Trial Outcomes & Findings for The CANTATA-D Trial (CANagliflozin Treatment and Trial Analysis - DPP-4 Inhibitor Comparator Trial) (NCT NCT01106677)
NCT ID: NCT01106677
Last Updated: 2013-07-30
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 or sitagliptin group minus placebo) in the LS mean change.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1284 participants
Primary outcome timeframe
Day 1 (Baseline) and Week 26
Results posted on
2013-07-30
Participant Flow
This study evaluated the efficacy and safety of canagliflozin compared with sitagliptin and placebo in patients with type 2 diabetes mellitus with inadequate control despite treatment with metformin. The study was conducted between 07 April 2010 and 17 August 2012 and recruited patients from 169 study centers in 22 countries worldwide.
1,284 patients were randomly allocated to the 4 treatment arms. All patients received at least 1 dose of study drug and were included in the modified intent-to-treat (mITT) analysis set (used for the Week 26 and week 52 efficacy analyses). All 1,284 patients were included in the Week 26 and Week 52 safety analysis sets.
Participant milestones
| Measure |
Placebo/Sitagliptin
Each patient received matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52. Placebo and sitagliptin were given with protocol-specified doses of metformin immediate release.
|
Canagliflozin 100 mg
Each patient received 100 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
|
Canagliflozin 300 mg
Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
|
Sitagliptin 100 mg
Each patient received 100 mg of sitagliptin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
|
|---|---|---|---|---|
|
Core Period: Baseline to Week 26
STARTED
|
183
|
368
|
367
|
366
|
|
Core Period: Baseline to Week 26
COMPLETED
|
155
|
322
|
323
|
319
|
|
Core Period: Baseline to Week 26
NOT COMPLETED
|
28
|
46
|
44
|
47
|
|
Extension Period: Week 26 to Week 52
STARTED
|
153
|
316
|
321
|
313
|
|
Extension Period: Week 26 to Week 52
COMPLETED
|
138
|
298
|
299
|
285
|
|
Extension Period: Week 26 to Week 52
NOT COMPLETED
|
15
|
18
|
22
|
28
|
Reasons for withdrawal
| Measure |
Placebo/Sitagliptin
Each patient received matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52. Placebo and sitagliptin were given with protocol-specified doses of metformin immediate release.
|
Canagliflozin 100 mg
Each patient received 100 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
|
Canagliflozin 300 mg
Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
|
Sitagliptin 100 mg
Each patient received 100 mg of sitagliptin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
|
|---|---|---|---|---|
|
Core Period: Baseline to Week 26
Adverse Event
|
7
|
18
|
6
|
8
|
|
Core Period: Baseline to Week 26
Death
|
0
|
0
|
1
|
0
|
|
Core Period: Baseline to Week 26
Lack of Efficacy
|
1
|
0
|
0
|
0
|
|
Core Period: Baseline to Week 26
Lost to Follow-up
|
3
|
1
|
6
|
3
|
|
Core Period: Baseline to Week 26
Physician Decision
|
2
|
1
|
3
|
1
|
|
Core Period: Baseline to Week 26
Protocol Violation
|
0
|
1
|
0
|
3
|
|
Core Period: Baseline to Week 26
Withdrawal by Subject
|
5
|
3
|
15
|
6
|
|
Core Period: Baseline to Week 26
Creatinine or eGFR withdrawal criteria
|
1
|
2
|
2
|
3
|
|
Core Period: Baseline to Week 26
Noncompliance with study drug
|
1
|
3
|
0
|
0
|
|
Core Period: Baseline to Week 26
Study terminated by sponsor
|
0
|
1
|
2
|
0
|
|
Core Period: Baseline to Week 26
Product quality complaint
|
0
|
1
|
1
|
0
|
|
Core Period: Baseline to Week 26
Other
|
8
|
14
|
8
|
23
|
|
Core Period: Baseline to Week 26
Pregnancy
|
0
|
1
|
0
|
0
|
|
Extension Period: Week 26 to Week 52
Adverse Event
|
1
|
1
|
5
|
9
|
|
Extension Period: Week 26 to Week 52
Death
|
0
|
0
|
0
|
1
|
|
Extension Period: Week 26 to Week 52
Lack of Efficacy
|
2
|
0
|
0
|
4
|
|
Extension Period: Week 26 to Week 52
Lost to Follow-up
|
0
|
2
|
2
|
2
|
|
Extension Period: Week 26 to Week 52
Physician Decision
|
2
|
3
|
2
|
3
|
|
Extension Period: Week 26 to Week 52
Protocol Violation
|
1
|
0
|
0
|
0
|
|
Extension Period: Week 26 to Week 52
Withdrawal by Subject
|
1
|
3
|
2
|
1
|
|
Extension Period: Week 26 to Week 52
Creatinine or eGFR withdrawal criteria
|
2
|
4
|
3
|
2
|
|
Extension Period: Week 26 to Week 52
Unable to take rescue therapy
|
0
|
0
|
0
|
1
|
|
Extension Period: Week 26 to Week 52
Other
|
6
|
5
|
8
|
5
|
Baseline Characteristics
The CANTATA-D Trial (CANagliflozin Treatment and Trial Analysis - DPP-4 Inhibitor Comparator Trial)
Baseline characteristics by cohort
| Measure |
Placebo/Sitagliptin
n=183 Participants
Each patient received matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52. Placebo and sitagliptin were given with protocol-specified doses of metformin immediate release.
