent change
Standard Error 0.3
|
-2.6 Percent change
Standard Error 0.3
|
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 SBP 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=150 Participants
Each patient received matching placebo once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
|
Canagliflozin 100 mg
n=156 Participants
Each patient received 100 mg of canagliflozin once daily for for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
|
Canagliflozin 300 mg
n=154 Participants
Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
|
|---|---|---|---|
|
Change in Systolic Blood Pressure (SBP) From Baseline to Week 26
|
-2.65 mmHg
Standard Error 0.982
|
-4.89 mmHg
Standard Error 0.976
|
-4.27 mmHg
Standard Error 0.980
|
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 percent change in triglycerides 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 percent change.
Outcome measures
| Measure |
Placebo
n=134 Participants
Each patient received matching placebo once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
|
Canagliflozin 100 mg
n=145 Participants
Each patient received 100 mg of canagliflozin once daily for for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
|
Canagliflozin 300 mg
n=142 Participants
Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
|
|---|---|---|---|
|
Percent Change in Triglycerides From Baseline to Week 26
|
11.6 Percent change
Standard Error 4.2
|
5.4 Percent change
Standard Error 4.2
|
8.5 Percent change
Standard Error 4.2
|
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 percent change in HDL-C 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 percent change.
Outcome measures
| Measure |
Placebo
n=135 Participants
Each patient received matching placebo once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
|
Canagliflozin 100 mg
n=145 Participants
Each patient received 100 mg of canagliflozin once daily for for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
|
Canagliflozin 300 mg
n=141 Participants
Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
|
|---|---|---|---|
|
Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 26
|
3.2 Percent change
Standard Error 1.3
|
5.7 Percent change
Standard Error 1.3
|
6.5 Percent change
Standard Error 1.3
|
Adverse Events
Placebo: Baseline to Week 26
Serious events: 9 serious events
Other events: 31 other events
Deaths: 0 deaths
Canagliflozin 100 mg: Baseline to Week 26
Serious events: 5 serious events
Other events: 42 other events
Deaths: 0 deaths
Canagliflozin 300 mg: Baseline to Week 26
Serious events: 6 serious events
Other events: 38 other events
Deaths: 0 deaths
Placebo: Baseline to Week 52
Serious events: 13 serious events
Other events: 52 other events
Deaths: 0 deaths
Canagliflozin 100 mg: Baseline to Week 52
Serious events: 7 serious events
Other events: 63 other events
Deaths: 0 deaths
Canagliflozin 300 mg: Baseline to Week 52
Serious events: 8 serious events
Other events: 54 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo: Baseline to Week 26
n=156 participants at risk
Each patient received matching placebo once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea. Data are presented for Baseline to Week 26.
|
Canagliflozin 100 mg: Baseline to Week 26
n=157 participants at risk
Each patient received 100 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea. Data are presented for Baseline to Week 26.
|
Canagliflozin 300 mg: Baseline to Week 26
n=156 participants at risk
Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea. Data are presented for Baseline to Week 26.
|
Placebo: Baseline to Week 52
n=156 participants at risk
Each patient received matching placebo once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea. Data are presented for Baseline to Week 52.
|
Canagliflozin 100 mg: Baseline to Week 52
n=157 participants at risk
Each patient received 100 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea. Data are presented for Baseline to Week 52.
|
Canagliflozin 300 mg: Baseline to Week 52
n=156 participants at risk
Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea. Data are presented for Baseline to Week 52.
|
|---|---|---|---|---|---|---|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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%
0/157 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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%
0/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.64%
1/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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%
0/157 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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%
0/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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
Chest pain
|
0.00%
0/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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%
0/157 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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%
0/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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%
0/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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%
0/157 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.64%
1/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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
Ankle fracture
|
0.00%
0/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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%
0/157 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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%
0/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.64%
1/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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%
0/157 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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%
0/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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
Road traffic accident
|
0.00%
0/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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%
0/157 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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%
0/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.64%
1/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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%
0/157 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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%
0/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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 ketoacidosis
|
0.00%
0/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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%
0/157 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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%
0/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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%
0/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.64%
1/157 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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%
0/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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
Nephrolithiasis
|
0.00%
0/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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%
0/157 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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%
0/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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%
0/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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%
0/157 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.64%
1/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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 incontinence
|
0.00%
0/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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%
0/157 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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%
0/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.64%
1/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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%
0/157 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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%
0/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Reproductive system and breast disorders
Uterine enlargement
|
0.00%
0/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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%
0/157 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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%
0/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.64%
1/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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%
0/157 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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%
0/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Reproductive system and breast disorders
Uterine prolapse
|
0.00%
0/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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%
0/157 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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%
0/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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%
0/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.64%
1/157 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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%
0/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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 fibrillation
|
0.00%
0/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.64%
1/157 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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%
0/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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%
0/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.64%
1/157 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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%
0/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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 stenosis
|
0.64%
1/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.64%
1/157 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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%
0/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.64%
1/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.64%
1/157 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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%
0/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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
|
0.64%
1/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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%
0/157 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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%
0/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.64%
1/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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%
0/157 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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%
0/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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
Abdominal pain
|
0.64%
1/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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%
0/157 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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%
0/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.64%
1/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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%
0/157 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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%
0/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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
Mechanical ileus
|
0.64%
1/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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%
0/157 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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%
0/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.64%
1/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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%
0/157 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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%
0/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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
Ulcer haemorrhage
|
0.00%
0/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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%
0/157 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.64%
1/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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%
0/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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%
0/157 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.64%
1/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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
Biliary dyskinesia
|
0.00%
0/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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%
0/157 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.64%
1/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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%
0/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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%
0/157 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.64%
1/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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
Cholecystitis
|
0.00%
0/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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%
0/157 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.64%
1/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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%
0/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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%
0/157 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.64%
1/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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
Cholecystitis chronic
|
0.64%
1/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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%
0/157 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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%
0/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.64%
1/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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%
0/157 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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%
0/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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
Diverticulitis
|
0.64%
1/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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%
0/157 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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%
0/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.64%
1/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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%
0/157 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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%
0/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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
Gangrene
|
0.64%
