Trial Outcomes & Findings for A Long-Term, Placebo-Controlled X-Ray Study Investigating the Safety and Efficacy of SD-6010 in Subjects With Osteoarthritis of the Knee (NCT NCT00565812)
NCT ID: NCT00565812
Last Updated: 2016-12-30
Results Overview
Rate of progression of joint space narrowing (JSN) was defined as narrowing in joint space width (JSW) over the course of the study. It was measured radiographically in the medial tibiofemoral of knee of participants with OA. The slope reported in millimeter per year (mm/year) over a 2 year period was used to assess the rate of progression of JSN. Negative values indicating a worsening of osteoarthritis.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
1457 participants
Primary outcome timeframe
Baseline up to Month 24
Results posted on
2016-12-30
Participant Flow
A total of 5077 participants were screened in the study, out of which only 1457 participants were randomized.
Participant milestones
| Measure |
SD-6010 50 Milligram (mg)
Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
|
SD-6010 200 mg
Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
|
Placebo
Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
|
|---|---|---|---|
|
Overall Study
STARTED
|
485
|
486
|
486
|
|
Overall Study
COMPLETED
|
341
|
351
|
356
|
|
Overall Study
NOT COMPLETED
|
144
|
135
|
130
|
Reasons for withdrawal
| Measure |
SD-6010 50 Milligram (mg)
Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
|
SD-6010 200 mg
Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
|
Placebo
Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
|
|---|---|---|---|
|
Overall Study
Death
|
2
|
1
|
3
|
|
Overall Study
Did not Meet Entrance Criteria
|
1
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
10
|
8
|
8
|
|
Overall Study
Withdrawal by Subject
|
58
|
47
|
48
|
|
Overall Study
Work Schedule
|
5
|
3
|
1
|
|
Overall Study
Protocol Violation
|
2
|
6
|
4
|
|
Overall Study
Adverse Event
|
41
|
54
|
40
|
|
Overall Study
Jury Duty
|
1
|
0
|
0
|
|
Overall Study
Relocated Out of Area
|
5
|
8
|
9
|
|
Overall Study
Sponsor Decision
|
1
|
5
|
1
|
|
Overall Study
Domestic Reasons
|
7
|
1
|
3
|
|
Overall Study
Research Site Closure
|
6
|
1
|
8
|
|
Overall Study
Surgical Intervention
|
0
|
1
|
2
|
|
Overall Study
Low Compliance
|
1
|
0
|
1
|
|
Overall Study
Follow-up Visit Not Completed
|
2
|
0
|
1
|
|
Overall Study
Physician Decision
|
2
|
0
|
0
|
Baseline Characteristics
A Long-Term, Placebo-Controlled X-Ray Study Investigating the Safety and Efficacy of SD-6010 in Subjects With Osteoarthritis of the Knee
Baseline characteristics by cohort
| Measure |
SD-6010 50 Milligram (mg)
n=485 Participants
Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
|
SD-6010 200 mg
n=486 Participants
Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
|
Placebo
n=486 Participants
Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
|
Total
n=1457 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
61.0 years
STANDARD_DEVIATION 8.7 • n=5 Participants
|
60.8 years
STANDARD_DEVIATION 8.6 • n=7 Participants
|
61.3 years
STANDARD_DEVIATION 9.1 • n=5 Participants
|
61.0 years
STANDARD_DEVIATION 8.8 • n=4 Participants
|
|
Gender
Female
|
383 Participants
n=5 Participants
|
367 Participants
n=7 Participants
|
364 Participants
n=5 Participants
|
1114 Participants
n=4 Participants
|
|
Gender
Male
|
102 Participants
n=5 Participants
|
119 Participants
n=7 Participants
|
122 Participants
n=5 Participants
|
343 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline up to Month 24Population: FAS included all participants randomized to the study. Here, 'number of participants analyzed' (N) signifies participants evaluable for this outcome measure.
Rate of progression of joint space narrowing (JSN) was defined as narrowing in joint space width (JSW) over the course of the study. It was measured radiographically in the medial tibiofemoral of knee of participants with OA. The slope reported in millimeter per year (mm/year) over a 2 year period was used to assess the rate of progression of JSN. Negative values indicating a worsening of osteoarthritis.
Outcome measures
| Measure |
SD-0610 50 Milligram (mg)
n=422 Participants
Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
|
SD-0610 200 mg
n=428 Participants
Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
|
Placebo
n=434 Participants
Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
|
|---|---|---|---|
|
Rate of Progression of Joint Space Narrowing
|
-0.101 mm/year
Standard Deviation 0.346 • Interval -0.128 to -0.078
|
-0.125 mm/year
Standard Deviation 0.298 • Interval -0.134 to -0.085
|
-0.109 mm/year
Standard Deviation 0.261 • Interval -0.139 to -0.091
|
PRIMARY outcome
Timeframe: Baseline up to Month 24Population: FAS included all participants randomized to the study. Here, 'N' signifies participants with KLG \<=2 and evaluable for this outcome measure.
Rate of progression of JSN was defined as narrowing in joint space width over the course of the study. It was measured radiographically in the medial tibiofemoral of knee of participants with OA. The slope reported in mm/year over a 2 year period was used to assess the rate of progression of JSN. KLG system was a method of classifying the severity of knee OA using five grades (0 \[no severity\] to 4 \[maximum severity\], higher grade indicating worse knee function). Negative values of slope indicating a worsening of osteoarthritis.
Outcome measures
| Measure |
SD-0610 50 Milligram (mg)
n=184 Participants
Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
|
SD-0610 200 mg
n=172 Participants
Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
|
Placebo
n=194 Participants
Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
|
|---|---|---|---|
|
Rate of Progression of Joint Space Narrowing in Participants With Kellgren and Lawrence Grade Less Than or Equal to (<=) 2
|
-0.061 mm/year
Standard Deviation 0.335 • Interval -0.087 to -0.023
|
-0.069 mm/year
Standard Deviation 0.254 • Interval -0.088 to -0.022
|
-0.075 mm/year
Standard Deviation 0.221 • Interval -0.108 to -0.047
|
PRIMARY outcome
Timeframe: Baseline up to Month 24Population: FAS included all participants randomized to the study. Here, 'N' signifies participants with KLG =3 and evaluable for this outcome measure.
Rate of progression of JSN was defined as narrowing in joint space width over the course of the study. It was measured radiographically in the medial tibiofemoral of knee of participants with OA. The slope reported in mm/year over a 2 year period was used to assess the rate of progression of JSN. KLG system was a method of classifying the severity of knee OA using five grades (0 \[no severity\] to 4 \[maximum severity\], higher grade indicating worse knee function). Negative values of slope indicating a worsening of osteoarthritis.
Outcome measures
| Measure |
SD-0610 50 Milligram (mg)
n=238 Participants
Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
|
SD-0610 200 mg
n=256 Participants
Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
|
Placebo
n=240 Participants
Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
|
|---|---|---|---|
|
Rate of Progression of Joint Space Narrowing in Participants With Kellgren and Lawrence Grade Equal to (=) 3
|
-0.133 mm/year
Standard Deviation 0.352 • Interval -0.176 to -0.104
|
-0.162 mm/year
Standard Deviation 0.319 • Interval -0.185 to -0.117
|
-0.136 mm/year
Standard Deviation 0.286 • Interval -0.179 to -0.109
|
SECONDARY outcome
Timeframe: Baseline, Month 3, 6, 12, 18, 24Population: FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.
The WOMAC was a self-administered, disease-specific instrument which probed clinically important, participant relevant symptoms in the areas of pain, stiffness, and physical function in participants with OA of the knee. The WOMAC composite index was the sum of 24 individual questions regarding subscales of pain, stiffness and physical function (for each item score range: 0 \[minimum\] to 4 \[maximum\], higher score indicating worse knee condition). Total score was sum of the 3 subscale scores, giving a possible overall score range of 0 (minimum) to 96 (maximum). Higher score indicating the worse level of pain, stiffness and physical function.
Outcome measures
| Measure |
SD-0610 50 Milligram (mg)
n=485 Participants
Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
|
SD-0610 200 mg
n=486 Participants
Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
|
Placebo
n=486 Participants
Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
|
|---|---|---|---|
|
Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index (WOMAC) Composite Index Score at Month 3, 6, 12, 18 and 24
Baseline (n =481, 482, 481)
|
39.07 units on a scale
Standard Deviation 18.85
|
37.29 units on a scale
Standard Deviation 17.98
|
38.45 units on a scale
Standard Deviation 18.91
|
|
Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index (WOMAC) Composite Index Score at Month 3, 6, 12, 18 and 24
Change at Month 3 (n =449, 450, 455)
|
-5.35 units on a scale
Standard Deviation 14.73
|
-5.08 units on a scale
Standard Deviation 13.14
|
-5.50 units on a scale
Standard Deviation 13.59
|
|
Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index (WOMAC) Composite Index Score at Month 3, 6, 12, 18 and 24
Change at Month 6 (n =424, 426, 433)
|
-7.20 units on a scale
Standard Deviation 15.99
|
-5.84 units on a scale
Standard Deviation 15.15
|
-7.07 units on a scale
Standard Deviation 15.62
|
|
Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index (WOMAC) Composite Index Score at Month 3, 6, 12, 18 and 24
Change at Month 12 (n =370, 388, 397)
|
-9.17 units on a scale
Standard Deviation 18.19
|
-9.25 units on a scale
Standard Deviation 15.82
|
-9.84 units on a scale
Standard Deviation 15.75
|
|
Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index (WOMAC) Composite Index Score at Month 3, 6, 12, 18 and 24
Change at Month 18 (n =344, 361, 357)
|
-9.91 units on a scale
Standard Deviation 17.98
|
-8.35 units on a scale
Standard Deviation 16.87
|
-8.82 units on a scale
Standard Deviation 18.00
|
|
Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index (WOMAC) Composite Index Score at Month 3, 6, 12, 18 and 24
Change at Month 24 (n =336, 339, 349)
|
-10.85 units on a scale
Standard Deviation 18.49
|
-10.98 units on a scale
Standard Deviation 17.62
|
-10.49 units on a scale
Standard Deviation 17.26
|
SECONDARY outcome
Timeframe: Baseline, Month 3, 6, 12, 18, 24Population: FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.
The WOMAC pain subscale was comprised of 5 questions regarding the amount of pain experienced due to OA in the study knee. The WOMAC pain subscale score for each question ranged from 0 (minimum) to 4 (maximum), higher scores signified worse pain. An overall subscale score range of 0 (minimum) to 20 (maximum), with higher scores indicating more pain.
Outcome measures
| Measure |
SD-0610 50 Milligram (mg)
n=485 Participants
Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
|
SD-0610 200 mg
n=486 Participants
Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
|
Placebo
n=486 Participants
Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
|
|---|---|---|---|
|
Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index Pain Subscale Score at Month 3, 6, 12, 18 and 24
Baseline (n =482, 484, 483)
|
7.96 units on a scale
Standard Deviation 3.94
|
7.44 units on a scale
Standard Deviation 3.87
|
7.59 units on a scale
Standard Deviation 4.03
|
|
Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index Pain Subscale Score at Month 3, 6, 12, 18 and 24
Change at Month 3 (n =451, 453, 458)
|
-1.32 units on a scale
Standard Deviation 3.41
|
-1.23 units on a scale
Standard Deviation 3.19
|
-1.25 units on a scale
Standard Deviation 3.15
|
|
Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index Pain Subscale Score at Month 3, 6, 12, 18 and 24
Change at Month 6 (n =426, 429, 435)
|
-1.73 units on a scale
Standard Deviation 3.73
|
-1.42 units on a scale
Standard Deviation 3.58
|
-1.59 units on a scale
Standard Deviation 3.45
|
|
Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index Pain Subscale Score at Month 3, 6, 12, 18 and 24
Change at Month 12 (n =372, 389, 398)
|
-2.17 units on a scale
Standard Deviation 4.25
|
-2.10 units on a scale
Standard Deviation 3.66
|
-2.08 units on a scale
Standard Deviation 3.47
|
|
Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index Pain Subscale Score at Month 3, 6, 12, 18 and 24
Change at Month 18 (n =347, 363, 359)
|
-2.24 units on a scale
Standard Deviation 4.16
|
-2.00 units on a scale
Standard Deviation 3.93
|
-1.86 units on a scale
Standard Deviation 3.88
|
|
Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index Pain Subscale Score at Month 3, 6, 12, 18 and 24
Change at Month 24 (n =337, 342, 351)
|
-2.48 units on a scale
Standard Deviation 4.02
|
-2.23 units on a scale
Standard Deviation 4.16
|
-2.19 units on a scale
Standard Deviation 3.79
|
SECONDARY outcome
Timeframe: Baseline, Month 3, 6, 12, 18, 24Population: FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.
Stiffness was defined as a sensation of decreased ease in which the participant moved the knee with OA. The WOMAC stiffness subscale was comprised of 2 questions regarding the degree of stiffness experienced in the study knee. The WOMAC stiffness subscale score for each question ranged from 0 (minimum) to 4 (maximum), higher scores signified worse stiffness. An overall score range of 0 (minimum) to 8 (maximum), with higher scores indicating more stiffness.
Outcome measures
| Measure |
SD-0610 50 Milligram (mg)
n=485 Participants
Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
|
SD-0610 200 mg
n=486 Participants
Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
|
Placebo
n=486 Participants
Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
|
|---|---|---|---|
|
Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index Pain Stiffness Subscale Score at Month 3, 6, 12, 18 and 24
Baseline (n =481, 484, 482)
|
3.48 units on a scale
Standard Deviation 1.80
|
3.33 units on a scale
Standard Deviation 1.78
|
3.44 units on a scale
Standard Deviation 1.77
|
|
Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index Pain Stiffness Subscale Score at Month 3, 6, 12, 18 and 24
Change at Month 3 (n =449, 455, 456)
|
-0.52 units on a scale
Standard Deviation 1.67
|
-0.51 units on a scale
Standard Deviation 1.58
|
-0.51 units on a scale
Standard Deviation 1.58
|
|
Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index Pain Stiffness Subscale Score at Month 3, 6, 12, 18 and 24
Change at Month 6 (n =425, 429, 434)
|
-0.67 units on a scale
Standard Deviation 1.70
|
-0.56 units on a scale
Standard Deviation 1.78
|
-0.62 units on a scale
Standard Deviation 1.73
|
|
Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index Pain Stiffness Subscale Score at Month 3, 6, 12, 18 and 24
Change at Month 12 (n =371, 389, 397)
|
-0.89 units on a scale
Standard Deviation 1.89
|
-0.79 units on a scale
Standard Deviation 1.83
|
-0.95 units on a scale
Standard Deviation 1.78
|
|
Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index Pain Stiffness Subscale Score at Month 3, 6, 12, 18 and 24
Change at Month 18 (n =346, 363, 358)
|
-0.88 units on a scale
Standard Deviation 1.86
|
-0.87 units on a scale
Standard Deviation 1.88
|
-0.82 units on a scale
Standard Deviation 1.82
|
|
Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index Pain Stiffness Subscale Score at Month 3, 6, 12, 18 and 24
Change at Month 24 (n =336, 342, 349)
|
-0.94 units on a scale
Standard Deviation 1.95
|
-1.10 units on a scale
Standard Deviation 1.95
|
-0.95 units on a scale
Standard Deviation 1.92
|
SECONDARY outcome
Timeframe: Baseline, Month 3, 6, 12, 18, 24Population: FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.
The WOMAC physical function subscale referred to the participant's ability to move around and perform usual activities of daily living. The WOMAC physical function subscale was comprised of 17 questions regarding the degree of difficulty experienced due to OA in the study knee. The WOMAC physical function subscale score for each question ranged from 0 (minimum) to 4 (maximum), higher scores signified worse physical function. An overall score range of 0 (minimum) to 68 (maximum), with higher scores indicating worse physical function.
Outcome measures
| Measure |
SD-0610 50 Milligram (mg)
n=485 Participants
Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
|
SD-0610 200 mg
n=486 Participants
Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
|
Placebo
n=486 Participants
Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
|
|---|---|---|---|
|
Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index Physical Function Subscale Score at Month 3, 6, 12, 18 and 24
Baseline (n =481, 482, 482)
|
27.63 units on a scale
Standard Deviation 13.88
|
26.49 units on a scale
Standard Deviation 13.18
|
27.39 units on a scale
Standard Deviation 13.81
|
|
Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index Physical Function Subscale Score at Month 3, 6, 12, 18 and 24
Change at Month 3 (n =449, 452, 456)
|
-3.50 units on a scale
Standard Deviation 10.77
|
-3.24 units on a scale
Standard Deviation 9.71
|
-3.72 units on a scale
Standard Deviation 9.99
|
|
Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index Physical Function Subscale Score at Month 3, 6, 12, 18 and 24
Change at Month 6 (n =424, 426, 434)
|
-4.78 units on a scale
Standard Deviation 11.73
|
-3.86 units on a scale
Standard Deviation 10.81
|
-4.82 units on a scale
Standard Deviation 11.43
|
|
Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index Physical Function Subscale Score at Month 3, 6, 12, 18 and 24
Change at Month 12 (n =370, 388, 398)
|
-6.09 units on a scale
Standard Deviation 13.21
|
-6.37 units on a scale
Standard Deviation 11.34
|
-6.79 units on a scale
Standard Deviation 11.55
|
|
Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index Physical Function Subscale Score at Month 3, 6, 12, 18 and 24
Change at Month 18 (n =344, 361, 358)
|
-6.74 units on a scale
Standard Deviation 12.95
|
-5.49 units on a scale
Standard Deviation 12.05
|
-6.12 units on a scale
Standard Deviation 13.22
|
|
Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index Physical Function Subscale Score at Month 3, 6, 12, 18 and 24
Change at Month 24 (n =336, 339, 350)
|
-7.42 units on a scale
Standard Deviation 13.47
|
-7.65 units on a scale
Standard Deviation 12.37
|
-7.35 units on a scale
Standard Deviation 12.54
|
SECONDARY outcome
Timeframe: Baseline, Month 3, 6, 12, 18, 24Population: FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.
