Trial Outcomes & Findings for A Placebo- and Active-Controlled Study of Preladenant in Early Parkinson's Disease (PD) (P05664) (NCT NCT01155479)
NCT ID: NCT01155479
Last Updated: 2018-11-07
Results Overview
The UPDRS is a clinician based rating scale used to measure motor impairments and disability. The UPDRS assesses six features of PD impairment. These are evaluated using a combination of data collected by interview and examination of the participant. The UPDRS Part 2 is the Activities of Daily Living (ADL) score and can range from 0-52 as determined by the physician. The UPDRS Part 3 is the Motor Examination (Total Motor Score \[TMS\]) and is defined as the total score, ranging from 0-108 as determined by the physician, of the tests given in the motor examination section. The combined scores of Parts 2 and 3 can range from 0-160 with the higher score indicating the worse condition. Change from baseline was analyzed using a constrained longitudinal analysis (cLDA) model with treatment, time, strata and treatment-by-time interaction as fixed effects and participant as a random effect.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
1022 participants
Primary outcome timeframe
Baseline and Week 26
Results posted on
2018-11-07
Participant Flow
Participants with a diagnosis of idiopathic PD for less than 5 years were selected to participate in this study.
In Part 1, participants were randomized to one of five treatment groups and treated for 26 weeks. In Part 2, which was conducted for an additional 26 weeks, participants continued taking the same study treatment from Part 1, except for placebo participants who were re-assigned to receive preladenant 5 mg twice daily.
Participant milestones
| Measure |
Preladenant 2 mg
Participants received preladenant 2 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 2 mg oral tablet in PM for 26 weeks (Part 1) and then for another 26 weeks (Part 2).
|
Preladenant 5 mg
Participants received preladenant 5 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 5 mg in the PM for 26 weeks (Part 1) and then for another 26 weeks (Part 2).
|
Preladenant 10 mg
Participants received preladenant 10 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 10 mg in the PM for 26 weeks (Part 1) and then for another 26 weeks (Part 2).
|
Placebo
Participants received placebo for preladenant and placebo for rasagiline in the AM followed by placebo for preladenant in the PM for 26 weeks (Part 1); preladenant 5 mg was taken twice daily for 26 weeks (Part 2).
|
Rasagiline
Participants received rasagiline 1 mg oral capsule and placebo for preladenant in the AM followed by placebo for preladenant in PM for 26 weeks (Part 1) and then for another 26 weeks (Part 2).
|
|---|---|---|---|---|---|
|
Part I
STARTED
|
204
|
204
|
206
|
204
|
204
|
|
Part I
Treated
|
200
|
202
|
204
|
198
|
203
|
|
Part I
COMPLETED
|
166
|
177
|
167
|
177
|
181
|
|
Part I
NOT COMPLETED
|
38
|
27
|
39
|
27
|
23
|
|
Part II
STARTED
|
166
|
177
|
167
|
177
|
181
|
|
Part II
COMPLETED
|
107
|
116
|
109
|
127
|
126
|
|
Part II
NOT COMPLETED
|
59
|
61
|
58
|
50
|
55
|
Reasons for withdrawal
| Measure |
Preladenant 2 mg
Participants received preladenant 2 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 2 mg oral tablet in PM for 26 weeks (Part 1) and then for another 26 weeks (Part 2).
|
Preladenant 5 mg
Participants received preladenant 5 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 5 mg in the PM for 26 weeks (Part 1) and then for another 26 weeks (Part 2).
|
Preladenant 10 mg
Participants received preladenant 10 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 10 mg in the PM for 26 weeks (Part 1) and then for another 26 weeks (Part 2).
|
Placebo
Participants received placebo for preladenant and placebo for rasagiline in the AM followed by placebo for preladenant in the PM for 26 weeks (Part 1); preladenant 5 mg was taken twice daily for 26 weeks (Part 2).
|
Rasagiline
Participants received rasagiline 1 mg oral capsule and placebo for preladenant in the AM followed by placebo for preladenant in PM for 26 weeks (Part 1) and then for another 26 weeks (Part 2).