|
Canagliflozin 100 mg
n=368 Participants
Each patient received 100 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
|
Canagliflozin 300 mg
n=367 Participants
Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
|
Sitagliptin 100 mg
n=366 Participants
Each patient received 100 mg of sitagliptin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
|
Total
n=1284 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
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
146 Participants
n=5 Participants
|
314 Participants
n=7 Participants
|
309 Participants
n=5 Participants
|
309 Participants
n=4 Participants
|
1078 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
37 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
57 Participants
n=4 Participants
|
206 Participants
n=21 Participants
|
|
Age Continuous
|
55.3 years
STANDARD_DEVIATION 9.76 • n=5 Participants
|
55.5 years
STANDARD_DEVIATION 9.38 • n=7 Participants
|
55.3 years
STANDARD_DEVIATION 9.19 • n=5 Participants
|
55.5 years
STANDARD_DEVIATION 9.55 • n=4 Participants
|
55.4 years
STANDARD_DEVIATION 9.42 • n=21 Participants
|
|
Sex: Female, Male
Female
|
89 Participants
n=5 Participants
|
194 Participants
n=7 Participants
|
202 Participants
n=5 Participants
|
194 Participants
n=4 Participants
|
679 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
94 Participants
n=5 Participants
|
174 Participants
n=7 Participants
|
165 Participants
n=5 Participants
|
172 Participants
n=4 Participants
|
605 Participants
n=21 Participants
|
|
Region Enroll
ARGENTINA
|
8 participants
n=5 Participants
|
9 participants
n=7 Participants
|
15 participants
n=5 Participants
|
11 participants
n=4 Participants
|
43 participants
n=21 Participants
|
|
Region Enroll
BULGARIA
|
4 participants
n=5 Participants
|
2 participants
n=7 Participants
|
1 participants
n=5 Participants
|
3 participants
n=4 Participants
|
10 participants
n=21 Participants
|
|
Region Enroll
COLOMBIA
|
4 participants
n=5 Participants
|
15 participants
n=7 Participants
|
8 participants
n=5 Participants
|
15 participants
n=4 Participants
|
42 participants
n=21 Participants
|
|
Region Enroll
CZECH REPUBLIC
|
7 participants
n=5 Participants
|
8 participants
n=7 Participants
|
8 participants
n=5 Participants
|
7 participants
n=4 Participants
|
30 participants
n=21 Participants
|
|
Region Enroll
ESTONIA
|
6 participants
n=5 Participants
|
6 participants
n=7 Participants
|
3 participants
n=5 Participants
|
5 participants
n=4 Participants
|
20 participants
n=21 Participants
|
|
Region Enroll
GREECE
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
4 participants
n=4 Participants
|
9 participants
n=21 Participants
|
|
Region Enroll
INDIA
|
13 participants
n=5 Participants
|
28 participants
n=7 Participants
|
31 participants
n=5 Participants
|
22 participants
n=4 Participants
|
94 participants
n=21 Participants
|
|
Region Enroll
ITALY
|
2 participants
n=5 Participants
|
3 participants
n=7 Participants
|
3 participants
n=5 Participants
|
1 participants
n=4 Participants
|
9 participants
n=21 Participants
|
|
Region Enroll
LATVIA
|
3 participants
n=5 Participants
|
7 participants
n=7 Participants
|
6 participants
n=5 Participants
|
10 participants
n=4 Participants
|
26 participants
n=21 Participants
|
|
Region Enroll
MALAYSIA
|
9 participants
n=5 Participants
|
7 participants
n=7 Participants
|
11 participants
n=5 Participants
|
7 participants
n=4 Participants
|
34 participants
n=21 Participants
|
|
Region Enroll
MEXICO
|
12 participants
n=5 Participants
|
20 participants
n=7 Participants
|
26 participants
n=5 Participants
|
18 participants
n=4 Participants
|
76 participants
n=21 Participants
|
|
Region Enroll
PERU
|
16 participants
n=5 Participants
|
36 participants
n=7 Participants
|
30 participants
n=5 Participants
|
37 participants
n=4 Participants
|
119 participants
n=21 Participants
|
|
Region Enroll
POLAND
|
1 participants
n=5 Participants
|
18 participants
n=7 Participants
|
14 participants
n=5 Participants
|
10 participants
n=4 Participants
|
43 participants
n=21 Participants
|
|
Region Enroll
PORTUGAL
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
2 participants
n=4 Participants
|
4 participants
n=21 Participants
|
|
Region Enroll
RUSSIAN FEDERATION
|
15 participants
n=5 Participants
|
34 participants
n=7 Participants
|
28 participants
n=5 Participants
|
22 participants
n=4 Participants