Pain VAS was a self-administered instrument, a 100 millimeter (mm) line marked by participant. Intensity of pain range (over past week): 0 (mm) =no pain to 100 (mm) =worst possible pain. Higher score indicating severe pain.
Outcome measures
| Measure |
SD-0610 50 Milligram (mg)
n=485 Participants
Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
|
SD-0610 200 mg
n=486 Participants
Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
|
Placebo
n=486 Participants
Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
|
|---|---|---|---|
|
Change From Baseline in Patient Assessment of Arthritic Pain Visual Analog Scale (VAS) Score at Month 3, 6, 12, 18 and 24
Change at Month 6 (n =422, 424, 435)
|
-10.13 mm
Standard Deviation 24.91
|
-7.92 mm
Standard Deviation 24.90
|
-10.17 mm
Standard Deviation 24.07
|
|
Change From Baseline in Patient Assessment of Arthritic Pain Visual Analog Scale (VAS) Score at Month 3, 6, 12, 18 and 24
Change at Month 12 (n =370, 384, 396)
|
-11.75 mm
Standard Deviation 30.38
|
-10.98 mm
Standard Deviation 25.28
|
-12.97 mm
Standard Deviation 24.26
|
|
Change From Baseline in Patient Assessment of Arthritic Pain Visual Analog Scale (VAS) Score at Month 3, 6, 12, 18 and 24
Baseline (n =478, 479, 482)
|
40.19 mm
Standard Deviation 24.77
|
37.59 mm
Standard Deviation 24.26
|
39.37 mm
Standard Deviation 23.91
|
|
Change From Baseline in Patient Assessment of Arthritic Pain Visual Analog Scale (VAS) Score at Month 3, 6, 12, 18 and 24
Change at Month 3 (n =446, 448, 455)
|
-7.21 mm
Standard Deviation 25.49
|
-7.02 mm
Standard Deviation 23.45
|
-9.12 mm
Standard Deviation 21.72
|
|
Change From Baseline in Patient Assessment of Arthritic Pain Visual Analog Scale (VAS) Score at Month 3, 6, 12, 18 and 24
Change at Month 18 (n =342, 360, 360)
|
-13.99 mm
Standard Deviation 26.78
|
-11.17 mm
Standard Deviation 25.60
|
-12.86 mm
Standard Deviation 26.47
|
|
Change From Baseline in Patient Assessment of Arthritic Pain Visual Analog Scale (VAS) Score at Month 3, 6, 12, 18 and 24
Change at Month 24 (n =333, 338, 348)
|
-14.59 mm
Standard Deviation 28.36
|
-13.36 mm
Standard Deviation 25.69
|
-13.29 mm
Standard Deviation 23.97
|
SECONDARY outcome
Timeframe: Baseline, Month 3, 6, 12, 18, 24Population: FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.
Participants answered: "Considering all the ways your arthritis affects you, how are you feeling today?" Participants responded by using the scale ranging from 1 (minimum) to 5 (maximum), where 1 =very good, 2 =good, 3 =fair, 4 =poor and 5 =very poor. Higher scores indicating worse condition.
Outcome measures
| Measure |
SD-0610 50 Milligram (mg)
n=485 Participants
Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
|
SD-0610 200 mg
n=486 Participants
Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
|
Placebo
n=486 Participants
Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
|
|---|---|---|---|
|
Change From Baseline in Patient Global Assessment of Arthritic Condition Score at Month 3, 6, 12, 18 and 24
Baseline (n =481, 482, 483)
|
2.684 units on a scale
Standard Deviation 0.904
|
2.610 units on a scale
Standard Deviation 0.883
|
2.634 units on a scale
Standard Deviation 0.883
|
|
Change From Baseline in Patient Global Assessment of Arthritic Condition Score at Month 3, 6, 12, 18 and 24
Change at Month 3 (n =449, 452, 455)
|
-0.232 units on a scale
Standard Deviation 0.909
|
-0.230 units on a scale
Standard Deviation 0.816
|
-0.202 units on a scale
Standard Deviation 0.787
|
|
Change From Baseline in Patient Global Assessment of Arthritic Condition Score at Month 3, 6, 12, 18 and 24
Change at Month 6 (n =424, 427, 435)
|
-0.337 units on a scale
Standard Deviation 0.876
|
-0.319 units on a scale
Standard Deviation 0.857
|
-0.260 units on a scale
Standard Deviation 0.879
|
|
Change From Baseline in Patient Global Assessment of Arthritic Condition Score at Month 3, 6, 12, 18 and 24
Change at Month 12 (n =368, 385, 397)
|
-0.405 units on a scale
Standard Deviation 0.908
|
-0.371 units on a scale
Standard Deviation 0.930
|
-0.370 units on a scale
Standard Deviation 0.848
|
|
Change From Baseline in Patient Global Assessment of Arthritic Condition Score at Month 3, 6, 12, 18 and 24
Change at Month 18 (n =344, 361, 358)
|
-0.442 units on a scale
Standard Deviation 0.979
|
-0.418 units on a scale
Standard Deviation 0.934
|
-0.388 units on a scale
Standard Deviation 0.903
|
|
Change From Baseline in Patient Global Assessment of Arthritic Condition Score at Month 3, 6, 12, 18 and 24
Change at Month 24 (n =335, 340, 351)
|
-0.513 units on a scale
Standard Deviation 0.950
|
-0.488 units on a scale
Standard Deviation 0.939
|
-0.473 units on a scale
Standard Deviation 0.934
|
SECONDARY outcome
Timeframe: Baseline, Month 3, 6, 12, 18, 24Population: FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.
Physician assessed the overall impact of arthritis on the participant's daily life. Participant's condition was rated by the physician using the scale ranging from 1 (minimum) to 5 (maximum), where 1= very good, 2= good, 3= fair, 4= poor and 5= very poor. Higher scores indicating worse condition.
Outcome measures
| Measure |
SD-0610 50 Milligram (mg)
n=485 Participants
Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
|
SD-0610 200 mg
n=486 Participants
Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
|
Placebo
n=486 Participants
Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
|
|---|---|---|---|
|
Change From Baseline in Physician's Global Assessment of Arthritic Condition Score at Month 3, 6, 12, 18 and 24
Baseline (n =480, 483, 480)
|
2.785 units on a scale
Standard Deviation 0.679
|
2.834 units on a scale
Standard Deviation 0.689
|
2.831 units on a scale
Standard Deviation 0.655
|
|
Change From Baseline in Physician's Global Assessment of Arthritic Condition Score at Month 3, 6, 12, 18 and 24
Change at Month 3 (n =449, 448, 453)
|
-0.379 units on a scale
Standard Deviation 0.782
|
-0.422 units on a scale
Standard Deviation 0.756
|
-0.415 units on a scale
Standard Deviation 0.764
|
|
Change From Baseline in Physician's Global Assessment of Arthritic Condition Score at Month 3, 6, 12, 18 and 24
Change at Month 6 (n =420, 426, 431)
|
-0.443 units on a scale
Standard Deviation 0.823
|
-0.561 units on a scale
Standard Deviation 0.841
|
-0.452 units on a scale
Standard Deviation 0.791
|
|
Change From Baseline in Physician's Global Assessment of Arthritic Condition Score at Month 3, 6, 12, 18 and 24
Change at Month 12 (n =367, 386, 396)
|
-0.548 units on a scale
Standard Deviation 0.873
|
-0.627 units on a scale
Standard Deviation 0.859
|
-0.535 units on a scale
Standard Deviation 0.828
|
|
Change From Baseline in Physician's Global Assessment of Arthritic Condition Score at Month 3, 6, 12, 18 and 24
Change at Month 18 (n =342, 359, 355)
|
-0.602 units on a scale
Standard Deviation 0.906
|
-0.643 units on a scale
Standard Deviation 0.833
|
-0.628 units on a scale
Standard Deviation 0.862
|
|
Change From Baseline in Physician's Global Assessment of Arthritic Condition Score at Month 3, 6, 12, 18 and 24
Change at Month 24 (n = 331, 340, 349)
|
-0.656 units on a scale
Standard Deviation 0.906
|
-0.662 units on a scale
Standard Deviation 0.879
|
-0.711 units on a scale
Standard Deviation 0.867
|
SECONDARY outcome
Timeframe: Baseline, Month 3, 6, 12, 18, 24Population: FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.
The pain VAS following a 50 foot walk was a single-item, self-administered instrument. Participants were asked to assess the pain due to OA in their study knee after a 50-foot walk. Participants responded on a VAS scale ranging from 0 (no pain) to 100 (severe pain). Higher scores indicating more pain.
Outcome measures
| Measure |
SD-0610 50 Milligram (mg)
n=485 Participants
Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
|
SD-0610 200 mg
n=486 Participants
Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
|
Placebo
n=486 Participants
Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
|
|---|---|---|---|
|
Change From Baseline in Pain After a 50-foot Walk Using Pain Visual Analog Scale Score at Month 3, 6, 12, 18 and 24
Baseline (n =480, 483, 482)
|
38.03 units on a scale
Standard Deviation 26.39
|
35.13 units on a scale
Standard Deviation 26.10
|
38.00 units on a scale
Standard Deviation 25.73
|
|
Change From Baseline in Pain After a 50-foot Walk Using Pain Visual Analog Scale Score at Month 3, 6, 12, 18 and 24
Change at Month 3 (n =446, 453, 456)
|
-5.78 units on a scale
Standard Deviation 25.30
|
-5.71 units on a scale
Standard Deviation 23.20
|
-7.45 units on a scale
Standard Deviation 23.15
|
|
Change From Baseline in Pain After a 50-foot Walk Using Pain Visual Analog Scale Score at Month 3, 6, 12, 18 and 24
Change at Month 6 (n =424, 428, 436)
|
-8.13 units on a scale
Standard Deviation 25.86
|
-7.17 units on a scale
Standard Deviation 25.42
|
-8.78 units on a scale
Standard Deviation 25.67
|
|
Change From Baseline in Pain After a 50-foot Walk Using Pain Visual Analog Scale Score at Month 3, 6, 12, 18 and 24
Change at Month 12 (n =370, 382, 397)
|
-11.32 units on a scale
Standard Deviation 27.42
|
-10.07 units on a scale
Standard Deviation 25.22
|
-11.91 units on a scale
Standard Deviation 24.04
|
|
Change From Baseline in Pain After a 50-foot Walk Using Pain Visual Analog Scale Score at Month 3, 6, 12, 18 and 24
Change at Month 18 (n = 345, 360, 357)
|
-11.17 units on a scale
Standard Deviation 27.51
|
-8.91 units on a scale
Standard Deviation 27.12
|
-11.86 units on a scale
Standard Deviation 26.04
|
|
Change From Baseline in Pain After a 50-foot Walk Using Pain Visual Analog Scale Score at Month 3, 6, 12, 18 and 24
Change at Month 24 (n =336, 340, 351)
|
-12.31 units on a scale
Standard Deviation 27.61
|
-12.86 units on a scale
Standard Deviation 26.73
|
-13.77 units on a scale
Standard Deviation 24.53
|
SECONDARY outcome
Timeframe: Baseline, Month 3, 6, 12, 18, 24Population: FAS included all participants randomized to the study. Here, 'n' signifies participants evaluated for this outcome measure at given time points for each group.
The OA pain and assessment tool-knee joint is also known as the intermittent and constant osteoarthritis pain (ICOAP) scale. The OA pain assessment tool-knee joint was an 11-item scale, with each item scored from 0 (minimum) to 4 (maximum), where 4 indicated worst health condition. The total score was calculated by adding the 11 items and rescaled to a 0 (minimum) to 100 (maximum) scale, where higher scores indicating worse health.
Outcome measures
| Measure |
SD-0610 50 Milligram (mg)
n=485 Participants
Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
|
SD-0610 200 mg
n=486 Participants
Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
|
Placebo
n=486 Participants
Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
|
|---|---|---|---|
|
Change From Baseline in Osteoarthritis Pain Assessment Tool-Knee Joint Total Score at Month 3, 6, 12, 18 and 24
Baseline (n =479, 480, 481)
|
39.35 units on a scale
Standard Deviation 23.06
|
36.55 units on a scale
Standard Deviation 21.78
|
38.79 units on a scale
Standard Deviation 22.29
|
|
Change From Baseline in Osteoarthritis Pain Assessment Tool-Knee Joint Total Score at Month 3, 6, 12, 18 and 24
Change at Month 3 (n =448, 450, 449)
|
-7.00 units on a scale
Standard Deviation 19.95
|
-6.68 units on a scale
Standard Deviation 17.77
|
-7.08 units on a scale
Standard Deviation 18.15
|
|
Change From Baseline in Osteoarthritis Pain Assessment Tool-Knee Joint Total Score at Month 3, 6, 12, 18 and 24
Change at Month 6 (n =422, 422, 430)
|
-9.09 units on a scale
Standard Deviation 21.43
|
-7.74 units on a scale
Standard Deviation 19.36
|
-8.27 units on a scale
Standard Deviation 19.68
|
|
Change From Baseline in Osteoarthritis Pain Assessment Tool-Knee Joint Total Score at Month 3, 6, 12, 18 and 24
Change at Month 12 (n = 365, 384, 397)
|
-13.00 units on a scale
Standard Deviation 21.93
|
-10.84 units on a scale
Standard Deviation 20.58
|
-12.26 units on a scale
Standard Deviation 20.24
|
|
Change From Baseline in Osteoarthritis Pain Assessment Tool-Knee Joint Total Score at Month 3, 6, 12, 18 and 24
Change at Month 18 (n =342, 359, 359)
|
-12.71 units on a scale
Standard Deviation 22.64
|
-9.59 units on a scale
Standard Deviation 21.26
|
-11.23 units on a scale
Standard Deviation 22.13
|
|
Change From Baseline in Osteoarthritis Pain Assessment Tool-Knee Joint Total Score at Month 3, 6, 12, 18 and 24
Change at Month 24 (n =330, 340, 349)
|
-13.02 units on a scale
Standard Deviation 22.30
|
-12.87 units on a scale
Standard Deviation 21.53
|
-13.79 units on a scale
Standard Deviation 21.81
|
SECONDARY outcome
Timeframe: Baseline, Month 3, 6, 12, 18, 24Population: FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.
The OA pain assessment tool-knee joint constant pain subscale was a 5 item scale, with each item scored from 0 (minimum) to 4 (maximum), where 4 indicated worst health condition. Overall subscale score was calculated by adding the 5 items and rescaled to a 0 (minimum) to 100 (maximum) scale, where higher scores indicating worse constant pain.
Outcome measures
| Measure |
SD-0610 50 Milligram (mg)
n=485 Participants
Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
|
SD-0610 200 mg
n=486 Participants
Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
|
Placebo
n=486 Participants
Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
|
|---|---|---|---|
|
Change From Baseline in Osteoarthritis Pain Assessment Tool-Knee Joint Constant Pain Subscale Score at Month 3, 6, 12, 18 and 24
Baseline (n =479, 481, 484)
|
35.25 units on a scale
Standard Deviation 24.83
|
33.01 units on a scale
Standard Deviation 24.09
|
35.21 units on a scale
Standard Deviation 24.45
|
|
Change From Baseline in Osteoarthritis Pain Assessment Tool-Knee Joint Constant Pain Subscale Score at Month 3, 6, 12, 18 and 24
Change at Month 3 (n =448, 452, 454)
|
-6.61 units on a scale
Standard Deviation 21.64
|
-6.41 units on a scale
Standard Deviation 19.44
|
-6.55 units on a scale
Standard Deviation 19.92
|
|
Change From Baseline in Osteoarthritis Pain Assessment Tool-Knee Joint Constant Pain Subscale Score at Month 3, 6, 12, 18 and 24
Change at Month 6 (n =423, 426, 434)
|
-7.88 units on a scale
Standard Deviation 23.11
|
-7.47 units on a scale
Standard Deviation 21.05
|
-8.25 units on a scale
Standard Deviation 20.55
|
|
Change From Baseline in Osteoarthritis Pain Assessment Tool-Knee Joint Constant Pain Subscale Score at Month 3, 6, 12, 18 and 24
Change at Month 12 (n = 367, 384, 399)
|
-11.78 units on a scale
Standard Deviation 23.21
|
-10.83 units on a scale
Standard Deviation 21.94
|
-11.75 units on a scale
Standard Deviation 21.85
|
|
Change From Baseline in Osteoarthritis Pain Assessment Tool-Knee Joint Constant Pain Subscale Score at Month 3, 6, 12, 18 and 24
Change at Month 18 (n = 343, 360, 360)
|
-11.63 units on a scale
Standard Deviation 23.68
|
-9.88 units on a scale
Standard Deviation 22.01
|
-10.62 units on a scale
Standard Deviation 23.82
|
|
Change From Baseline in Osteoarthritis Pain Assessment Tool-Knee Joint Constant Pain Subscale Score at Month 3, 6, 12, 18 and 24
Change at Month 24 (n = 330, 340, 350)
|
-11.59 units on a scale
Standard Deviation 23.68
|
-12.51 units on a scale
Standard Deviation 23.17
|
-13.15 units on a scale
Standard Deviation 23.37
|
SECONDARY outcome
Timeframe: Baseline, Month 3, 6, 12, 18, 24Population: FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.
