Trial Outcomes & Findings for CANagliflozin Treatment And Trial Analysis-Sulfonylurea (CANTATA-SU) SGLT2 Add-on to Metformin Versus Glimepiride (NCT NCT00968812)
NCT ID: NCT00968812
Last Updated: 2017-01-30
Results Overview
The table below shows the least-squares (LS) mean change in HbA1c from Baseline to Week 52 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus glimepiride) in the LS mean change.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1452 participants
Primary outcome timeframe
Day 1 (Baseline) and Week 52
Results posted on
2017-01-30
Participant Flow
This study evaluated the efficacy and safety of canagliflozin (JNJ-28431754) compared with glimepiride in participants with type 2 diabetes mellitus with inadequate glycemic control despite metformin treatment. The study was conducted between 28 August 2009 and 25 January 2013 and included 157 study centers in 19 countries worldwide.
1,452 participants were randomly allocated to the 3 treatment arms. 1450 participants received at least 1 dose of study drug and were included in the modified intent-to-treat (mITT) analysis set and safety analysis set. Participant flow is presented for Baseline to Week 104.
Participant milestones
| Measure |
Canagliflozin 100 mg: Baseline to Week 104
Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily with protocol-specified doses of metformin for 104 weeks.
|
Canagliflozin 300 mg: Baseline to Week 104
Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily with protocol-specified doses of metformin for 104 weeks.
|
Glimepiride: Baseline to Week 104
Each patient received glimepiride, at protocol-specified doses, once daily in combination with protocol-specified doses of metformin for 104 weeks.
|
|---|---|---|---|
|
Overall Study
STARTED
|
483
|
485
|
482
|
|
Overall Study
COMPLETED
|
343
|
323
|
314
|
|
Overall Study
NOT COMPLETED
|
140
|
162
|
168
|
Reasons for withdrawal
| Measure |
Canagliflozin 100 mg: Baseline to Week 104
Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily with protocol-specified doses of metformin for 104 weeks.
|
Canagliflozin 300 mg: Baseline to Week 104
Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily with protocol-specified doses of metformin for 104 weeks.
|
Glimepiride: Baseline to Week 104
Each patient received glimepiride, at protocol-specified doses, once daily in combination with protocol-specified doses of metformin for 104 weeks.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
30
|
46
|
33
|
|
Overall Study
Death
|
2
|
2
|
1
|
|
Overall Study
Lack of Efficacy
|
9
|
7
|
16
|
|
Overall Study
Lost to Follow-up
|
17
|
12
|
11
|
|
Overall Study
Physician Decision
|
8
|
5
|
9
|
|
Overall Study
Protocol Violation
|
7
|
4
|
3
|
|
Overall Study
Withdrawal by Subject
|
17
|
23
|
25
|
|
Overall Study
Creatinine or eGFR withdrawal criteria
|
9
|
13
|
7
|
|
Overall Study
Noncompliance with study drug
|
4
|
1
|
6
|
|
Overall Study
Unable to take rescue therapy
|
12
|
12
|
17
|
|
Overall Study
Other
|
25
|
37
|
40
|
Baseline Characteristics
CANagliflozin Treatment And Trial Analysis-Sulfonylurea (CANTATA-SU) SGLT2 Add-on to Metformin Versus Glimepiride
Baseline characteristics by cohort
| Measure |
Canagliflozin 100 mg
n=483 Participants
Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily with protocol-specified doses of metformin for 104 weeks.
|
Canagliflozin 300 mg
n=485 Participants
Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily with protocol-specified doses of metformin for 104 weeks.
|
Glimepiride
n=482 Participants
Each patient received glimepiride, at protocol-specified doses, once daily in combination with protocol-specified doses of metformin for 104 weeks.
|
Total
n=1450 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
397 Participants
n=5 Participants
|
411 Participants
n=7 Participants
|
399 Participants
n=5 Participants
|
1207 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
86 Participants
n=5 Participants
|
74 Participants
n=7 Participants
|
83 Participants
n=5 Participants
|
243 Participants
n=4 Participants
|
|
Age, Continuous
|
56.4 years
STANDARD_DEVIATION 9.49 • n=5 Participants
|
55.8 years
STANDARD_DEVIATION 9.17 • n=7 Participants
|
56.3 years
STANDARD_DEVIATION 9.01 • n=5 Participants
|
56.2 years
STANDARD_DEVIATION 9.22 • n=4 Participants
|
|
Gender
Female
|
231 Participants
n=5 Participants
|
244 Participants
n=7 Participants
|
219 Participants
n=5 Participants
|
694 Participants
n=4 Participants
|
|
Gender
Male
|
252 Participants
n=5 Participants
|
241 Participants
n=7 Participants
|
263 Participants
n=5 Participants
|
756 Participants
n=4 Participants
|
|
Region Enroll
ARGENTINA
|
18 participants
n=5 Participants
|
18 participants
n=7 Participants
|
18 participants
n=5 Participants
|
54 participants
n=4 Participants
|
|
Region Enroll
BULGARIA
|
7 participants
n=5 Participants
|
7 participants
n=7 Participants
|
7 participants
n=5 Participants
|
21 participants
n=4 Participants
|
|
Region Enroll
CANADA
|
19 participants
n=5 Participants
|
20 participants
n=7 Participants
|
19 participants
n=5 Participants
|
58 participants
n=4 Participants
|
|
Region Enroll
COSTA RICA
|
10 participants
n=5 Participants
|
9 participants
n=7 Participants
|
9 participants
n=5 Participants
|
28 participants
n=4 Participants
|
|
Region Enroll
DENMARK
|
24 participants
n=5 Participants
|
25 participants
n=7 Participants
|
25 participants
n=5 Participants
|
74 participants
n=4 Participants
|
|
Region Enroll
FINLAND
|
18 participants
n=5 Participants
|
17 participants
n=7 Participants
|
19 participants
n=5 Participants
|
54 participants
n=4 Participants
|
|
Region Enroll
GERMANY
|
6 participants
n=5 Participants
|
7 participants
n=7 Participants
|
6 participants
n=5 Participants
|
19 participants
n=4 Participants
|
|
Region Enroll
INDIA
|
55 participants
n=5 Participants
|
55 participants
n=7 Participants
|
56 participants
n=5 Participants
|
166 participants
n=4 Participants
|
|
Region Enroll
ISRAEL
|
14 participants
n=5 Participants
|
15 participants
n=7 Participants
|
14 participants
n=5 Participants
|
43 participants
n=4 Participants
|
|
Region Enroll
MEXICO
|
24 participants
n=5 Participants
|
25 participants
n=7 Participants
|
24 participants
n=5 Participants
|
73 participants
n=4 Participants
|
|
Region Enroll
NORWAY
|
9 participants
n=5 Participants
|
9 participants
n=7 Participants
|
9 participants
n=5 Participants
|
27 participants
n=4 Participants
|
|
Region Enroll
PHILIPPINES
|
14 participants
n=5 Participants
|
13 participants
n=7 Participants
|
13 participants
n=5 Participants
|
40 participants
n=4 Participants
|
|
Region Enroll
POLAND
|
14 participants
n=5 Participants
|
15 participants
n=7 Participants
|
15 participants
n=5 Participants
|
44 participants
n=4 Participants
|
|
Region Enroll
ROMANIA
|
43 participants
n=5 Participants
|
43 participants
n=7 Participants
|
44 participants
n=5 Participants
|
130 participants
n=4 Participants
|
|
Region Enroll
RUSSIAN FEDERATION
|
23 participants
n=5 Participants
|
22 participants
n=7 Participants
|
22 participants
n=5 Participants
|
67 participants
n=4 Participants
|
|
Region Enroll
SLOVAKIA
|
15 participants
n=5 Participants
|
14 participants
n=7 Participants
|
13 participants
n=5 Participants
|
42 participants
n=4 Participants
|
|
Region Enroll
SOUTH KOREA
|
31 participants
n=5 Participants
|
32 participants
n=7 Participants
|
31 participants
n=5 Participants
|
94 participants
n=4 Participants
|
|
Region Enroll
UKRAINE
|
22 participants
n=5 Participants
|
22 participants
n=7 Participants
|
22 participants
n=5 Participants
|
66 participants
n=4 Participants
|
|
Region Enroll
UNITED STATES
|
117 participants
n=5 Participants
|
117 participants
n=7 Participants
|
116 participants
n=5 Participants
|
350 participants
n=4 Participants
|
PRIMARY 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 treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus glimepiride) in the LS mean change.
Outcome measures
| Measure |
Canagliflozin 100 mg
n=478 Participants
Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily with protocol-specified doses of metformin for 104 weeks.
|
Canagliflozin 300 mg
n=474 Participants
Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily with protocol-specified doses of metformin for 104 weeks.
|
Glimepiride
n=473 Participants
Each patient received glimepiride, at protocol-specified doses, once daily in combination with protocol-specified doses of metformin for 104 weeks.
|
|---|---|---|---|
|
Change in HbA1c From Baseline to Week 52
|
-0.82 Percent
Standard Error 0.039
|
-0.93 Percent
Standard Error 0.039
|
-0.81 Percent
Standard Error 0.039
|
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 percentage of patients who experienced at least 1 documented hypoglycemic event from Baseline to Week 52 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus glimepiride) in percentages.
Outcome measures
| Measure |
Canagliflozin 100 mg
n=483 Participants
Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily with protocol-specified doses of metformin for 104 weeks.
|
Canagliflozin 300 mg
n=485 Participants
Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily with protocol-specified doses of metformin for 104 weeks.
|
Glimepiride
n=482 Participants
Each patient received glimepiride, at protocol-specified doses, once daily in combination with protocol-specified doses of metformin for 104 weeks.
|
|---|---|---|---|
|
Percentage of Patients Experiencing at Least 1 Hypoglycemic Event From Baseline to Week 52
|
5.6 Percentage of patients
|
4.9 Percentage of patients
|
34.2 Percentage of patients
|
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 treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus glimepiride) in the LS mean percent change.
Outcome measures
| Measure |
Canagliflozin 100 mg
n=479 Participants
Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily with protocol-specified doses of metformin for 104 weeks.
|
Canagliflozin 300 mg
n=480 Participants
Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily with protocol-specified doses of metformin for 104 weeks.
|
Glimepiride
n=478 Participants
Each patient received glimepiride, at protocol-specified doses, once daily in combination with protocol-specified doses of metformin for 104 weeks.
|
|---|---|---|---|
|
Percent Change in Body Weight From Baseline to Week 52
|
-4.2 Percent change
Standard Error 0.2
|
-4.7 Percent change
Standard Error 0.2
|
1.0 Percent change
Standard Error 0.2
|
SECONDARY outcome
Timeframe: Baseline, Week 104Population: Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug).
The table below shows the least-squares (LS) mean change in HbA1c from Baseline to Week 104 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus glimepiride) in the LS mean change.
Outcome measures
| Measure |
Canagliflozin 100 mg
n=478 Participants
Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily with protocol-specified doses of metformin for 104 weeks.
|
Canagliflozin 300 mg
n=474 Participants
Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily with protocol-specified doses of metformin for 104 weeks.
|
Glimepiride
n=474 Participants
Each patient received glimepiride, at protocol-specified doses, once daily in combination with protocol-specified doses of metformin for 104 weeks.
|
|---|---|---|---|
|
Change in HbA1c From Baseline to Week 104
|
-0.65 Percent
Standard Error 0.042 • Interval 0.1 to 0.22
|
-0.74 Percent
Standard Error 0.042 • Interval 0.1 to 0.21
|
-0.55 Percent
Standard Error 0.043 • Interval 0.31 to 0.43
|
Adverse Events
Canagliflozin 100 mg: Baseline to Week 52
Serious events: 24 serious events
Other events: 138 other events
Deaths: 0 deaths
Canagliflozin 300 mg: Baseline to Week 52
Serious events: 26 serious events
Other events: 150 other events
Deaths: 0 deaths
Glimepiride: Baseline to Week 52
Serious events: 39 serious events
Other events: 175 other events
Deaths: 0 deaths
Canagliflozin 100 mg: Baseline to Week 104
Serious events: 47 serious events
Other events: 198 other events
Deaths: 0 deaths
Canagliflozin 300 mg: Baseline to Week 104
Serious events: 47 serious events
Other events: 204 other events
Deaths: 0 deaths
Glimepiride: Baseline to Week 104
Serious events: 69 serious events
Other events: 242 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Canagliflozin 100 mg: Baseline to Week 52
n=483 participants at risk
Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily with protocol-specified doses of metformin for 104 weeks. Data are presented for Baseline to Week 52.
|
Canagliflozin 300 mg: Baseline to Week 52
n=485 participants at risk
Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily with protocol-specified doses of metformin for 104 weeks. Data are presented for Baseline to Week 52.
|
Glimepiride: Baseline to Week 52
n=482 participants at risk
Each patient received glimepiride, at protocol-specified doses, once daily in combination with protocol-specified doses of metformin for 104 weeks. Data are presented for Baseline to Week 52.
|
Canagliflozin 100 mg: Baseline to Week 104
n=483 participants at risk
Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily with protocol-specified doses of metformin for 104 weeks. Data are presented for Baseline to Week 104.
|
Canagliflozin 300 mg: Baseline to Week 104
n=485 participants at risk
Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily with protocol-specified doses of metformin for 104 weeks. Data are presented for Baseline to Week 104.
|
Glimepiride: Baseline to Week 104
n=482 participants at risk
Each patient received glimepiride, at protocol-specified doses, once daily in combination with protocol-specified doses of metformin for 104 weeks. Data are presented for Baseline to Week 104.
|
|---|---|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.21%
1/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
Cardiac disorders
Angina pectoris
|
0.21%
1/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.41%
2/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.41%
2/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.62%
3/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.41%
2/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.62%
3/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.41%
2/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
Cardiac disorders
Aortic valve incompetence
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.41%
2/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
Cardiac disorders
Bundle branch block left
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
Cardiac disorders
Cardiomyopathy
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.41%
2/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
Cardiac disorders
Diabetic cardiomyopathy
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
Cardiac disorders
Mitral valve incompetence
|
0.21%
1/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
Cardiac disorders
Myocardial infarction
|
0.21%
1/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.41%
2/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
Eye disorders
Angle closure glaucoma
|
0.21%
1/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
Eye disorders
Cataract
|
0.21%
1/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.41%
2/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.21%
1/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
Gastrointestinal disorders
Duodenitis
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.21%
1/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
Gastrointestinal disorders
Small intestinal perforation
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
General disorders
Asthenia
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.41%
2/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.41%
2/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.62%
3/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
General disorders
Oedema peripheral
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.62%
3/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.83%
4/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
Hepatobiliary disorders
Hepatic cyst
|
0.21%
1/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.41%
2/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.41%
2/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
Infections and infestations
Endometritis
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
Infections and infestations
Localised infection
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
Infections and infestations
Lobar pneumonia
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
Infections and infestations
Lung infection
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
Infections and infestations
Pneumonia
|
0.21%
1/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.41%
2/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.41%
2/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.41%
2/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
Infections and infestations
Postoperative wound infection
|
0.21%
1/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
Infections and infestations
Respiratory tract infection viral
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
Infections and infestations
Staphylococcal infection
|
0.21%
1/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
Infections and infestations
Urinary tract infection
|
0.21%
1/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.41%
2/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
Injury, poisoning and procedural complications
Eye injury
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.21%
1/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.21%
1/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.41%
2/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.21%
1/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
Injury, poisoning and procedural complications
Meniscus lesion
|
0.41%
2/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.41%
2/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
Injury, poisoning and procedural complications
Muscle injury
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
Injury, poisoning and procedural complications
Muscle rupture
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.21%
1/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
Injury, poisoning and procedural complications
Skull fracture
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.21%
1/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.21%
1/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.21%
1/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
Investigations
Blood creatinine increased
|
0.21%
1/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.21%
1/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.41%
2/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer stage I
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of the cervix
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.41%
2/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.62%
3/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
Nervous system disorders
Carotid arterial embolus
|
0.21%
1/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
Nervous system disorders
Cerebral infarction
|
0.21%
1/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.41%
2/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.41%
2/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.41%
2/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
Nervous system disorders
Hemiplegic migraine
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
Nervous system disorders
Vertebrobasilar insufficiency
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
Psychiatric disorders
Stress
|
0.21%
1/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
Renal and urinary disorders
Incontinence
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
Reproductive system and breast disorders
Dysfunctional uterine bleeding
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
Reproductive system and breast disorders
Menstrual disorder
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic bronchitis
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.41%
2/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.41%
2/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.41%
2/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.41%
2/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
Vascular disorders
Haematoma
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
Vascular disorders
Hypertension
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
Vascular disorders
Intermittent claudication
|
0.21%
1/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.41%
2/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
Cardiac disorders
Coronary artery occlusion
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
Congenital, familial and genetic disorders
Arnold-Chiari malformation
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
Congenital, familial and genetic disorders
Philmosis
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
Eye disorders
Diabetic retinopathy
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
Eye disorders
Vitreous haemorrhage
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
Gastrointestinal disorders
Abdominal strangulated herina
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
Gastrointestinal disorders
Pancreatitis chronic
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
General disorders
Cyst
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.41%
2/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
Infections and infestations
Orchitis
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
Infections and infestations
Sepsis
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
Injury, poisoning and procedural complications
Chemical poisoning
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
Injury, poisoning and procedural complications
Heat exhaustion
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
Injury, poisoning and procedural complications
Procedural complication
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
Injury, poisoning and procedural complications
Procedural nausea
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
Investigations
Electrocardiogram T wave biphasic
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
Metabolism and nutrition disorders
Obesity
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
Musculoskeletal and connective tissue disorders
Polyarthritis
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer stage I
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal tract adenoma
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic neoplasm
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
Nervous system disorders
Complex regional pain syndrome
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
Nervous system disorders
Syncope
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
Renal and urinary disorders
Calculus ureteric
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
Renal and urinary disorders
Urethral stenosis
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
Reproductive system and breast disorders
Prostatitis
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
Reproductive system and breast disorders
Prostatomegaly
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
Social circumstances
Familial risk factor
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
Vascular disorders
Hypotension
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
Infections and infestations
Infection
|
0.21%
1/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
Surgical and medical procedures
Small bowel perforation
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.21%
1/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
0.00%
0/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
Other adverse events
| Measure |
Canagliflozin 100 mg: Baseline to Week 52
n=483 participants at risk
Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily with protocol-specified doses of metformin for 104 weeks. Data are presented for Baseline to Week 52.
|
Canagliflozin 300 mg: Baseline to Week 52
n=485 participants at risk
Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily with protocol-specified doses of metformin for 104 weeks. Data are presented for Baseline to Week 52.
|
Glimepiride: Baseline to Week 52
n=482 participants at risk
Each patient received glimepiride, at protocol-specified doses, once daily in combination with protocol-specified doses of metformin for 104 weeks. Data are presented for Baseline to Week 52.
|
Canagliflozin 100 mg: Baseline to Week 104
n=483 participants at risk
Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily with protocol-specified doses of metformin for 104 weeks. Data are presented for Baseline to Week 104.
|
Canagliflozin 300 mg: Baseline to Week 104
n=485 participants at risk
Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily with protocol-specified doses of metformin for 104 weeks. Data are presented for Baseline to Week 104.
|
Glimepiride: Baseline to Week 104
n=482 participants at risk
Each patient received glimepiride, at protocol-specified doses, once daily in combination with protocol-specified doses of metformin for 104 weeks. Data are presented for Baseline to Week 104.
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
5.0%
24/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
6.8%
33/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
6.0%
29/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
5.2%
25/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
8.0%
39/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
7.1%
34/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
Gastrointestinal disorders
Nausea
|
3.3%
16/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
5.2%
25/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
2.7%
13/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
4.1%
20/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
5.6%
27/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
3.9%
19/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
Infections and infestations
Nasopharyngitis
|
6.8%
33/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
7.6%
37/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
7.7%
37/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
9.7%
47/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
11.3%
55/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
10.6%
51/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
Infections and infestations
Upper respiratory tract infection
|
3.5%
17/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
5.6%
27/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
8.5%
41/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
7.5%
36/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
7.8%
38/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
11.6%
56/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
Infections and infestations
Urinary tract infection
|
5.4%
26/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
4.7%
23/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
3.7%
18/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
9.1%
44/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
6.8%
33/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
5.6%
27/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
3.1%
15/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
1.9%
9/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
12.7%
61/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
3.5%
17/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
3.3%
16/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
17.8%
86/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.0%
29/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
3.7%
18/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
4.1%
20/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
7.0%
34/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
5.8%
28/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
5.4%
26/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
Nervous system disorders
Headache
|
2.9%
14/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
5.2%
25/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
5.0%
24/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
4.3%
21/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
6.0%
29/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
6.8%
33/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
Vascular disorders
Hypertension
|
1.7%
8/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
2.1%
10/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
2.7%
13/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
3.1%
15/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
2.3%
11/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
6.2%
30/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
Infections and infestations
Influenza
|
2.9%
14/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
3.5%
17/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
1.5%
7/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
5.2%
25/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
4.7%
23/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
2.7%
13/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.7%
18/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
2.7%
13/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
3.7%
18/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
5.4%
26/483 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
3.3%
16/485 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
5.0%
24/482 • Adverse event data were collected for the duration of the study (104 weeks).
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.
|
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