|
99 participants
n=21 Participants
|
|
Region Enroll
SINGAPORE
|
3 participants
n=5 Participants
|
5 participants
n=7 Participants
|
3 participants
n=5 Participants
|
3 participants
n=4 Participants
|
14 participants
n=21 Participants
|
|
Region Enroll
SLOVAKIA
|
12 participants
n=5 Participants
|
16 participants
n=7 Participants
|
21 participants
n=5 Participants
|
17 participants
n=4 Participants
|
66 participants
n=21 Participants
|
|
Region Enroll
SWEDEN
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
2 participants
n=5 Participants
|
4 participants
n=4 Participants
|
12 participants
n=21 Participants
|
|
Region Enroll
THAILAND
|
4 participants
n=5 Participants
|
9 participants
n=7 Participants
|
11 participants
n=5 Participants
|
8 participants
n=4 Participants
|
32 participants
n=21 Participants
|
|
Region Enroll
TURKEY
|
1 participants
n=5 Participants
|
5 participants
n=7 Participants
|
11 participants
n=5 Participants
|
9 participants
n=4 Participants
|
26 participants
n=21 Participants
|
|
Region Enroll
UKRAINE
|
8 participants
n=5 Participants
|
24 participants
n=7 Participants
|
29 participants
n=5 Participants
|
30 participants
n=4 Participants
|
91 participants
n=21 Participants
|
|
Region Enroll
UNITED STATES
|
50 participants
n=5 Participants
|
111 participants
n=7 Participants
|
103 participants
n=5 Participants
|
121 participants
n=4 Participants
|
385 participants
n=21 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 or sitagliptin group minus placebo) in the LS mean change.
Outcome measures
| Measure |
Placebo/Sitagliptin
n=181 Participants
Each patient received matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52. Placebo and sitagliptin were given with protocol-specified doses of metformin immediate release.
|
Canagliflozin 100 mg
n=365 Participants
Each patient received 100 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
|
Canagliflozin 300 mg
n=360 Participants
Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
|
Sitagliptin 100 mg
n=354 Participants
Each patient received 100 mg of sitagliptin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
|
|---|---|---|---|---|
|
Change in HbA1c From Baseline to Week 26
|
-0.17 Percent
Standard Error 0.060
|
-0.79 Percent
Standard Error 0.044
|
-0.94 Percent
Standard Error 0.044
|
-0.82 Percent
Standard Error 0.044
|
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 between each canagliflozin or sitagliptin group and placebo.
Outcome measures
| Measure |
Placebo/Sitagliptin
n=181 Participants
Each patient received matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52. Placebo and sitagliptin were given with protocol-specified doses of metformin immediate release.
|
Canagliflozin 100 mg
n=365 Participants
Each patient received 100 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
|
Canagliflozin 300 mg
n=360 Participants
Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
|
Sitagliptin 100 mg
n=354 Participants
Each patient received 100 mg of sitagliptin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
|
|---|---|---|---|---|
|
Percentage of Patients With HbA1c <7% at Week 26
|
29.8 Percentage of patients
|
45.5 Percentage of patients
|
57.8 Percentage of patients
|
54.5 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 or sitagliptin group minus placebo) in the LS mean change.
Outcome measures
| Measure |
Placebo/Sitagliptin
n=181 Participants
Each patient received matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52. Placebo and sitagliptin were given with protocol-specified doses of metformin immediate release.
|
Canagliflozin 100 mg
n=365 Participants
Each patient received 100 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
|
Canagliflozin 300 mg
n=360 Participants
Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
|
Sitagliptin 100 mg
n=354 Participants
Each patient received 100 mg of sitagliptin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
|
|---|---|---|---|---|
|
Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26
|
2.47 mg/dL
Standard Error 2.576
|
-27.3 mg/dL
Standard Error 1.873
|
-37.8 mg/dL
Standard Error 1.893
|
-20.2 mg/dL
Standard Error 1.908
|
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 2-hour post-prandial glucose from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin or sitagliptin group minus placebo) in the LS mean change.