The OA pain assessment tool-knee joint intermittent pain subscale score a 6 item scale, with each item scored from 0 (minimum) to 4 (maximum), where 4 indicated worst health condition. Overall subscale score was calculated by adding the 6 items and rescaled to a 0 (minimum) to 100 (maximum) scale, where higher scores indicating worse intermittent pain.
Outcome measures
| Measure |
SD-0610 50 Milligram (mg)
n=485 Participants
Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
|
SD-0610 200 mg
n=486 Participants
Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
|
Placebo
n=486 Participants
Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
|
|---|---|---|---|
|
Change From Baseline in Osteoarthritis Pain Assessment Tool-Knee Joint Intermittent Pain Subscale Score at Month 3, 6, 12, 18 and 24
Baseline (n =479, 480, 481)
|
42.76 units on a scale
Standard Deviation 22.85
|
39.44 units on a scale
Standard Deviation 21.46
|
41.73 units on a scale
Standard Deviation 22.10
|
|
Change From Baseline in Osteoarthritis Pain Assessment Tool-Knee Joint Intermittent Pain Subscale Score at Month 3, 6, 12, 18 and 24
Change at Month 3 (n =448, 450, 450)
|
-7.32 units on a scale
Standard Deviation 20.68
|
-6.93 units on a scale
Standard Deviation 18.95
|
-7.48 units on a scale
Standard Deviation 19.28
|
|
Change From Baseline in Osteoarthritis Pain Assessment Tool-Knee Joint Intermittent Pain Subscale Score at Month 3, 6, 12, 18 and 24
Change at Month 6 (n =422, 422, 430)
|
-10.18 units on a scale
Standard Deviation 22.28
|
-7.96 units on a scale
Standard Deviation 20.34
|
-8.31 units on a scale
Standard Deviation 21.44
|
|
Change From Baseline in Osteoarthritis Pain Assessment Tool-Knee Joint Intermittent Pain Subscale Score at Month 3, 6, 12, 18 and 24
Change at Month 12 (n =365, 385, 397)
|
-14.15 units on a scale
Standard Deviation 22.93
|
-10.93 units on a scale
Standard Deviation 21.86
|
-12.54 units on a scale
Standard Deviation 21.64
|
|
Change From Baseline in Osteoarthritis Pain Assessment Tool-Knee Joint Intermittent Pain Subscale Score at Month 3, 6, 12, 18 and 24
Change at Month 18 (n =342, 359, 359)
|
-13.56 units on a scale
Standard Deviation 23.72
|
-9.45 units on a scale
Standard Deviation 23.07
|
-11.69 units on a scale
Standard Deviation 23.02
|
|
Change From Baseline in Osteoarthritis Pain Assessment Tool-Knee Joint Intermittent Pain Subscale Score at Month 3, 6, 12, 18 and 24
Change at Month 24 (n =330, 340, 349)
|
-14.20 units on a scale
Standard Deviation 23.11
|
-13.17 units on a scale
Standard Deviation 22.74
|
-14.27 units on a scale
Standard Deviation 22.66
|
SECONDARY outcome
Timeframe: Baseline, Month 3, 6, 12, 18, 24Population: FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.
The OARSI knee function survey was an 11-item scale with each item scored 0 (minimum) to 4 (maximum), where 4 indicated worst health condition. The total score was the sum of the 11 items and ranged from 0 (minimum) to 44 (maximum), where higher scores indicating worse health condition.
Outcome measures
| Measure |
SD-0610 50 Milligram (mg)
n=485 Participants
Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
|
SD-0610 200 mg
n=486 Participants
Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
|
Placebo
n=486 Participants
Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
|
|---|---|---|---|
|
Change From Baseline in Osteoarthritis Research Society International (OARSI) Knee Function Survey Score at Month 3, 6, 12, 18 and 24
Baseline (n =382, 376, 391)
|
22.19 units on a scale
Standard Deviation 8.96
|
21.49 units on a scale
Standard Deviation 8.59
|
21.80 units on a scale
Standard Deviation 8.92
|
|
Change From Baseline in Osteoarthritis Research Society International (OARSI) Knee Function Survey Score at Month 3, 6, 12, 18 and 24
Change at Month 3 (n = 309, 304, 315)
|
-2.20 units on a scale
Standard Deviation 7.70
|
-2.24 units on a scale
Standard Deviation 6.57
|
-2.99 units on a scale
Standard Deviation 7.12
|
|
Change From Baseline in Osteoarthritis Research Society International (OARSI) Knee Function Survey Score at Month 3, 6, 12, 18 and 24
Change at Month 6 (n =270, 283, 294)
|
-3.24 units on a scale
Standard Deviation 8.42
|
-3.29 units on a scale
Standard Deviation 7.80
|
-3.53 units on a scale
Standard Deviation 8.26
|
|
Change From Baseline in Osteoarthritis Research Society International (OARSI) Knee Function Survey Score at Month 3, 6, 12, 18 and 24
Change at Month 12 (n =240, 263, 266)
|
-4.57 units on a scale
Standard Deviation 8.65
|
-4.35 units on a scale
Standard Deviation 7.76
|
-4.46 units on a scale
Standard Deviation 7.99
|
|
Change From Baseline in Osteoarthritis Research Society International (OARSI) Knee Function Survey Score at Month 3, 6, 12, 18 and 24
Change at Month 18 (n =225, 239, 243)
|
-5.14 units on a scale
Standard Deviation 9.37
|
-4.61 units on a scale
Standard Deviation 8.56
|
-4.93 units on a scale
Standard Deviation 9.22
|
|
Change From Baseline in Osteoarthritis Research Society International (OARSI) Knee Function Survey Score at Month 3, 6, 12, 18 and 24
Change at Month 24(n = 227, 224, 237)
|
-5.31 units on a scale
Standard Deviation 9.40
|
-5.13 units on a scale
Standard Deviation 8.36
|
-5.62 units on a scale
Standard Deviation 9.28
|
SECONDARY outcome
Timeframe: Baseline, Month 3, 6, 12, 18, 24Population: FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.
The KOOS-PS was used to rate participant's opinions about the difficulties they experienced with activity due to problems with their knee. It was a 7-item scale, each item scored from 0 (minimum) to 4 (maximum), where 4 indicated worst health condition. Total score was calculated by adding the responses to 7 items and rescaled to a 0 (minimum) to 100 (maximum) scale, where higher scores indicating worse health condition.
Outcome measures
| Measure |
SD-0610 50 Milligram (mg)
n=485 Participants
Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
|
SD-0610 200 mg
n=486 Participants
Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
|
Placebo
n=486 Participants
Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
|
|---|---|---|---|
|
Change From Baseline in Knee Injury and Osteoarthritis Outcome Score - Physical Function Short Form (KOOS-PS) Score at Month 3, 6, 12, 18 and 24
Baseline (n =432, 423, 428)
|
42.75 units on a scale
Standard Deviation 14.69
|
41.82 units on a scale
Standard Deviation 13.85
|
42.60 units on a scale
Standard Deviation 14.76
|
|
Change From Baseline in Knee Injury and Osteoarthritis Outcome Score - Physical Function Short Form (KOOS-PS) Score at Month 3, 6, 12, 18 and 24
Change at Month 3 (n =376, 363, 370)
|
-3.50 units on a scale
Standard Deviation 12.68
|
-4.31 units on a scale
Standard Deviation 11.38
|
-5.23 units on a scale
Standard Deviation 11.47
|
|
Change From Baseline in Knee Injury and Osteoarthritis Outcome Score - Physical Function Short Form (KOOS-PS) Score at Month 3, 6, 12, 18 and 24
Change at Month 6 (n =336, 335, 348)
|
-5.42 units on a scale
Standard Deviation 13.70
|
-5.41 units on a scale
Standard Deviation 13.93
|
-6.03 units on a scale
Standard Deviation 14.02
|
|
Change From Baseline in Knee Injury and Osteoarthritis Outcome Score - Physical Function Short Form (KOOS-PS) Score at Month 3, 6, 12, 18 and 24
Change at Month 12 (n =288, 315, 320)
|
-7.01 units on a scale
Standard Deviation 14.60
|
-7.67 units on a scale
Standard Deviation 13.26
|
-7.32 units on a scale
Standard Deviation 13.52
|
|
Change From Baseline in Knee Injury and Osteoarthritis Outcome Score - Physical Function Short Form (KOOS-PS) Score at Month 3, 6, 12, 18 and 24
Change at Month 18 (n =284, 284, 280)
|
-8.10 units on a scale
Standard Deviation 16.00
|
-7.44 units on a scale
Standard Deviation 14.09
|
-7.47 units on a scale
Standard Deviation 15.00
|
|
Change From Baseline in Knee Injury and Osteoarthritis Outcome Score - Physical Function Short Form (KOOS-PS) Score at Month 3, 6, 12, 18 and 24
Change at Month 24 (n =272, 272, 278)
|
-8.49 units on a scale
Standard Deviation 16.06
|
-9.01 units on a scale
Standard Deviation 14.74
|
-9.60 units on a scale
Standard Deviation 15.48
|
SECONDARY outcome
Timeframe: Baseline, Month 12, 24Population: FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.
The SF-36 was a participant administered scale assessing general quality of life. It consisted of self-administered 36-item questionnaire that measured 8 health domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. These 8 domains were also summarized as physical and mental component scores. The score for each domain and component score was the mean of the individual question scores, which were scaled from 0 (minimum) to 100 (maximum), where higher scores indicated highest level of health/functioning. Linear transformations were performed to transform scores and rescaled to a score range of 16.18 (minimum) to 57.11 (maximum), with higher scores indicating better physical functioning.
Outcome measures
| Measure |
SD-0610 50 Milligram (mg)
n=485 Participants
Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
|
SD-0610 200 mg
n=486 Participants
Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
|
Placebo
n=486 Participants
Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
|
|---|---|---|---|
|
Change From Baseline in Short Form-36 (SF-36) Physical Functioning Domain Score at Month 12 and 24
Baseline (n =481, 482, 485)
|
35.67 units on a scale
Standard Deviation 9.74
|
36.84 units on a scale
Standard Deviation 9.42
|
36.32 units on a scale
Standard Deviation 9.15
|
|
Change From Baseline in Short Form-36 (SF-36) Physical Functioning Domain Score at Month 12 and 24
Change at Month 12 (n =368, 381, 397)
|
2.59 units on a scale
Standard Deviation 8.80
|
2.41 units on a scale
Standard Deviation 8.66
|
2.55 units on a scale
Standard Deviation 8.84
|
|
Change From Baseline in Short Form-36 (SF-36) Physical Functioning Domain Score at Month 12 and 24
Change at Month 24 (n =332, 341, 352)
|
3.53 units on a scale
Standard Deviation 9.50
|
3.23 units on a scale
Standard Deviation 9.66
|
3.51 units on a scale
Standard Deviation 9.54
|
SECONDARY outcome
Timeframe: Baseline, Month 12, 24Population: FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.
The SF-36 was a participant administered scale assessing general quality of life. It consisted of self-administered 36-item questionnaire that measured 8 health domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. These 8 domains were also summarized as physical and mental component scores. The score for each domain and component score was the mean of the individual question scores, which were scaled from 0 (minimum) to 100 (maximum), where higher scores indicated highest level of health/functioning. Linear transformations were performed to transform scores and rescaled to a score range of 18.45 (minimum) to 56.62 (maximum), with higher scores indicating better role-physical.
Outcome measures
| Measure |
SD-0610 50 Milligram (mg)
n=485 Participants
Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
|
SD-0610 200 mg
n=486 Participants
Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
|
Placebo
n=486 Participants
Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
|
|---|---|---|---|
|
Change From Baseline in Short Form-36 Role - Physical Domain Score at Month 12 and 24
Baseline (n =481, 482, 485)
|
39.99 units on a scale
Standard Deviation 9.85
|
40.37 units on a scale
Standard Deviation 9.73
|
40.14 units on a scale
Standard Deviation 10.03
|
|
Change From Baseline in Short Form-36 Role - Physical Domain Score at Month 12 and 24
Change at Month 12 (n =368, 381, 397)
|
2.06 units on a scale
Standard Deviation 9.55
|
2.35 units on a scale
Standard Deviation 8.75
|
2.22 units on a scale
Standard Deviation 8.85
|
|
Change From Baseline in Short Form-36 Role - Physical Domain Score at Month 12 and 24
Change at Month 24 (n =333, 341, 352)
|
2.44 units on a scale
Standard Deviation 9.53
|
2.44 units on a scale
Standard Deviation 9.34
|
2.70 units on a scale
Standard Deviation 9.35
|
SECONDARY outcome
Timeframe: Baseline, Month 12, 24Population: FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.
The SF-36 was a participant administered scale assessing general quality of life. It consisted of self-administered 36-item questionnaire that measured 8 health domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. These 8 domains were also summarized as physical and mental component scores. The score for each domain and component score was the mean of the individual question scores, which were scaled from 0 (minimum) to 100 (maximum), where higher scores indicated highest level of health/functioning. Linear transformations were performed to transform scores and rescaled to a score range of 19.23 (minimum) to 60.88 (maximum), with higher scores indicating lower bodily pain.
Outcome measures
| Measure |
SD-0610 50 Milligram (mg)
n=485 Participants
Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
|
SD-0610 200 mg
n=486 Participants
Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
|
Placebo
n=486 Participants
Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
|
|---|---|---|---|
|
Change From Baseline in Short Form-36 Bodily Pain Domain Score at Month 12 and 24
Baseline (n =481, 482, 485)
|
38.81 units on a scale
Standard Deviation 8.63
|
39.77 units on a scale
Standard Deviation 8.34
|
38.90 units on a scale
Standard Deviation 8.22
|
|
Change From Baseline in Short Form-36 Bodily Pain Domain Score at Month 12 and 24
Change at Month 12 (n =368, 381, 397)
|
4.07 units on a scale
Standard Deviation 9.64
|
3.72 units on a scale
Standard Deviation 8.32
|
4.06 units on a scale
Standard Deviation 8.97
|
|
Change From Baseline in Short Form-36 Bodily Pain Domain Score at Month 12 and 24
Change at Month 24 (n =332, 341, 352)
|
4.25 units on a scale
Standard Deviation 9.54
|
4.65 units on a scale
Standard Deviation 9.90
|
4.46 units on a scale
Standard Deviation 9.44
|
SECONDARY outcome
Timeframe: Baseline, Month 12, 24Population: FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.
The SF-36 was a participant administered scale assessing general quality of life. It consisted of self-administered 36-item questionnaire that measured 8 health domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. These 8 domains were also summarized as physical and mental component scores. The score for each domain and component score was the mean of the individual question scores, which were scaled from 0 (minimum) to 100 (maximum), where higher scores indicated highest level of health/functioning. Linear transformations were performed to transform scores and rescaled to a score range of 16.75 (minimum) to 63.72 (maximum), with higher scores indicating better general health.
Outcome measures
| Measure |
SD-0610 50 Milligram (mg)
n=485 Participants
Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
|
SD-0610 200 mg
n=486 Participants
Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
|
Placebo
n=486 Participants
Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
|
|---|---|---|---|
|
Change From Baseline in Short Form-36 General Health Domain Score at Month 12 and 24
Baseline (n =481, 481, 484)
|
44.77 units on a scale
Standard Deviation 10.15
|
46.49 units on a scale
Standard Deviation 9.79
|
45.19 units on a scale
Standard Deviation 9.63
|
|
Change From Baseline in Short Form-36 General Health Domain Score at Month 12 and 24
Change at Month 12 (n =367, 381, 395)
|
1.33 units on a scale
Standard Deviation 7.52
|
1.10 units on a scale
Standard Deviation 7.64
|
1.20 units on a scale
Standard Deviation 6.93
|
|
Change From Baseline in Short Form-36 General Health Domain Score at Month 12 and 24
Change at Month 24 (n =331, 341, 352)
|
1.13 units on a scale
Standard Deviation 8.43
|
0.40 units on a scale
Standard Deviation 7.76
|
1.25 units on a scale
Standard Deviation 7.77
|
SECONDARY outcome
Timeframe: Baseline, Month 12, 24Population: FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.