1/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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%
0/157 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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%
0/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.64%
1/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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%
0/157 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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%
0/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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
|
0.64%
1/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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%
0/157 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.64%
1/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.64%
1/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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%
0/157 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.64%
1/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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
|
0.00%
0/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.64%
1/157 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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%
0/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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%
0/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.64%
1/157 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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%
0/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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
Scrotal gangrene
|
0.64%
1/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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%
0/157 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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%
0/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.64%
1/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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%
0/157 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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%
0/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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
|
0.00%
0/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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%
0/157 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.64%
1/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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%
0/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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%
0/157 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.64%
1/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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
Urosepsis
|
0.00%
0/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.64%
1/157 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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%
0/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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%
0/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.64%
1/157 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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%
0/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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%
0/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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%
0/157 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.64%
1/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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%
0/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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%
0/157 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.64%
1/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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
|
0.00%
0/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.64%
1/157 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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%
0/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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%
0/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.64%
1/157 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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%
0/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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
Musculoskeletal chest pain
|
0.00%
0/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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%
0/157 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.64%
1/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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%
0/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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%
0/157 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.64%
1/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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
Spinal osteoarthritis
|
0.64%
1/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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%
0/157 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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%
0/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.64%
1/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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%
0/157 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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%
0/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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)
Colon cancer
|
0.64%
1/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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%
0/157 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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%
0/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.64%
1/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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%
0/157 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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%
0/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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%
0/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.64%
1/157 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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%
0/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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%
0/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.64%
1/157 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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%
0/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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
Calculus ureteric
|
0.00%
0/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.64%
1/157 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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%
0/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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%
0/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.64%
1/157 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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%
0/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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
Hydronephrosis
|
0.00%
0/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.64%
1/157 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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%
0/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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%
0/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.64%
1/157 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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%
0/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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
|
0.00%
0/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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%
0/157 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.64%
1/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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%
0/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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%
0/157 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.64%
1/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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%
0/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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%
0/157 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.64%
1/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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%
0/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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%
0/157 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.64%
1/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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
|
0.64%
1/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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%
0/157 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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%
0/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.64%
1/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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%
0/157 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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%
0/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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=156 participants at risk
Each patient received matching placebo once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea. Data are presented for Baseline to Week 26.
|
Canagliflozin 100 mg: Baseline to Week 26
n=157 participants at risk
Each patient received 100 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea. Data are presented for Baseline to Week 26.
|
Canagliflozin 300 mg: Baseline to Week 26
n=156 participants at risk
Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea. Data are presented for Baseline to Week 26.
|
Placebo: Baseline to Week 52
n=156 participants at risk
Each patient received matching placebo once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea. Data are presented for Baseline to Week 52.
|
Canagliflozin 100 mg: Baseline to Week 52
n=157 participants at risk
Each patient received 100 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea. Data are presented for Baseline to Week 52.
|
Canagliflozin 300 mg: Baseline to Week 52
n=156 participants at risk
Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea. Data are presented for Baseline to Week 52.
|
|---|---|---|---|---|---|---|
|
Infections and infestations
Influenza
|
0.00%
0/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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%
0/157 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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%
0/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
5.1%
8/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
2.5%
4/157 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
5.1%
8/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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
Sinusitis
|
0.00%
0/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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%
0/157 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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%
0/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
1.9%
3/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
5.1%
8/157 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
1.9%
3/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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
|
0.00%
0/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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%
0/157 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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%
0/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
5.1%
8/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
5.1%
8/157 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
5.1%
8/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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
|
0.00%
0/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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%
0/157 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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%
0/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
3.2%
5/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
7.0%
11/157 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
1.3%
2/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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
|
3.2%
5/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
3.2%
5/157 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
6.4%
10/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
3.2%
5/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
5.1%
8/157 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
7.1%
11/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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
|
2.6%
4/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
3.8%
6/157 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
5.1%
8/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
6.4%
10/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
5.7%
9/157 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
5.8%
9/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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 infection
|
6.4%
10/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
10.8%
17/157 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
3.8%
6/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
8.3%
13/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
13.4%
21/157 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
5.8%
9/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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
|
5.1%
8/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
5.7%
9/157 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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%
7/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
7.7%
12/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
7.6%
12/157 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
5.8%
9/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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
Vulvovaginal mycotic infection
|
1.3%
2/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
5.1%
8/157 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
5.1%
8/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
1.3%
2/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
5.7%
9/157 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
5.1%
8/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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
|
3.8%
6/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
7.0%
11/157 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
5.8%
9/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
5.8%
9/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
8.3%
13/157 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
7.1%
11/156 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are 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