Outcome measures
| Measure |
Placebo/Sitagliptin
n=129 Participants
Each patient received matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52. Placebo and sitagliptin were given with protocol-specified doses of metformin immediate release.
|
Canagliflozin 100 mg
n=298 Participants
Each patient received 100 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
|
Canagliflozin 300 mg
n=288 Participants
Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
|
Sitagliptin 100 mg
n=295 Participants
Each patient received 100 mg of sitagliptin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
|
|---|---|---|---|---|
|
Change in 2-hour Post-prandial Glucose From Baseline to Week 26
|
-9.79 mg/dL
Standard Error 4.860
|
-47.9 mg/dL
Standard Error 3.305
|
-57.1 mg/dL
Standard Error 3.356
|
-49.3 mg/dL
Standard Error 3.340
|
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 or sitagliptin group minus placebo) in the LS mean percent change.
Outcome measures
| Measure |
Placebo/Sitagliptin
n=181 Participants
Each patient received matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52. Placebo and sitagliptin were given with protocol-specified doses of metformin immediate release.
|
Canagliflozin 100 mg
n=365 Participants
Each patient received 100 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
|
Canagliflozin 300 mg
n=360 Participants
Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
|
Sitagliptin 100 mg
n=355 Participants
Each patient received 100 mg of sitagliptin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
|
|---|---|---|---|---|
|
Percent Change in Body Weight From Baseline to Week 26
|
-1.2 Percent change
Standard Error 0.3
|
-3.7 Percent change
Standard Error 0.2
|
-4.2 Percent change
Standard Error 0.2
|
-1.2 Percent change
Standard Error 0.2
|
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 change in SBP from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin or sitagliptin group minus placebo) in the LS mean change.
Outcome measures
| Measure |
Placebo/Sitagliptin
n=181 Participants
Each patient received matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52. Placebo and sitagliptin were given with protocol-specified doses of metformin immediate release.
|
Canagliflozin 100 mg
n=365 Participants
Each patient received 100 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
|
Canagliflozin 300 mg
n=360 Participants
Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
|
Sitagliptin 100 mg
n=355 Participants
Each patient received 100 mg of sitagliptin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
|
|---|---|---|---|---|
|
Change in Systolic Blood Pressure (SBP) From Baseline to Week 26
|
1.52 mmHg
Standard Error 0.829
|
-3.84 mmHg
Standard Error 0.602
|
-5.06 mmHg
Standard Error 0.605
|
-1.83 mmHg
Standard Error 0.611
|
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 or sitagliptin group minus placebo) in the LS mean percent change.
Outcome measures
| Measure |
Placebo/Sitagliptin
n=171 Participants
Each patient received matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52. Placebo and sitagliptin were given with protocol-specified doses of metformin immediate release.
|
Canagliflozin 100 mg
n=358 Participants
Each patient received 100 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
|
Canagliflozin 300 mg
n=341 Participants
Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
|
Sitagliptin 100 mg
n=338 Participants
Each patient received 100 mg of sitagliptin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
|
|---|---|---|---|---|
|
Percent Change in Triglycerides From Baseline to Week 26
|
3.2 Percent change
Standard Error 3.6
|
1.6 Percent change
Standard Error 2.6
|
-1.4 Percent change
Standard Error 2.6
|
1.0 Percent change
Standard Error 2.7
|
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 or sitagliptin group minus placebo) in the LS mean percent change.
Outcome measures
| Measure |
Placebo/Sitagliptin
n=171 Participants
Each patient received matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52. Placebo and sitagliptin were given with protocol-specified doses of metformin immediate release.
|
Canagliflozin 100 mg
n=357 Participants
Each patient received 100 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
|
Canagliflozin 300 mg
n=336 Participants
Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
|
Sitagliptin 100 mg
n=336 Participants
Each patient received 100 mg of sitagliptin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
|
|---|---|---|---|---|
|
Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 26
|
3.7 Percent change
Standard Error 1.3
|
10.4 Percent change
Standard Error 0.9
|
12.1 Percent change
Standard Error 1.0
|
5.0 Percent change
Standard Error 1.0
|
SECONDARY outcome
Timeframe: Day 1 (Baseline) and Week 52Population: 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 52 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 52 for each active treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus sitagliptin) in the LS mean change.
Outcome measures
| Measure |
Placebo/Sitagliptin
n=365 Participants
Each patient received matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52. Placebo and sitagliptin were given with protocol-specified doses of metformin immediate release.
|
Canagliflozin 100 mg
n=360 Participants
Each patient received 100 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
|
Canagliflozin 300 mg
n=354 Participants
Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
|
Sitagliptin 100 mg
Each patient received 100 mg of sitagliptin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
|
|---|---|---|---|---|
|
Change in HbA1c From Baseline to Week 52
|
-0.73 Percent
Standard Error 0.047
|
-0.88 Percent
Standard Error 0.047
|
-0.73 Percent
Standard Error 0.047
|
—
|
SECONDARY outcome
Timeframe: Day 1 (Baseline) and Week 52Population: 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 52 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 52 for each active treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus sitagliptin) in the LS mean change.