|
|---|---|---|---|---|---|
|
Part I
Adverse Event
|
13
|
8
|
18
|
7
|
6
|
|
Part I
Administrative
|
2
|
2
|
2
|
0
|
0
|
|
Part I
Did Not Meet Protocol Eligibility
|
3
|
1
|
2
|
1
|
3
|
|
Part I
Withdrawal by Subject
|
11
|
13
|
8
|
8
|
9
|
|
Part I
Lost to Follow-up
|
0
|
0
|
1
|
1
|
0
|
|
Part I
Treatment Failure
|
3
|
0
|
3
|
1
|
2
|
|
Part I
Did Not Receive Treatment
|
4
|
2
|
2
|
6
|
1
|
|
Part I
Non-Compliance with Protocol
|
2
|
1
|
3
|
3
|
2
|
|
Part II
Adverse Event
|
7
|
6
|
8
|
3
|
4
|
|
Part II
Administrative
|
43
|
49
|
36
|
38
|
46
|
|
Part II
Withdrawal by Subject
|
8
|
4
|
12
|
7
|
3
|
|
Part II
Lost to Follow-up
|
1
|
0
|
0
|
0
|
1
|
|
Part II
Treatment Failure
|
0
|
1
|
2
|
0
|
1
|
|
Part II
Non-Compliance with Protocol
|
0
|
1
|
0
|
2
|
0
|
Baseline Characteristics
A Placebo- and Active-Controlled Study of Preladenant in Early Parkinson's Disease (PD) (P05664)
Baseline characteristics by cohort
| Measure |
Preladenant 2 mg
n=204 Participants
Participants received preladenant 2 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 2 mg oral tablet in PM for 26 weeks (Part 1) and then for another 26 weeks (Part 2).
|
Preladenant 5 mg
n=204 Participants
Participants received preladenant 5 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 5 mg in the PM for 26 weeks (Part 1) and then for another 26 weeks (Part 2).
|
Preladenant 10 mg
n=206 Participants
Participants received preladenant 10 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 10 mg in the PM for 26 weeks (Part 1) and then for another 26 weeks (Part 2).
|
Placebo
n=204 Participants
Participants received placebo for preladenant and placebo for rasagiline in the AM followed by placebo for preladenant in the PM for 26 weeks (Part 1); preladenant 5 mg was taken twice daily for 26 weeks (Part 2).
|
Rasagiline
n=204 Participants
Participants received rasagiline 1 mg oral capsule and placebo for preladenant in the AM followed by placebo for preladenant in PM for 26 weeks (Part 1) and then for another 26 weeks (Part 2).
|
Total
n=1022 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
63.0 Years
STANDARD_DEVIATION 10.5 • n=5 Participants
|
62.3 Years
STANDARD_DEVIATION 10.2 • n=7 Participants
|
63.8 Years
STANDARD_DEVIATION 11.1 • n=5 Participants
|
63.3 Years
STANDARD_DEVIATION 10.0 • n=4 Participants
|
62.9 Years
STANDARD_DEVIATION 10.2 • n=21 Participants
|
63.1 Years
STANDARD_DEVIATION 10.4 • n=8 Participants
|
|
Sex: Female, Male
Female
|
78 Participants
n=5 Participants
|
90 Participants
n=7 Participants
|
90 Participants
n=5 Participants
|
82 Participants
n=4 Participants
|
85 Participants
n=21 Participants
|
425 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
126 Participants
n=5 Participants
|
114 Participants
n=7 Participants
|
116 Participants
n=5 Participants
|
122 Participants
n=4 Participants
|
119 Participants
n=21 Participants
|
597 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 26Population: Full Analysis Set (FAS): All randomized and treated participants with at least one post-baseline value.
The UPDRS is a clinician based rating scale used to measure motor impairments and disability. The UPDRS assesses six features of PD impairment. These are evaluated using a combination of data collected by interview and examination of the participant. The UPDRS Part 2 is the Activities of Daily Living (ADL) score and can range from 0-52 as determined by the physician. The UPDRS Part 3 is the Motor Examination (Total Motor Score \[TMS\]) and is defined as the total score, ranging from 0-108 as determined by the physician, of the tests given in the motor examination section. The combined scores of Parts 2 and 3 can range from 0-160 with the higher score indicating the worse condition. Change from baseline was analyzed using a constrained longitudinal analysis (cLDA) model with treatment, time, strata and treatment-by-time interaction as fixed effects and participant as a random effect.
Outcome measures
| Measure |
Preladenant 2 mg (Part 1)
n=195 Participants
Participants received preladenant 2 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 2 mg oral tablet in PM for 26 weeks.
|
Preladenant 5 mg (Part 1)
n=202 Participants
Participants received preladenant 5 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 5 mg in the PM for 26 weeks.
|
Preladenant 10 mg (Part 1)
n=200 Participants
Participants received preladenant 10 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 10 mg in the PM for 26 weeks.
|
Placebo (Part 1)
n=195 Participants
Participants received placebo for preladenant and placebo for rasagiline in the AM followed by placebo for preladenant in the PM for 26 weeks.
|
Rasagiline (Part 1)
n=195 Participants
Participants received rasagiline 1 mg oral capsule and placebo for preladenant in the AM followed by placebo for preladenant in PM for 26 weeks.
|
|---|---|---|---|---|---|
|
Change From Baseline in the Sum of Unified Parkinson's Disease Rating Scale Parts 2 and 3 Scores (UPDRS2+3)
|
0.3 Score on a Scale
Standard Error 0.63
|
-1.0 Score on a Scale
Standard Error 0.60
|
-1.8 Score on a Scale
Standard Error 0.61
|
-2.2 Score on a Scale
Standard Error 0.61
|
-1.9 Score on a Scale
Standard Error 0.61
|
PRIMARY outcome
Timeframe: Day 1 to Week 26Population: All Participants as Treated: All participants who received at least one dose of study treatment.