The SF-36 was a participant administered scale assessing general quality of life. It consisted of self-administered 36-item questionnaire that measured 8 health domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. These 8 domains were also summarized as physical and mental component scores. The score for each domain and component score was the mean of the individual question scores, which were scaled from 0 (minimum) to 100 (maximum), where higher scores indicated highest level of health/functioning. Linear transformations were performed to transform scores and rescaled to a score range of 22.02 (minimum) to 69.92 (maximum), with higher scores indicating better vitality.
Outcome measures
| Measure |
SD-0610 50 Milligram (mg)
n=485 Participants
Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
|
SD-0610 200 mg
n=486 Participants
Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
|
Placebo
n=486 Participants
Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
|
|---|---|---|---|
|
Change From Baseline in Short Form-36 Vitality Domain Score at Month 12 and 24
Baseline (n =481, 481, 484)
|
47.57 units on a scale
Standard Deviation 9.44
|
49.00 units on a scale
Standard Deviation 9.20
|
48.08 units on a scale
Standard Deviation 9.53
|
|
Change From Baseline in Short Form-36 Vitality Domain Score at Month 12 and 24
Change at Month 12 (n =368, 381, 396)
|
1.52 units on a scale
Standard Deviation 8.51
|
0.48 units on a scale
Standard Deviation 8.04
|
1.04 units on a scale
Standard Deviation 8.22
|
|
Change From Baseline in Short Form-36 Vitality Domain Score at Month 12 and 24
Change at Month 24 (n =332, 340, 351)
|
1.53 units on a scale
Standard Deviation 8.71
|
0.78 units on a scale
Standard Deviation 8.62
|
1.42 units on a scale
Standard Deviation 8.70
|
SECONDARY outcome
Timeframe: Baseline, Month 12, 24Population: FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.
The SF-36 was a participant administered scale assessing general quality of life. It consisted of self-administered 36-item questionnaire that measured 8 health domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. These 8 domains were also summarized as physical and mental component scores. The score for each domain and component score was the mean of the individual question scores, which were scaled from 0 (minimum) to 100 (maximum), where higher scores indicated highest level of health/functioning. Linear transformations were performed to transform scores and rescaled to a score range of 13.38 (minimum) to 56.40 (maximum), with higher scores indicating better social functioning.
Outcome measures
| Measure |
SD-0610 50 Milligram (mg)
n=485 Participants
Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
|
SD-0610 200 mg
n=486 Participants
Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
|
Placebo
n=486 Participants
Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
|
|---|---|---|---|
|
Change From Baseline in Short Form-36 Social Functioning Domain Score at Month 12 and 24
Baseline (n =481, 482, 485)
|
45.15 units on a scale
Standard Deviation 11.06
|
46.23 units on a scale
Standard Deviation 10.19
|
45.64 units on a scale
Standard Deviation 10.36
|
|
Change From Baseline in Short Form-36 Social Functioning Domain Score at Month 12 and 24
Change at Month 12 (n =368, 381, 397)
|
1.11 units on a scale
Standard Deviation 10.28
|
-0.28 units on a scale
Standard Deviation 9.16
|
-0.15 units on a scale
Standard Deviation 9.74
|
|
Change From Baseline in Short Form-36 Social Functioning Domain Score at Month 12 and 24
Change at Month 24 (n =333, 341, 352)
|
1.31 units on a scale
Standard Deviation 10.62
|
0.88 units on a scale
Standard Deviation 10.15
|
0.12 units on a scale
Standard Deviation 10.03
|
SECONDARY outcome
Timeframe: Baseline, Month 12, 24Population: FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.
The SF-36 was a participant administered scale assessing general quality of life. It consisted of self-administered 36-item questionnaire that measured 8 health domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. These 8 domains were also summarized as physical and mental component scores. The score for each domain and component score was the mean of the individual question scores, which were scaled from 0 (minimum) to 100 (maximum), where higher scores indicated highest level of health/functioning. Linear transformations were performed to transform scores and rescaled to a score range of 10.25 (minimum) to 55.68 (maximum), with higher scores indicating better role-emotional.
Outcome measures
| Measure |
SD-0610 50 Milligram (mg)
n=485 Participants
Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
|
SD-0610 200 mg
n=486 Participants
Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
|
Placebo
n=486 Participants
Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
|
|---|---|---|---|
|
Change From Baseline in Short Form-36 Role-Emotional Domain Score at Month 12 and 24
Baseline (n =481, 482, 485)
|
43.73 units on a scale
Standard Deviation 12.79
|
43.27 units on a scale
Standard Deviation 12.09
|
43.37 units on a scale
Standard Deviation 12.35
|
|
Change From Baseline in Short Form-36 Role-Emotional Domain Score at Month 12 and 24
Change at Month 12 (n =368, 381, 396)
|
0.05 units on a scale
Standard Deviation 12.06
|
-0.18 units on a scale
Standard Deviation 10.55
|
-0.25 units on a scale
Standard Deviation 11.47
|
|
Change From Baseline in Short Form-36 Role-Emotional Domain Score at Month 12 and 24
Change at Month 24 (n =333, 341, 352)
|
-0.28 units on a scale
Standard Deviation 12.77
|
0.60 units on a scale
Standard Deviation 11.69
|
0.32 units on a scale
Standard Deviation 11.98
|
SECONDARY outcome
Timeframe: Baseline, Month 12, 24Population: FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.
The SF-36 was a participant administered scale assessing general quality of life. It consisted of self-administered 36-item questionnaire that measured 8 health domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. These 8 domains were also summarized as physical and mental component scores. The score for each domain and component score was the mean of the individual question scores, which were scaled from 0 (minimum) to 100 (maximum), where higher scores indicated highest level of health/functioning. Linear transformations were performed to transform scores and rescaled to a score range of 8.02 (minimum) to 63.43 (maximum), with higher scores indicating better mental health.
Outcome measures
| Measure |
SD-0610 50 Milligram (mg)
n=485 Participants
Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
|
SD-0610 200 mg
n=486 Participants
Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
|
Placebo
n=486 Participants
Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
|
|---|---|---|---|
|
Change From Baseline in Short Form-36 Mental Health Domain Score at Month 12 and 24
Baseline (n =481, 481, 484)
|
47.01 units on a scale
Standard Deviation 10.80
|
47.70 units on a scale
Standard Deviation 10.73
|
47.26 units on a scale
Standard Deviation 11.15
|
|
Change From Baseline in Short Form-36 Mental Health Domain Score at Month 12 and 24
Change at Month 12 (n =368, 381, 396)
|
0.95 units on a scale
Standard Deviation 10.08
|
0.19 units on a scale
Standard Deviation 9.10
|
-0.31 units on a scale
Standard Deviation 9.50
|
|
Change From Baseline in Short Form-36 Mental Health Domain Score at Month 12 and 24
Change at Month 24 (n =332, 340, 351)
|
1.12 units on a scale
Standard Deviation 10.26
|
0.26 units on a scale
Standard Deviation 10.01
|
-0.01 units on a scale
Standard Deviation 9.81
|
SECONDARY outcome
Timeframe: Baseline, Month 12, 24Population: FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.
The SF-36 was a participant administered scale assessing general quality of life. It consisted of self-administered 36-item questionnaire that measured 8 health domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. These 8 domains were also summarized as physical and mental component scores. The score for each domain and component score was the mean of the individual question scores, which were scaled from 0 (minimum) to 100 (maximum), where higher scores indicated highest level of health/functioning. Linear transformations were performed to transform scores and rescaled to a score range of 22.88 (minimum) to 58.69 (maximum), with higher scores indicating better physical health.
Outcome measures
| Measure |
SD-0610 50 Milligram (mg)
n=485 Participants
Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
|
SD-0610 200 mg
n=486 Participants
Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
|
Placebo
n=486 Participants
Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
|
|---|---|---|---|
|
Change From Baseline in Short Form-36 Physical Health Component Score at Month 12 and 24
Baseline (n =481, 480, 483)
|
37.38 units on a scale
Standard Deviation 8.84
|
38.69 units on a scale
Standard Deviation 8.35
|
37.84 units on a scale
Standard Deviation 8.46
|
|
Change From Baseline in Short Form-36 Physical Health Component Score at Month 12 and 24
Change at Month 12 (n =367, 381, 395)
|
3.26 units on a scale
Standard Deviation 7.98
|
3.31 units on a scale
Standard Deviation 7.69
|
3.58 units on a scale
Standard Deviation 7.87
|
|
Change From Baseline in Short Form-36 Physical Health Component Score at Month 12 and 24
Change at Month 24 (n =329, 340, 351)
|
3.77 units on a scale
Standard Deviation 8.48
|
3.66 units on a scale
Standard Deviation 8.32
|
4.18 units on a scale
Standard Deviation 8.48
|
SECONDARY outcome
Timeframe: Baseline, Month 12, 24Population: FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.
The SF-36 was a participant administered scale assessing general quality of life. It consisted of self-administered 36-item questionnaire that measured 8 health domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. These 8 domains were also summarized as physical and mental component scores. The score for each domain and component score was the mean of the individual question scores, which were scaled from 0 (minimum) to 100 (maximum), where higher scores indicated highest level of health/functioning. Linear transformations were performed to transform scores and rescaled to a score range of 11.11 (minimum) to 61.67 (maximum), with higher scores indicating better mental health.
Outcome measures
| Measure |
SD-0610 50 Milligram (mg)
n=485 Participants
Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
|
SD-0610 200 mg
n=486 Participants
Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
|
Placebo
n=486 Participants
Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
|
|---|---|---|---|
|
Change From Baseline in Short Form-36 Mental Health Component Score at Month 12 and 24
Baseline (n =481, 480, 483)
|
49.65 units on a scale
Standard Deviation 11.79
|
49.97 units on a scale
Standard Deviation 11.11
|
49.65 units on a scale
Standard Deviation 11.62
|
|
Change From Baseline in Short Form-36 Mental Health Component Score at Month 12 and 24
Change at Month 12 (n =367, 381, 395)
|
-0.13 units on a scale
Standard Deviation 10.64
|
-1.17 units on a scale
Standard Deviation 9.48
|
-1.27 units on a scale
Standard Deviation 9.65
|
|
Change From Baseline in Short Form-36 Mental Health Component Score at Month 12 and 24
Change at Month 24 (n =329, 340, 351)
|
-0.41 units on a scale
Standard Deviation 11.24
|
-0.70 units on a scale
Standard Deviation 10.08
|
-1.09 units on a scale
Standard Deviation 10.18
|
SECONDARY outcome
Timeframe: Baseline, Month 12, 24Population: FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.
EQ-5D: participant rated questionnaire to assess health-related quality of life. Health state profile component assessed level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, anxiety and depression. EQ-5D mobility domain score scale ranged from 1 (minimum) to 3 (maximum), where 1 =better health (no problem), 2 =moderate health (some problems) and 3 =worst health (confined to bed). Higher scores indicating worse health condition. Participants with EQ-5D mobility domain score were reported in this measure.
Outcome measures
| Measure |
SD-0610 50 Milligram (mg)
n=485 Participants
Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
|
SD-0610 200 mg
n=486 Participants
Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
|
Placebo
n=486 Participants
Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
|
|---|---|---|---|
|
Number of Participants With EuroQoL-5D (EQ-5D) Mobility Domain Score
Baseline: No problem (n =481, 481, 485)
|
132 participants
|
135 participants
|
163 participants
|
|
Number of Participants With EuroQoL-5D (EQ-5D) Mobility Domain Score
Baseline: Some problems (n =481, 481, 485)
|
348 participants
|
345 participants
|
322 participants
|
|
Number of Participants With EuroQoL-5D (EQ-5D) Mobility Domain Score
Baseline: Confined to bed (n =481, 481, 485)
|
1 participants
|
1 participants
|
0 participants
|
|
Number of Participants With EuroQoL-5D (EQ-5D) Mobility Domain Score
Month 12: No problem (n =371, 382, 399)
|
174 participants
|
186 participants
|
178 participants
|
|
Number of Participants With EuroQoL-5D (EQ-5D) Mobility Domain Score
Month 12: Some problems (n =371, 382, 399)
|
197 participants
|
196 participants
|
221 participants
|
|
Number of Participants With EuroQoL-5D (EQ-5D) Mobility Domain Score
Month 12: Confined to bed (n =371, 382, 399)
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With EuroQoL-5D (EQ-5D) Mobility Domain Score
Month 24: No problem (n =334, 341, 353)
|
167 participants
|
161 participants
|
178 participants
|
|
Number of Participants With EuroQoL-5D (EQ-5D) Mobility Domain Score
Month 24: Some problems (n =334, 341, 353)
|
165 participants
|
180 participants
|
175 participants
|
|
Number of Participants With EuroQoL-5D (EQ-5D) Mobility Domain Score
Month 24: Confined to bed (n =334, 341, 353)
|
2 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline, Month 12, 24Population: FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.
EQ-5D: participant rated questionnaire to assess health-related quality of life. Health state profile component assessed level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, anxiety and depression. EQ-5D self-care domain score scale ranged from 1 (minimum) to 3 (maximum), where 1 =better health (no problems with self-care), 2 =moderate health (some problems) and 3 =worst health (unable to wash or dress). Higher scores indicating worse health condition. Participants with EQ-5D self-care domain score were reported in this measure.
Outcome measures
| Measure |
SD-0610 50 Milligram (mg)
n=485 Participants
Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
|
SD-0610 200 mg
n=486 Participants
Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
|
Placebo
n=486 Participants
Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
|
|---|---|---|---|
|
Number of Participants With EuroQoL-5D Self-Care Domain Score
Baseline: No problem (n =480, 481, 485)
|
383 participants
|
387 participants
|
386 participants
|
|
Number of Participants With EuroQoL-5D Self-Care Domain Score
Baseline: Some problems (n =480, 481, 485)
|
92 participants
|
93 participants
|
97 participants
|
|
Number of Participants With EuroQoL-5D Self-Care Domain Score
Baseline: Unable to wash/dress (n =480, 481, 485)
|
5 participants
|
1 participants
|
2 participants
|
|
Number of Participants With EuroQoL-5D Self-Care Domain Score
Month 12: No problem (n =371, 382, 399)
|
305 participants
|
327 participants
|
331 participants
|
|
Number of Participants With EuroQoL-5D Self-Care Domain Score
Month 12: Some problems (n =371, 382, 399)
|
66 participants
|
51 participants
|
67 participants
|
|
Number of Participants With EuroQoL-5D Self-Care Domain Score
Month 12: Unable to wash/dress (n =371, 382, 399)
|
0 participants
|
4 participants
|
1 participants
|
|
Number of Participants With EuroQoL-5D Self-Care Domain Score
Month 24: No problem (n =334, 341, 352)
|
280 participants
|
286 participants
|
299 participants
|
|
Number of Participants With EuroQoL-5D Self-Care Domain Score
Month 24: Some problems (n =334, 341, 352)
|
54 participants
|
55 participants
|
51 participants
|
|
Number of Participants With EuroQoL-5D Self-Care Domain Score
Month 24: Unable to wash/dress (n =334, 341, 352)
|
0 participants
|
0 participants
|
2 participants
|
SECONDARY outcome
Timeframe: Baseline, Month 12, 24Population: FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.
EQ-5D: participant rated questionnaire to assess health-related quality of life. Health state profile component assessed level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, anxiety and depression. EQ-5D usual activity domain score scale ranged from 1 (minimum) to 3 (maximum), where 1 =better health (no problems), 2 =moderate health (some problems) and 3 =worst health state (unable to perform usual activities). Higher scores indicating worse health condition. Participants with EQ-5D usual activity domain score were reported in this measure.
Outcome measures
| Measure |
SD-0610 50 Milligram (mg)
n=485 Participants
Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
|
SD-0610 200 mg
n=486 Participants
Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
|
Placebo
n=486 Participants
Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
|
|---|---|---|---|
|
Number of Participants With EuroQoL-5D Usual Activity Domain Score
Baseline: No problem (n =481, 481, 485)
|
186 participants
|
185 participants
|
190 participants
|
|
Number of Participants With EuroQoL-5D Usual Activity Domain Score
Baseline: Some problems (n =481, 481, 485)
|
285 participants
|
291 participants
|
289 participants
|
|
Number of Participants With EuroQoL-5D Usual Activity Domain Score
Baseline: Unable to do activities(n=481,481,485)
|
10 participants
|
5 participants
|
6 participants
|
|
Number of Participants With EuroQoL-5D Usual Activity Domain Score
Month 12: No problem (n =371, 382, 399)
|
192 participants
|
201 participants
|
193 participants
|
|
Number of Participants With EuroQoL-5D Usual Activity Domain Score
Month 12: Some problems (n =371, 382, 399)
|
176 participants
|
180 participants
|
204 participants
|
|
Number of Participants With EuroQoL-5D Usual Activity Domain Score
Month 12: Unable to do activities(n =371,382,399)
|
3 participants
|
1 participants
|
2 participants
|
|
Number of Participants With EuroQoL-5D Usual Activity Domain Score
Month 24: No problem (n =334, 340, 352)
|
187 participants
|
186 participants
|
205 participants
|
|
Number of Participants With EuroQoL-5D Usual Activity Domain Score
Month 24: Some problems (n =334, 340, 352)
|
140 participants
|
151 participants
|
144 participants
|
|
Number of Participants With EuroQoL-5D Usual Activity Domain Score
Month 24: Unable to do activities(n =334,340,352)
|
7 participants
|
3 participants
|
3 participants
|
SECONDARY outcome
Timeframe: Baseline, Month 12, 24Population: FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.