Outcome measures
| Measure |
Placebo/Sitagliptin
n=365 Participants
Each patient received matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52. Placebo and sitagliptin were given with protocol-specified doses of metformin immediate release.
|
Canagliflozin 100 mg
n=360 Participants
Each patient received 100 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
|
Canagliflozin 300 mg
n=354 Participants
Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
|
Sitagliptin 100 mg
Each patient received 100 mg of sitagliptin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
|
|---|---|---|---|---|
|
Change in Fasting Plasma Glucose (FPG) From Baseline to Week 52
|
-26.2 mg/dL
Standard Error 1.814
|
-35.2 mg/dL
Standard Error 1.833
|
-17.7 mg/dL
Standard Error 1.848
|
—
|
SECONDARY outcome
Timeframe: Day 1 (Baseline) and Week 52Population: 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 52 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 52 for each active treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus sitagliptin) in the LS mean percent change.
Outcome measures
| Measure |
Placebo/Sitagliptin
n=365 Participants
Each patient received matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52. Placebo and sitagliptin were given with protocol-specified doses of metformin immediate release.
|
Canagliflozin 100 mg
n=360 Participants
Each patient received 100 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
|
Canagliflozin 300 mg
n=355 Participants
Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
|
Sitagliptin 100 mg
Each patient received 100 mg of sitagliptin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
|
|---|---|---|---|---|
|
Percent Change in Body Weight From Baseline to Week 52
|
-3.8 Percent change
Standard Error 0.2
|
-4.2 Percent change
Standard Error 0.2
|
-1.3 Percent change
Standard Error 0.2
|
—
|
SECONDARY outcome
Timeframe: Day 1 (Baseline) and Week 52Population: 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 52 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 52 for each active treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus sitagliptin) in the LS mean change.
Outcome measures
| Measure |
Placebo/Sitagliptin
n=365 Participants
Each patient received matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52. Placebo and sitagliptin were given with protocol-specified doses of metformin immediate release.
|
Canagliflozin 100 mg
n=360 Participants
Each patient received 100 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
|
Canagliflozin 300 mg
n=355 Participants
Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
|
Sitagliptin 100 mg
Each patient received 100 mg of sitagliptin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
|
|---|---|---|---|---|
|
Change in Systolic Blood Pressure (SBP) From Baseline to Week 52
|
-3.53 mmHg
Standard Error 0.615
|
-4.65 mmHg
Standard Error 0.618
|
-0.66 mmHg
Standard Error 0.625
|
—
|
SECONDARY outcome
Timeframe: Day 1 (Baseline) and Week 52Population: 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 52 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 52 for each active treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus sitagliptin) in the LS mean percent change.
Outcome measures
| Measure |
Placebo/Sitagliptin
n=359 Participants
Each patient received matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52. Placebo and sitagliptin were given with protocol-specified doses of metformin immediate release.
|
Canagliflozin 100 mg
n=343 Participants
Each patient received 100 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
|
Canagliflozin 300 mg
n=339 Participants
Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
|
Sitagliptin 100 mg
Each patient received 100 mg of sitagliptin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
|
|---|---|---|---|---|
|
Percent Change in Triglycerides From Baseline to Week 52
|
1.9 Percent change
Standard Error 2.4
|
2.7 Percent change
Standard Error 2.4
|
-0.4 Percent change
Standard Error 2.5
|
—
|
SECONDARY outcome
Timeframe: Day 1 (Baseline) and Week 52Population: 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 52 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 52 for each active treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus sitagliptin) in the LS mean percent change.
Outcome measures
| Measure |
Placebo/Sitagliptin
n=359 Participants
Each patient received matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52. Placebo and sitagliptin were given with protocol-specified doses of metformin immediate release.
|
Canagliflozin 100 mg
n=343 Participants
Each patient received 100 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
|
Canagliflozin 300 mg
n=338 Participants
Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
|
Sitagliptin 100 mg
Each patient received 100 mg of sitagliptin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
|
|---|---|---|---|---|
|
Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 52
|
11.2 Percent change
Standard Error 1.0
|
13.3 Percent change
Standard Error 1.1
|
6.0 Percent change
Standard Error 1.1
|
—
|
Adverse Events
Placebo/Sitagliptin: Baseline to Week 26
Serious events: 4 serious events
Other events: 31 other events
Deaths: 0 deaths
Canagliflozin 100 mg: Baseline to Week 26
Serious events: 12 serious events
Other events: 55 other events
Deaths: 0 deaths
Canagliflozin 300 mg: Baseline to Week 26
Serious events: 10 serious events
Other events: 45 other events
Deaths: 0 deaths
Sitagliptin 100 mg: Baseline to Week 26
Serious events: 8 serious events
Other events: 42 other events
Deaths: 0 deaths
Placebo/Sitagliptin: Baseline to Week 52
Serious events: 7 serious events
Other events: 55 other events
Deaths: 0 deaths
Canagliflozin 100 mg: Baseline to Week 52
Serious events: 15 serious events
Other events: 108 other events
Deaths: 0 deaths
Canagliflozin 300 mg: Baseline to Week 52
Serious events: 12 serious events
Other events: 101 other events
Deaths: 0 deaths
Sitagliptin 100mg: Baseline to Week 52
Serious events: 18 serious events
Other events: 109 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo/Sitagliptin: Baseline to Week 26
n=183 participants at risk
Each patient received matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52. Placebo and sitagliptin were given with protocol-specified doses of metformin immediate release. Data are presented for Baseline to Week 26.