An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product.
Outcome measures
| Measure |
Preladenant 2 mg (Part 1)
n=200 Participants
Participants received preladenant 2 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 2 mg oral tablet in PM for 26 weeks.
|
Preladenant 5 mg (Part 1)
n=202 Participants
Participants received preladenant 5 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 5 mg in the PM for 26 weeks.
|
Preladenant 10 mg (Part 1)
n=204 Participants
Participants received preladenant 10 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 10 mg in the PM for 26 weeks.
|
Placebo (Part 1)
n=198 Participants
Participants received placebo for preladenant and placebo for rasagiline in the AM followed by placebo for preladenant in the PM for 26 weeks.
|
Rasagiline (Part 1)
n=203 Participants
Participants received rasagiline 1 mg oral capsule and placebo for preladenant in the AM followed by placebo for preladenant in PM for 26 weeks.
|
|---|---|---|---|---|---|
|
Number of Participants With Adverse Events (AEs) in Part 1
|
108 Participants
|
110 Participants
|
121 Participants
|
102 Participants
|
105 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Week 26Population: All Participants as Treated: All participants who received at least one dose of study treatment.
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product.
Outcome measures
| Measure |
Preladenant 2 mg (Part 1)
n=200 Participants
Participants received preladenant 2 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 2 mg oral tablet in PM for 26 weeks.
|
Preladenant 5 mg (Part 1)
n=202 Participants
Participants received preladenant 5 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 5 mg in the PM for 26 weeks.
|
Preladenant 10 mg (Part 1)
n=204 Participants
Participants received preladenant 10 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 10 mg in the PM for 26 weeks.
|
Placebo (Part 1)
n=198 Participants
Participants received placebo for preladenant and placebo for rasagiline in the AM followed by placebo for preladenant in the PM for 26 weeks.
|
Rasagiline (Part 1)
n=203 Participants
Participants received rasagiline 1 mg oral capsule and placebo for preladenant in the AM followed by placebo for preladenant in PM for 26 weeks.
|
|---|---|---|---|---|---|
|
Number of Participants Who Discontinued Study Due to an AE in Part 1
|
13 Participants
|
8 Participants
|
20 Participants
|
8 Participants
|
6 Participants
|
PRIMARY outcome
Timeframe: Week 27 to Week 52Population: All Participants as Treated: All participants who received at least one dose of study treatment.
An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product.
Outcome measures
| Measure |
Preladenant 2 mg (Part 1)
n=166 Participants
Participants received preladenant 2 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 2 mg oral tablet in PM for 26 weeks.
|
Preladenant 5 mg (Part 1)
n=177 Participants
Participants received preladenant 5 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 5 mg in the PM for 26 weeks.
|
Preladenant 10 mg (Part 1)
n=167 Participants
Participants received preladenant 10 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 10 mg in the PM for 26 weeks.
|
Placebo (Part 1)
n=177 Participants
Participants received placebo for preladenant and placebo for rasagiline in the AM followed by placebo for preladenant in the PM for 26 weeks.
|
Rasagiline (Part 1)
n=181 Participants
Participants received rasagiline 1 mg oral capsule and placebo for preladenant in the AM followed by placebo for preladenant in PM for 26 weeks.
|
|---|---|---|---|---|---|
|
Number of Participants With Adverse Events (AEs) in Part 2
|
116 Participants
|
120 Participants
|
113 Participants
|
120 Participants
|
119 Participants
|
PRIMARY outcome
Timeframe: Week 27 to Week 52Population: All Participants as Treated (APaT): All participants who received at least one dose of study treatment.
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product.
Outcome measures
| Measure |
Preladenant 2 mg (Part 1)
n=166 Participants
Participants received preladenant 2 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 2 mg oral tablet in PM for 26 weeks.
|
Preladenant 5 mg (Part 1)
n=177 Participants
Participants received preladenant 5 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 5 mg in the PM for 26 weeks.
|
Preladenant 10 mg (Part 1)
n=167 Participants
Participants received preladenant 10 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 10 mg in the PM for 26 weeks.
|
Placebo (Part 1)
n=177 Participants
Participants received placebo for preladenant and placebo for rasagiline in the AM followed by placebo for preladenant in the PM for 26 weeks.
|
Rasagiline (Part 1)
n=181 Participants
Participants received rasagiline 1 mg oral capsule and placebo for preladenant in the AM followed by placebo for preladenant in PM for 26 weeks.
|
|---|---|---|---|---|---|
|
Number of Participants Who Discontinued Study Due to an AE in Part 2
|
7 Participants
|
5 Participants
|
8 Participants
|
3 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Baseline and Week 26Population: Full Analysis Set (FAS): All randomized and treated participants with at least one post-baseline value.