EQ-5D: participant rated questionnaire to assess health-related quality of life. Health state profile component assessed level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, anxiety and depression. EQ-5D pain and discomfort domain score scale ranged from 1 (minimum) to 3 (maximum), where 1 =better health (no pain and discomfort), 2 =moderate health (moderate pain and discomfort) and 3 =worst health state (extreme pain and discomfort). Higher scores indicated worse health condition. Participants with EQ-5D pain and discomfort domain score were reported in this measure.
Outcome measures
| Measure |
SD-0610 50 Milligram (mg)
n=485 Participants
Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
|
SD-0610 200 mg
n=486 Participants
Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
|
Placebo
n=486 Participants
Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
|
|---|---|---|---|
|
Number of Participants With EuroQo-5D Pain and Discomfort Domain Score
Month 24: Extreme (n =334, 341, 352)
|
16 participants
|
20 participants
|
14 participants
|
|
Number of Participants With EuroQo-5D Pain and Discomfort Domain Score
Baseline: None (n =481, 481, 485)
|
42 participants
|
48 participants
|
38 participants
|
|
Number of Participants With EuroQo-5D Pain and Discomfort Domain Score
Baseline: Moderate (n =481, 481, 485)
|
383 participants
|
391 participants
|
403 participants
|
|
Number of Participants With EuroQo-5D Pain and Discomfort Domain Score
Baseline: Extreme (n =481, 481, 485)
|
56 participants
|
42 participants
|
44 participants
|
|
Number of Participants With EuroQo-5D Pain and Discomfort Domain Score
Month 12: None (n =371, 382, 399)
|
91 participants
|
89 participants
|
82 participants
|
|
Number of Participants With EuroQo-5D Pain and Discomfort Domain Score
Month 12: Moderate (n =371, 382, 399)
|
259 participants
|
280 participants
|
293 participants
|
|
Number of Participants With EuroQo-5D Pain and Discomfort Domain Score
Month 12: Extreme (n =371, 382, 399)
|
21 participants
|
13 participants
|
24 participants
|
|
Number of Participants With EuroQo-5D Pain and Discomfort Domain Score
Month 24: None (n =334, 341, 352)
|
92 participants
|
89 participants
|
98 participants
|
|
Number of Participants With EuroQo-5D Pain and Discomfort Domain Score
Month 24: Moderate (n =334, 341, 352)
|
226 participants
|
232 participants
|
240 participants
|
SECONDARY outcome
Timeframe: Baseline, Month 12, 24Population: FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.
EQ-5D: participant rated questionnaire to assess health-related quality of life. Health state profile component assessed level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. EQ-5D anxiety and depression domain score scale ranged from 1 (minimum) to 3 (maximum), where 1 =better health (not anxious, depressed), 2 =moderate health (moderately anxious, depressed) and 3 =worst health (extremely anxious, depressed). Higher scores indicating worse health condition. Participants with EQ-5D anxiety and depression domain score were reported in this measure.
Outcome measures
| Measure |
SD-0610 50 Milligram (mg)
n=485 Participants
Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
|
SD-0610 200 mg
n=486 Participants
Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
|
Placebo
n=486 Participants
Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
|
|---|---|---|---|
|
Number of Participants With EuroQoL-5D Anxiety and Depression Domain Score
Baseline: None (n =481, 481, 485)
|
297 participants
|
306 participants
|
303 participants
|
|
Number of Participants With EuroQoL-5D Anxiety and Depression Domain Score
Baseline: Moderate (n =481, 481, 485)
|
166 participants
|
164 participants
|
168 participants
|
|
Number of Participants With EuroQoL-5D Anxiety and Depression Domain Score
Baseline: Extreme (n =481, 481, 485)
|
18 participants
|
11 participants
|
14 participants
|
|
Number of Participants With EuroQoL-5D Anxiety and Depression Domain Score
Month 12: None (n =371, 382, 399)
|
251 participants
|
256 participants
|
261 participants
|
|
Number of Participants With EuroQoL-5D Anxiety and Depression Domain Score
Month 12: Moderate (n =371, 382, 399)
|
111 participants
|
116 participants
|
127 participants
|
|
Number of Participants With EuroQoL-5D Anxiety and Depression Domain Score
Month12: Extreme (n =371, 382, 399)
|
9 participants
|
10 participants
|
11 participants
|
|
Number of Participants With EuroQoL-5D Anxiety and Depression Domain Score
Month 24: None (n =334, 341, 352)
|
235 participants
|
244 participants
|
237 participants
|
|
Number of Participants With EuroQoL-5D Anxiety and Depression Domain Score
Month 24: Moderate (n =334, 341, 352)
|
93 participants
|
89 participants
|
109 participants
|
|
Number of Participants With EuroQoL-5D Anxiety and Depression Domain Score
Month 24: Extreme (n =334, 341, 352)
|
6 participants
|
8 participants
|
6 participants
|
SECONDARY outcome
Timeframe: Baseline, Month 12, 24Population: FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.
The EQ-5D VAS score was a participant rated questionnaire to assess health-related quality of life in terms of a single index value. It was a visual analogue scale that ranged from 0 (minimum) to 100 (maximum), with higher scores indicating a better health condition.
Outcome measures
| Measure |
SD-0610 50 Milligram (mg)
n=485 Participants
Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
|
SD-0610 200 mg
n=486 Participants
Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
|
Placebo
n=486 Participants
Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
|
|---|---|---|---|
|
EuroQoL-5D Visual Analog Scale Score
Baseline (n =480, 479, 484)
|
66.75 units on a scale
Standard Deviation 21.52
|
68.59 units on a scale
Standard Deviation 19.69
|
67.86 units on a scale
Standard Deviation 19.36
|
|
EuroQoL-5D Visual Analog Scale Score
Month 12 (n =369, 381, 399)
|
72.34 units on a scale
Standard Deviation 19.01
|
72.55 units on a scale
Standard Deviation 19.48
|
70.58 units on a scale
Standard Deviation 19.91
|
|
EuroQoL-5D Visual Analog Scale Score
Month 24 (n =334, 341, 352)
|
73.18 units on a scale
Standard Deviation 19.64
|
73.95 units on a scale
Standard Deviation 18.85
|
72.36 units on a scale
Standard Deviation 19.36
|
SECONDARY outcome
Timeframe: Month 12, 24Population: FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.
Increase in total analgesic medication use for OA in the study knee was a comparison back to baseline of an increased and sustained use of standard background and/or rescue medication for more than 28 days as measured at the Month 12 and 24 visits. Only medications for OA knee pain were considered.
Outcome measures
| Measure |
SD-0610 50 Milligram (mg)
n=485 Participants
Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
|
SD-0610 200 mg
n=486 Participants
Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
|
Placebo
n=486 Participants
Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
|
|---|---|---|---|
|
Number of Participants With Increase in Total Analgesic Medication Use
Month 12 (n =372, 395, 408)
|
21 participants
|
29 participants
|
24 participants
|
|
Number of Participants With Increase in Total Analgesic Medication Use
Month 24 (n =344, 353, 354)
|
24 participants
|
34 participants
|
30 participants
|
SECONDARY outcome
Timeframe: Month 12, 24Population: FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.
Decrease in total analgesic medication use for OA in the study knee was a comparison back to baseline of a decreased and irregular use of standard background and/or rescue medication for more than 28 days as measured at the Month 12 and 24 visits. Only medications for OA knee pain were considered.
Outcome measures
| Measure |
SD-0610 50 Milligram (mg)
n=485 Participants
Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
|
SD-0610 200 mg
n=486 Participants
Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
|
Placebo
n=486 Participants
Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
|
|---|---|---|---|
|
Number of Participants With Decrease in Total Analgesic Medication Use
Month 12 (n =372, 395, 408)
|
29 participants
|
38 participants
|
43 participants
|
|
Number of Participants With Decrease in Total Analgesic Medication Use
Month 24 (n =344, 353, 354)
|
29 participants
|
38 participants
|
47 participants
|
SECONDARY outcome
Timeframe: Month 24Population: FAS included all participants randomized to the study. Here, 'N' signifies participants evaluable for this outcome measure.
Patient global impression of change was a participant-rated instrument that measured change in participant's overall status on a 7-point scale ranging from: 1 =very much improved, 2 =much improved, 3 =minimally improved, 4 =no change, 5 =minimally worse, 6 =much worse and 7 =very much worse. Higher scores indicating worse condition.
Outcome measures
| Measure |
SD-0610 50 Milligram (mg)
n=434 Participants
Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
|
SD-0610 200 mg
n=426 Participants
Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
|
Placebo
n=434 Participants
Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
|
|---|---|---|---|
|
Patient Global Impression of Change Score
|
2.97 units on a scale
Standard Deviation 1.26
|
3.02 units on a scale
Standard Deviation 1.34
|
3.00 units on a scale
Standard Deviation 1.35
|
SECONDARY outcome
Timeframe: Month 24Population: FAS included all participants randomized to the study. Here, 'N' signifies participants evaluable for this outcome measure.
The OMERACT-OARSI responder index was used to determine whether participants may be considered responders to treatment. An OMERACT-OARSI responder was a participant who had a better response on the WOMAC pain subscale score, a better response on the WOMAC physical function subscale score or improvement on at least two of the three domains: WOMAC pain subscale score (overall score range of 0 \[minimum\] to 20 \[maximum\], higher scores indicating more pain), WOMAC physical function subscale score (overall score range of 0 \[minimum\] to 68 \[maximum\], higher scores indicating worse physical function) and patient global assessment of arthritic condition score (overall score range of 1 \[minimum\] to 5 \[maximum\], higher scores indicating worse condition). Number of participants who were OMERACT-OARSI responder were reported in this measure.
Outcome measures
| Measure |
SD-0610 50 Milligram (mg)
n=468 Participants
Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
|
SD-0610 200 mg
n=469 Participants
Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
|
Placebo
n=470 Participants
Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
|
|---|---|---|---|
|
Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index
|
222 participants
|
226 participants
|
219 participants
|
SECONDARY outcome
Timeframe: Month 24Population: FAS included all participants randomized to the study. Here, 'N' signifies participants evaluable for this outcome measure.
JSN progressor was defined as a participant with a decrease in joint space width that was greater in magnitude than the smallest detectable difference (0.199 mm).
Outcome measures
| Measure |
SD-0610 50 Milligram (mg)
n=419 Participants
Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
|
SD-0610 200 mg
n=423 Participants
Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
|
Placebo
n=429 Participants
Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
|
|---|---|---|---|
|
Number of Participants With Joint Space Narrowing Progression
|
136 participants
|
153 participants
|
165 participants
|
SECONDARY outcome
Timeframe: Month 24Population: FAS included all participants randomized to the study. Here, 'N' signifies participants evaluable for this outcome measure.
A virtual joint replacement candidate was defined as a participant whose last two WOMAC pain subscale scores (overall score range of 0 \[minimum\] to 20 \[maximum\], higher scores indicating more pain) were at least 8, last two WOMAC physical function subscale scores (overall score range of 0 \[minimum\] to 68 \[maximum\], higher scores indicating worse physical function) were at least 28 and was a joint space narrowing progressor (a participant with a decrease in JSW that was greater in magnitude than the smallest detectable difference =0.199 mm).
Outcome measures
| Measure |
SD-0610 50 Milligram (mg)
n=405 Participants
Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
|
SD-0610 200 mg
n=411 Participants
Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
|
Placebo
n=425 Participants
Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
|
|---|---|---|---|
|
Number of Participants Applicable for Virtual Joint Replacement
|
28 participants
|
34 participants
|
28 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline up to 7-10 days after last dose of study drug (Week 111)Population: The safety analysis set included all participants in the FAS who received at least 1 dose of the randomized study medication.
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to 7-10 days after last dose that were absent before treatment or that worsened relative to pre-treatment state. Adverse events included both serious and non-serious adverse events.
Outcome measures
| Measure |
SD-0610 50 Milligram (mg)
n=482 Participants
Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
|
SD-0610 200 mg
n=485 Participants
Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
|
Placebo
n=485 Participants
Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
|
|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Adverse events
|
371 participants
|
381 participants
|
364 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Serious adverse events
|
43 participants
|
61 participants
|
49 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Month 3, 6, 12, 18, 24Population: The safety analysis set included all participants in the FAS who received at least 1 dose of the randomized study medication. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.
Atrial (enlargement, fibrillation, premature beat), axis deviation, atrioventricular (accelerated conduction, first/second degree block), left anterior and posterior hemiblock, left atrial hypertrophy, left and right (complete/incomplete bundle branch block, ventricular hypertrophy), QRS (high/low voltage, nonspecific, prolongation greater than \[\>\]140 milliseconds \[msec\]), junctional/paced rhythm, intraventricular conduction delay (\>120 msec), early repolarization, ventricular premature contraction and beat, prolonged QTC, sinus (arrhythmia, bradycardia/tachycardia), supraventricular extra systole and premature beat, short PR syndrome. Abnormal Q-wave (\>=30 msec), P-wave left/right atrial abnormality, T-wave flattened/inverted abnormality, U-wave abnormality, ST-T indeterminate abnormality, ST-T nonspecific changes, ST-T changes compatible with ischemia and pericarditis. ECG findings were judged by investigators for qualitative evaluation of abnormalities.
Outcome measures
| Measure |
SD-0610 50 Milligram (mg)
n=482 Participants
Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
|
SD-0610 200 mg
n=485 Participants
Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
|
Placebo
n=485 Participants
Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
|
|---|---|---|---|
|
Number of Participants With Electrocardiogram (ECG) Abnormalities
Baseline (n =481, 484, 485)
|
0 participants
|
0 participants
|
1 participants
|
|
Number of Participants With Electrocardiogram (ECG) Abnormalities
Month 6 (n =414, 427, 427)
|
3 participants
|
0 participants
|
1 participants
|
|
Number of Participants With Electrocardiogram (ECG) Abnormalities
Month 12 (n =373 , 397, 403)
|
4 participants
|
1 participants
|
2 participants
|
|
Number of Participants With Electrocardiogram (ECG) Abnormalities
Month 18 (n =351, 366, 362)
|
2 participants
|
2 participants
|
6 participants
|
|
Number of Participants With Electrocardiogram (ECG) Abnormalities
Month 24 (n =338, 344, 351)
|
3 participants
|
1 participants
|
6 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline up to Week 111Population: The safety analysis set included all participants in the FAS who received at least 1 dose of the randomized study medication. Here, 'N' signifies participants evaluable for this outcome measure.
Criteria for laboratory abnormalities: Hemoglobin (Hgb), hematocrit (hct), red blood cell(RBC) count: less than(\<)0.8\*lower limit of normal(LLN), platelet: \<0.5\*LLN or greater than (\>)1.75\*upper limit of normal (ULN), white blood cell (WBC): \<0.6\*LLN or \>1.5\*ULN, lymphocyte, neutrophil:\<0.8\*LLN or \>1.2\*ULN, basophil, eosinophil, monocyte:\>1.2\*ULN; total bilirubin \>1.5\*ULN, aspartate aminotransferase, alanine aminotransferase, gammaglutamyl transferase, alkaline phosphatase:\> 3.0\*ULN, total protein, albumin: \<0.8\*LLN or \>1.2\*ULN; blood urea nitrogen, creatinine:\>1.3\*ULN, uric acid \>1.2\*ULN; sodium \<0.95\*LLN or \>1.05\*ULN, potassium, chloride, calcium, magnesium, bicarbonate: \<0.9\*LLN or \>1.1\*ULN, phosphate \<0.8\*LLN or \>1.2\*ULN; glucose \<0.6\*LLN or \>1.5\*ULN, lipase \>1.5\*ULN; urine (specific gravity \<1.003 or \>1.030, pH \<4.5 or \>8, glucose, ketones, protein, blood/Hgb greater than or equal to \[\>=\]1); pancreatic amylase \>1.5\*ULN.
Outcome measures
| Measure |
SD-0610 50 Milligram (mg)
n=479 Participants
Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
|
SD-0610 200 mg
n=480 Participants
Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
|
Placebo
n=481 Participants
Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
|
|---|---|---|---|
|
Number of Participants With Laboratory Test Abnormalities
|
289 participants
|
297 participants
|
288 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 2, 4, 12, 24, 36, 48, 60, 72, 84, 96Population: The safety analysis set included all participants in the FAS who received at least 1 dose of the study medication. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.
Blood pressure (BP) was measured by sphygmomanometer while participant was in supine position. Conditions were kept constant from visit to visit including observer, participant's same arm, cuff size, supine position, location, temperature, noise level. The same size BP cuff which was properly sized and calibrated, was used to measure BP each time.