|
Canagliflozin 100 mg: Baseline to Week 26
n=368 participants at risk
Each patient received 100 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release. Data are presented for Baseline to Week 26.
|
Canagliflozin 300 mg: Baseline to Week 26
n=367 participants at risk
Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release. Data are presented for Baseline to Week 26.
|
Sitagliptin 100 mg: Baseline to Week 26
n=366 participants at risk
Each patient received 100 mg of sitagliptin once daily for 52 weeks with protocol-specified doses of metformin immediate release. Data are presented for Baseline to Week 26.
|
Placebo/Sitagliptin: Baseline to Week 52
n=183 participants at risk
Each patient received matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52. Placebo and sitagliptin were given with protocol-specified doses of metformin immediate release. Data are presented for Baseline to Week 52.
|
Canagliflozin 100 mg: Baseline to Week 52
n=368 participants at risk
Each patient received 100 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release. Data are presented for Baseline to Week 52.
|
Canagliflozin 300 mg: Baseline to Week 52
n=367 participants at risk
Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release. Data are presented for Baseline to Week 52.
|
Sitagliptin 100mg: Baseline to Week 52
n=366 participants at risk
Each patient received 100 mg of sitagliptin once daily for 52 weeks with protocol-specified doses of metformin immediate release. Data are presented for Baseline to Week 52.
|
|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Acute coronary syndrome
|
0.55%
1/183 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/368 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/367 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/366 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.55%
1/183 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/368 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/367 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/366 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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
Angina unstable
|
0.00%
0/183 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/368 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/367 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.27%
1/366 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/183 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/368 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/367 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.27%
1/366 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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 disease
|
0.00%
0/183 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.27%
1/368 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/367 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/366 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/183 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.27%
1/368 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/367 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.27%
1/366 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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
Stress cardiomyopathy
|
0.00%
0/183 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/368 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/367 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.27%
1/366 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/183 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/368 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/367 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.27%
1/366 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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
Supraventricular tachycardia
|
0.00%
0/183 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.27%
1/368 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/367 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/366 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/183 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.27%
1/368 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/367 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/366 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/183 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.27%
1/368 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/367 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/366 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/183 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.27%
1/368 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/367 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/366 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Eye disorders
Cataract nuclear
|
0.00%
0/183 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/368 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.27%
1/367 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/366 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/183 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/368 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/367 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/366 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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
|
0.00%
0/183 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/368 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/367 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.27%
1/366 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/183 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/368 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/367 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/366 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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
Constipation
|
0.00%
0/183 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/368 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.27%
1/367 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/366 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/183 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/368 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.27%
1/367 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/366 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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
Inguinal hernia
|
0.55%
1/183 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.27%
1/368 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.27%
1/367 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/366 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.55%
1/183 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.27%
1/368 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.27%
1/367 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/366 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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
Umbilical hernia
|
0.00%
0/183 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.27%
1/368 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/367 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/366 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/183 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.27%
1/368 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/367 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/366 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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
Hernia obstructive
|
0.00%
0/183 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/368 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/367 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.27%
1/366 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/183 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/368 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/367 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/366 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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
Cholangitis
|
0.00%
0/183 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.27%
1/368 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/367 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/366 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/183 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.27%
1/368 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/367 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/366 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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 acute
|
0.00%
0/183 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/368 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.27%
1/367 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/366 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/183 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/368 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.27%
1/367 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/366 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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
Cellulitis
|
0.00%
0/183 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/368 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/367 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.27%
1/366 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.55%
1/183 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/368 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/367 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.27%
1/366 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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
Gastroenteritis
|
0.00%
0/183 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.27%
1/368 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/367 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/366 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/183 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.27%
1/368 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/367 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.27%
1/366 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/183 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.27%
1/368 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/367 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/366 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/183 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.27%
1/368 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/367 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/366 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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
Pyothorax
|
0.00%
0/183 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.27%
1/368 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/367 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/366 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/183 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/368 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/367 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/366 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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
Sepsis
|
0.00%
0/183 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.27%
1/368 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/367 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/366 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.55%
1/183 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.27%
1/368 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/367 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/366 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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
Subcutaneous abscess
|
0.00%
0/183 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.27%
1/368 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/367 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/366 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/183 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.27%
1/368 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/367 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/366 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/183 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.27%
1/368 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/367 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/366 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/183 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.27%
1/368 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.27%
1/367 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/366 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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
Burns second degree
|
0.00%
0/183 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.27%
1/368 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/367 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/366 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/183 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.27%
1/368 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/367 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/366 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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
Cervical vertebral fracture
|
0.00%
0/183 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.27%
1/368 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/367 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/366 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/183 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.27%
1/368 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/367 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/366 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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