UPDRS is a clinician based rating scale used to measure motor impairments and disability; it assesses 6 features of PD impairment. These are evaluated using a combination of data collected by interview and examination of the participant. UPDRS Part 2 is Activities of Daily Living score and ranges from 0-52. UPDRS Part 3 is Motor Examination and ranges from 0-108. The combined scores of Parts 2 and 3 can range from 0-160 with the higher score indicating the worse condition. A Responder is defined as a participant with at least 20% improvement in UPDRS2+3 from Baseline to Week 26 (End of Part 1 Treatment); a participant with at least a 20% decrease from Baseline score in UPDRS2+3 is defined as a responder. The proportion of Responders was analyzed using a generalized linear mixed model with treatment effect, strata and Baseline UPDRS2+3 as a covariate, and treatment-by-time interaction as fixed effects and subject as random effect.
Outcome measures
| Measure |
Preladenant 2 mg (Part 1)
n=195 Participants
Participants received preladenant 2 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 2 mg oral tablet in PM for 26 weeks.
|
Preladenant 5 mg (Part 1)
n=202 Participants
Participants received preladenant 5 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 5 mg in the PM for 26 weeks.
|
Preladenant 10 mg (Part 1)
n=200 Participants
Participants received preladenant 10 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 10 mg in the PM for 26 weeks.
|
Placebo (Part 1)
n=195 Participants
Participants received placebo for preladenant and placebo for rasagiline in the AM followed by placebo for preladenant in the PM for 26 weeks.
|
Rasagiline (Part 1)
n=195 Participants
Participants received rasagiline 1 mg oral capsule and placebo for preladenant in the AM followed by placebo for preladenant in PM for 26 weeks.
|
|---|---|---|---|---|---|
|
Percentage of Responders (Participants With a ≥20% Improvement in UPDRS2+3)
|
25.90 Percentage of Responders
Interval 18.95 to 34.33
|
29.50 Percentage of Responders
Interval 22.5 to 37.72
|
31.50 Percentage of Responders
Interval 24.06 to 40.02
|
35.20 Percentage of Responders
Interval 27.49 to 43.82
|
33.10 Percentage of Responders
Interval 25.6 to 41.51
|
SECONDARY outcome
Timeframe: Baseline and Week 26Population: Full Analysis Set (FAS): All randomized and treated participants with at least one post-baseline value.
The UPDRS is a clinician based rating scale used to measure motor impairments and disability. The UPDRS assesses six features of PD impairment. These are evaluated using a combination of data collected by interview and examination of the participant. The UPDRS Part 2 is the Activities of Daily Living (ADL) score and can range from 0-52 as determined by the physician with the higher score indicating the worse condition. Change from baseline was analyzed using a cLDA model with treatment, time, strata and treatment-by-time interaction as fixed effects and participant as a random effect.
Outcome measures
| Measure |
Preladenant 2 mg (Part 1)
n=195 Participants
Participants received preladenant 2 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 2 mg oral tablet in PM for 26 weeks.
|
Preladenant 5 mg (Part 1)
n=202 Participants
Participants received preladenant 5 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 5 mg in the PM for 26 weeks.
|
Preladenant 10 mg (Part 1)
n=200 Participants
Participants received preladenant 10 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 10 mg in the PM for 26 weeks.
|
Placebo (Part 1)
n=195 Participants
Participants received placebo for preladenant and placebo for rasagiline in the AM followed by placebo for preladenant in the PM for 26 weeks.
|
Rasagiline (Part 1)
n=195 Participants
Participants received rasagiline 1 mg oral capsule and placebo for preladenant in the AM followed by placebo for preladenant in PM for 26 weeks.
|
|---|---|---|---|---|---|
|
Change From Baseline in the UPDRS Part 2 Score (Activities of Daily Living [ADL])
|
0.30 Score on a Scale
Standard Error 0.22
|
0.10 Score on a Scale
Standard Error 0.21
|
-0.20 Score on a Scale
Standard Error 0.21
|
-0.40 Score on a Scale
Standard Error 0.21
|
-0.20 Score on a Scale
Standard Error 0.21
|
Adverse Events
Preladenant 2 mg - Part 1
Serious events: 4 serious events
Other events: 33 other events
Deaths: 0 deaths
Preladenant 5 mg - Part 1
Serious events: 5 serious events
Other events: 39 other events
Deaths: 0 deaths
Preladenant 10 mg - Part 1
Serious events: 8 serious events
Other events: 40 other events
Deaths: 0 deaths
Placebo - Part 1
Serious events: 3 serious events
Other events: 36 other events
Deaths: 0 deaths
Rasagiline - Part 1
Serious events: 9 serious events
Other events: 34 other events
Deaths: 0 deaths
Preladenant 2 mg - Part 2
Serious events: 7 serious events
Other events: 18 other events
Deaths: 0 deaths
Preladenant 5 mg - Part 2
Serious events: 1 serious events
Other events: 22 other events
Deaths: 0 deaths
Preladenant 10 mg - Part 2
Serious events: 8 serious events
Other events: 17 other events
Deaths: 0 deaths
Placebo/Preladenant 5 Mg-Part 2
Serious events: 4 serious events
Other events: 16 other events
Deaths: 0 deaths
Rasagiline - Part 2
Serious events: 8 serious events
Other events: 19 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Preladenant 2 mg - Part 1
n=200 participants at risk
Participants received preladenant 2 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 2 mg oral tablet in PM for 26 weeks (Part 1).
|
Preladenant 5 mg - Part 1
n=202 participants at risk
Participants received preladenant 5 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 5 mg in the PM for 26 weeks (Part 1).
|
Preladenant 10 mg - Part 1
n=204 participants at risk
Participants received preladenant 10 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 10 mg in the PM for 26 weeks (Part 1).
|
Placebo - Part 1
n=198 participants at risk
Participants received placebo for preladenant and placebo for rasagiline in the AM followed by placebo for preladenant in the PM for 26 weeks (Part 1).
|
Rasagiline - Part 1
n=203 participants at risk
Participants received rasagiline 1 mg oral capsule and placebo for preladenant in the AM followed by placebo for preladenant in PM for 26 weeks (Part 1).
|
Preladenant 2 mg - Part 2
n=166 participants at risk
Participants received preladenant 2 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 2 mg oral tablet in PM for 26 weeks (Part 2).
|
Preladenant 5 mg - Part 2
n=177 participants at risk
Participants received preladenant 5 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 5 mg in the PM for 26 weeks (Part 2).
|
Preladenant 10 mg - Part 2
n=167 participants at risk
Participants received preladenant 10 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 10 mg in the PM for 26 weeks (Part 2).
|
Placebo/Preladenant 5 Mg-Part 2
n=177 participants at risk
Participants received preladenant 5 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 5 mg oral tablet in the PM for 26 weeks (Part 2).
|
Rasagiline - Part 2
n=181 participants at risk
Participants received rasagiline 1 mg oral capsule and placebo for preladenant in the AM followed by placebo for preladenant in PM for 26 weeks (Part 2).
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Renal and urinary disorders
Cystitis Haemorrhagic
|
0.00%
0/200 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/202 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/204 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/198 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/203 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.60%
1/166 • Number of events 1 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/177 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/167 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/177 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/181 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/200 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/202 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.49%
1/204 • Number of events 1 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/198 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/203 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.60%
1/166 • Number of events 1 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/177 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/167 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/177 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/181 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
|
Cardiac disorders
Acute Coronary Syndrome
|
0.00%
0/200 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.50%
1/202 • Number of events 1 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/204 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/198 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/203 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/166 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/177 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/167 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/177 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/181 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
|
Cardiac disorders
Acute Myocardial Infarction
|
0.00%
0/200 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/202 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/204 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/198 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/203 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/166 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/177 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.60%
1/167 • Number of events 1 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/177 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/181 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
|
Cardiac disorders
Angina Pectoris
|
0.00%
0/200 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/202 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/204 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/198 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/203 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/166 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/177 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/167 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/177 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.55%
1/181 • Number of events 1 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
|
Cardiac disorders
Angina Unstable
|
0.00%
0/200 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/202 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/204 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/198 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.49%
1/203 • Number of events 1 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/166 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/177 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/167 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/177 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.55%
1/181 • Number of events 1 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
|
Cardiac disorders
Cardiac Failure
|
0.00%
0/200 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/202 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.49%
1/204 • Number of events 1 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/198 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/203 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/166 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/177 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/167 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.56%
1/177 • Number of events 1 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/181 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
|
Cardiac disorders
Coronary Artery Disease
|
0.00%
0/200 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/202 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/204 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/198 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.49%
1/203 • Number of events 1 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/166 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/177 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/167 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/177 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/181 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
|
Cardiac disorders
Left Ventricular Failure
|
0.00%
0/200 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/202 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/204 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/198 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/203 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/166 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/177 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/167 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.56%
1/177 • Number of events 1 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/181 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
|
Cardiac disorders
Myocardial Infarction
|
0.00%
0/200 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/202 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/204 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/198 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.49%
1/203 • Number of events 1 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/166 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/177 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/167 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/177 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/181 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/200 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/202 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/204 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/198 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/203 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/166 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/177 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.60%
1/167 • Number of events 1 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/177 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/181 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
|
General disorders
Local Swelling
|
0.00%
0/200 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/202 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/204 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/198 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/203 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/166 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/177 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/167 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/177 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.55%
1/181 • Number of events 1 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/200 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/202 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/204 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.51%
1/198 • Number of events 1 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/203 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/166 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/177 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/167 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/177 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/181 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
|
Gastrointestinal disorders
Pancreatitis Acute
|
0.00%
0/200 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/202 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/204 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/198 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.49%
1/203 • Number of events 1 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/166 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/177 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/167 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/177 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/181 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
|
General disorders
Chest Pain
|
0.00%
0/200 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/202 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/204 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/198 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.49%
1/203 • Number of events 1 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/166 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/177 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/167 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/177 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/181 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/200 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/202 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/204 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.51%
1/198 • Number of events 1 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/203 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/166 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.56%
1/177 • Number of events 1 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/167 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/177 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/181 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
|
Hepatobiliary disorders
Cholecystitis Acute
|
0.00%
0/200 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/202 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/204 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.51%
1/198 • Number of events 1 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/203 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/166 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/177 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/167 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/177 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/181 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
|
Hepatobiliary disorders
Jaundice Cholestatic
|
0.00%
0/200 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/202 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/204 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.51%
1/198 • Number of events 1 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/203 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/166 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/177 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/167 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/177 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/181 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/200 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/202 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.49%
1/204 • Number of events 1 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/198 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/203 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.60%
1/166 • Number of events 1 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/177 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/167 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/177 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/181 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
|
Infections and infestations
Erysipelas
|
0.00%
0/200 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/202 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/204 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/198 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/203 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/166 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/177 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.60%
1/167 • Number of events 1 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/177 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/181 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/200 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/202 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.49%
1/204 • Number of events 1 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/198 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/203 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/166 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/177 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/167 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/177 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/181 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
|
Infections and infestations
Lower Respiratory Tract Infection
|
0.00%
0/200 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/202 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/204 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/198 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/203 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/166 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/177 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/167 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.56%
1/177 • Number of events 1 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/181 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/200 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/202 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/204 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/198 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/203 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.60%
1/166 • Number of events 1 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/177 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/167 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/177 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/181 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
|
Infections and infestations
Pneumonia Bacterial
|
0.00%
0/200 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/202 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/204 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/198 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.49%
1/203 • Number of events 1 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/166 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/177 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/167 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/177 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/181 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
|
Infections and infestations
Sepsis
|
0.00%
0/200 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/202 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/204 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/198 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.49%
1/203 • Number of events 1 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/166 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/177 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/167 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.56%
1/177 • Number of events 1 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/181 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.00%
0/200 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/202 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.49%
1/204 • Number of events 1 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/198 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/203 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/166 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/177 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/167 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/177 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/181 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
|
Infections and infestations
Urinary Tract Infection
|
0.50%
1/200 • Number of events 1 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/202 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/204 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/198 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/203 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/166 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/177 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/167 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/177 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/181 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
|
Injury, poisoning and procedural complications
Brain Contusion
|
0.00%
0/200 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/202 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.49%
1/204 • Number of events 1 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/198 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/203 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/166 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/177 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/167 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/177 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/181 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
|
Injury, poisoning and procedural complications
Femur Fracture
|
0.00%
0/200 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/202 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/204 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/198 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/203 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.60%
1/166 • Number of events 1 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/177 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/167 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/177 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/181 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
|
Injury, poisoning and procedural complications
Fibula Fracture
|
0.00%
0/200 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/202 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/204 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/198 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/203 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/166 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/177 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/167 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.56%
1/177 • Number of events 1 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/181 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
|
Injury, poisoning and procedural complications
Hip Fracture
|
0.00%
0/200 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/202 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/204 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/198 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/203 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/166 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/177 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/167 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/177 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.55%
1/181 • Number of events 1 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
|
Injury, poisoning and procedural complications
Pelvic Fracture
|
0.00%
0/200 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/202 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/204 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/198 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/203 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/166 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/177 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/167 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/177 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.55%
1/181 • Number of events 1 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
|
Injury, poisoning and procedural complications
Tendon Rupture
|
0.00%
0/200 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/202 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/204 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/198 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.49%
1/203 • Number of events 1 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/166 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/177 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/167 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/177 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/181 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
|
Injury, poisoning and procedural complications
Tibia Fracture
|
0.00%
0/200 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/202 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/204 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/198 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/203 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/166 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/177 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/167 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.56%
1/177 • Number of events 1 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/181 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
|
Investigations
Alanine Aminotransferase Increased
|
0.00%
0/200 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.50%
1/202 • Number of events 2 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/204 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/198 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/203 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/166 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/177 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/167 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/177 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/181 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
|
Investigations
Antinuclear Antibody Increased
|
0.00%
0/200 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/202 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.49%
1/204 • Number of events 1 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/198 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/203 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/166 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/177 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/167 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/177 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/181 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
|
Investigations
Aspartate Aminotransferase Increased
|
0.00%
0/200 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.50%
1/202 • Number of events 1 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/204 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/198 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/203 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/166 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/177 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/167 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/177 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/181 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
|
Investigations
Hepatic Enzyme Increased
|
0.00%
0/200 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.50%
1/202 • Number of events 1 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/204 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/198 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/203 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/166 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/177 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/167 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/177 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/181 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/200 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/202 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.49%
1/204 • Number of events 1 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/198 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/203 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/166 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/177 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/167 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/177 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/181 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
|
Metabolism and nutrition disorders
Vitamin B12 Deficiency
|
0.00%
0/200 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/202 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.49%
1/204 • Number of events 1 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/198 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/203 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/166 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/177 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/167 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/177 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/181 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/200 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.50%
1/202 • Number of events 1 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/204 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/198 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/203 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/166 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/177 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/167 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/177 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/181 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon Cancer
|
0.00%
0/200 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/202 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.49%
1/204 • Number of events 1 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/198 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/203 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/166 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/177 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/167 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/177 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/181 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Osteoma
|
0.00%
0/200 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/202 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/204 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/198 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/203 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/166 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/177 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.60%
1/167 • Number of events 1 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/177 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/181 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Sinonasal Papilloma
|
0.00%
0/200 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/202 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/204 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/198 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/203 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/166 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/177 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/167 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/177 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.55%
1/181 • Number of events 1 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine Leiomyoma
|
0.00%
0/200 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/202 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/204 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/198 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/203 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.60%
1/166 • Number of events 1 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/177 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/167 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/177 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/181 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
|
Nervous system disorders
Cerebrovascular Accident
|
0.00%
0/200 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/202 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/204 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/198 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/203 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/166 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/177 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.60%
1/167 • Number of events 1 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/177 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/181 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
|
Nervous system disorders
Haemorrhagic Stroke
|
0.00%
0/200 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/202 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.49%
1/204 • Number of events 1 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/198 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/203 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/166 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/177 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/167 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/177 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/181 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
|
Nervous system disorders
Parkinson's Disease
|
0.00%
0/200 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/202 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/204 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/198 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/203 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/166 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/177 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.60%
1/167 • Number of events 1 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/177 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.55%
1/181 • Number of events 1 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/200 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/202 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/204 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.51%
1/198 • Number of events 1 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/203 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/166 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/177 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/167 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/177 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/181 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
|
Nervous system disorders
Vertebrobasilar Insufficiency
|
0.00%
0/200 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/202 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/204 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/198 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/203 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/166 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/177 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/167 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.56%
1/177 • Number of events 1 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/181 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
|
Psychiatric disorders
Depression Suicidal
|
0.00%
0/200 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/202 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/204 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/198 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.49%
1/203 • Number of events 1 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/166 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/177 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/167 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/177 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/181 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
|
Psychiatric disorders
Suicidal Ideation
|
0.50%
1/200 • Number of events 1 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/202 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/204 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/198 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/203 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/166 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/177 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/167 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/177 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/181 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
|
Psychiatric disorders
Suicide Attempt
|
0.00%
0/200 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/202 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/204 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/198 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/203 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.60%
1/166 • Number of events 1 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/177 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/167 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/177 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/181 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/200 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/202 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.49%
1/204 • Number of events 1 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/198 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/203 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/166 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/177 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/167 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/177 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/181 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
|
Renal and urinary disorders
Renal Failure Acute
|
0.50%
1/200 • Number of events 1 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/202 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/204 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/198 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/203 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/166 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/177 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/167 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/177 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/181 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
|
Renal and urinary disorders
Renal Failure Chronic
|
0.00%
0/200 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.50%
1/202 • Number of events 1 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/204 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/198 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/203 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/166 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/177 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/167 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/177 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/181 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
|
Reproductive system and breast disorders
Benign Prostatic Hyperplasia
|
0.50%
1/200 • Number of events 1 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/202 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/204 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/198 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/203 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/166 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/177 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.60%
1/167 • Number of events 1 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/177 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/181 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.00%
0/200 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/202 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/204 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/198 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/203 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.60%
1/166 • Number of events 1 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/177 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/167 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/177 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.55%
1/181 • Number of events 1 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Fibrosis
|
0.00%
0/200 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/202 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/204 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/198 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/203 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/166 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/177 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/167 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.56%
1/177 • Number of events 1 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/181 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
|
Social circumstances
Pregnancy of Partner
|
0.00%
0/200 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/202 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/204 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/198 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.49%
1/203 • Number of events 1 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/166 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/177 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/167 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/177 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/181 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
|
Vascular disorders
Phlebitis
|
0.00%
0/200 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/202 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/204 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/198 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/203 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.60%
1/166 • Number of events 1 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/177 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/167 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/177 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/181 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
|
General disorders
Sudden Cardiac Death
|
0.00%
0/200 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/202 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/204 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/198 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/203 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/166 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/177 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.60%
1/167 • Number of events 1 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/177 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.00%
0/181 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
Other adverse events
| Measure |
Preladenant 2 mg - Part 1
n=200 participants at risk
Participants received preladenant 2 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 2 mg oral tablet in PM for 26 weeks (Part 1).
|
Preladenant 5 mg - Part 1
n=202 participants at risk
Participants received preladenant 5 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 5 mg in the PM for 26 weeks (Part 1).
|
Preladenant 10 mg - Part 1
n=204 participants at risk
Participants received preladenant 10 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 10 mg in the PM for 26 weeks (Part 1).
|
Placebo - Part 1
n=198 participants at risk
Participants received placebo for preladenant and placebo for rasagiline in the AM followed by placebo for preladenant in the PM for 26 weeks (Part 1).
|
Rasagiline - Part 1
n=203 participants at risk
Participants received rasagiline 1 mg oral capsule and placebo for preladenant in the AM followed by placebo for preladenant in PM for 26 weeks (Part 1).
|
Preladenant 2 mg - Part 2
n=166 participants at risk
Participants received preladenant 2 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 2 mg oral tablet in PM for 26 weeks (Part 2).
|
Preladenant 5 mg - Part 2
n=177 participants at risk
Participants received preladenant 5 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 5 mg in the PM for 26 weeks (Part 2).
|
Preladenant 10 mg - Part 2
n=167 participants at risk
Participants received preladenant 10 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 10 mg in the PM for 26 weeks (Part 2).
|
Placebo/Preladenant 5 Mg-Part 2
n=177 participants at risk
Participants received preladenant 5 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 5 mg oral tablet in the PM for 26 weeks (Part 2).
|
Rasagiline - Part 2
n=181 participants at risk
Participants received rasagiline 1 mg oral capsule and placebo for preladenant in the AM followed by placebo for preladenant in PM for 26 weeks (Part 2).
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
2.5%
5/200 • Number of events 6 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
4.5%
9/202 • Number of events 10 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
5.4%
11/204 • Number of events 11 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
2.5%
5/198 • Number of events 5 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
1.5%
3/203 • Number of events 3 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.60%
1/166 • Number of events 1 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.56%
1/177 • Number of events 1 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
2.4%
4/167 • Number of events 4 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
2.3%
4/177 • Number of events 5 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
1.1%
2/181 • Number of events 2 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
3.0%
6/200 • Number of events 6 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
5.0%
10/202 • Number of events 11 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
3.9%
8/204 • Number of events 8 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
3.0%
6/198 • Number of events 6 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
3.0%
6/203 • Number of events 6 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
1.8%
3/166 • Number of events 3 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
5.1%
9/177 • Number of events 9 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
1.8%
3/167 • Number of events 3 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
4.0%
7/177 • Number of events 8 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
3.9%
7/181 • Number of events 7 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
|
Nervous system disorders
Dizziness
|
3.5%
7/200 • Number of events 7 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
5.4%
11/202 • Number of events 12 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
2.5%
5/204 • Number of events 6 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
4.5%
9/198 • Number of events 9 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
4.9%
10/203 • Number of events 11 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
2.4%
4/166 • Number of events 4 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.56%
1/177 • Number of events 1 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
2.4%
4/167 • Number of events 4 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.56%
1/177 • Number of events 2 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
3.3%
6/181 • Number of events 7 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
|
Nervous system disorders
Headache
|
6.5%
13/200 • Number of events 19 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
5.0%
10/202 • Number of events 13 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
7.4%
15/204 • Number of events 20 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
2.5%
5/198 • Number of events 7 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
4.9%
10/203 • Number of events 10 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
6.6%
11/166 • Number of events 16 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
2.3%
4/177 • Number of events 6 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
5.4%
9/167 • Number of events 11 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
2.8%
5/177 • Number of events 5 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
3.9%
7/181 • Number of events 8 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
|
Nervous system disorders
Tremor
|
4.0%
8/200 • Number of events 15 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
3.5%
7/202 • Number of events 11 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
1.5%
3/204 • Number of events 3 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
5.6%
11/198 • Number of events 13 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
3.0%
6/203 • Number of events 8 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
4.2%
7/166 • Number of events 8 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
6.2%
11/177 • Number of events 12 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
3.0%
5/167 • Number of events 5 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
4.5%
8/177 • Number of events 10 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
3.3%
6/181 • Number of events 7 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
|
Vascular disorders
Hypertension
|
2.0%
4/200 • Number of events 4 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
5.4%
11/202 • Number of events 13 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
5.4%
11/204 • Number of events 12 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
5.6%
11/198 • Number of events 12 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
5.4%
11/203 • Number of events 11 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
0.60%
1/166 • Number of events 1 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
2.8%
5/177 • Number of events 6 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
3.6%
6/167 • Number of events 7 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
2.3%
4/177 • Number of events 4 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
2.8%
5/181 • Number of events 5 • Up to 54 weeks (including 2 weeks of follow-up)
All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The Investigator agrees not to publish or publicly present any interim results of the trial without the prior written consent of the sponsor. The Investigator further agrees to provide the sponsor 45 days prior to submission for publication or presentation, review copies of abstracts or manuscripts for publication that report any results of the trial. The sponsor shall have the right to review and comment.
- Publication restrictions are in place
Restriction type: OTHER