Outcome measures
| Measure |
SD-0610 50 Milligram (mg)
n=482 Participants
Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
|
SD-0610 200 mg
n=485 Participants
Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
|
Placebo
n=485 Participants
Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
|
|---|---|---|---|
|
Change From Baseline in Systolic Blood Pressure (SBP) at Week 2, 4, 12, 24, 36, 48, 60, 72, 84 and 96
Baseline (n =482, 485, 485)
|
127.04 millimeters of mercury (mmHg)
Standard Deviation 12.42
|
127.45 millimeters of mercury (mmHg)
Standard Deviation 12.18
|
127.45 millimeters of mercury (mmHg)
Standard Deviation 12.32
|
|
Change From Baseline in Systolic Blood Pressure (SBP) at Week 2, 4, 12, 24, 36, 48, 60, 72, 84 and 96
Change at Week 2 (n =459, 466, 462)
|
-0.06 millimeters of mercury (mmHg)
Standard Deviation 9.76
|
0.82 millimeters of mercury (mmHg)
Standard Deviation 10.66
|
-0.01 millimeters of mercury (mmHg)
Standard Deviation 10.71
|
|
Change From Baseline in Systolic Blood Pressure (SBP) at Week 2, 4, 12, 24, 36, 48, 60, 72, 84 and 96
Change at Week 4 (n =467, 467, 465)
|
-1.08 millimeters of mercury (mmHg)
Standard Deviation 11.37
|
0.99 millimeters of mercury (mmHg)
Standard Deviation 11.12
|
-0.94 millimeters of mercury (mmHg)
Standard Deviation 10.73
|
|
Change From Baseline in Systolic Blood Pressure (SBP) at Week 2, 4, 12, 24, 36, 48, 60, 72, 84 and 96
Change at Week 12 (n =450, 455, 461)
|
-0.11 millimeters of mercury (mmHg)
Standard Deviation 11.59
|
1.74 millimeters of mercury (mmHg)
Standard Deviation 12.09
|
-0.76 millimeters of mercury (mmHg)
Standard Deviation 12.33
|
|
Change From Baseline in Systolic Blood Pressure (SBP) at Week 2, 4, 12, 24, 36, 48, 60, 72, 84 and 96
Change at Week 24 (n =425, 432, 439)
|
-0.47 millimeters of mercury (mmHg)
Standard Deviation 12.07
|
0.97 millimeters of mercury (mmHg)
Standard Deviation 12.14
|
-0.73 millimeters of mercury (mmHg)
Standard Deviation 11.46
|
|
Change From Baseline in Systolic Blood Pressure (SBP) at Week 2, 4, 12, 24, 36, 48, 60, 72, 84 and 96
Change at Week 36 (n =385, 415, 418)
|
-0.11 millimeters of mercury (mmHg)
Standard Deviation 11.98
|
-0.80 millimeters of mercury (mmHg)
Standard Deviation 12.02
|
-1.58 millimeters of mercury (mmHg)
Standard Deviation 12.99
|
|
Change From Baseline in Systolic Blood Pressure (SBP) at Week 2, 4, 12, 24, 36, 48, 60, 72, 84 and 96
Change at Week 48 (n =377, 400, 410)
|
-0.83 millimeters of mercury (mmHg)
Standard Deviation 12.36
|
-0.22 millimeters of mercury (mmHg)
Standard Deviation 11.39
|
-0.28 millimeters of mercury (mmHg)
Standard Deviation 12.01
|
|
Change From Baseline in Systolic Blood Pressure (SBP) at Week 2, 4, 12, 24, 36, 48, 60, 72, 84 and 96
Change at Week 60 (n =360, 377, 384)
|
-1.02 millimeters of mercury (mmHg)
Standard Deviation 12.38
|
0.33 millimeters of mercury (mmHg)
Standard Deviation 12.02
|
-1.36 millimeters of mercury (mmHg)
Standard Deviation 12.24
|
|
Change From Baseline in Systolic Blood Pressure (SBP) at Week 2, 4, 12, 24, 36, 48, 60, 72, 84 and 96
Change at Week 72 (n =357, 374, 370)
|
-0.82 millimeters of mercury (mmHg)
Standard Deviation 12.94
|
-0.15 millimeters of mercury (mmHg)
Standard Deviation 13.00
|
-0.20 millimeters of mercury (mmHg)
Standard Deviation 13.00
|
|
Change From Baseline in Systolic Blood Pressure (SBP) at Week 2, 4, 12, 24, 36, 48, 60, 72, 84 and 96
Change at Week 84 (n =346, 366, 362)
|
-1.43 millimeters of mercury (mmHg)
Standard Deviation 13.45
|
-0.77 millimeters of mercury (mmHg)
Standard Deviation 12.98
|
-1.15 millimeters of mercury (mmHg)
Standard Deviation 13.08
|
|
Change From Baseline in Systolic Blood Pressure (SBP) at Week 2, 4, 12, 24, 36, 48, 60, 72, 84 and 96
Change at Week 96 (n =344, 353, 356)
|
-0.55 millimeters of mercury (mmHg)
Standard Deviation 12.84
|
0.02 millimeters of mercury (mmHg)
Standard Deviation 12.52
|
-0.71 millimeters of mercury (mmHg)
Standard Deviation 12.79
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 2, 4, 12, 24, 36, 48, 60, 72, 84, 96Population: The safety analysis set included all participants in the FAS who received at least 1 dose of the study medication. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.
BP was measured by sphygmomanometer while participant was in supine position. Conditions were kept constant from visit to visit including observer, participant's same arm, cuff size, supine position, location, temperature, noise level. The same size BP cuff which was properly sized and calibrated, was used to measure BP each time.
Outcome measures
| Measure |
SD-0610 50 Milligram (mg)
n=482 Participants
Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
|
SD-0610 200 mg
n=485 Participants
Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
|
Placebo
n=485 Participants
Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
|
|---|---|---|---|
|
Change From Baseline in Diastolic Blood Pressure (DBP) at Week 2, 4, 12, 24, 36, 48, 60, 72, 84 and 96
Baseline (n =482, 485, 485)
|
76.46 mmHg
Standard Deviation 7.68
|
77.06 mmHg
Standard Deviation 7.53
|
76.85 mmHg
Standard Deviation 7.71
|
|
Change From Baseline in Diastolic Blood Pressure (DBP) at Week 2, 4, 12, 24, 36, 48, 60, 72, 84 and 96
Change at Week 2 (n =459, 466, 462)
|
0.13 mmHg
Standard Deviation 6.63
|
0.58 mmHg
Standard Deviation 6.61
|
0.37 mmHg
Standard Deviation 7.07
|
|
Change From Baseline in Diastolic Blood Pressure (DBP) at Week 2, 4, 12, 24, 36, 48, 60, 72, 84 and 96
Change at Week 4 (n =467, 467, 465)
|
0.07 mmHg
Standard Deviation 7.04
|
0.78 mmHg
Standard Deviation 7.33
|
-0.41 mmHg
Standard Deviation 7.11
|
|
Change From Baseline in Diastolic Blood Pressure (DBP) at Week 2, 4, 12, 24, 36, 48, 60, 72, 84 and 96
Change at Week 12 (n =450, 455, 461)
|
0.02 mmHg
Standard Deviation 7.29
|
1.21 mmHg
Standard Deviation 7.56
|
0.05 mmHg
Standard Deviation 7.58
|
|
Change From Baseline in Diastolic Blood Pressure (DBP) at Week 2, 4, 12, 24, 36, 48, 60, 72, 84 and 96
Change at Week 24 (n =425, 432, 439)
|
0.02 mmHg
Standard Deviation 7.46
|
0.53 mmHg
Standard Deviation 7.80
|
-0.33 mmHg
Standard Deviation 7.52
|
|
Change From Baseline in Diastolic Blood Pressure (DBP) at Week 2, 4, 12, 24, 36, 48, 60, 72, 84 and 96
Change at Week 36 (n =385, 415, 418)
|
-0.21 mmHg
Standard Deviation 7.86
|
-0.31 mmHg
Standard Deviation 7.58
|
-1.18 mmHg
Standard Deviation 7.86
|
|
Change From Baseline in Diastolic Blood Pressure (DBP) at Week 2, 4, 12, 24, 36, 48, 60, 72, 84 and 96
Change at Week 48 (n =377, 400, 410)
|
-0.16 mmHg
Standard Deviation 8.28
|
-0.19 mmHg
Standard Deviation 7.99
|
-0.07 mmHg
Standard Deviation 7.67
|
|
Change From Baseline in Diastolic Blood Pressure (DBP) at Week 2, 4, 12, 24, 36, 48, 60, 72, 84 and 96
Change at Week 60 (n =360, 377, 384)
|
-0.69 mmHg
Standard Deviation 7.56
|
0.10 mmHg
Standard Deviation 7.91
|
-0.84 mmHg
Standard Deviation 8.32
|
|
Change From Baseline in Diastolic Blood Pressure (DBP) at Week 2, 4, 12, 24, 36, 48, 60, 72, 84 and 96
Change at Week 72 (n =357, 374, 370)
|
-0.49 mmHg
Standard Deviation 8.06
|
0.30 mmHg
Standard Deviation 8.81
|
-0.77 mmHg
Standard Deviation 8.14
|
|
Change From Baseline in Diastolic Blood Pressure (DBP) at Week 2, 4, 12, 24, 36, 48, 60, 72, 84 and 96
Change at Week 84 (n= 346, 366, 362)
|
-0.39 mmHg
Standard Deviation 8.03
|
-0.28 mmHg
Standard Deviation 7.93
|
-0.78 mmHg
Standard Deviation 8.60
|
|
Change From Baseline in Diastolic Blood Pressure (DBP) at Week 2, 4, 12, 24, 36, 48, 60, 72, 84 and 96
Change at Week 96 (n =344, 353, 356)
|
-0.21 mmHg
Standard Deviation 8.02
|
-0.20 mmHg
Standard Deviation 8.82
|
-0.70 mmHg
Standard Deviation 8.47
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 2, 4, 12, 24, 36, 48, 60, 72, 84, 96Population: The safety analysis set included all participants in the FAS who received at least 1 dose of the study medication. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.
Outcome measures
| Measure |
SD-0610 50 Milligram (mg)
n=482 Participants
Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
|
SD-0610 200 mg
n=485 Participants
Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
|
Placebo
n=485 Participants
Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
|
|---|---|---|---|
|
Change From Baseline in Heart Rate at Week 2, 4, 12, 24, 36, 48, 60, 72, 84 and 96
Change at Week 12 (n =450, 455, 461)
|
0.13 beats per minute (bpm)
Standard Deviation 7.70
|
-0.17 beats per minute (bpm)
Standard Deviation 7.61
|
0.05 beats per minute (bpm)
Standard Deviation 8.24
|
|
Change From Baseline in Heart Rate at Week 2, 4, 12, 24, 36, 48, 60, 72, 84 and 96
Change at Week 24 (n =425, 432, 439)
|
0.45 beats per minute (bpm)
Standard Deviation 8.30
|
-0.42 beats per minute (bpm)
Standard Deviation 7.46
|
0.06 beats per minute (bpm)
Standard Deviation 8.37
|
|
Change From Baseline in Heart Rate at Week 2, 4, 12, 24, 36, 48, 60, 72, 84 and 96
Change at Week 36 (n =384, 415, 418)
|
-0.08 beats per minute (bpm)
Standard Deviation 8.58
|
-0.07 beats per minute (bpm)
Standard Deviation 7.80
|
0.76 beats per minute (bpm)
Standard Deviation 8.41
|
|
Change From Baseline in Heart Rate at Week 2, 4, 12, 24, 36, 48, 60, 72, 84 and 96
Change at Week 48 (n =377, 399, 410)
|
-0.82 beats per minute (bpm)
Standard Deviation 8.45
|
-1.37 beats per minute (bpm)
Standard Deviation 8.23
|
-0.11 beats per minute (bpm)
Standard Deviation 8.59
|
|
Change From Baseline in Heart Rate at Week 2, 4, 12, 24, 36, 48, 60, 72, 84 and 96
Change at Week 60 (n =360, 377, 384)
|
-0.42 beats per minute (bpm)
Standard Deviation 8.37
|
0.04 beats per minute (bpm)
Standard Deviation 7.56
|
0.47 beats per minute (bpm)
Standard Deviation 8.90
|
|
Change From Baseline in Heart Rate at Week 2, 4, 12, 24, 36, 48, 60, 72, 84 and 96
Change at Week 72 (n =357, 374, 370)
|
-0.95 beats per minute (bpm)
Standard Deviation 8.75
|
-0.99 beats per minute (bpm)
Standard Deviation 7.91
|
0.85 beats per minute (bpm)
Standard Deviation 9.56
|
|
Change From Baseline in Heart Rate at Week 2, 4, 12, 24, 36, 48, 60, 72, 84 and 96
Change at Week 84 (n =346, 366, 362)
|
-0.31 beats per minute (bpm)
Standard Deviation 8.65
|
-0.15 beats per minute (bpm)
Standard Deviation 7.88
|
0.57 beats per minute (bpm)
Standard Deviation 8.64
|
|
Change From Baseline in Heart Rate at Week 2, 4, 12, 24, 36, 48, 60, 72, 84 and 96
Change at Week 96 (n =344, 353, 356)
|
-1.09 beats per minute (bpm)
Standard Deviation 8.91
|
-0.61 beats per minute (bpm)
Standard Deviation 8.53
|
0.36 beats per minute (bpm)
Standard Deviation 8.61
|
|
Change From Baseline in Heart Rate at Week 2, 4, 12, 24, 36, 48, 60, 72, 84 and 96
Baseline (n =482, 485, 485)
|
69.74 beats per minute (bpm)
Standard Deviation 9.11
|
69.12 beats per minute (bpm)
Standard Deviation 8.72
|
69.34 beats per minute (bpm)
Standard Deviation 8.26
|
|
Change From Baseline in Heart Rate at Week 2, 4, 12, 24, 36, 48, 60, 72, 84 and 96
Change at Week 2 (n =459, 466, 461)
|
0.58 beats per minute (bpm)
Standard Deviation 7.35
|
-0.29 beats per minute (bpm)
Standard Deviation 6.68
|
0.71 beats per minute (bpm)
Standard Deviation 7.55
|
|
Change From Baseline in Heart Rate at Week 2, 4, 12, 24, 36, 48, 60, 72, 84 and 96
Change at Week 4 (n =467, 466, 465)
|
0.24 beats per minute (bpm)
Standard Deviation 7.53
|
0.23 beats per minute (bpm)
Standard Deviation 7.46
|
0.78 beats per minute (bpm)
Standard Deviation 7.77
|
Adverse Events
SD-6010 50 Milligram (mg)
Serious events: 43 serious events
Other events: 365 other events
Deaths: 0 deaths
SD-6010 200 mg
Serious events: 61 serious events
Other events: 371 other events
Deaths: 0 deaths
Placebo
Serious events: 49 serious events
Other events: 360 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SD-6010 50 Milligram (mg)
n=482 participants at risk
Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
|
SD-6010 200 mg
n=485 participants at risk
Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
|
Placebo
n=485 participants at risk
Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.41%
2/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Cardiac disorders
Atrial fibrillation
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.62%
3/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Cardiac disorders
Bradyarrhythmia
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Cardiac disorders
Cardiac disorder
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Cardiac disorders
Cardiac failure chronic
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.41%
2/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Cardiac disorders
Coronary artery occlusion
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Cardiac disorders
Coronary artery stenosis
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.62%
3/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Cardiac disorders
Prinzmetal angina
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Gastrointestinal disorders
Colonic polyp
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Gastrointestinal disorders
Constipation
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Gastrointestinal disorders
Diverticulum
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Gastrointestinal disorders
Gastric disorder
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Gastrointestinal disorders
Hernial eventration
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Gastrointestinal disorders
Internal hernia
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
General disorders
Chest pain
|
0.83%
4/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.62%
3/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.41%
2/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
General disorders
Device dislocation
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
General disorders
Fatigue
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
General disorders
Medical device complication
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
General disorders
Pyrexia
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.41%
2/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.41%
2/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Hepatobiliary disorders
Gallbladder polyp
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Infections and infestations
Abdominal abscess
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Infections and infestations
Abdominal wall abscess
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Infections and infestations
Abscess limb
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Infections and infestations
Appendicitis
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.41%
2/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.41%
2/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Infections and infestations
Enterocolitis infectious
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Infections and infestations
Gastric ulcer helicobacter
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Infections and infestations
Gastroenteritis
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Infections and infestations
Helicobacter infection
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Infections and infestations
Infectious peritonitis
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Infections and infestations
Meningitis bacterial
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Infections and infestations
Pneumonia
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.41%
2/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Infections and infestations
Pseudomembranous colitis
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Infections and infestations
Sepsis
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Infections and infestations
Septic shock
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.41%
2/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Infections and infestations
Viral infection
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Infections and infestations
Wound infection
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Injury, poisoning and procedural complications
Anastomotic ulcer
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Injury, poisoning and procedural complications
Comminuted fracture
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Injury, poisoning and procedural complications
Deep vein thrombosis postoperative
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Injury, poisoning and procedural complications
Fall
|
0.41%
2/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.41%
2/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Injury, poisoning and procedural complications
Ligament injury
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Injury, poisoning and procedural complications
Meniscus lesion
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Injury, poisoning and procedural complications
Operative haemorrhage
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Injury, poisoning and procedural complications
Skull fracture
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Injury, poisoning and procedural complications
Splenic rupture
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Investigations
Blood pressure increased
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Investigations
Borrelia test positive
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.41%
2/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.62%
3/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.41%
2/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
1.2%
6/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
1.4%
7/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Systemic lupus erythematosus
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.41%
2/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.41%
2/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.41%
2/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic lymphocytic leukaemia
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma in situ
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Nasal cavity cancer
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer stage III
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer recurrent
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine cancer
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Nervous system disorders
Facial paresis
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Nervous system disorders
Lacunar infarction
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Nervous system disorders
Orthostatic intolerance
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Nervous system disorders
Presyncope
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Nervous system disorders
Spinal cord compression
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Nervous system disorders
Spinal vascular disorder
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.41%
2/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Nervous system disorders
Tremor
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Psychiatric disorders
Depression
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Renal and urinary disorders
Bladder perforation
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Renal and urinary disorders
Urogenital disorder
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Reproductive system and breast disorders
Cystocele
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.62%
3/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Reproductive system and breast disorders
Endometrial disorder
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Reproductive system and breast disorders
Metrorrhagia
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.41%
2/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Reproductive system and breast disorders
Uterine haemorrhage
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Reproductive system and breast disorders
Uterine prolapse
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.41%
2/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Vascular disorders
Deep vein thrombosis
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Vascular disorders
Hypertension
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.41%
2/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
Other adverse events
| Measure |
SD-6010 50 Milligram (mg)
n=482 participants at risk
Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
|
SD-6010 200 mg
n=485 participants at risk
Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
|
Placebo
n=485 participants at risk
Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.41%
2/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.41%
2/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
1.9%
9/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.41%
2/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Blood and lymphatic system disorders
Hypochromasia
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Blood and lymphatic system disorders
Hypochromic anaemia
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.41%
2/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.41%
2/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Blood and lymphatic system disorders
Lymphocytosis
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.41%
2/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.62%
3/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.41%
2/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Cardiac disorders
Aortic valve incompetence
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.41%
2/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Cardiac disorders
Arrhythmia supraventricular
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Cardiac disorders
Atrial fibrillation
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.82%
4/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.41%
2/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.41%
2/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.62%
3/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Cardiac disorders
Bundle branch block left
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.41%
2/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Cardiac disorders
Bundle branch block right
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.62%
3/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Cardiac disorders
Cardiac flutter
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Cardiac disorders
Cardiomegaly
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Cardiac disorders
Extrasystoles
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Cardiac disorders
Mitral valve incompetence
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Cardiac disorders
Palpitations
|
0.62%
3/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
1.4%
7/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.62%
3/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Cardiac disorders
Sick sinus syndrome
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Cardiac disorders
Sinus arrhythmia
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Cardiac disorders
Supraventricular extrasystoles
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Cardiac disorders
Tachycardia
|
0.41%
2/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.41%
2/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Cardiac disorders
Tricuspid valve incompetence
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.41%
2/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.82%
4/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Congenital, familial and genetic disorders
Brain malformation
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Congenital, familial and genetic disorders
Vascular anomaly
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Ear and labyrinth disorders
Cerumen impaction
|
0.62%
3/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.41%
2/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Ear and labyrinth disorders
Ear disorder
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Ear and labyrinth disorders
Ear pain
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.82%
4/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Ear and labyrinth disorders
Ear pruritus
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Ear and labyrinth disorders
Inner ear inflammation
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.62%
3/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.62%
3/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Ear and labyrinth disorders
Tympanic membrane perforation
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Ear and labyrinth disorders
Vertigo
|
1.5%
7/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.82%
4/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
1.4%
7/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Endocrine disorders
Goitre
|
0.83%
4/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.82%
4/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Endocrine disorders
Hypogonadism
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Endocrine disorders
Hypoparathyroidism
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Endocrine disorders
Thyroid cyst
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Endocrine disorders
Thyroiditis
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Endocrine disorders
Hypothyroidism
|
1.2%
6/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.62%
3/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.62%
3/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Eye disorders
Abnormal sensation in eye
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Eye disorders
Age-related macular degeneration
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Eye disorders
Arcus lipoides
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Eye disorders
Blepharitis
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Eye disorders
Cataract
|
1.0%
5/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
1.4%
7/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.41%
2/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Eye disorders
Cataract subcapsular
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Eye disorders
Conjunctivitis
|
0.41%
2/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.82%
4/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Eye disorders
Dry eye
|
0.41%
2/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Eye disorders
Erythema of eyelid
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Eye disorders
Eye allergy
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Eye disorders
Eye inflammation
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Eye disorders
Eye pain
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Eye disorders
Eye pruritus
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Eye disorders
Eyelid irritation
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Eye disorders
Eyelid ptosis
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Eye disorders
Glaucoma
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Eye disorders
Maculopathy
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Eye disorders
Ocular hyperaemia
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Eye disorders
Ocular hypertension
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Eye disorders
Papilloedema
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Eye disorders
Retinal detachment
|
0.62%
3/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Eye disorders
Retinal disorder
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Eye disorders
Retinal haemorrhage
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Eye disorders
Vision blurred
|
0.41%
2/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Eye disorders
Visual acuity reduced
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
1.0%
5/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.82%
4/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
1.6%
8/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.62%
3/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.7%
8/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
2.3%
11/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
2.9%
14/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.41%
2/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.82%
4/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.41%
2/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.9%
9/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
2.7%
13/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
2.5%
12/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Gastrointestinal disorders
Abdominal tenderness
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.41%
2/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Gastrointestinal disorders
Anal polyp
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Gastrointestinal disorders
Breath odour
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Gastrointestinal disorders
Change of bowel habit
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Gastrointestinal disorders
Cheilitis
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Gastrointestinal disorders
Colitis
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Gastrointestinal disorders
Colitis microscopic
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Gastrointestinal disorders
Colonic polyp
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.41%
2/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Gastrointestinal disorders
Constipation
|
1.7%
8/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
1.9%
9/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
1.6%
8/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Gastrointestinal disorders
Dental caries
|
0.62%
3/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.41%
2/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
4.6%
22/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
5.6%
27/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
6.0%
29/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Gastrointestinal disorders
Diverticulum
|
0.41%
2/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.41%
2/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Gastrointestinal disorders
Dry mouth
|
1.0%
5/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
1.2%
6/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Gastrointestinal disorders
Dyspepsia
|
2.1%
10/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
2.9%
14/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
2.9%
14/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Gastrointestinal disorders
Dysphagia
|
0.41%
2/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Gastrointestinal disorders
Femoral hernia
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Gastrointestinal disorders
Flatulence
|
1.0%
5/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.41%
2/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.82%
4/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Gastrointestinal disorders
Food poisoning
|
0.41%
2/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Gastrointestinal disorders
Frequent bowel movements
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Gastrointestinal disorders
Gastric disorder
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Gastrointestinal disorders
Gastric polyps
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Gastrointestinal disorders
Gastritis
|
0.83%
4/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
2.3%
11/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.82%
4/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
2.1%
10/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
2.5%
12/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