Incisional hernia
|
0.55%
1/183 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/368 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/367 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/366 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.55%
1/183 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/368 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/367 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/366 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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
Plantar fasciitis
|
0.00%
0/183 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/368 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.27%
1/367 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/366 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/183 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/368 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.27%
1/367 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/366 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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 column stenosis
|
0.00%
0/183 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/368 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/367 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.27%
1/366 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/183 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/368 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/367 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.27%
1/366 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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)
Breast cancer in situ
|
0.00%
0/183 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/368 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.27%
1/367 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/366 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/183 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/368 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.27%
1/367 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/366 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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)
Gastric cancer
|
0.55%
1/183 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/368 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/367 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/366 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.55%
1/183 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/368 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/367 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/366 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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)
Malignant mesenchymoma
|
0.00%
0/183 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/368 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/367 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.27%
1/366 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/183 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/368 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/367 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.27%
1/366 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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)
Meningioma
|
0.00%
0/183 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/368 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.27%
1/367 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/366 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/183 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/368 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.27%
1/367 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/366 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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
Brain oedema
|
0.00%
0/183 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/368 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.27%
1/367 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/366 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/183 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/368 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.27%
1/367 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/366 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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
Coma
|
0.00%
0/183 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/368 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.27%
1/367 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/366 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/183 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/368 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.27%
1/367 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/366 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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
Ischaemic stroke
|
0.00%
0/183 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/368 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.27%
1/367 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/366 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/183 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/368 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.27%
1/367 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/366 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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
Transient ischaemic attack
|
0.00%
0/183 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.27%
1/368 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/367 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/366 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/183 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.27%
1/368 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/367 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/366 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Pregnancy, puerperium and perinatal conditions
High risk pregnancy
|
0.00%
0/183 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/368 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.27%
1/367 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/366 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/183 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/368 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.27%
1/367 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/366 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/183 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/368 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/367 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.27%
1/366 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/183 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/368 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/367 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.27%
1/366 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/183 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/368 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/367 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.27%
1/366 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/183 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/368 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/367 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.27%
1/366 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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
Arterial thrombosis
|
0.00%
0/183 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/368 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.27%
1/367 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/366 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/183 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/368 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.27%
1/367 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/366 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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
Hypertensive crisis
|
0.00%
0/183 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/368 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/367 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.27%
1/366 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.55%
1/183 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/368 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/367 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.27%
1/366 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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
Acute myocardial infarction
|
0.00%
0/183 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/368 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/367 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/366 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/183 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/368 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/367 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.27%
1/366 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/183 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/368 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/367 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/366 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/183 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.27%
1/368 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/367 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/366 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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
Cardiac arrest
|
0.00%
0/183 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/368 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/367 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/366 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/183 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/368 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/367 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.27%
1/366 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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
Cardiomyopathy
|
0.00%
0/183 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/368 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/367 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/366 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/183 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.27%
1/368 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/367 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/366 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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
|
0.00%
0/183 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/368 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/367 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/366 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/183 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/368 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.27%
1/367 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/366 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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 hernia
|
0.00%
0/183 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/368 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/367 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/366 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/183 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/368 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/367 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.27%
1/366 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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
Diverticulum
|
0.00%
0/183 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/368 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/367 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/366 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/183 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/368 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/367 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.27%
1/366 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/183 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/368 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/367 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/366 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/183 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.27%
1/368 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/367 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/366 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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
Dengue fever
|
0.00%
0/183 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/368 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/367 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/366 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/183 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/368 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/367 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.27%
1/366 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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
Infectious pleural effusion
|
0.00%
0/183 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/368 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/367 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/366 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/183 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.27%
1/368 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/367 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/366 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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
|
0.00%
