Trial Outcomes & Findings for A Phase 3 Study With P2B001 in Subjects With Early Parkinson's (NCT NCT03329508)
NCT ID: NCT03329508
Last Updated: 2023-03-21
Results Overview
Differences between P2B 0.6/0.75 mg as compared to its individual components in the change of total UPDRS score (defined as sum of parts II and III, scores (0-160). UPDRS- Unified Parkinson's Disease Rating Scale, minimum value is 0 points and maximum value is 160. High score mean worse outcome.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
544 participants
Primary outcome timeframe
baseline to week 12
Results posted on
2023-03-21
Participant Flow
Participant milestones
| Measure |
P2B001
Fixed dose combination once daily capsule of pramipexole and rasagiline
P2B001: Fixed dose once daily combination capsule of pramipexole and rasagiline
|
Rasagiline Capsule
rasagiline Once daily capsule
Rasagiline: Rasagiline oral capsule
|
Pramipexole Capsule
Pramipexole once daily capsule
Pramipexole: Pramipexole low dose oral capsule
|
Pramipexole Extended Release
pramipexole ER tablet titrated to optimal dose of 1.5, 3.0 or 4.5mg
Pramipexole ER: Pramipexole ER titrated to optimal dose
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
157
|
154
|
156
|
77
|
|
Overall Study
COMPLETED
|
137
|
134
|
137
|
67
|
|
Overall Study
NOT COMPLETED
|
20
|
20
|
19
|
10
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Twenty-five (25) subjects as explained above were enrolled and randomized into treatment groups, but withdrew from study prior to first dose. They did not came to baseline visit , receive study drug nor did they receive a post-randomization evaluation. The baseline was measured to 519 subjects who came to baseline visit , had assessment and took at least one dose of study medication . These are also the safety dataset.
Baseline characteristics by cohort
| Measure |
P2B001
n=157 Participants
Fixed dose combination once daily capsule of pramipexole and rasagiline
P2B001: Fixed dose once daily combination capsule of pramipexole and rasagiline
|
Rasagiline Capsule
n=154 Participants
rasagiline Once daily capsule
Rasagiline: Rasagiline oral capsule
|
Pramipexole Capsule
n=156 Participants
Pramipexole once daily capsule
Pramipexole: Pramipexole low dose oral capsule
|
Pramipexole Extended Release
n=77 Participants
pramipexole ER tablet titrated to optimal dose of 1.5, 3.0 or 4.5mg
Pramipexole ER: Pramipexole ER titrated to optimal dose
|
Total
n=544 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=157 Participants
|
0 Participants
n=154 Participants
|
0 Participants
n=156 Participants
|
0 Participants
n=77 Participants
|
0 Participants
n=544 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
79 Participants
n=157 Participants
|
71 Participants
n=154 Participants
|
77 Participants
n=156 Participants
|
41 Participants
n=77 Participants
|
268 Participants
n=544 Participants
|
|
Age, Categorical
>=65 years
|
78 Participants
n=157 Participants
|
83 Participants
n=154 Participants
|
79 Participants
n=156 Participants
|
36 Participants
n=77 Participants
|
276 Participants
n=544 Participants
|
|
Age, Continuous
|
63 Years
STANDARD_DEVIATION 9 • n=157 Participants
|
65 Years
STANDARD_DEVIATION 1 • n=154 Participants
|
64 Years
STANDARD_DEVIATION 9 • n=156 Participants
|
63 Years
STANDARD_DEVIATION 9 • n=77 Participants
|
64 Years
STANDARD_DEVIATION 6 • n=544 Participants
|
|
Sex: Female, Male
Female
|
51 Participants
n=157 Participants
|
48 Participants
n=154 Participants
|
52 Participants
n=156 Participants
|
24 Participants
n=77 Participants
|
175 Participants
n=544 Participants
|
|
Sex: Female, Male
Male
|
106 Participants
n=157 Participants
|
106 Participants
n=154 Participants
|
104 Participants
n=156 Participants
|
53 Participants
n=77 Participants
|
369 Participants
n=544 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=157 Participants
|
1 Participants
n=154 Participants
|
0 Participants
n=156 Participants
|
0 Participants
n=77 Participants
|
3 Participants
n=544 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=157 Participants
|
3 Participants
n=154 Participants
|
0 Participants
n=156 Participants
|
1 Participants
n=77 Participants
|
4 Participants
n=544 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=157 Participants
|
2 Participants
n=154 Participants
|
2 Participants
n=156 Participants
|
0 Participants
n=77 Participants
|
5 Participants
n=544 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=157 Participants
|
3 Participants
n=154 Participants
|
5 Participants
n=156 Participants
|
1 Participants
n=77 Participants
|
11 Participants
n=544 Participants
|
|
Race (NIH/OMB)
White
|
150 Participants
n=157 Participants
|
145 Participants
n=154 Participants
|
147 Participants
n=156 Participants
|
74 Participants
n=77 Participants
|
516 Participants
n=544 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=157 Participants
|
0 Participants
n=154 Participants
|
1 Participants
n=156 Participants
|
0 Participants
n=77 Participants
|
1 Participants
n=544 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=157 Participants
|
0 Participants
n=154 Participants
|
1 Participants
n=156 Participants
|
1 Participants
n=77 Participants
|
4 Participants
n=544 Participants
|
|
Region of Enrollment
Canada
|
1 participants
n=157 Participants
|
0 participants
n=154 Participants
|
1 participants
n=156 Participants
|
0 participants
n=77 Participants
|
2 participants
n=544 Participants
|
|
Region of Enrollment
United States
|
109 participants
n=157 Participants
|
109 participants
n=154 Participants
|
108 participants
n=156 Participants
|
54 participants
n=77 Participants
|
380 participants
n=544 Participants
|
|
Region of Enrollment
Germany
|
29 participants
n=157 Participants
|
29 participants
n=154 Participants
|
30 participants
n=156 Participants
|
15 participants
n=77 Participants
|
103 participants
n=544 Participants
|
|
Region of Enrollment
Spain
|
18 participants
n=157 Participants
|
16 participants
n=154 Participants
|
17 participants
n=156 Participants
|
8 participants
n=77 Participants
|
59 participants
n=544 Participants
|
|
Total UPDRS
|
30.7 units on a scale
STANDARD_DEVIATION 9.9 • n=150 Participants • Twenty-five (25) subjects as explained above were enrolled and randomized into treatment groups, but withdrew from study prior to first dose. They did not came to baseline visit , receive study drug nor did they receive a post-randomization evaluation. The baseline was measured to 519 subjects who came to baseline visit , had assessment and took at least one dose of study medication . These are also the safety dataset.
|
31.3 units on a scale
STANDARD_DEVIATION 10.2 • n=148 Participants • Twenty-five (25) subjects as explained above were enrolled and randomized into treatment groups, but withdrew from study prior to first dose. They did not came to baseline visit , receive study drug nor did they receive a post-randomization evaluation. The baseline was measured to 519 subjects who came to baseline visit , had assessment and took at least one dose of study medication . These are also the safety dataset.
|
31.3 units on a scale
STANDARD_DEVIATION 11.0 • n=147 Participants • Twenty-five (25) subjects as explained above were enrolled and randomized into treatment groups, but withdrew from study prior to first dose. They did not came to baseline visit , receive study drug nor did they receive a post-randomization evaluation. The baseline was measured to 519 subjects who came to baseline visit , had assessment and took at least one dose of study medication . These are also the safety dataset.
|
28.8 units on a scale
STANDARD_DEVIATION 10.0 • n=74 Participants • Twenty-five (25) subjects as explained above were enrolled and randomized into treatment groups, but withdrew from study prior to first dose. They did not came to baseline visit , receive study drug nor did they receive a post-randomization evaluation. The baseline was measured to 519 subjects who came to baseline visit , had assessment and took at least one dose of study medication . These are also the safety dataset.
|
30.8 units on a scale
STANDARD_DEVIATION 10.3 • n=519 Participants • Twenty-five (25) subjects as explained above were enrolled and randomized into treatment groups, but withdrew from study prior to first dose. They did not came to baseline visit , receive study drug nor did they receive a post-randomization evaluation. The baseline was measured to 519 subjects who came to baseline visit , had assessment and took at least one dose of study medication . These are also the safety dataset.
|
|
Epworth Sleepiness Score
|
5.5 units on a scale
STANDARD_DEVIATION 4.0 • n=150 Participants • Twenty-five (25) subjects as explained above were enrolled and randomized into treatment groups, but withdrew from study prior to first dose. They did not came to baseline visit , receive study drug nor did they receive a post-randomization evaluation. The baseline was measured to 519 subjects who came to baseline visit , had assessment and took at least one dose of study medication . These are also the safety dataset.
|
5.7 units on a scale
STANDARD_DEVIATION 4.3 • n=147 Participants • Twenty-five (25) subjects as explained above were enrolled and randomized into treatment groups, but withdrew from study prior to first dose. They did not came to baseline visit , receive study drug nor did they receive a post-randomization evaluation. The baseline was measured to 519 subjects who came to baseline visit , had assessment and took at least one dose of study medication . These are also the safety dataset.
|
6.2 units on a scale
STANDARD_DEVIATION 4.0 • n=148 Participants • Twenty-five (25) subjects as explained above were enrolled and randomized into treatment groups, but withdrew from study prior to first dose. They did not came to baseline visit , receive study drug nor did they receive a post-randomization evaluation. The baseline was measured to 519 subjects who came to baseline visit , had assessment and took at least one dose of study medication . These are also the safety dataset.
|
6.1 units on a scale
STANDARD_DEVIATION 4.1 • n=74 Participants • Twenty-five (25) subjects as explained above were enrolled and randomized into treatment groups, but withdrew from study prior to first dose. They did not came to baseline visit , receive study drug nor did they receive a post-randomization evaluation. The baseline was measured to 519 subjects who came to baseline visit , had assessment and took at least one dose of study medication . These are also the safety dataset.
|
5.8 units on a scale
STANDARD_DEVIATION 4.1 • n=519 Participants • Twenty-five (25) subjects as explained above were enrolled and randomized into treatment groups, but withdrew from study prior to first dose. They did not came to baseline visit , receive study drug nor did they receive a post-randomization evaluation. The baseline was measured to 519 subjects who came to baseline visit , had assessment and took at least one dose of study medication . These are also the safety dataset.
|
PRIMARY outcome
Timeframe: baseline to week 12Population: mITT
Differences between P2B 0.6/0.75 mg as compared to its individual components in the change of total UPDRS score (defined as sum of parts II and III, scores (0-160). UPDRS- Unified Parkinson's Disease Rating Scale, minimum value is 0 points and maximum value is 160. High score mean worse outcome.
Outcome measures
| Measure |
P2B001
n=147 Participants
Fixed dose combination once daily capsule of pramipexole and rasagiline
P2B001: Fixed dose once daily combination capsule of pramipexole and rasagiline
|
Rasagiline Capsule
n=144 Participants
rasagiline Once daily capsule
Rasagiline: Rasagiline oral capsule
|
Pramipexole Capsule
n=144 Participants
Pramipexole once daily capsule
Pramipexole: Pramipexole low dose oral capsule
|
Pramipexole Extended Release
n=72 Participants
pramipexole ER tablet titrated to optimal dose of 1.5, 3.0 or 4.5mg
Pramipexole ER: Pramipexole ER titrated to optimal dose
|
|---|---|---|---|---|
|
Change in Total Unified Parkinson's Disease Rating Scale (UPDRS) Score (Defined as Sum of Parts II and III, Scores (0-160).
|
-7.98 score on a scale
Standard Error 0.60
|
-4.69 score on a scale
Standard Error 0.61
|
-5.32 score on a scale
Standard Error 0.61
|
-8.35 score on a scale
Standard Error 0.86
|
SECONDARY outcome
Timeframe: baseline to week 12Population: mITT
Differences between P2B 0.6/0.75 mg as compared to pramipexole ER tablets in the change of Epworth Sleepiness Scale (ESS) score. Scale is 0-24 , when 24 is worse outcome
Outcome measures
| Measure |
P2B001
n=147 Participants
Fixed dose combination once daily capsule of pramipexole and rasagiline
P2B001: Fixed dose once daily combination capsule of pramipexole and rasagiline
|
Rasagiline Capsule
n=144 Participants
rasagiline Once daily capsule
Rasagiline: Rasagiline oral capsule
|
Pramipexole Capsule
n=144 Participants
Pramipexole once daily capsule
Pramipexole: Pramipexole low dose oral capsule
|
Pramipexole Extended Release
n=72 Participants
pramipexole ER tablet titrated to optimal dose of 1.5, 3.0 or 4.5mg
Pramipexole ER: Pramipexole ER titrated to optimal dose
|
|---|---|---|---|---|
|
Change in Epworth Sleepiness Scale (ESS) Score.
|
-0.33 score on a scale
Standard Error 0.25
|
-0.81 score on a scale
Standard Error 0.26
|
0.39 score on a scale
Standard Error 0.25
|
2.33 score on a scale
Standard Error 0.36
|
SECONDARY outcome
Timeframe: baseline to week 12Population: mITT
Differences between P2B 0.6/0.75 mg as compared to its individual components in the change of Motor UPDRS score (UPDRS Part III ). UPDRS- Unified Parkinson's Disease Rating Scale, part III motor . min is 0 and Max is 108 (Worse outcome)
Outcome measures
| Measure |
P2B001
n=147 Participants
Fixed dose combination once daily capsule of pramipexole and rasagiline
P2B001: Fixed dose once daily combination capsule of pramipexole and rasagiline
|
Rasagiline Capsule
n=144 Participants
rasagiline Once daily capsule
Rasagiline: Rasagiline oral capsule
|
Pramipexole Capsule
n=144 Participants
Pramipexole once daily capsule
Pramipexole: Pramipexole low dose oral capsule
|
Pramipexole Extended Release
n=72 Participants
pramipexole ER tablet titrated to optimal dose of 1.5, 3.0 or 4.5mg
Pramipexole ER: Pramipexole ER titrated to optimal dose
|
|---|---|---|---|---|
|
Change From Baseline to Week 12 in Total UPDRS III Motor
|
-5.82 score on a scale
Standard Error 0.47
|
-4.07 score on a scale
Standard Error 0.48
|
-4.30 score on a scale
Standard Error 0.48
|
-6.36 score on a scale
Standard Error 0.68
|
SECONDARY outcome
Timeframe: Baseline to week 12Population: mITT
Differences between of P2B 0.6/0.75 mg as compared to its individual components in the change of ADL UPDRS score (UPDRS part II) Activity of daily Life UPDRS part II minimum is 0 point and max is 52 point (worse outcome)
Outcome measures
| Measure |
P2B001
n=147 Participants
Fixed dose combination once daily capsule of pramipexole and rasagiline
P2B001: Fixed dose once daily combination capsule of pramipexole and rasagiline
|
Rasagiline Capsule
n=144 Participants
rasagiline Once daily capsule
Rasagiline: Rasagiline oral capsule
|
Pramipexole Capsule
n=144 Participants
Pramipexole once daily capsule
Pramipexole: Pramipexole low dose oral capsule
|
Pramipexole Extended Release
n=72 Participants
pramipexole ER tablet titrated to optimal dose of 1.5, 3.0 or 4.5mg
Pramipexole ER: Pramipexole ER titrated to optimal dose
|
|---|---|---|---|---|
|
Change From Baseline to Week 12 in Total UPDRS II ADL
|
-2.14 score on a scale
Standard Error 0.22
|
-0.62 score on a scale
Standard Error 0.22
|
-0.97 score on a scale
Standard Error 0.22
|
-2.02 score on a scale
Standard Error 0.31
|
SECONDARY outcome
Timeframe: Baseline to week 12Population: mITT
The efficacy of P2B 0.6/0.75 mg as compared to Pramipexole ER tablet titrated to optimal dose. ADL PDQ39- Activity of daily life part in Parkinson's Disease Questionaries' 39 Score 0-100 when 100 is the worse outcome
Outcome measures
| Measure |
P2B001
n=147 Participants
Fixed dose combination once daily capsule of pramipexole and rasagiline
P2B001: Fixed dose once daily combination capsule of pramipexole and rasagiline
|
Rasagiline Capsule
n=144 Participants
rasagiline Once daily capsule
Rasagiline: Rasagiline oral capsule
|
Pramipexole Capsule
n=144 Participants
Pramipexole once daily capsule
Pramipexole: Pramipexole low dose oral capsule
|
Pramipexole Extended Release
n=72 Participants
pramipexole ER tablet titrated to optimal dose of 1.5, 3.0 or 4.5mg
Pramipexole ER: Pramipexole ER titrated to optimal dose
|
|---|---|---|---|---|
|
Change From Baseline to End of Week 12 Visit in ADL Subscale of PDQ39
|
-5.30 score on a scale
Standard Error 0.89
|
-2.04 score on a scale
Standard Error 0.92
|
-3.40 score on a scale
Standard Error 0.90
|
-3.12 score on a scale
Standard Error 1.27
|
Adverse Events
P2B001
Serious events: 3 serious events
Other events: 78 other events
Deaths: 0 deaths
Rasagiline Capsule
Serious events: 2 serious events
Other events: 52 other events
Deaths: 0 deaths
Pramipexole Capsule
Serious events: 3 serious events
Other events: 86 other events
Deaths: 0 deaths
Pramipexole Extended Release
Serious events: 0 serious events
Other events: 54 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
P2B001
n=150 participants at risk
Fixed dose combination once daily capsule of pramipexole and rasagiline
P2B001: Fixed dose once daily combination capsule of pramipexole and rasagiline
|
Rasagiline Capsule
n=147 participants at risk
rasagiline Once daily capsule
Rasagiline: Rasagiline oral capsule
|
Pramipexole Capsule
n=148 participants at risk
Pramipexole once daily capsule
Pramipexole: Pramipexole low dose oral capsule
|
Pramipexole Extended Release
n=74 participants at risk
pramipexole ER tablet titrated to optimal dose of 1.5, 3.0 or 4.5mg
Pramipexole ER: Pramipexole ER titrated to optimal dose
|
|---|---|---|---|---|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.67%
1/150 • Number of events 3 • 14 weeks
|
0.00%
0/147 • 14 weeks
|
0.00%
0/148 • 14 weeks
|
0.00%
0/74 • 14 weeks
|
|
Nervous system disorders
Cerebrovascular accident
|
0.67%
1/150 • Number of events 1 • 14 weeks
|
0.00%
0/147 • 14 weeks
|
0.00%
0/148 • 14 weeks
|
0.00%
0/74 • 14 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.67%
1/150 • Number of events 1 • 14 weeks
|
0.00%
0/147 • 14 weeks
|
0.00%
0/148 • 14 weeks
|
0.00%
0/74 • 14 weeks
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/150 • 14 weeks
|
0.00%
0/147 • 14 weeks
|
0.68%
1/148 • Number of events 2 • 14 weeks
|
0.00%
0/74 • 14 weeks
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/150 • 14 weeks
|
0.00%
0/147 • 14 weeks
|
0.68%
1/148 • Number of events 1 • 14 weeks
|
0.00%
0/74 • 14 weeks
|
|
Infections and infestations
corona virus
|
0.00%
0/150 • 14 weeks
|
0.00%
0/147 • 14 weeks
|
0.68%
1/148 • 14 weeks
|
0.00%
0/74 • 14 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscle haemorrhage
|
0.00%
0/150 • 14 weeks
|
0.00%
0/147 • 14 weeks
|
0.68%
1/148 • 14 weeks
|
0.00%
0/74 • 14 weeks
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/150 • 14 weeks
|
0.00%
0/147 • 14 weeks
|
0.68%
1/148 • Number of events 1 • 14 weeks
|
0.00%
0/74 • 14 weeks
|
|
Reproductive system and breast disorders
Prostatitis
|
0.00%
0/150 • 14 weeks
|
0.00%
0/147 • 14 weeks
|
0.68%
1/148 • 14 weeks
|
0.00%
0/74 • 14 weeks
|
|
Infections and infestations
Klebsiella sepsis
|
0.00%
0/150 • 14 weeks
|
0.68%
1/147 • 14 weeks
|
0.00%
0/148 • 14 weeks
|
0.00%
0/74 • 14 weeks
|
|
Infections and infestations
Sepsis
|
0.00%
0/150 • 14 weeks
|
0.68%
1/147 • 14 weeks
|
0.00%
0/148 • 14 weeks
|
0.00%
0/74 • 14 weeks
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/150 • 14 weeks
|
0.68%
1/147 • 14 weeks
|
0.00%
0/148 • 14 weeks
|
0.00%
0/74 • 14 weeks
|
Other adverse events
| Measure |
P2B001
n=150 participants at risk
Fixed dose combination once daily capsule of pramipexole and rasagiline
P2B001: Fixed dose once daily combination capsule of pramipexole and rasagiline
|
Rasagiline Capsule
n=147 participants at risk
rasagiline Once daily capsule
Rasagiline: Rasagiline oral capsule
|
Pramipexole Capsule
n=148 participants at risk
Pramipexole once daily capsule
Pramipexole: Pramipexole low dose oral capsule
|
Pramipexole Extended Release
n=74 participants at risk
pramipexole ER tablet titrated to optimal dose of 1.5, 3.0 or 4.5mg
Pramipexole ER: Pramipexole ER titrated to optimal dose
|
|---|---|---|---|---|
|
Gastrointestinal disorders
nausea
|
18.7%
28/150 • Number of events 33 • 14 weeks
|
6.8%
10/147 • Number of events 10 • 14 weeks
|
16.2%
24/148 • Number of events 29 • 14 weeks
|
23.0%
17/74 • Number of events 22 • 14 weeks
|
|
General disorders
fatigue
|
15.3%
23/150 • Number of events 27 • 14 weeks
|
1.4%
2/147 • Number of events 2 • 14 weeks
|
14.9%
22/148 • Number of events 25 • 14 weeks
|
17.6%
13/74 • Number of events 14 • 14 weeks
|
|
Nervous system disorders
somnolence
|
14.7%
22/150 • Number of events 25 • 14 weeks
|
4.8%
7/147 • Number of events 7 • 14 weeks
|
18.2%
27/148 • Number of events 32 • 14 weeks
|
31.1%
23/74 • Number of events 29 • 14 weeks
|
|
Nervous system disorders
dizziness
|
10.7%
16/150 • Number of events 18 • 14 weeks
|
12.9%
19/147 • Number of events 21 • 14 weeks
|
9.5%
14/148 • Number of events 15 • 14 weeks
|
9.5%
7/74 • Number of events 7 • 14 weeks
|
|
Psychiatric disorders
insomnia
|
8.7%
13/150 • Number of events 14 • 14 weeks
|
2.7%
4/147 • Number of events 4 • 14 weeks
|
6.1%
9/148 • Number of events 9 • 14 weeks
|
9.5%
7/74 • Number of events 8 • 14 weeks
|
|
Nervous system disorders
headache
|
6.0%
9/150 • Number of events 14 • 14 weeks
|
6.1%
9/147 • Number of events 12 • 14 weeks
|
9.5%
14/148 • Number of events 15 • 14 weeks
|
6.8%
5/74 • Number of events 5 • 14 weeks
|
|
Gastrointestinal disorders
constipation
|
4.0%
6/150 • Number of events 6 • 14 weeks
|
6.1%
9/147 • Number of events 9 • 14 weeks
|
7.4%
11/148 • Number of events 12 • 14 weeks
|
9.5%
7/74 • Number of events 7 • 14 weeks
|
|
Musculoskeletal and connective tissue disorders
pain in extremity
|
1.3%
2/150 • Number of events 2 • 14 weeks
|
1.4%
2/147 • Number of events 2 • 14 weeks
|
6.8%
10/148 • Number of events 11 • 14 weeks
|
5.4%
4/74 • Number of events 4 • 14 weeks
|
|
Injury, poisoning and procedural complications
fall
|
4.0%
6/150 • Number of events 6 • 14 weeks
|
3.4%
5/147 • Number of events 12 • 14 weeks
|
5.4%
8/148 • Number of events 10 • 14 weeks
|
1.4%
1/74 • Number of events 2 • 14 weeks
|
|
Congenital, familial and genetic disorders
memory impairment
|
0.00%
0/150 • 14 weeks
|
0.68%
1/147 • Number of events 1 • 14 weeks
|
0.00%
0/148 • 14 weeks
|
5.4%
4/74 • Number of events 5 • 14 weeks
|
|
Vascular disorders
Orthostatic hypotension
|
2.7%
4/150 • Number of events 4 • 14 weeks
|
2.7%
4/147 • Number of events 4 • 14 weeks
|
3.4%
5/148 • Number of events 6 • 14 weeks
|
12.2%
9/74 • Number of events 9 • 14 weeks
|
|
Gastrointestinal disorders
Decreased appetite
|
2.0%
3/150 • Number of events 4 • 14 weeks
|
1.4%
2/147 • Number of events 3 • 14 weeks
|
1.4%
2/148 • Number of events 2 • 14 weeks
|
5.4%
4/74 • Number of events 4 • 14 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place