1.9%
9/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Gastrointestinal disorders
Gingival disorder
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Gastrointestinal disorders
Gingival recession
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Gastrointestinal disorders
Gingivitis
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Gastrointestinal disorders
Haematochezia
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.41%
2/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Gastrointestinal disorders
Haemorrhoids
|
1.2%
6/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.41%
2/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.41%
2/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Gastrointestinal disorders
Hyperchlorhydria
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.41%
2/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Gastrointestinal disorders
Lip swelling
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Gastrointestinal disorders
Nausea
|
4.1%
20/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
3.1%
15/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
2.9%
14/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Gastrointestinal disorders
Oesophageal disorder
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Gastrointestinal disorders
Oesophageal stenosis
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Gastrointestinal disorders
Omental infarction
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Gastrointestinal disorders
Oral disorder
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Gastrointestinal disorders
Pancreatic cyst
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Gastrointestinal disorders
Pancreatic disorder
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Gastrointestinal disorders
Pancreatitis chronic
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Gastrointestinal disorders
Paraesthesia oral
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Gastrointestinal disorders
Peptic ulcer
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Gastrointestinal disorders
Periodontitis
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Gastrointestinal disorders
Rectal polyp
|
0.41%
2/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Gastrointestinal disorders
Steatorrhoea
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Gastrointestinal disorders
Swollen tongue
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Gastrointestinal disorders
Tooth impacted
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Gastrointestinal disorders
Toothache
|
1.0%
5/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.41%
2/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
1.6%
8/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Gastrointestinal disorders
Vomiting
|
1.9%
9/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
2.5%
12/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.62%
3/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
General disorders
Application site dermatitis
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
General disorders
Asthenia
|
0.62%
3/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.41%
2/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
General disorders
Chest discomfort
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.41%
2/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
General disorders
Chest pain
|
1.2%
6/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
1.6%
8/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
1.6%
8/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
General disorders
Chills
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
General disorders
Cyst
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
General disorders
Facial pain
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
General disorders
Fatigue
|
2.1%
10/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
2.5%
12/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
2.7%
13/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
General disorders
Feeling cold
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
General disorders
Gait disturbance
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
General disorders
Inflammation
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
General disorders
Influenza like illness
|
0.41%
2/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
1.2%
6/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
General disorders
Injection site erythema
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
General disorders
Injection site inflammation
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
General disorders
Injection site pruritus
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
General disorders
Irritability
|
0.83%
4/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
General disorders
Malaise
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
General disorders
Medical device pain
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
General disorders
Medical device site reaction
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
General disorders
Non-cardiac chest pain
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
General disorders
Oedema
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
General disorders
Oedema peripheral
|
3.1%
15/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
3.1%
15/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
3.9%
19/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
General disorders
Pain
|
0.83%
4/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
1.2%
6/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.41%
2/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
General disorders
Polyp
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.41%
2/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
General disorders
Pyrexia
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.41%
2/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
General disorders
Soft tissue inflammation
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
General disorders
Tenderness
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
General disorders
Thirst
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.41%
2/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
General disorders
Ulcer
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
General disorders
Ulcer haemorrhage
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Hepatobiliary disorders
Biliary colic
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Hepatobiliary disorders
Biliary tract disorder
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.62%
3/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.41%
2/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Hepatobiliary disorders
Gallbladder polyp
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.41%
2/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.41%
2/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Hepatobiliary disorders
Hydrocholecystis
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Hepatobiliary disorders
Liver disorder
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Immune system disorders
Allergy to arthropod sting
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Immune system disorders
Drug hypersensitivity
|
0.41%
2/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Immune system disorders
Food allergy
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.41%
2/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Immune system disorders
Sarcoidosis
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Immune system disorders
Seasonal allergy
|
0.62%
3/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Infections and infestations
Abscess
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Infections and infestations
Abscess limb
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Infections and infestations
Acariasis
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Infections and infestations
Acute sinusitis
|
1.0%
5/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
1.2%
6/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
1.0%
5/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Infections and infestations
Appendicitis
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Infections and infestations
Arthritis infective
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Infections and infestations
Beta haemolytic streptococcal infection
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Infections and infestations
Body tinea
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Infections and infestations
Borrelia infection
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Infections and infestations
Bronchitis
|
5.2%
25/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
6.2%
30/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
4.1%
20/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Infections and infestations
Bronchitis viral
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Infections and infestations
Candidiasis
|
0.62%
3/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.41%
2/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Infections and infestations
Carbuncle
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Infections and infestations
Cellulitis
|
0.62%
3/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
1.6%
8/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
1.2%
6/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Infections and infestations
Cystitis
|
0.62%
3/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
1.2%
6/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.62%
3/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Infections and infestations
Device related infection
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Infections and infestations
Diarrhoea infectious
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Infections and infestations
Diverticulitis
|
0.41%
2/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.62%
3/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Infections and infestations
Ear infection
|
1.7%
8/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
1.6%
8/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.41%
2/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Infections and infestations
Erysipelas
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Infections and infestations
Erythema migrans
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Infections and infestations
Eye infection
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Infections and infestations
Folliculitis
|
0.41%
2/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Infections and infestations
Fungal infection
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.41%
2/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.41%
2/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Infections and infestations
Gastroenteritis
|
1.9%
9/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
1.9%
9/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.82%
4/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Infections and infestations
Gastroenteritis viral
|
1.0%
5/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.62%
3/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Infections and infestations
Gastrointestinal infection
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.41%
2/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Infections and infestations
Gastrointestinal viral infection
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Infections and infestations
Genital infection fungal
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Infections and infestations
Giardiasis
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.41%
2/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Infections and infestations
Gingival infection
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Infections and infestations
Helicobacter infection
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Infections and infestations
Herpes ophthalmic
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Infections and infestations
Herpes simplex
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Infections and infestations
Herpes virus infection
|
0.41%
2/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Infections and infestations
Herpes zoster
|
1.9%
9/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
1.0%
5/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
1.0%
5/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Infections and infestations
Hordeolum
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Infections and infestations
Impetigo
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Infections and infestations
Infected cyst
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Infections and infestations
Infection parasitic
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Infections and infestations
Influenza
|
2.7%
13/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
2.5%
12/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
2.9%
14/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Infections and infestations
Labyrinthitis
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Infections and infestations
Laryngitis
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.41%
2/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.41%
2/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Infections and infestations
Laryngitis viral
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Infections and infestations
Localised infection
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.41%
2/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.62%
3/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Infections and infestations
Lyme disease
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.41%
2/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Infections and infestations
Mastitis bacterial
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Infections and infestations
Nasopharyngitis
|
6.8%
33/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
8.5%
41/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
5.2%
25/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Infections and infestations
Onychomycosis
|
0.62%
3/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.41%
2/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.41%
2/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.41%
2/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Infections and infestations
Oral herpes
|
0.41%
2/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.41%
2/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Infections and infestations
Osteomyelitis
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Infections and infestations
Otitis externa
|
0.41%
2/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Infections and infestations
Otitis media
|
0.41%
2/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.62%
3/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Infections and infestations
Otitis media acute
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Infections and infestations
Paronychia
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Infections and infestations
Pharyngitis
|
1.5%
7/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
3.3%
16/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
1.4%
7/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Infections and infestations
Pharyngitis bacterial
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.83%
4/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.41%
2/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Infections and infestations
Pharyngotonsillitis
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Infections and infestations
Pilonidal cyst
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Infections and infestations
Pneumonia
|
0.83%
4/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
1.2%
6/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.82%
4/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Infections and infestations
Post procedural infection
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Infections and infestations
Postoperative wound infection
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Infections and infestations
Pyelonephritis
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Infections and infestations
Renal abscess
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Infections and infestations
Respiratory tract infection
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.41%
2/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.41%
2/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Infections and infestations
Respiratory tract infection viral
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Infections and infestations
Rhinitis
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.41%
2/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Infections and infestations
Sinusitis
|
3.7%
18/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
3.7%
18/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
2.9%
14/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Infections and infestations
Skin infection
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Infections and infestations
Subcutaneous abscess
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Infections and infestations
Tinea pedis
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Infections and infestations
Tonsillitis
|
0.41%
2/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Infections and infestations
Tooth abscess
|
1.2%
6/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.82%
4/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.41%
2/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Infections and infestations
Tracheitis
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Infections and infestations
Typhus
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Infections and infestations
Upper respiratory tract infection
|
8.3%
40/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
6.4%
31/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
6.2%
30/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Infections and infestations
Upper respiratory tract infection bacterial
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Infections and infestations
Urinary tract infection
|
5.0%
24/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
4.3%
21/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
5.4%
26/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Infections and infestations
Vaginal infection
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.41%
2/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Infections and infestations
Viral infection
|
0.41%
2/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.41%
2/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Infections and infestations
Viral pharyngitis
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Infections and infestations
Viral tonsillitis
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.41%
2/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.41%
2/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Infections and infestations
Vulvovaginitis
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.41%
2/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Infections and infestations
Wound infection
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Infections and infestations
Tooth infection
|
0.83%
4/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.82%
4/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.41%
2/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.41%
2/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.62%
3/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Injury, poisoning and procedural complications
Back injury
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Injury, poisoning and procedural complications
Bone fragmentation
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Injury, poisoning and procedural complications
Burns first degree
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Injury, poisoning and procedural complications
Burns second degree
|
0.41%
2/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Injury, poisoning and procedural complications
Chest injury
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.62%
3/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Injury, poisoning and procedural complications
Contusion
|
2.5%
12/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
2.5%
12/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
2.1%
10/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Injury, poisoning and procedural complications
Corneal abrasion
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.41%
2/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Injury, poisoning and procedural complications
Epicondylitis
|
0.41%
2/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.62%
3/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.62%
3/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Injury, poisoning and procedural complications
Eschar
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.83%
4/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.82%
4/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
1.0%
5/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Injury, poisoning and procedural complications
Fall
|
5.4%
26/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
8.5%
41/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
5.8%
28/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.82%
4/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.41%
2/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Injury, poisoning and procedural complications
Forearm fracture
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Injury, poisoning and procedural complications
Foreign body in eye
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.41%
2/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Injury, poisoning and procedural complications
Heat exhaustion
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.41%
2/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.82%
4/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.62%
3/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.82%
4/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.41%
2/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Injury, poisoning and procedural complications
Ligament injury
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
1.7%
8/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
2.3%
11/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
1.4%
7/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Injury, poisoning and procedural complications
Meniscus lesion
|
1.2%
6/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
1.2%
6/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
1.9%
9/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Injury, poisoning and procedural complications
Muscle rupture
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
1.7%
8/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
1.0%
5/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
1.2%
6/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Injury, poisoning and procedural complications
Periorbital haematoma
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Injury, poisoning and procedural complications
Periorbital haemorrhage
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Injury, poisoning and procedural complications
Post-traumatic neck syndrome
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.62%
3/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.41%
2/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.41%
2/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.41%
2/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Injury, poisoning and procedural complications
Scratch
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Injury, poisoning and procedural complications
Skeletal injury
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Injury, poisoning and procedural complications
Soft tissue injury
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Injury, poisoning and procedural complications
Stab wound
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Injury, poisoning and procedural complications
Stress fracture
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Injury, poisoning and procedural complications
Tendon injury
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.41%
2/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Injury, poisoning and procedural complications
Traumatic haematoma
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.62%
3/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Investigations
Alanine aminotransferase increased
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
1.0%
5/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.41%
2/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Investigations
Aspartate aminotransferase increased
|
0.62%
3/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.41%
2/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.41%
2/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Investigations
Blood amylase increased
|
0.62%
3/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
1.2%
6/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.62%
3/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Investigations
Blood bicarbonate decreased
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Investigations
Blood calcium increased
|
0.62%
3/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.41%
2/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Investigations
Blood cholesterol abnormal
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Investigations
Blood cholesterol increased
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.62%
3/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.41%
2/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Investigations
Blood creatine increased
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Investigations
Blood creatinine increased
|
0.41%
2/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.62%
3/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.82%
4/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Investigations
Blood glucose increased
|
0.41%
2/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.62%
3/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.62%
3/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Investigations
Blood potassium decreased
|
0.41%
2/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Investigations
Blood pressure decreased
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Investigations
Blood pressure increased
|
2.7%
13/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
4.9%
24/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
4.3%
21/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Investigations
Blood testosterone decreased
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Investigations
Blood thyroid stimulating hormone increased
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Investigations
Blood triglycerides increased
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Investigations
Blood urea increased
|
0.83%
4/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Investigations
Blood uric acid increased
|
0.41%
2/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.62%
3/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Investigations
Blood urine present
|
0.41%
2/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Investigations
Body temperature increased
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Investigations
Cardiac murmur
|
0.62%
3/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Investigations
Ceruloplasmin increased
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Investigations
ECG signs of myocardial ischaemia
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Investigations
Electrocardiogram T wave abnormal
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Investigations
Eosinophil count increased
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Investigations
Femoral bruit
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
2.1%
10/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.82%
4/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Investigations
Haematocrit decreased
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Investigations
Haematology test abnormal
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Investigations
Haemoglobin decreased
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Investigations
Heart rate increased
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Investigations
Heart rate irregular
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Investigations
Helicobacter test positive
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Investigations
Hepatic enzyme abnormal
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Investigations
Hepatic enzyme increased
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.41%
2/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Investigations
Lipase increased
|
1.5%
7/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
1.6%
8/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
1.4%
7/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Investigations
Liver function test abnormal
|
0.62%
3/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.62%
3/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Investigations
Low density lipoprotein increased
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Investigations
Monocyte count decreased
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.41%
2/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Investigations
Neutrophil count increased
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Investigations
Pancreatic enzymes increased
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Investigations
Prostatic specific antigen increased
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.41%
2/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Investigations
Protein urine present
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Investigations
Red blood cell burr cells present
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Investigations
Serum ferritin increased
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Investigations
Tandem gait test abnormal
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Investigations
Transaminases increased
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.41%
2/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.41%
2/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Investigations
Ultrasound kidney abnormal
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Investigations
Vitamin B12 decreased
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Investigations
Vitamin D decreased
|
0.41%
2/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Investigations
Waist circumference increased
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Investigations
Weight decreased
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Investigations
Weight increased
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
1.4%
7/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
1.0%
5/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Investigations
White blood cell count abnormal
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.41%