0/183 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/368 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/367 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/366 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/183 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/368 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/367 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.27%
1/366 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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
Septic shock
|
0.00%
0/183 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/368 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/367 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/366 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/183 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/368 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/367 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.27%
1/366 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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
Incisional hernia, obstructive
|
0.00%
0/183 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/368 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/367 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/366 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/183 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/368 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/367 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.27%
1/366 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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
Multiple drug overdose
|
0.00%
0/183 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/368 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/367 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/366 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/183 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/368 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.27%
1/367 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/366 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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
Thermal burn
|
0.00%
0/183 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/368 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/367 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/366 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/183 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/368 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/367 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.27%
1/366 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/183 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/368 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/367 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/366 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/183 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/368 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/367 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.27%
1/366 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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
Intervertebral disc protrusion
|
0.00%
0/183 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/368 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/367 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/366 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/183 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/368 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/367 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.27%
1/366 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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)
Bronchial carcinoma
|
0.00%
0/183 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/368 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/367 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/366 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/183 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/368 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.27%
1/367 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/366 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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)
Colorectal cancer
|
0.00%
0/183 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/368 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/367 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/366 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/183 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/368 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.27%
1/367 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/366 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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)
Large cell lung cancer stage III
|
0.00%
0/183 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/368 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/367 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/366 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/183 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/368 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/367 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.27%
1/366 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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)
Prostate cancer
|
0.00%
0/183 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/368 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/367 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/366 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/183 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/368 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.27%
1/367 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/366 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/183 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/368 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/367 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/366 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/183 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/368 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/367 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.27%
1/366 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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
Trigeminal neuralgia
|
0.00%
0/183 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/368 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/367 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/366 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.55%
1/183 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/368 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/367 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/366 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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
Renal failure acute
|
0.00%
0/183 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/368 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/367 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/366 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/183 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/368 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
0/367 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.27%
1/366 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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/Sitagliptin: Baseline to Week 26
n=183 participants at risk
Each patient received matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52. Placebo and sitagliptin were given with protocol-specified doses of metformin immediate release. Data are presented for Baseline to Week 26.
|
Canagliflozin 100 mg: Baseline to Week 26
n=368 participants at risk
Each patient received 100 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release. Data are presented for Baseline to Week 26.
|
Canagliflozin 300 mg: Baseline to Week 26
n=367 participants at risk
Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release. Data are presented for Baseline to Week 26.
|
Sitagliptin 100 mg: Baseline to Week 26
n=366 participants at risk
Each patient received 100 mg of sitagliptin once daily for 52 weeks with protocol-specified doses of metformin immediate release. Data are presented for Baseline to Week 26.
|
Placebo/Sitagliptin: Baseline to Week 52
n=183 participants at risk
Each patient received matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52. Placebo and sitagliptin were given with protocol-specified doses of metformin immediate release. Data are presented for Baseline to Week 52.
|
Canagliflozin 100 mg: Baseline to Week 52
n=368 participants at risk
Each patient received 100 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release. Data are presented for Baseline to Week 52.
|
Canagliflozin 300 mg: Baseline to Week 52
n=367 participants at risk
Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release. Data are presented for Baseline to Week 52.
|
Sitagliptin 100mg: Baseline to Week 52
n=366 participants at risk
Each patient received 100 mg of sitagliptin once daily for 52 weeks with protocol-specified doses of metformin immediate release. Data are presented for Baseline to Week 52.
|
|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
6.6%
12/183 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
3.3%
12/368 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
4.9%
18/367 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
4.4%
16/366 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
13/183 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
4.1%
15/368 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
6.3%
23/367 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
6.3%
23/366 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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
|
7.1%
13/183 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
4.1%
15/368 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
2.7%
10/367 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
14/366 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
13/183 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
4.9%
18/368 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
4.4%
16/367 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
6.0%
22/366 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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
|
6.6%
12/183 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
3.3%
12/368 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
2.7%
10/367 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
4.4%
16/366 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
13/183 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
5.2%
19/368 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
3.5%
13/367 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
5.2%
19/366 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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
Pollakiuria
|
0.55%
1/183 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
21/368 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
2.7%
10/367 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.55%
2/366 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.55%
1/183 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
21/368 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
3.0%
11/367 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.55%
2/366 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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
|
3.3%
6/183 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
1.4%
5/368 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
4.9%
18/367 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
4.9%
18/366 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
5.5%
10/183 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
3.3%
12/368 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
6.3%
23/367 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
6.0%
22/366 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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
|
2.2%
4/183 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
4.9%
18/368 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
3.5%
13/367 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
3.3%
12/366 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
6.6%
12/183 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
7.3%
27/368 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
4.6%
17/367 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
6.0%
22/366 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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
|
4.9%
9/183 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
7/368 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
1.1%
4/367 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
3.0%
11/366 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
6.0%
11/183 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
2.7%
10/368 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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%
9/367 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
4.6%
17/366 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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
|
3.3%
6/183 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
2.2%
8/368 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
3.3%
12/367 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
1.1%
4/366 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
5.5%
10/183 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
3.5%
13/368 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
4.1%
15/367 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
2.7%
10/366 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table 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