2/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Metabolism and nutrition disorders
Cholesterosis
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.62%
3/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.82%
4/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.82%
4/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.62%
3/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
1.0%
5/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Metabolism and nutrition disorders
Fluid retention
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Metabolism and nutrition disorders
Glucose tolerance impaired
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Metabolism and nutrition disorders
Gout
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.41%
2/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
1.9%
9/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.62%
3/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.82%
4/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.62%
3/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.62%
3/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.41%
2/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.82%
4/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.41%
2/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.62%
3/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
1.2%
6/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.41%
2/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.41%
2/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Metabolism and nutrition disorders
Increased appetite
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Metabolism and nutrition disorders
Lactose intolerance
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Metabolism and nutrition disorders
Obesity
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.83%
4/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.41%
2/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
1.0%
5/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Metabolism and nutrition disorders
Vitamin B12 deficiency
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.41%
2/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.62%
3/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
14.3%
69/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
13.4%
65/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
13.4%
65/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
1.6%
8/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.82%
4/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Arthrofibrosis
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Arthropathy
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.41%
2/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Articular calcification
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.41%
2/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.4%
31/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
6.6%
32/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
8.9%
43/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Bone loss
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.41%
2/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.41%
2/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.62%
3/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Bone swelling
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Bunion
|
0.41%
2/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
2.5%
12/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.41%
2/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
1.4%
7/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Chondrocalcinosis
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Chondrocalcinosis pyrophosphate
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Chondromalacia
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.41%
2/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Chondropathy
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.41%
2/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Connective tissue disorder
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Connective tissue inflammation
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Exostosis
|
0.83%
4/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.41%
2/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.41%
2/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Facet joint syndrome
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Fasciitis
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Fibromyalgia
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.41%
2/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Foot deformity
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Haemarthrosis
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc compression
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.62%
3/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.41%
2/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.62%
3/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.62%
3/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Joint crepitation
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.62%
3/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
1.0%
5/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Joint instability
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.41%
2/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Joint lock
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
1.0%
5/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
0.41%
2/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
2.9%
14/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
1.6%
8/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
1.4%
7/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Joint warmth
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Lordosis
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Meniscal degeneration
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Metatarsalgia
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Muscle contracture
|
0.41%
2/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Muscle disorder
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
2.5%
12/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
1.9%
9/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.62%
3/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.41%
2/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.41%
2/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
1.0%
5/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
2.5%
12/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
2.7%
13/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
3.5%
17/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.41%
2/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.41%
2/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.0%
5/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
1.2%
6/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
1.0%
5/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Myofascial pain syndrome
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.41%
2/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Neck mass
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
1.2%
6/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
2.5%
12/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
1.4%
7/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Nodal osteoarthritis
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Osteitis
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.82%
4/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
4.4%
21/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
4.7%
23/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
2.9%
14/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Osteopenia
|
0.41%
2/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.62%
3/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.41%
2/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.41%
2/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.7%
13/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
3.9%
19/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
4.3%
21/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
0.41%
2/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Plantar fasciitis
|
1.2%
6/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.62%
3/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
1.9%
9/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Polyarthritis
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Polymyalgia rheumatica
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.62%
3/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Resorption bone increased
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.41%
2/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
1.2%
6/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
1.0%
5/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Sjogren's syndrome
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Soft tissue mass
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Spinal disorder
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
1.2%
6/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.62%
3/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.62%
3/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Spondylitis
|
0.41%
2/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Spondylolysis
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.62%
3/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.41%
2/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.82%
4/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.62%
3/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Tendon disorder
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.41%
2/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
1.9%
9/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
2.9%
14/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
2.3%
11/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis stenosans
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.41%
2/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Trigger finger
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acrochordon
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign breast neoplasm
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of skin
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lip neoplasm malignant stage unspecified
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.41%
2/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.41%
2/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic naevus
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Morton's neuroma
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm of appendix
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroma
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian adenoma
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Paranasal sinus benign neoplasm
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seborrhoeic keratosis
|
0.41%
2/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.62%
3/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid neoplasm
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Nervous system disorders
Amnesia
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Nervous system disorders
Burning sensation
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.41%
2/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Nervous system disorders
Carotid artery disease
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Nervous system disorders
Carotid artery stenosis
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal discomfort
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.62%
3/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.41%
2/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
1.2%
6/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Nervous system disorders
Cerebral microangiopathy
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Nervous system disorders
Cervicobrachial syndrome
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Nervous system disorders
Cluster headache
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Nervous system disorders
Decreased vibratory sense
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Nervous system disorders
Diabetic neuropathy
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Nervous system disorders
Dizziness
|
3.5%
17/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
4.5%
22/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
2.3%
11/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Nervous system disorders
Dysgeusia
|
0.62%
3/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Nervous system disorders
Headache
|
6.6%
32/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
5.6%
27/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
3.7%
18/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Nervous system disorders
Hemiparesis
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.41%
2/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Nervous system disorders
Hypertonia
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Nervous system disorders
Hypoaesthesia
|
0.83%
4/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
1.0%
5/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.41%
2/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Nervous system disorders
Hyporeflexia
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Nervous system disorders
Lethargy
|
0.62%
3/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Nervous system disorders
Loss of consciousness
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Nervous system disorders
Lumbar radiculopathy
|
0.41%
2/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.41%
2/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Nervous system disorders
Memory impairment
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Nervous system disorders
Meralgia paraesthetica
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Nervous system disorders
Migraine
|
1.2%
6/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
1.4%
7/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Nervous system disorders
Migraine with aura
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Nervous system disorders
Multiple sclerosis
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Nervous system disorders
Muscle contractions involuntary
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Nervous system disorders
Nerve compression
|
0.41%
2/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.62%
3/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Nervous system disorders
Neuralgia
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Nervous system disorders
Neuritis
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.41%
2/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.41%
2/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Nervous system disorders
Paraesthesia
|
1.0%
5/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.62%
3/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.62%
3/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Nervous system disorders
Parkinson's disease
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.41%
2/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Nervous system disorders
Presyncope
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Nervous system disorders
Radicular syndrome
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Nervous system disorders
Radiculitis
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Nervous system disorders
Radiculitis cervical
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Nervous system disorders
Restless legs syndrome
|
0.62%
3/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.41%
2/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Nervous system disorders
Sciatic nerve neuropathy
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Nervous system disorders
Sciatica
|
0.83%
4/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
2.1%
10/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.41%
2/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Nervous system disorders
Sinus headache
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.62%
3/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Nervous system disorders
Sleep phase rhythm disturbance
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.41%
2/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Nervous system disorders
Syncope
|
0.62%
3/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Nervous system disorders
Tension headache
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.41%
2/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Nervous system disorders
Tremor
|
0.41%
2/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.41%
2/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Nervous system disorders
VIIth nerve paralysis
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Nervous system disorders
Vascular encephalopathy
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Psychiatric disorders
Anxiety
|
1.2%
6/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
1.4%
7/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
1.0%
5/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Psychiatric disorders
Confusional state
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Psychiatric disorders
Depressed mood
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Psychiatric disorders
Depression
|
2.5%
12/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
2.5%
12/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
1.2%
6/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Psychiatric disorders
Disorientation
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Psychiatric disorders
Emotional distress
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Psychiatric disorders
Euphoric mood
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Psychiatric disorders
Insomnia
|
1.9%
9/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
1.0%
5/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
1.4%
7/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Psychiatric disorders
Mood swings
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Psychiatric disorders
Nervousness
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Psychiatric disorders
Panic attack
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Psychiatric disorders
Substance abuse
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Renal and urinary disorders
Bladder disorder
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Renal and urinary disorders
Bladder spasm
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Renal and urinary disorders
Calculus bladder
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.41%
2/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Renal and urinary disorders
Dysuria
|
1.0%
5/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Renal and urinary disorders
Haematuria
|
1.0%
5/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.41%
2/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
1.2%
6/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Renal and urinary disorders
Haemorrhage urinary tract
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Renal and urinary disorders
Hypertonic bladder
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Renal and urinary disorders
Incontinence
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Renal and urinary disorders
Micturition urgency
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.41%
2/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.82%
4/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.62%
3/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Renal and urinary disorders
Pollakiuria
|
0.41%
2/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Renal and urinary disorders
Proteinuria
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.62%
3/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Renal and urinary disorders
Renal cyst
|
0.41%
2/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.41%
2/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Renal and urinary disorders
Renal failure chronic
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Renal and urinary disorders
Stress urinary incontinence
|
0.41%
2/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Renal and urinary disorders
Urethral disorder
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.41%
2/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Renal and urinary disorders
Urinary retention
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Renal and urinary disorders
Urinary tract inflammation
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Renal and urinary disorders
Urine flow decreased
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Reproductive system and breast disorders
Atrophic vulvovaginitis
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.41%
2/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Reproductive system and breast disorders
Breast cyst
|
0.41%
2/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Reproductive system and breast disorders
Breast disorder
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Reproductive system and breast disorders
Breast pain
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Reproductive system and breast disorders
Cervical polyp
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Reproductive system and breast disorders
Cystocele
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.41%
2/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Reproductive system and breast disorders
Endometrial hypertrophy
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Reproductive system and breast disorders
Erection increased
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Reproductive system and breast disorders
Fallopian tube cyst
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Reproductive system and breast disorders
Menopausal disorder
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Reproductive system and breast disorders
Menstrual disorder
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Reproductive system and breast disorders
Metrorrhagia
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.41%
2/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Reproductive system and breast disorders
Nipple pain
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.41%
2/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Reproductive system and breast disorders
Postmenopausal haemorrhage
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Reproductive system and breast disorders
Prostatitis
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Reproductive system and breast disorders
Prostatomegaly
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Reproductive system and breast disorders
Rectocele
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Reproductive system and breast disorders
Sexual dysfunction
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Reproductive system and breast disorders
Uterine enlargement
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Reproductive system and breast disorders
Uterine polyp
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Reproductive system and breast disorders
Uterine prolapse
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Reproductive system and breast disorders
Vaginal discharge
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Reproductive system and breast disorders
Vaginal prolapse
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Reproductive system and breast disorders
Vulvovaginal dryness
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Reproductive system and breast disorders
Vulvovaginal pain
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Reproductive system and breast disorders
Vulvovaginal pruritus
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic bronchitis
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.83%
4/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
1.4%
7/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.62%
3/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma exercise induced
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis chronic
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.62%
3/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.1%
10/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
1.9%
9/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
1.6%
8/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.41%
2/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.41%
2/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.62%
3/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.41%
2/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.82%
4/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.62%
3/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.62%
3/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.41%
2/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoventilation
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
1.0%
5/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.82%
4/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.41%
2/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal polyps
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal septum deviation
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal turbinate hypertrophy
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Nocturnal dyspnoea
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
1.5%
7/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
1.4%
7/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
1.0%
5/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus hypersecretion
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
0.41%
2/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.41%
2/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
1.0%
5/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.62%
3/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis perennial
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Rhonchi
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
1.2%
6/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
1.0%
5/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.41%
2/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.41%
2/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.41%
2/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Vasomotor rhinitis
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.41%
2/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
0.83%
4/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.41%
2/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.62%
3/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Cold sweat
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Cutis laxa
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.41%
2/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.62%
3/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.62%
3/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.62%
3/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
1.6%
8/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.41%
2/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.41%
2/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.83%
4/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.41%
2/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.82%
4/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Haemorrhage subcutaneous
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.83%
4/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.41%
2/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.82%
4/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Hypertrichosis
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Idiopathic urticaria
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Increased tendency to bruise
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Ingrown hair
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Mechanical urticaria
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Nail dystrophy
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Onycholysis
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Papule
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Photodermatosis
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
1.0%
5/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
1.0%
5/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.7%
13/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
2.5%
12/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
1.6%
8/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Rosacea
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Scab
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Seborrhoea
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.62%
3/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.82%
4/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.41%
2/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Subcutaneous nodule
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.62%
3/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.41%
2/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Vascular disorders
Aortic aneurysm
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Vascular disorders
Arteriosclerosis
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Vascular disorders
Bleeding varicose vein
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Vascular disorders
Deep vein thrombosis
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.41%
2/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Vascular disorders
Diastolic hypertension
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Vascular disorders
Flushing
|
0.62%
3/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Vascular disorders
Haematoma
|
0.41%
2/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.41%
2/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Vascular disorders
Haemorrhage
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Vascular disorders
Hot flush
|
0.41%
2/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.82%
4/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Vascular disorders
Hypertension
|
7.1%
34/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
5.6%
27/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
3.9%
19/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Vascular disorders
Hypotension
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Vascular disorders
Phlebitis
|
0.62%
3/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.62%
3/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Vascular disorders
Phlebitis deep
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Vascular disorders
Phlebitis superficial
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Vascular disorders
Systolic hypertension
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Vascular disorders
Thrombophlebitis
|
0.00%
0/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Vascular disorders
Thrombophlebitis superficial
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Vascular disorders
Varicose vein
|
0.21%
1/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.62%
3/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Vascular disorders
Venous insufficiency
|
0.83%
4/482 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.41%
2/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.21%
1/485 • Baseline up to Week 111
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER