Trial Outcomes & Findings for A 12-week Randomized Study to Evaluate Oral Istradefylline in Subjects With Moderate to Severe Parkinson's Disease (NCT NCT01968031)
NCT ID: NCT01968031
Last Updated: 2024-04-25
Results Overview
Based on the 24-hour ON/OFF patient diary data.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
613 participants
Primary outcome timeframe
Baseline, Week 2, Week 6, Week 10 and Week 12.
Results posted on
2024-04-25
Participant Flow
Participant milestones
| Measure |
Placebo
Placebo to match istradefylline 20 mg and placebo to match istradefylline 40 mg:
A daily, oral, double-blind treatment dose of both tablets will be taken in the morning for 12 weeks.
Placebo: Placebo
|
Istradefylline 20 mg/Day
Istradefylline 20 mg and placebo to match istradefylline 40 mg:
A daily, oral, double-blind treatment dose of both tablets will be taken in the morning for 12 weeks.
Istradefylline 20 mg: Istradefylline 20 mg and placebo
Placebo: Placebo
|
Istradefylline 40 mg/Day
Istradefylline 40 mg and placebo to match istradefylline 20 mg:
A daily, oral, double-blind treatment dose of both tablets will be taken in the morning for 12 weeks.
Istradefylline 40 mg: Istradefylline 40 mg and placebo
Placebo: Placebo
|
|---|---|---|---|
|
Overall Study
STARTED
|
204
|
202
|
207
|
|
Overall Study
Completed Week 2
|
197
|
190
|
199
|
|
Overall Study
Completed Week 6
|
191
|
183
|
187
|
|
Overall Study
Completed Week 10
|
187
|
181
|
181
|
|
Overall Study
COMPLETED
|
186
|
182
|
178
|
|
Overall Study
NOT COMPLETED
|
18
|
20
|
29
|
Reasons for withdrawal
| Measure |
Placebo
Placebo to match istradefylline 20 mg and placebo to match istradefylline 40 mg:
A daily, oral, double-blind treatment dose of both tablets will be taken in the morning for 12 weeks.
Placebo: Placebo
|
Istradefylline 20 mg/Day
Istradefylline 20 mg and placebo to match istradefylline 40 mg:
A daily, oral, double-blind treatment dose of both tablets will be taken in the morning for 12 weeks.
Istradefylline 20 mg: Istradefylline 20 mg and placebo
Placebo: Placebo
|
Istradefylline 40 mg/Day
Istradefylline 40 mg and placebo to match istradefylline 20 mg:
A daily, oral, double-blind treatment dose of both tablets will be taken in the morning for 12 weeks.
Istradefylline 40 mg: Istradefylline 40 mg and placebo
Placebo: Placebo
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
13
|
10
|
22
|
|
Overall Study
Withdrawal by Subject
|
3
|
7
|
3
|
|
Overall Study
Did not meet entry criteria
|
1
|
1
|
1
|
|
Overall Study
Noncompliance
|
0
|
0
|
2
|
|
Overall Study
Failed inclusion criteria
|
0
|
2
|
0
|
|
Overall Study
Death
|
0
|
0
|
1
|
|
Overall Study
Prohibited concomitant medication
|
1
|
0
|
0
|
Baseline Characteristics
A 12-week Randomized Study to Evaluate Oral Istradefylline in Subjects With Moderate to Severe Parkinson's Disease
Baseline characteristics by cohort
| Measure |
Placebo
n=204 Participants
Placebo to match istradefylline 20 mg and placebo to match istradefylline 40 mg:
A daily, oral, double-blind treatment dose of both tablets will be taken in the morning for 12 weeks.
Placebo: Placebo
|
Istradefylline 20 mg/Day
n=201 Participants
Istradefylline 20 mg and placebo to match istradefylline 40 mg:
A daily, oral, double-blind treatment dose of both tablets will be taken in the morning for 12 weeks.
Istradefylline 20 mg: Istradefylline 20 mg and placebo
Placebo: Placebo
|
Istradefylline 40 mg/Day
n=207 Participants
Istradefylline 40 mg and placebo to match istradefylline 20 mg:
A daily, oral, double-blind treatment dose of both tablets will be taken in the morning for 12 weeks.
Istradefylline 40 mg: Istradefylline 40 mg and placebo
Placebo: Placebo
|
Total
n=612 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
104 Participants
n=5 Participants
|
108 Participants
n=7 Participants
|
101 Participants
n=5 Participants
|
313 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
100 Participants
n=5 Participants
|
93 Participants
n=7 Participants
|
106 Participants
n=5 Participants
|
299 Participants
n=4 Participants
|
|
Age, Continuous
|
63.8 years
n=5 Participants
|
63.5 years
n=7 Participants
|
64.5 years
n=5 Participants
|
63.9 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
80 Participants
n=5 Participants
|
76 Participants
n=7 Participants
|
81 Participants
n=5 Participants
|
237 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
124 Participants
n=5 Participants
|
125 Participants
n=7 Participants
|
126 Participants
n=5 Participants
|
375 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
199 Participants
n=5 Participants
|
192 Participants
n=7 Participants
|
200 Participants
n=5 Participants
|
591 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other - Filipino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other - Hispanic
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other - Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other - Indian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other - Indian/Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other - Puerto Rican
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other - did not wish to specify
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Region of Enrollment
Canada
|
11 participants
n=5 Participants
|
11 participants
n=7 Participants
|
10 participants
n=5 Participants
|
32 participants
n=4 Participants
|
|
Region of Enrollment
United States
|
93 participants
n=5 Participants
|
92 participants
n=7 Participants
|
92 participants
n=5 Participants
|
277 participants
n=4 Participants
|
|
Region of Enrollment
Czechia
|
22 participants
n=5 Participants
|
23 participants
n=7 Participants
|
23 participants
n=5 Participants
|
68 participants
n=4 Participants
|
|
Region of Enrollment
Poland
|
24 participants
n=5 Participants
|
23 participants
n=7 Participants
|
23 participants
n=5 Participants
|
70 participants
n=4 Participants
|
|
Region of Enrollment
Italy
|
21 participants
n=5 Participants
|
18 participants
n=7 Participants
|
20 participants
n=5 Participants
|
59 participants
n=4 Participants
|
|
Region of Enrollment
Israel
|
11 participants
n=5 Participants
|
12 participants
n=7 Participants
|
12 participants
n=5 Participants
|
35 participants
n=4 Participants
|
|
Region of Enrollment
Serbia
|
9 participants
n=5 Participants
|
7 participants
n=7 Participants
|
9 participants
n=5 Participants
|
25 participants
n=4 Participants
|
|
Region of Enrollment
Germany
|
13 participants
n=5 Participants
|
15 participants
n=7 Participants
|
17 participants
n=5 Participants
|
45 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 2, Week 6, Week 10 and Week 12.Population: The number of subjects in each row is based on the number of subjects with valid diary entries for the corresponding week
Based on the 24-hour ON/OFF patient diary data.
Outcome measures
| Measure |
Placebo
n=198 Participants
Placebo to match istradefylline 20 mg and placebo to match istradefylline 40 mg:
A daily, oral, double-blind treatment dose of both tablets will be taken in the morning for 12 weeks.
Placebo: Placebo
|
Istradefylline 20 mg/Day
n=194 Participants
Istradefylline 20 mg and placebo to match istradefylline 40 mg:
A daily, oral, double-blind treatment dose of both tablets will be taken in the morning for 12 weeks.
Istradefylline 20 mg: Istradefylline 20 mg and placebo
Placebo: Placebo
|
Istradefylline 40 mg/Day
n=200 Participants
Istradefylline 40 mg and placebo to match istradefylline 20 mg:
A daily, oral, double-blind treatment dose of both tablets will be taken in the morning for 12 weeks.
Istradefylline 40 mg: Istradefylline 40 mg and placebo
Placebo: Placebo
|
|---|---|---|---|
|
Change From Baseline in the Total Hours of Awake Time/Day Spent in the OFF State at Week 12
Baseline
|
5.17 hours
Interval 2.0 to 14.3
|
5.33 hours
Interval 1.0 to 12.2
|
4.92 hours
Interval 1.2 to 11.0
|
|
Change From Baseline in the Total Hours of Awake Time/Day Spent in the OFF State at Week 12
Week 2
|
4.83 hours
Interval 0.0 to 13.8
|
4.33 hours
Interval 0.0 to 11.5
|
4.08 hours
Interval 0.2 to 9.8
|
|
Change From Baseline in the Total Hours of Awake Time/Day Spent in the OFF State at Week 12
Week 6
|
4.17 hours
Interval 0.0 to 10.8
|
3.83 hours
Interval 0.0 to 9.5
|
3.83 hours
Interval 0.0 to 9.8
|
|
Change From Baseline in the Total Hours of Awake Time/Day Spent in the OFF State at Week 12
Week 10
|
4.33 hours
Interval 0.0 to 17.0
|
3.83 hours
Interval 0.0 to 11.3
|
3.50 hours
Interval 0.0 to 10.7
|
|
Change From Baseline in the Total Hours of Awake Time/Day Spent in the OFF State at Week 12
Week 12
|
4.17 hours
Interval 0.0 to 16.7
|
4.00 hours
Interval 0.0 to 11.3
|
3.83 hours
Interval 0.0 to 13.8
|
SECONDARY outcome
Timeframe: Baseline, Week 2, Week 6, Week 10 and Week 12.Population: The number of subjects in each row is based on the number of subjects with valid diary entries for the corresponding week
Based on Patient's ON/OFF Diary
Outcome measures
| Measure |
Placebo
n=198 Participants
Placebo to match istradefylline 20 mg and placebo to match istradefylline 40 mg:
A daily, oral, double-blind treatment dose of both tablets will be taken in the morning for 12 weeks.
Placebo: Placebo
|
Istradefylline 20 mg/Day
n=194 Participants
Istradefylline 20 mg and placebo to match istradefylline 40 mg:
A daily, oral, double-blind treatment dose of both tablets will be taken in the morning for 12 weeks.
Istradefylline 20 mg: Istradefylline 20 mg and placebo
Placebo: Placebo
|
Istradefylline 40 mg/Day
n=200 Participants
Istradefylline 40 mg and placebo to match istradefylline 20 mg:
A daily, oral, double-blind treatment dose of both tablets will be taken in the morning for 12 weeks.
Istradefylline 40 mg: Istradefylline 40 mg and placebo
Placebo: Placebo
|
|---|---|---|---|
|
Total Hours of ON Time Per Day Without Troublesome Dyskinesia
Week 6
|
10.18 hours
Interval 0.0 to 16.0
|
10.74 hours
Interval 0.0 to 17.0
|
10.46 hours
Interval 0.0 to 17.2
|
|
Total Hours of ON Time Per Day Without Troublesome Dyskinesia
Baseline
|
9.22 hours
Interval 1.0 to 14.8
|
9.68 hours
Interval 1.8 to 15.0
|
9.72 hours
Interval 1.2 to 16.0
|
|
Total Hours of ON Time Per Day Without Troublesome Dyskinesia
Week 2
|
9.89 hours
Interval 0.5 to 15.3
|
10.20 hours
Interval 0.0 to 16.8
|
10.46 hours
Interval 0.0 to 16.7
|
|
Total Hours of ON Time Per Day Without Troublesome Dyskinesia
Week 10
|
10.12 hours
Interval 0.0 to 16.8
|
10.68 hours
Interval 0.0 to 16.2
|
10.53 hours
Interval 0.7 to 17.5
|
|
Total Hours of ON Time Per Day Without Troublesome Dyskinesia
Week 12
|
10.13 hours
Interval 0.0 to 17.0
|
10.71 hours
Interval 0.0 to 17.8
|
10.53 hours
Interval 0.3 to 17.3
|
SECONDARY outcome
Timeframe: Baseline, Week 2, Week 6, Week 10 and Week 12.Population: The number of subjects in each row is based on the number of subjects with data for the corresponding week
The Unified Parkinson's Disease Rating Scale (UPDRS) evaluates various aspects of Parkinson's disease including non-motor and motor experiences of daily living and motor complications. Part III assesses the motor signs of Parkinson's Disease with a rating from 0 to 4, where 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe. The possible score range of Part III is 0 to 68. The lower the score, the more favorable the response.
Outcome measures
| Measure |
Placebo
n=198 Participants
Placebo to match istradefylline 20 mg and placebo to match istradefylline 40 mg:
A daily, oral, double-blind treatment dose of both tablets will be taken in the morning for 12 weeks.
Placebo: Placebo
|
Istradefylline 20 mg/Day
n=194 Participants
Istradefylline 20 mg and placebo to match istradefylline 40 mg:
A daily, oral, double-blind treatment dose of both tablets will be taken in the morning for 12 weeks.
Istradefylline 20 mg: Istradefylline 20 mg and placebo
Placebo: Placebo
|
Istradefylline 40 mg/Day
n=200 Participants
Istradefylline 40 mg and placebo to match istradefylline 20 mg:
A daily, oral, double-blind treatment dose of both tablets will be taken in the morning for 12 weeks.
Istradefylline 40 mg: Istradefylline 40 mg and placebo
Placebo: Placebo
|
|---|---|---|---|
|
Unified Parkinson's Disease Rating Scale (UPDRS) Motor Examination Score (Part III);
Baseline
|
22 score on a scale
Interval 3.0 to 68.0
|
22.6 score on a scale
Interval 4.0 to 62.0
|
23.5 score on a scale
Interval 2.0 to 64.0
|
|
Unified Parkinson's Disease Rating Scale (UPDRS) Motor Examination Score (Part III);
Week 2
|
20.1 score on a scale
Interval 2.0 to 67.0
|
20.8 score on a scale
Interval 2.0 to 61.0
|
20.7 score on a scale
Interval 2.0 to 64.0
|
|
Unified Parkinson's Disease Rating Scale (UPDRS) Motor Examination Score (Part III);
Week 6
|
19.9 score on a scale
Interval 0.0 to 67.0
|
20.2 score on a scale
Interval 0.0 to 61.0
|
20.2 score on a scale
Interval 2.0 to 64.0
|
|
Unified Parkinson's Disease Rating Scale (UPDRS) Motor Examination Score (Part III);
Week 10
|
19.2 score on a scale
Interval 2.0 to 67.0
|
19.4 score on a scale
Interval 0.0 to 60.0
|
19.9 score on a scale
Interval 2.0 to 63.0
|
|
Unified Parkinson's Disease Rating Scale (UPDRS) Motor Examination Score (Part III);
Week 12
|
19.4 score on a scale
Interval 1.0 to 57.0
|
19.7 score on a scale
Interval 0.0 to 60.0
|
19.6 score on a scale
Interval 2.0 to 62.0
|
SECONDARY outcome
Timeframe: Baseline, Week 2, Week 6, Week 10 and Week 12.Population: The number of subjects in each row is based on the number of subjects with data for the corresponding week
The Unified Parkinson's Disease Rating Scale (UPDRS) evaluates various aspects of Parkinson's disease including non-motor and motor experiences of daily living and motor complications. Part II is a self-evaluation of the activities of daily life (ADL) including speech, swallowing, handwriting, dressing, hygiene, falling, salivating, turning in bed, walking, and cutting food with a rating from 0 to 4, where 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe. The possible score range of Part II is 0 to 52. The lower the score, the more favorable the response.
Outcome measures
| Measure |
Placebo
n=198 Participants
Placebo to match istradefylline 20 mg and placebo to match istradefylline 40 mg:
A daily, oral, double-blind treatment dose of both tablets will be taken in the morning for 12 weeks.
Placebo: Placebo
|
Istradefylline 20 mg/Day
n=194 Participants
Istradefylline 20 mg and placebo to match istradefylline 40 mg:
A daily, oral, double-blind treatment dose of both tablets will be taken in the morning for 12 weeks.
Istradefylline 20 mg: Istradefylline 20 mg and placebo
Placebo: Placebo
|
Istradefylline 40 mg/Day
n=200 Participants
Istradefylline 40 mg and placebo to match istradefylline 20 mg:
A daily, oral, double-blind treatment dose of both tablets will be taken in the morning for 12 weeks.
Istradefylline 40 mg: Istradefylline 40 mg and placebo
Placebo: Placebo
|
|---|---|---|---|
|
Unified Parkinson's Disease Rating Scale (UPDRS) Activities of Daily Living (ADL) Score (Part II)
Baseline
|
12.2 score on a scale
Interval 0.0 to 27.0
|
12.0 score on a scale
Interval 1.0 to 34.0
|
13.1 score on a scale
Interval 0.0 to 32.0
|
|
Unified Parkinson's Disease Rating Scale (UPDRS) Activities of Daily Living (ADL) Score (Part II)
Week 2
|
11.1 score on a scale
Interval 1.0 to 27.0
|
10.7 score on a scale
Interval 1.0 to 32.0
|
11.5 score on a scale
Interval 0.0 to 32.0
|
|
Unified Parkinson's Disease Rating Scale (UPDRS) Activities of Daily Living (ADL) Score (Part II)
Week 6
|
11.0 score on a scale
Interval 0.0 to 27.0
|
10.5 score on a scale
Interval 0.0 to 32.0
|
11.8 score on a scale
Interval 0.0 to 32.0
|
|
Unified Parkinson's Disease Rating Scale (UPDRS) Activities of Daily Living (ADL) Score (Part II)
Week 10
|
10.9 score on a scale
Interval 0.0 to 27.0
|
10.8 score on a scale
Interval 0.0 to 30.0
|
11.6 score on a scale
Interval 0.0 to 31.0
|
|
Unified Parkinson's Disease Rating Scale (UPDRS) Activities of Daily Living (ADL) Score (Part II)
Week 12
|
10.9 score on a scale
Interval 0.0 to 27.0
|
10.7 score on a scale
Interval 0.0 to 30.0
|
11.8 score on a scale
Interval 0.0 to 30.0
|
SECONDARY outcome
Timeframe: Baseline, Week 2, Week 6, Week 10 and Week 12.Population: The number of subjects in each row is based on the number of subjects with data for the corresponding week
The Unified Parkinson's Disease Rating Scale (UPDRS) evaluates various aspects of Parkinson's disease including non-motor and motor experiences of daily living and motor complications. Part I is the evaluation of mentation, behavior, and mood with a rating from 0 to 4, where 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe. The possible score range of Part I is 0 to 16. The lower the score, the more favorable the response.
Outcome measures
| Measure |
Placebo
n=198 Participants
Placebo to match istradefylline 20 mg and placebo to match istradefylline 40 mg:
A daily, oral, double-blind treatment dose of both tablets will be taken in the morning for 12 weeks.
Placebo: Placebo
|
Istradefylline 20 mg/Day
n=194 Participants
Istradefylline 20 mg and placebo to match istradefylline 40 mg:
A daily, oral, double-blind treatment dose of both tablets will be taken in the morning for 12 weeks.
Istradefylline 20 mg: Istradefylline 20 mg and placebo
Placebo: Placebo
|
Istradefylline 40 mg/Day
n=200 Participants
Istradefylline 40 mg and placebo to match istradefylline 20 mg:
A daily, oral, double-blind treatment dose of both tablets will be taken in the morning for 12 weeks.
Istradefylline 40 mg: Istradefylline 40 mg and placebo
Placebo: Placebo
|
|---|---|---|---|
|
Unified Parkinson's Disease Rating Scale (UPDRS Mentation, Behaviour) and Mood (Part I)
Baseline
|
1.8 score on a scale
Interval 0.0 to 7.0
|
1.3 score on a scale
Interval 0.0 to 7.0
|
1.7 score on a scale
Interval 0.0 to 9.0
|
|
Unified Parkinson's Disease Rating Scale (UPDRS Mentation, Behaviour) and Mood (Part I)
Week 2
|
1.4 score on a scale
Interval 0.0 to 9.0
|
1.1 score on a scale
Interval 0.0 to 5.0
|
1.3 score on a scale
Interval 0.0 to 8.0
|
|
Unified Parkinson's Disease Rating Scale (UPDRS Mentation, Behaviour) and Mood (Part I)
Week 6
|
1.5 score on a scale
Interval 0.0 to 7.0
|
1.3 score on a scale
Interval 0.0 to 6.0
|
1.5 score on a scale
Interval 0.0 to 7.0
|
|
Unified Parkinson's Disease Rating Scale (UPDRS Mentation, Behaviour) and Mood (Part I)
Week 10
|
1.5 score on a scale
Interval 0.0 to 7.0
|
1.4 score on a scale
Interval 0.0 to 8.0
|
1.4 score on a scale
Interval 0.0 to 6.0
|
|
Unified Parkinson's Disease Rating Scale (UPDRS Mentation, Behaviour) and Mood (Part I)
Week 12
|
1.5 score on a scale
Interval 0.0 to 7.0
|
1.4 score on a scale
Interval 0.0 to 8.0
|
1.4 score on a scale
Interval 0.0 to 6.0
|
SECONDARY outcome
Timeframe: Baseline, Week 2, Week 6, Week 10 and Week 12.Population: The number of subjects in each row is based on the number of subjects with data for the corresponding week
The Unified Parkinson's Disease Rating Scale (UPDRS) evaluates various aspects of Parkinson's disease including non-motor and motor experiences of daily living and motor complications with a rating from 0 to 4, where 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe. The total possible score range for all parts combined is 0 to 136. The lower the score, the more favorable the response.
Outcome measures
| Measure |
Placebo
n=198 Participants
Placebo to match istradefylline 20 mg and placebo to match istradefylline 40 mg:
A daily, oral, double-blind treatment dose of both tablets will be taken in the morning for 12 weeks.
Placebo: Placebo
|
Istradefylline 20 mg/Day
n=194 Participants
Istradefylline 20 mg and placebo to match istradefylline 40 mg:
A daily, oral, double-blind treatment dose of both tablets will be taken in the morning for 12 weeks.
Istradefylline 20 mg: Istradefylline 20 mg and placebo
Placebo: Placebo
|
Istradefylline 40 mg/Day
n=200 Participants
Istradefylline 40 mg and placebo to match istradefylline 20 mg:
A daily, oral, double-blind treatment dose of both tablets will be taken in the morning for 12 weeks.
Istradefylline 40 mg: Istradefylline 40 mg and placebo
Placebo: Placebo
|
|---|---|---|---|
|
Total UPDRS (Parts I + II + III);
Baseline
|
35.9 score on a scale
Interval 10.0 to 98.0
|
35.9 score on a scale
Interval 9.0 to 102.0
|
38.3 score on a scale
Interval 8.0 to 102.0
|
|
Total UPDRS (Parts I + II + III);
Week 2
|
32.6 score on a scale
Interval 8.0 to 96.0
|
32.7 score on a scale
Interval 5.0 to 98.0
|
33.6 score on a scale
Interval 4.0 to 102.0
|
|
Total UPDRS (Parts I + II + III);
Week 6
|
32.4 score on a scale
Interval 3.0 to 96.0
|
31.9 score on a scale
Interval 3.0 to 98.0
|
33.5 score on a scale
Interval 4.0 to 102.0
|
|
Total UPDRS (Parts I + II + III);
Week 10
|
31.6 score on a scale
Interval 6.0 to 96.0
|
31.6 score on a scale
Interval 2.0 to 93.0
|
33.0 score on a scale
Interval 5.0 to 100.0
|
|
Total UPDRS (Parts I + II + III);
Week 12
|
31.9 score on a scale
Interval 7.0 to 86.0
|
31.9 score on a scale
Interval 1.0 to 93.0
|
32.9 score on a scale
Interval 5.0 to 98.0
|
SECONDARY outcome
Timeframe: Baseline, Week 2, Week 6, Week 10, Week 12 and 30-day FU visitPopulation: The number of subjects in each row is based on the number of subjects with data for the corresponding week
The "key symptom" on the PGI-I was evaluated at baseline and subsequent post-baseline visits for the subject's overall condition and the symptoms of fatigue, sleep, motivation to get things done, and each subject's key symptom. Subjects rated each on a scale of 1 to 5 for change from baseline utilizing the following scale: * 1 = Moderate improvement (or greater) * 2 = Mild improvement * 3 = No change from baseline * 4 = Mild deterioration * 5 = Moderate deterioration (or greater) A lower number is a better outcome. Overall condition is presented below.
Outcome measures
| Measure |
Placebo
n=198 Participants
Placebo to match istradefylline 20 mg and placebo to match istradefylline 40 mg:
A daily, oral, double-blind treatment dose of both tablets will be taken in the morning for 12 weeks.
Placebo: Placebo
|
Istradefylline 20 mg/Day
n=194 Participants
Istradefylline 20 mg and placebo to match istradefylline 40 mg:
A daily, oral, double-blind treatment dose of both tablets will be taken in the morning for 12 weeks.
Istradefylline 20 mg: Istradefylline 20 mg and placebo
Placebo: Placebo
|
Istradefylline 40 mg/Day
n=200 Participants
Istradefylline 40 mg and placebo to match istradefylline 20 mg:
A daily, oral, double-blind treatment dose of both tablets will be taken in the morning for 12 weeks.
Istradefylline 40 mg: Istradefylline 40 mg and placebo
Placebo: Placebo
|
|---|---|---|---|
|
Patient Global Impression - Improvement (PGI-I) Scale
Week 12 · 4 = Mild deterioration
|
20 Participants
|
26 Participants
|
23 Participants
|
|
Patient Global Impression - Improvement (PGI-I) Scale
30-Day Follow Up · 1 = Moderate improvement (or greater)
|
3 Participants
|
1 Participants
|
3 Participants
|
|
Patient Global Impression - Improvement (PGI-I) Scale
30-Day Follow Up · 3 = No change from baseline
|
22 Participants
|
21 Participants
|
28 Participants
|
|
Patient Global Impression - Improvement (PGI-I) Scale
30-Day Follow Up · 4 = Mild deterioration
|
9 Participants
|
14 Participants
|
16 Participants
|
|
Patient Global Impression - Improvement (PGI-I) Scale
Week 2 · 1 = Moderate improvement (or greater)
|
20 Participants
|
26 Participants
|
20 Participants
|
|
Patient Global Impression - Improvement (PGI-I) Scale
Week 2 · 2 = Mild improvement
|
73 Participants
|
80 Participants
|
68 Participants
|
|
Patient Global Impression - Improvement (PGI-I) Scale
Week 2 · 3 = No change from baseline
|
87 Participants
|
68 Participants
|
94 Participants
|
|
Patient Global Impression - Improvement (PGI-I) Scale
Week 2 · 4 = Mild deterioration
|
15 Participants
|
13 Participants
|
15 Participants
|
|
Patient Global Impression - Improvement (PGI-I) Scale
Week 2 · 5 = Moderate deterioration (or greater)
|
3 Participants
|
6 Participants
|
2 Participants
|
|
Patient Global Impression - Improvement (PGI-I) Scale
Week 6 · 1 = Moderate improvement (or greater)
|
31 Participants
|
37 Participants
|
35 Participants
|
|
Patient Global Impression - Improvement (PGI-I) Scale
Week 6 · 2 = Mild improvement
|
61 Participants
|
65 Participants
|
56 Participants
|
|
Patient Global Impression - Improvement (PGI-I) Scale
Week 6 · 3 = No change from baseline
|
83 Participants
|
63 Participants
|
66 Participants
|
|
Patient Global Impression - Improvement (PGI-I) Scale
Week 6 · 4 = Mild deterioration
|
21 Participants
|
19 Participants
|
37 Participants
|
|
Patient Global Impression - Improvement (PGI-I) Scale
Week 6 · 5 = Moderate deterioration (or greater)
|
1 Participants
|
3 Participants
|
3 Participants
|
|
Patient Global Impression - Improvement (PGI-I) Scale
Week 10 · 1 = Moderate improvement (or greater)
|
28 Participants
|
33 Participants
|
32 Participants
|
|
Patient Global Impression - Improvement (PGI-I) Scale
Week 10 · 2 = Mild improvement
|
66 Participants
|
63 Participants
|
57 Participants
|
|
Patient Global Impression - Improvement (PGI-I) Scale
Week 10 · 3 = No change from baseline
|
68 Participants
|
58 Participants
|
65 Participants
|
|
Patient Global Impression - Improvement (PGI-I) Scale
Week 10 · 4 = Mild deterioration
|
22 Participants
|
22 Participants
|
24 Participants
|
|
Patient Global Impression - Improvement (PGI-I) Scale
Week 10 · 5 = Moderate deterioration (or greater)
|
5 Participants
|
7 Participants
|
5 Participants
|
|
Patient Global Impression - Improvement (PGI-I) Scale
Week 12 · 1 = Moderate improvement (or greater)
|
32 Participants
|
38 Participants
|
29 Participants
|
|
Patient Global Impression - Improvement (PGI-I) Scale
Week 12 · 2 = Mild improvement
|
59 Participants
|
62 Participants
|
60 Participants
|
|
Patient Global Impression - Improvement (PGI-I) Scale
Week 12 · 3 = No change from baseline
|
72 Participants
|
52 Participants
|
59 Participants
|
|
Patient Global Impression - Improvement (PGI-I) Scale
Week 12 · 5 = Moderate deterioration (or greater)
|
5 Participants
|
3 Participants
|
6 Participants
|
|
Patient Global Impression - Improvement (PGI-I) Scale
30-Day Follow Up · 2 = Mild improvement
|
10 Participants
|
3 Participants
|
7 Participants
|
|
Patient Global Impression - Improvement (PGI-I) Scale
30-Day Follow Up · 5 = Moderate deterioration (or greater)
|
2 Participants
|
12 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 2, Week 6, Week 10 and Week 12.Population: The number of subjects in each row is based on the number of subjects with valid diary entries for the corresponding week
Outcome measures
| Measure |
Placebo
n=198 Participants
Placebo to match istradefylline 20 mg and placebo to match istradefylline 40 mg:
A daily, oral, double-blind treatment dose of both tablets will be taken in the morning for 12 weeks.
Placebo: Placebo
|
Istradefylline 20 mg/Day
n=194 Participants
Istradefylline 20 mg and placebo to match istradefylline 40 mg:
A daily, oral, double-blind treatment dose of both tablets will be taken in the morning for 12 weeks.
Istradefylline 20 mg: Istradefylline 20 mg and placebo
Placebo: Placebo
|
Istradefylline 40 mg/Day
n=200 Participants
Istradefylline 40 mg and placebo to match istradefylline 20 mg:
A daily, oral, double-blind treatment dose of both tablets will be taken in the morning for 12 weeks.
Istradefylline 40 mg: Istradefylline 40 mg and placebo
Placebo: Placebo
|
|---|---|---|---|
|
Sleep Time in Hours Per Day Based Upon 24-hour Diaries.
Baseline
|
8.11 hours
Interval 2.2 to 15.7
|
8.04 hours
Interval 3.7 to 13.2
|
8.11 hours
Interval 3.0 to 14.0
|
|
Sleep Time in Hours Per Day Based Upon 24-hour Diaries.
Week 2
|
8.10 hours
Interval 4.0 to 14.0
|
8.14 hours
Interval 2.8 to 15.3
|
8.13 hours
Interval 3.5 to 14.8
|
|
Sleep Time in Hours Per Day Based Upon 24-hour Diaries.
Week 6
|
8.23 hours
Interval 4.3 to 12.5
|
8.21 hours
Interval 3.0 to 15.5
|
8.40 hours
Interval 3.8 to 16.8
|
|
Sleep Time in Hours Per Day Based Upon 24-hour Diaries.
Week 10
|
8.38 hours
Interval 3.7 to 13.7
|
8.30 hours
Interval 2.8 to 14.5
|
8.44 hours
Interval 4.3 to 14.2
|
|
Sleep Time in Hours Per Day Based Upon 24-hour Diaries.
Week 12
|
8.26 hours
Interval 2.3 to 12.7
|
8.13 hours
Interval 3.2 to 14.2
|
8.30 hours
Interval 3.8 to 15.0
|
SECONDARY outcome
Timeframe: Baseline, Week 2, Week 6, Week 10 and Week 12.Population: The number of subjects in each row is based on the number of subjects with valid diary entries for the corresponding week
Outcome measures
| Measure |
Placebo
n=198 Participants
Placebo to match istradefylline 20 mg and placebo to match istradefylline 40 mg:
A daily, oral, double-blind treatment dose of both tablets will be taken in the morning for 12 weeks.
Placebo: Placebo
|
Istradefylline 20 mg/Day
n=194 Participants
Istradefylline 20 mg and placebo to match istradefylline 40 mg:
A daily, oral, double-blind treatment dose of both tablets will be taken in the morning for 12 weeks.
Istradefylline 20 mg: Istradefylline 20 mg and placebo
Placebo: Placebo
|
Istradefylline 40 mg/Day
n=200 Participants
Istradefylline 40 mg and placebo to match istradefylline 20 mg:
A daily, oral, double-blind treatment dose of both tablets will be taken in the morning for 12 weeks.
Istradefylline 40 mg: Istradefylline 40 mg and placebo
Placebo: Placebo
|
|---|---|---|---|
|
Percentage of Awake Time Per Day Spent in the OFF State
Baseline
|
34.55 percentage of hours
Interval 12.7 to 84.4
|
33.92 percentage of hours
Interval 7.1 to 82.1
|
33.16 percentage of hours
Interval 8.2 to 72.2
|
|
Percentage of Awake Time Per Day Spent in the OFF State
Week 2
|
30.95 percentage of hours
Interval 0.0 to 93.2
|
29.46 percentage of hours
Interval 0.0 to 76.0
|
27.45 percentage of hours
Interval 1.0 to 60.2
|
|
Percentage of Awake Time Per Day Spent in the OFF State
Week 6
|
28.04 percentage of hours
Interval 0.0 to 76.5
|
26.31 percentage of hours
Interval 0.0 to 76.4
|
26.39 percentage of hours
Interval 0.0 to 63.9
|
|
Percentage of Awake Time Per Day Spent in the OFF State
Week 10
|
28.80 percentage of hours
Interval 0.0 to 89.2
|
25.69 percentage of hours
Interval 0.0 to 75.3
|
25.09 percentage of hours
Interval 0.0 to 65.6
|
|
Percentage of Awake Time Per Day Spent in the OFF State
Week 12
|
28.62 percentage of hours
Interval 0.0 to 92.9
|
26.24 percentage of hours
Interval 0.0 to 85.2
|
26.51 percentage of hours
Interval 0.0 to 74.5
|
SECONDARY outcome
Timeframe: Baseline, Week 2, Week 6, Week 10 and Week 12.Population: The number of subjects in each row is based on the number of subjects with valid diary entries for the corresponding week
Outcome measures
| Measure |
Placebo
n=198 Participants
Placebo to match istradefylline 20 mg and placebo to match istradefylline 40 mg:
A daily, oral, double-blind treatment dose of both tablets will be taken in the morning for 12 weeks.
Placebo: Placebo
|
Istradefylline 20 mg/Day
n=194 Participants
Istradefylline 20 mg and placebo to match istradefylline 40 mg:
A daily, oral, double-blind treatment dose of both tablets will be taken in the morning for 12 weeks.
Istradefylline 20 mg: Istradefylline 20 mg and placebo
Placebo: Placebo
|
Istradefylline 40 mg/Day
n=200 Participants
Istradefylline 40 mg and placebo to match istradefylline 20 mg:
A daily, oral, double-blind treatment dose of both tablets will be taken in the morning for 12 weeks.
Istradefylline 40 mg: Istradefylline 40 mg and placebo
Placebo: Placebo
|
|---|---|---|---|
|
Percentage of ON Time Per Day Without Troublesome Dyskinesia.
Baseline
|
58.54 percentage of hours
Interval 5.4 to 85.2
|
61.04 percentage of hours
Interval 11.5 to 86.0
|
61.54 percentage of hours
Interval 6.9 to 91.8
|
|
Percentage of ON Time Per Day Without Troublesome Dyskinesia.
Week 2
|
62.99 percentage of hours
Interval 2.7 to 100.0
|
64.72 percentage of hours
Interval 0.0 to 100.0
|
66.26 percentage of hours
Interval 0.0 to 96.7
|
|
Percentage of ON Time Per Day Without Troublesome Dyskinesia.
Week 6
|
65.34 percentage of hours
Interval 0.0 to 99.0
|
68.51 percentage of hours
Interval 0.0 to 98.8
|
67.55 percentage of hours
Interval 0.0 to 100.0
|
|
Percentage of ON Time Per Day Without Troublesome Dyskinesia.
Week 10
|
65.33 percentage of hours
Interval 0.0 to 100.0
|
68.65 percentage of hours
Interval 0.0 to 100.0
|
68.17 percentage of hours
Interval 4.4 to 100.0
|
|
Percentage of ON Time Per Day Without Troublesome Dyskinesia.
Week 12
|
65.17 percentage of hours
Interval 0.0 to 100.0
|
68.17 percentage of hours
Interval 0.0 to 100.0
|
67.64 percentage of hours
Interval 2.0 to 100.0
|
SECONDARY outcome
Timeframe: Baseline and Week 12.Population: Intent-to-Treat Analysis set: Includes all subjects randomized to a treatment arm and with both a valid baseline and at least one valid post-baseline patient diary.
The Montreal Cognitive Assessment (MoCA) assesses different cognitive domains, broken down as follows: Visuospatial and executive functioning: 5 points Animal Naming: 3 points Attention: 6 points Language: 3 points Abstraction: 2 points Delayed recall (short-term memory): 5 points Orientation: 6 points Scores can range from 0 to 30. A score of 26 or above is considered normal.
Outcome measures
| Measure |
Placebo
n=198 Participants
Placebo to match istradefylline 20 mg and placebo to match istradefylline 40 mg:
A daily, oral, double-blind treatment dose of both tablets will be taken in the morning for 12 weeks.
Placebo: Placebo
|
Istradefylline 20 mg/Day
n=194 Participants
Istradefylline 20 mg and placebo to match istradefylline 40 mg:
A daily, oral, double-blind treatment dose of both tablets will be taken in the morning for 12 weeks.
Istradefylline 20 mg: Istradefylline 20 mg and placebo
Placebo: Placebo
|
Istradefylline 40 mg/Day
n=200 Participants
Istradefylline 40 mg and placebo to match istradefylline 20 mg:
A daily, oral, double-blind treatment dose of both tablets will be taken in the morning for 12 weeks.
Istradefylline 40 mg: Istradefylline 40 mg and placebo
Placebo: Placebo
|
|---|---|---|---|
|
Montreal Cognitive Assessment (MoCA)
Score at Baseline
|
28 score on a scale
Interval 26.0 to 30.0
|
28 score on a scale
Interval 26.0 to 30.0
|
28 score on a scale
Interval 26.0 to 30.0
|
|
Montreal Cognitive Assessment (MoCA)
Score at Week 12
|
27.8 score on a scale
Interval 19.0 to 30.0
|
27.9 score on a scale
Interval 18.0 to 30.0
|
27.7 score on a scale
Interval 20.0 to 30.0
|
SECONDARY outcome
Timeframe: Baseline and Week 12.Population: The number of subjects in each row is based on the number of subjects with data for the corresponding week
The Beck Depression Inventory is a 21-question test that measures the severity of depression. Subjects rated each on a scale of 0 to 3 for change from baseline utilizing the following scale: * 0 = I do not feel sad * 1 = I feel sad * 2 = I am sad all the time and I can't snap out of it * 3 = I am so sad or unhappy that I can't stand it The test is scored for each question using the above scale to determine the severity of depression. Scoring is as shown below: * 0 to 9: minimal depression * 10 to 18: mild depression * 19 to 29: moderate depression * 30 to 63: severe depression
Outcome measures
| Measure |
Placebo
n=198 Participants
Placebo to match istradefylline 20 mg and placebo to match istradefylline 40 mg:
A daily, oral, double-blind treatment dose of both tablets will be taken in the morning for 12 weeks.
Placebo: Placebo
|
Istradefylline 20 mg/Day
n=194 Participants
Istradefylline 20 mg and placebo to match istradefylline 40 mg:
A daily, oral, double-blind treatment dose of both tablets will be taken in the morning for 12 weeks.
Istradefylline 20 mg: Istradefylline 20 mg and placebo
Placebo: Placebo
|
Istradefylline 40 mg/Day
n=199 Participants
Istradefylline 40 mg and placebo to match istradefylline 20 mg:
A daily, oral, double-blind treatment dose of both tablets will be taken in the morning for 12 weeks.
Istradefylline 40 mg: Istradefylline 40 mg and placebo
Placebo: Placebo
|
|---|---|---|---|
|
Beck Depression Inventory (BDI)
Week 12
|
7.9 score on a scale
Interval 0.0 to 28.0
|
7.5 score on a scale
Interval 0.0 to 27.0
|
8.3 score on a scale
Interval 0.0 to 32.0
|
|
Beck Depression Inventory (BDI)
Baseline
|
8.8 score on a scale
Interval 0.0 to 20.0
|
8.6 score on a scale
Interval 0.0 to 28.0
|
9.3 score on a scale
Interval 0.0 to 20.0
|
Adverse Events
Placebo
Serious events: 7 serious events
Other events: 111 other events
Deaths: 0 deaths
Istradefylline 20 mg/Day
Serious events: 6 serious events
Other events: 117 other events
Deaths: 0 deaths
Istradefylline 40 mg/Day
Serious events: 8 serious events
Other events: 132 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Placebo
n=204 participants at risk
Placebo to match istradefylline 20 mg and placebo to match istradefylline 40 mg:
A daily, oral, double-blind treatment dose of both tablets will be taken in the morning for 12 weeks.
Placebo: Placebo
|
Istradefylline 20 mg/Day
n=201 participants at risk
Istradefylline 20 mg and placebo to match istradefylline 40 mg:
A daily, oral, double-blind treatment dose of both tablets will be taken in the morning for 12 weeks.
Istradefylline 20 mg: Istradefylline 20 mg and placebo
Placebo: Placebo
|
Istradefylline 40 mg/Day
n=207 participants at risk
Istradefylline 40 mg and placebo to match istradefylline 20 mg:
A daily, oral, double-blind treatment dose of both tablets will be taken in the morning for 12 weeks.
Istradefylline 40 mg: Istradefylline 40 mg and placebo
Placebo: Placebo
|
|---|---|---|---|
|
Cardiac disorders
Cardiac failure acute
|
0.00%
0/204
|
0.00%
0/201
|
0.48%
1/207 • Number of events 1
|
|
Cardiac disorders
Mitral valve prolapse
|
0.00%
0/204
|
0.50%
1/201 • Number of events 1
|
0.00%
0/207
|
|
Cardiac disorders
Angina pectoris
|
0.49%
1/204 • Number of events 1
|
0.00%
0/201
|
0.00%
0/207
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/204
|
0.00%
0/201
|
0.48%
1/207 • Number of events 1
|
|
Cardiac disorders
Mitral valve incompetence
|
0.00%
0/204
|
0.50%
1/201 • Number of events 1
|
0.00%
0/207
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/204
|
0.50%
1/201 • Number of events 1
|
0.00%
0/207
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/204
|
0.50%
1/201 • Number of events 1
|
0.00%
0/207
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.00%
0/204
|
0.00%
0/201
|
0.48%
1/207 • Number of events 1
|
|
Gastrointestinal disorders
Pancreatitis
|
0.49%
1/204 • Number of events 1
|
0.00%
0/201
|
0.00%
0/207
|
|
Gastrointestinal disorders
Nausea
|
0.49%
1/204 • Number of events 1
|
0.00%
0/201
|
0.00%
0/207
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/204
|
0.50%
1/201 • Number of events 1
|
0.00%
0/207
|
|
Gastrointestinal disorders
Inguinal hernia, obstructive
|
0.49%
1/204 • Number of events 1
|
0.00%
0/201
|
0.00%
0/207
|
|
General disorders
Oedema
|
0.00%
0/204
|
0.00%
0/201
|
0.48%
1/207 • Number of events 1
|
|
General disorders
Fatigue
|
0.00%
0/204
|
0.50%
1/201 • Number of events 1
|
0.00%
0/207
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/204
|
0.50%
1/201 • Number of events 1
|
0.00%
0/207
|
|
Infections and infestations
Wound infection
|
0.00%
0/204
|
0.00%
0/201
|
0.48%
1/207 • Number of events 1
|
|
Infections and infestations
Septic shock
|
0.00%
0/204
|
0.50%
1/201 • Number of events 1
|
0.00%
0/207
|
|
Infections and infestations
Sepsis syndrome
|
0.00%
0/204
|
0.50%
1/201 • Number of events 1
|
0.00%
0/207
|
|
Infections and infestations
Pneumonia
|
0.49%
1/204 • Number of events 1
|
0.00%
0/201
|
0.48%
1/207 • Number of events 1
|
|
Infections and infestations
Peritonitis
|
0.00%
0/204
|
0.00%
0/201
|
0.48%
1/207 • Number of events 2
|
|
Infections and infestations
Infectious pleural effusion
|
0.49%
1/204 • Number of events 1
|
0.00%
0/201
|
0.00%
0/207
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/204
|
0.50%
1/201 • Number of events 1
|
0.00%
0/207
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.00%
0/204
|
0.50%
1/201 • Number of events 1
|
0.00%
0/207
|
|
Injury, poisoning and procedural complications
Anaesthetic complication neurological
|
0.49%
1/204 • Number of events 1
|
0.00%
0/201
|
0.00%
0/207
|
|
Investigations
Medical observation
|
0.00%
0/204
|
0.00%
0/201
|
0.48%
1/207 • Number of events 1
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/204
|
0.50%
1/201 • Number of events 1
|
0.00%
0/207
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/204
|
0.50%
1/201 • Number of events 1
|
0.00%
0/207
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/204
|
0.50%
1/201 • Number of events 1
|
0.00%
0/207
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/204
|
0.50%
1/201 • Number of events 1
|
0.00%
0/207
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/204
|
0.50%
1/201 • Number of events 1
|
0.00%
0/207
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.49%
1/204 • Number of events 1
|
0.00%
0/201
|
0.00%
0/207
|
|
Nervous system disorders
Parkinson's disease
|
0.00%
0/204
|
0.00%
0/201
|
0.48%
1/207 • Number of events 1
|
|
Psychiatric disorders
Delirium
|
0.00%
0/204
|
0.00%
0/201
|
0.48%
1/207 • Number of events 1
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/204
|
0.00%
0/201
|
0.48%
1/207 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.49%
1/204 • Number of events 1
|
0.00%
0/201
|
0.00%
0/207
|
Other adverse events
| Measure |
Placebo
n=204 participants at risk
Placebo to match istradefylline 20 mg and placebo to match istradefylline 40 mg:
A daily, oral, double-blind treatment dose of both tablets will be taken in the morning for 12 weeks.
Placebo: Placebo
|
Istradefylline 20 mg/Day
n=201 participants at risk
Istradefylline 20 mg and placebo to match istradefylline 40 mg:
A daily, oral, double-blind treatment dose of both tablets will be taken in the morning for 12 weeks.
Istradefylline 20 mg: Istradefylline 20 mg and placebo
Placebo: Placebo
|
Istradefylline 40 mg/Day
n=207 participants at risk
Istradefylline 40 mg and placebo to match istradefylline 20 mg:
A daily, oral, double-blind treatment dose of both tablets will be taken in the morning for 12 weeks.
Istradefylline 40 mg: Istradefylline 40 mg and placebo
Placebo: Placebo
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.5%
3/204 • Number of events 4
|
1.00%
2/201 • Number of events 2
|
1.4%
3/207 • Number of events 3
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.98%
2/204 • Number of events 2
|
0.00%
0/201
|
0.00%
0/207
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/204
|
0.00%
0/201
|
0.48%
1/207 • Number of events 1
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/204
|
1.00%
2/201 • Number of events 2
|
0.97%
2/207 • Number of events 2
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.49%
1/204 • Number of events 1
|
0.00%
0/201
|
0.00%
0/207
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.49%
1/204 • Number of events 1
|
0.00%
0/201
|
0.00%
0/207
|
|
Cardiac disorders
Heart alternation
|
0.00%
0/204
|
0.50%
1/201 • Number of events 1
|
0.00%
0/207
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/204
|
0.50%
1/201 • Number of events 1
|
0.00%
0/207
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/204
|
0.50%
1/201 • Number of events 1
|
0.00%
0/207
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/204
|
0.50%
1/201 • Number of events 1
|
0.00%
0/207
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.49%
1/204 • Number of events 1
|
0.00%
0/201
|
0.48%
1/207 • Number of events 1
|
|
Cardiac disorders
Left ventricular hypertrophy
|
0.00%
0/204
|
0.00%
0/201
|
0.48%
1/207 • Number of events 1
|
|
Cardiac disorders
Bradycardia
|
0.49%
1/204 • Number of events 1
|
0.50%
1/201 • Number of events 1
|
0.48%
1/207 • Number of events 1
|
|
Cardiac disorders
Atrial fibrillation
|
0.49%
1/204 • Number of events 1
|
0.00%
0/201
|
0.00%
0/207
|
|
Cardiac disorders
Palpitations
|
0.49%
1/204 • Number of events 1
|
0.00%
0/201
|
0.00%
0/207
|
|
Cardiac disorders
Arrhythmia supraventricular
|
0.00%
0/204
|
0.50%
1/201 • Number of events 1
|
0.00%
0/207
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/204
|
0.00%
0/201
|
0.48%
1/207 • Number of events 1
|
|
Ear and labyrinth disorders
Vertigo
|
0.49%
1/204 • Number of events 1
|
0.50%
1/201 • Number of events 1
|
0.97%
2/207 • Number of events 2
|
|
Ear and labyrinth disorders
Presbyacusis
|
0.49%
1/204 • Number of events 1
|
0.00%
0/201
|
0.00%
0/207
|
|
Ear and labyrinth disorders
Ear discomfort
|
0.00%
0/204
|
0.00%
0/201
|
0.48%
1/207 • Number of events 1
|
|
Ear and labyrinth disorders
Cerumen impaction
|
0.49%
1/204 • Number of events 1
|
0.00%
0/201
|
0.00%
0/207
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/204
|
0.00%
0/201
|
0.48%
1/207 • Number of events 1
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/204
|
0.00%
0/201
|
0.97%
2/207 • Number of events 2
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/204
|
0.00%
0/201
|
0.48%
1/207 • Number of events 1
|
|
Eye disorders
Diplopia
|
0.00%
0/204
|
0.50%
1/201 • Number of events 1
|
0.00%
0/207
|
|
Eye disorders
Myopia
|
0.49%
1/204 • Number of events 1
|
0.00%
0/201
|
0.00%
0/207
|
|
Eye disorders
Dry eye
|
0.49%
1/204 • Number of events 1
|
0.00%
0/201
|
0.00%
0/207
|
|
Eye disorders
Vision blurred
|
0.00%
0/204
|
0.50%
1/201 • Number of events 1
|
0.97%
2/207 • Number of events 2
|
|
Eye disorders
Binocular eye movement disorder
|
0.00%
0/204
|
0.50%
1/201 • Number of events 1
|
0.00%
0/207
|
|
Eye disorders
Conjunctival haemorrhage
|
0.49%
1/204 • Number of events 1
|
0.00%
0/201
|
0.00%
0/207
|
|
Eye disorders
Vitreous detachment
|
0.00%
0/204
|
0.50%
1/201 • Number of events 1
|
0.00%
0/207
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/204
|
0.50%
1/201 • Number of events 1
|
0.00%
0/207
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/204
|
1.5%
3/201 • Number of events 3
|
2.9%
6/207 • Number of events 6
|
|
Gastrointestinal disorders
Salivary hypersecretion
|
0.00%
0/204
|
0.50%
1/201 • Number of events 1
|
0.00%
0/207
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/204
|
1.00%
2/201 • Number of events 2
|
0.48%
1/207 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
0.98%
2/204 • Number of events 2
|
4.0%
8/201 • Number of events 8
|
5.8%
12/207 • Number of events 13
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.49%
1/204 • Number of events 1
|
0.00%
0/201
|
0.00%
0/207
|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
0.00%
0/204
|
0.00%
0/201
|
0.48%
1/207 • Number of events 1
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.00%
0/204
|
0.00%
0/201
|
0.48%
1/207 • Number of events 1
|
|
Gastrointestinal disorders
Diverticulitis
|
0.49%
1/204 • Number of events 1
|
0.00%
0/201
|
0.00%
0/207
|
|
Gastrointestinal disorders
Faecal incontinence
|
0.00%
0/204
|
0.00%
0/201
|
0.48%
1/207 • Number of events 1
|
|
Gastrointestinal disorders
Dyspepsia
|
2.5%
5/204 • Number of events 5
|
0.50%
1/201 • Number of events 1
|
0.00%
0/207
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/204
|
0.00%
0/201
|
1.4%
3/207 • Number of events 3
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/204
|
0.00%
0/201
|
0.97%
2/207 • Number of events 2
|
|
Gastrointestinal disorders
Abdominal pain
|
0.49%
1/204 • Number of events 1
|
0.50%
1/201 • Number of events 1
|
0.48%
1/207 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.49%
1/204 • Number of events 1
|
0.00%
0/201
|
0.48%
1/207 • Number of events 1
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/204
|
0.50%
1/201 • Number of events 1
|
0.00%
0/207
|
|
Gastrointestinal disorders
Diarrhoea
|
3.9%
8/204 • Number of events 8
|
0.50%
1/201 • Number of events 1
|
1.9%
4/207 • Number of events 5
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.98%
2/204 • Number of events 2
|
0.50%
1/201 • Number of events 1
|
1.4%
3/207 • Number of events 3
|
|
Gastrointestinal disorders
Constipation
|
0.98%
2/204 • Number of events 2
|
1.5%
3/201 • Number of events 3
|
3.9%
8/207 • Number of events 8
|
|
Gastrointestinal disorders
Intestinal polyp
|
0.49%
1/204 • Number of events 1
|
0.00%
0/201
|
0.00%
0/207
|
|
Gastrointestinal disorders
Anal spasm
|
0.00%
0/204
|
0.50%
1/201 • Number of events 1
|
0.00%
0/207
|
|
Gastrointestinal disorders
Dry mouth
|
0.49%
1/204 • Number of events 1
|
0.00%
0/201
|
0.48%
1/207 • Number of events 1
|
|
Gastrointestinal disorders
Faecaloma
|
0.00%
0/204
|
0.50%
1/201 • Number of events 1
|
0.00%
0/207
|
|
Gastrointestinal disorders
Flatulence
|
0.49%
1/204 • Number of events 1
|
0.50%
1/201 • Number of events 1
|
0.48%
1/207 • Number of events 1
|
|
General disorders
Irritability
|
0.98%
2/204 • Number of events 2
|
0.50%
1/201 • Number of events 1
|
0.48%
1/207 • Number of events 1
|
|
General disorders
Influenza like illness
|
0.49%
1/204 • Number of events 1
|
0.00%
0/201
|
0.00%
0/207
|
|
General disorders
Fatigue
|
2.9%
6/204 • Number of events 6
|
1.5%
3/201 • Number of events 3
|
3.9%
8/207 • Number of events 8
|
|
General disorders
Energy increased
|
0.00%
0/204
|
0.00%
0/201
|
0.48%
1/207 • Number of events 1
|
|
General disorders
Asthenia
|
0.00%
0/204
|
0.50%
1/201 • Number of events 1
|
0.97%
2/207 • Number of events 2
|
|
General disorders
Chest discomfort
|
0.00%
0/204
|
0.50%
1/201 • Number of events 1
|
0.00%
0/207
|
|
General disorders
General physical health deterioration
|
0.00%
0/204
|
0.00%
0/201
|
0.48%
1/207 • Number of events 1
|
|
General disorders
Therapeutic response decreased
|
0.00%
0/204
|
0.50%
1/201 • Number of events 1
|
0.00%
0/207
|
|
General disorders
Pyrexia
|
0.49%
1/204 • Number of events 1
|
1.00%
2/201 • Number of events 2
|
0.48%
1/207 • Number of events 1
|
|
General disorders
Suprapubic pain
|
0.49%
1/204 • Number of events 1
|
0.00%
0/201
|
0.00%
0/207
|
|
General disorders
Pain
|
0.00%
0/204
|
0.50%
1/201 • Number of events 1
|
0.00%
0/207
|
|
General disorders
Oedema peripheral
|
1.5%
3/204 • Number of events 3
|
1.5%
3/201 • Number of events 3
|
0.97%
2/207 • Number of events 2
|
|
General disorders
Oedema
|
0.00%
0/204
|
0.00%
0/201
|
0.48%
1/207 • Number of events 1
|
|
General disorders
Non-cardiac chest pain
|
0.98%
2/204 • Number of events 2
|
0.00%
0/201
|
0.48%
1/207 • Number of events 1
|
|
General disorders
Malaise
|
0.00%
0/204
|
0.50%
1/201 • Number of events 1
|
0.00%
0/207
|
|
General disorders
Gait disturbance
|
0.98%
2/204 • Number of events 2
|
0.00%
0/201
|
1.9%
4/207 • Number of events 4
|
|
General disorders
Vessel puncture site bruise
|
0.49%
1/204 • Number of events 1
|
0.00%
0/201
|
0.00%
0/207
|
|
General disorders
Local swelling
|
0.49%
1/204 • Number of events 1
|
0.00%
0/201
|
0.00%
0/207
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/204
|
0.00%
0/201
|
0.48%
1/207 • Number of events 2
|
|
Hepatobiliary disorders
Liver disorder
|
0.00%
0/204
|
0.50%
1/201 • Number of events 1
|
0.00%
0/207
|
|
Infections and infestations
Viral infection
|
0.49%
1/204 • Number of events 1
|
0.00%
0/201
|
0.48%
1/207 • Number of events 1
|
|
Infections and infestations
Urinary tract infection
|
2.9%
6/204 • Number of events 7
|
3.0%
6/201 • Number of events 6
|
3.4%
7/207 • Number of events 8
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/204
|
1.00%
2/201 • Number of events 2
|
0.48%
1/207 • Number of events 1
|
|
Infections and infestations
Tinea pedis
|
0.49%
1/204 • Number of events 1
|
0.00%
0/201
|
0.00%
0/207
|
|
Infections and infestations
Sinusitis
|
0.00%
0/204
|
0.50%
1/201 • Number of events 1
|
1.4%
3/207 • Number of events 3
|
|
Infections and infestations
Rhinitis
|
0.49%
1/204 • Number of events 1
|
0.00%
0/201
|
0.97%
2/207 • Number of events 2
|
|
Infections and infestations
Nasopharyngitis
|
0.98%
2/204 • Number of events 2
|
4.0%
8/201 • Number of events 10
|
0.97%
2/207 • Number of events 2
|
|
Infections and infestations
Nail infection
|
0.00%
0/204
|
0.00%
0/201
|
0.48%
1/207 • Number of events 1
|
|
Infections and infestations
Lyme disease
|
0.00%
0/204
|
0.50%
1/201 • Number of events 1
|
0.00%
0/207
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/204
|
0.50%
1/201 • Number of events 1
|
0.00%
0/207
|
|
Infections and infestations
Laryngitis
|
0.49%
1/204 • Number of events 1
|
0.00%
0/201
|
0.48%
1/207 • Number of events 1
|
|
Infections and infestations
Influenza
|
0.49%
1/204 • Number of events 1
|
2.0%
4/201 • Number of events 4
|
1.9%
4/207 • Number of events 4
|
|
Infections and infestations
Croup infectious
|
0.49%
1/204 • Number of events 1
|
0.00%
0/201
|
0.00%
0/207
|
|
Infections and infestations
Abscess limb
|
0.00%
0/204
|
0.50%
1/201 • Number of events 1
|
0.00%
0/207
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/204
|
0.00%
0/201
|
0.48%
1/207 • Number of events 1
|
|
Infections and infestations
Upper respiratory tract infection
|
2.9%
6/204 • Number of events 6
|
1.00%
2/201 • Number of events 2
|
1.4%
3/207 • Number of events 3
|
|
Infections and infestations
Cellulitis
|
0.00%
0/204
|
0.00%
0/201
|
0.48%
1/207 • Number of events 1
|
|
Infections and infestations
Bronchitis
|
0.00%
0/204
|
1.5%
3/201 • Number of events 3
|
0.97%
2/207 • Number of events 2
|
|
Infections and infestations
Cystitis
|
0.00%
0/204
|
0.50%
1/201 • Number of events 1
|
0.97%
2/207 • Number of events 2
|
|
Infections and infestations
Ear infection
|
0.00%
0/204
|
0.00%
0/201
|
0.48%
1/207 • Number of events 1
|
|
Infections and infestations
Herpes zoster
|
0.49%
1/204 • Number of events 1
|
0.00%
0/201
|
0.48%
1/207 • Number of events 1
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/204
|
0.00%
0/201
|
0.48%
1/207 • Number of events 1
|
|
Injury, poisoning and procedural complications
Wound
|
0.49%
1/204 • Number of events 1
|
0.00%
0/201
|
0.00%
0/207
|
|
Injury, poisoning and procedural complications
Suture rupture
|
0.00%
0/204
|
0.00%
0/201
|
0.48%
1/207 • Number of events 1
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/204
|
0.50%
1/201 • Number of events 1
|
1.4%
3/207 • Number of events 3
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.00%
0/204
|
0.00%
0/201
|
0.48%
1/207 • Number of events 1
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/204
|
0.50%
1/201 • Number of events 1
|
0.00%
0/207
|
|
Injury, poisoning and procedural complications
Periorbital contusion
|
0.49%
1/204 • Number of events 1
|
0.00%
0/201
|
0.00%
0/207
|
|
Injury, poisoning and procedural complications
Musculoskeletal injury
|
0.49%
1/204 • Number of events 1
|
0.00%
0/201
|
0.00%
0/207
|
|
Injury, poisoning and procedural complications
Lip injury
|
0.49%
1/204 • Number of events 1
|
0.50%
1/201 • Number of events 1
|
0.00%
0/207
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/204
|
0.00%
0/201
|
0.48%
1/207 • Number of events 1
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/204
|
0.50%
1/201 • Number of events 1
|
0.48%
1/207 • Number of events 1
|
|
Injury, poisoning and procedural complications
Laceration
|
1.5%
3/204 • Number of events 3
|
0.50%
1/201 • Number of events 1
|
0.00%
0/207
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/204
|
0.00%
0/201
|
0.97%
2/207 • Number of events 4
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/204
|
0.50%
1/201 • Number of events 1
|
0.00%
0/207
|
|
Injury, poisoning and procedural complications
Head injury
|
0.49%
1/204 • Number of events 1
|
0.00%
0/201
|
0.97%
2/207 • Number of events 2
|
|
Injury, poisoning and procedural complications
Fall
|
4.4%
9/204 • Number of events 12
|
6.5%
13/201 • Number of events 17
|
8.7%
18/207 • Number of events 22
|
|
Injury, poisoning and procedural complications
Sternal fracture
|
0.00%
0/204
|
0.50%
1/201 • Number of events 1
|
0.00%
0/207
|
|
Injury, poisoning and procedural complications
Contusion
|
0.49%
1/204 • Number of events 1
|
2.0%
4/201 • Number of events 4
|
1.9%
4/207 • Number of events 5
|
|
Injury, poisoning and procedural complications
Back injury
|
0.00%
0/204
|
0.00%
0/201
|
0.48%
1/207 • Number of events 1
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/204
|
0.50%
1/201 • Number of events 1
|
0.00%
0/207
|
|
Injury, poisoning and procedural complications
Face injury
|
0.00%
0/204
|
0.50%
1/201 • Number of events 1
|
0.00%
0/207
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/204
|
0.50%
1/201 • Number of events 1
|
0.00%
0/207
|
|
Injury, poisoning and procedural complications
Corneal abrasion
|
0.49%
1/204 • Number of events 1
|
0.00%
0/201
|
0.00%
0/207
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.49%
1/204 • Number of events 1
|
2.5%
5/201 • Number of events 5
|
1.4%
3/207 • Number of events 5
|
|
Investigations
Blood calcium increased
|
0.49%
1/204 • Number of events 1
|
0.00%
0/201
|
0.00%
0/207
|
|
Investigations
Blood calcium decreased
|
0.49%
1/204 • Number of events 1
|
0.50%
1/201 • Number of events 1
|
0.00%
0/207
|
|
Investigations
Blood alkaline phosphatase increased
|
0.98%
2/204 • Number of events 2
|
0.00%
0/201
|
0.48%
1/207 • Number of events 2
|
|
Investigations
Alanine aminotransferase increased
|
0.49%
1/204 • Number of events 1
|
0.00%
0/201
|
0.48%
1/207 • Number of events 1
|
|
Investigations
Biopsy skin
|
0.00%
0/204
|
0.50%
1/201 • Number of events 1
|
0.00%
0/207
|
|
Investigations
Blood bilirubin increased
|
0.98%
2/204 • Number of events 2
|
1.00%
2/201 • Number of events 2
|
0.48%
1/207 • Number of events 1
|
|
Investigations
Amylase increased
|
2.0%
4/204 • Number of events 4
|
1.00%
2/201 • Number of events 2
|
0.97%
2/207 • Number of events 3
|
|
Investigations
White blood cells urine positive
|
0.49%
1/204 • Number of events 1
|
0.00%
0/201
|
0.00%
0/207
|
|
Investigations
White blood cell count decreased
|
0.49%
1/204 • Number of events 2
|
0.50%
1/201 • Number of events 1
|
0.48%
1/207 • Number of events 1
|
|
Investigations
Weight increased
|
0.49%
1/204 • Number of events 1
|
0.50%
1/201 • Number of events 1
|
0.00%
0/207
|
|
Investigations
Weight decreased
|
0.49%
1/204 • Number of events 1
|
1.5%
3/201 • Number of events 3
|
0.97%
2/207 • Number of events 2
|
|
Investigations
Urine transitional cells present
|
0.49%
1/204 • Number of events 1
|
0.00%
0/201
|
0.00%
0/207
|
|
Investigations
Urine ketone body present
|
0.49%
1/204 • Number of events 1
|
0.00%
0/201
|
0.00%
0/207
|
|
Investigations
Urinary casts
|
0.00%
0/204
|
0.00%
0/201
|
0.48%
1/207 • Number of events 1
|
|
Investigations
White blood cell count increased
|
0.00%
0/204
|
0.00%
0/201
|
0.48%
1/207 • Number of events 1
|
|
Investigations
Specific gravity urine increased
|
0.49%
1/204 • Number of events 1
|
0.00%
0/201
|
0.00%
0/207
|
|
Investigations
Red blood cell count decreased
|
0.00%
0/204
|
1.00%
2/201 • Number of events 2
|
0.00%
0/207
|
|
Investigations
QRS axis abnormal
|
0.49%
1/204 • Number of events 1
|
0.00%
0/201
|
0.00%
0/207
|
|
Investigations
Protein urine present
|
0.49%
1/204 • Number of events 1
|
0.00%
0/201
|
0.00%
0/207
|
|
Investigations
Precancerous cells present
|
0.49%
1/204 • Number of events 1
|
0.00%
0/201
|
0.00%
0/207
|
|
Investigations
Occult blood
|
0.49%
1/204 • Number of events 1
|
0.00%
0/201
|
0.00%
0/207
|
|
Investigations
Neutrophil count increased
|
0.00%
0/204
|
0.00%
0/201
|
0.48%
1/207 • Number of events 1
|
|
Investigations
Monocyte count increased
|
0.49%
1/204 • Number of events 1
|
0.50%
1/201 • Number of events 1
|
0.00%
0/207
|
|
Investigations
Nitrite urine present
|
0.00%
0/204
|
0.00%
0/201
|
0.48%
1/207 • Number of events 1
|
|
Investigations
Lymphocyte percentage decreased
|
0.49%
1/204 • Number of events 1
|
0.00%
0/201
|
0.00%
0/207
|
|
Investigations
Lymphocyte count decreased
|
0.98%
2/204 • Number of events 2
|
0.00%
0/201
|
0.48%
1/207 • Number of events 2
|
|
Investigations
Lipase increased
|
2.5%
5/204 • Number of events 5
|
1.00%
2/201 • Number of events 2
|
0.97%
2/207 • Number of events 3
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/204
|
0.00%
0/201
|
0.48%
1/207 • Number of events 1
|
|
Investigations
Heart rate increased
|
0.49%
1/204 • Number of events 1
|
0.00%
0/201
|
0.00%
0/207
|
|
Investigations
Haemoglobin decreased
|
0.49%
1/204 • Number of events 1
|
0.50%
1/201 • Number of events 1
|
0.48%
1/207 • Number of events 1
|
|
Investigations
Haematocrit decreased
|
0.49%
1/204 • Number of events 1
|
1.00%
2/201 • Number of events 2
|
0.00%
0/207
|
|
Investigations
Red blood cells urine positive
|
0.49%
1/204 • Number of events 1
|
0.00%
0/201
|
0.48%
1/207 • Number of events 1
|
|
Investigations
Eosinophil percentage increased
|
0.49%
1/204 • Number of events 1
|
0.00%
0/201
|
0.00%
0/207
|
|
Investigations
Eosinophil count increased
|
0.49%
1/204 • Number of events 1
|
0.00%
0/201
|
0.97%
2/207 • Number of events 2
|
|
Investigations
Electrocardiogram abnormal
|
0.98%
2/204 • Number of events 2
|
0.00%
0/201
|
0.48%
1/207 • Number of events 1
|
|
Investigations
Crystal urine present
|
0.49%
1/204 • Number of events 1
|
0.50%
1/201 • Number of events 1
|
0.48%
1/207 • Number of events 2
|
|
Investigations
Cardiac murmur
|
0.49%
1/204 • Number of events 1
|
0.50%
1/201 • Number of events 1
|
0.00%
0/207
|
|
Investigations
Blood urea increased
|
0.49%
1/204 • Number of events 1
|
1.00%
2/201 • Number of events 2
|
0.48%
1/207 • Number of events 1
|
|
Investigations
Blood triglycerides increased
|
1.5%
3/204 • Number of events 3
|
1.00%
2/201 • Number of events 2
|
0.00%
0/207
|
|
Investigations
Blood pressure increased
|
0.00%
0/204
|
0.00%
0/201
|
0.97%
2/207 • Number of events 2
|
|
Investigations
Blood uric acid increased
|
0.00%
0/204
|
1.5%
3/201 • Number of events 3
|
0.97%
2/207 • Number of events 2
|
|
Investigations
Blood potassium increased
|
0.98%
2/204 • Number of events 2
|
0.00%
0/201
|
0.48%
1/207 • Number of events 1
|
|
Investigations
Blood phosphorus decreased
|
0.00%
0/204
|
0.50%
1/201 • Number of events 1
|
0.00%
0/207
|
|
Investigations
Blood lactate dehydrogenase increased
|
1.5%
3/204 • Number of events 3
|
0.00%
0/201
|
0.48%
1/207 • Number of events 1
|
|
Investigations
Blood creatinine increased
|
0.00%
0/204
|
0.50%
1/201 • Number of events 1
|
1.4%
3/207 • Number of events 3
|
|
Investigations
Blood urine present
|
0.49%
1/204 • Number of events 1
|
0.00%
0/201
|
0.00%
0/207
|
|
Investigations
Blood creatine phosphokinase increased
|
2.5%
5/204 • Number of events 5
|
1.5%
3/201 • Number of events 3
|
1.4%
3/207 • Number of events 3
|
|
Investigations
Blood cholesterol increased
|
0.49%
1/204 • Number of events 1
|
0.00%
0/201
|
0.00%
0/207
|
|
Metabolism and nutrition disorders
Vitamin B12 deficiency
|
0.00%
0/204
|
0.50%
1/201 • Number of events 1
|
0.00%
0/207
|
|
Metabolism and nutrition disorders
Lactose intolerance
|
0.00%
0/204
|
0.50%
1/201 • Number of events 1
|
0.00%
0/207
|
|
Metabolism and nutrition disorders
Lactic acidosis
|
0.00%
0/204
|
0.50%
1/201 • Number of events 1
|
0.00%
0/207
|
|
Metabolism and nutrition disorders
Increased appetite
|
0.49%
1/204 • Number of events 1
|
0.00%
0/201
|
0.00%
0/207
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/204
|
1.00%
2/201 • Number of events 2
|
0.00%
0/207
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/204
|
0.50%
1/201 • Number of events 1
|
0.00%
0/207
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/204
|
0.50%
1/201 • Number of events 1
|
0.00%
0/207
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.49%
1/204 • Number of events 1
|
0.00%
0/201
|
0.00%
0/207
|
|
Metabolism and nutrition disorders
Hyperphagia
|
0.00%
0/204
|
0.00%
0/201
|
0.48%
1/207 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.98%
2/204 • Number of events 2
|
1.00%
2/201 • Number of events 2
|
0.48%
1/207 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/204
|
1.5%
3/201 • Number of events 3
|
0.48%
1/207 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.49%
1/204 • Number of events 1
|
0.00%
0/201
|
0.00%
0/207
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
0.00%
0/204
|
0.50%
1/201 • Number of events 1
|
0.00%
0/207
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.49%
1/204 • Number of events 1
|
0.50%
1/201 • Number of events 1
|
0.00%
0/207
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.00%
0/204
|
0.50%
1/201 • Number of events 1
|
0.00%
0/207
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.49%
1/204 • Number of events 1
|
0.00%
0/201
|
0.00%
0/207
|
|
Musculoskeletal and connective tissue disorders
Sensation of heaviness
|
0.00%
0/204
|
0.00%
0/201
|
0.48%
1/207 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/204
|
0.50%
1/201 • Number of events 1
|
0.48%
1/207 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.49%
1/204 • Number of events 1
|
0.00%
0/201
|
0.00%
0/207
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/204
|
1.00%
2/201 • Number of events 2
|
1.4%
3/207 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.49%
1/204 • Number of events 1
|
1.5%
3/201 • Number of events 3
|
0.97%
2/207 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.98%
2/204 • Number of events 2
|
0.00%
0/201
|
0.97%
2/207 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/204
|
0.50%
1/201 • Number of events 1
|
0.48%
1/207 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.98%
2/204 • Number of events 4
|
0.00%
0/201
|
1.4%
3/207 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.49%
1/204 • Number of events 1
|
0.00%
0/201
|
0.00%
0/207
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.49%
1/204 • Number of events 1
|
0.00%
0/201
|
0.48%
1/207 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
0.49%
1/204 • Number of events 1
|
0.00%
0/201
|
0.00%
0/207
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.98%
2/204 • Number of events 2
|
0.50%
1/201 • Number of events 1
|
0.97%
2/207 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Muscle rigidity
|
0.49%
1/204 • Number of events 1
|
0.50%
1/201 • Number of events 1
|
0.00%
0/207
|
|
Musculoskeletal and connective tissue disorders
Muscle fatigue
|
0.49%
1/204 • Number of events 1
|
0.00%
0/201
|
0.00%
0/207
|
|
Musculoskeletal and connective tissue disorders
Mobility decreased
|
0.49%
1/204 • Number of events 2
|
0.00%
0/201
|
0.00%
0/207
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/204
|
0.00%
0/201
|
0.48%
1/207 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Myosclerosis
|
0.49%
1/204 • Number of events 1
|
0.00%
0/201
|
0.00%
0/207
|
|
Musculoskeletal and connective tissue disorders
Posture abnormal
|
0.00%
0/204
|
0.50%
1/201 • Number of events 1
|
0.00%
0/207
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/204
|
0.50%
1/201 • Number of events 1
|
0.00%
0/207
|
|
Musculoskeletal and connective tissue disorders
Facial asymmetry
|
0.00%
0/204
|
0.50%
1/201 • Number of events 1
|
0.00%
0/207
|
|
Musculoskeletal and connective tissue disorders
Chondropathy
|
0.00%
0/204
|
0.50%
1/201 • Number of events 1
|
0.00%
0/207
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/204
|
0.00%
0/201
|
0.48%
1/207 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/204
|
0.50%
1/201 • Number of events 1
|
0.00%
0/207
|
|
Musculoskeletal and connective tissue disorders
Bone disorder
|
0.00%
0/204
|
0.50%
1/201 • Number of events 1
|
0.00%
0/207
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.5%
3/204 • Number of events 3
|
1.5%
3/201 • Number of events 3
|
0.97%
2/207 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Arthropathy
|
0.49%
1/204 • Number of events 1
|
0.00%
0/201
|
0.00%
0/207
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.9%
6/204 • Number of events 7
|
2.0%
4/201 • Number of events 4
|
2.4%
5/207 • Number of events 5
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid neoplasm
|
0.00%
0/204
|
0.00%
0/201
|
0.48%
1/207 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seborrhoeic keratosis
|
0.49%
1/204 • Number of events 1
|
0.50%
1/201 • Number of events 1
|
0.00%
0/207
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Parathyroid tumour benign
|
0.00%
0/204
|
0.00%
0/201
|
0.48%
1/207 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic naevus
|
0.49%
1/204 • Number of events 1
|
0.00%
0/201
|
0.00%
0/207
|
|
Nervous system disorders
Syncope
|
0.49%
1/204 • Number of events 1
|
0.00%
0/201
|
0.48%
1/207 • Number of events 1
|
|
Nervous system disorders
Speech disorder
|
0.00%
0/204
|
0.00%
0/201
|
0.48%
1/207 • Number of events 1
|
|
Nervous system disorders
Somnolence
|
2.5%
5/204 • Number of events 5
|
2.0%
4/201 • Number of events 4
|
2.4%
5/207 • Number of events 5
|
|
Nervous system disorders
Restless legs syndrome
|
0.00%
0/204
|
0.00%
0/201
|
0.97%
2/207 • Number of events 2
|
|
Nervous system disorders
Psychomotor hyperactivity
|
0.49%
1/204 • Number of events 1
|
0.50%
1/201 • Number of events 1
|
0.00%
0/207
|
|
Nervous system disorders
Presyncope
|
0.00%
0/204
|
0.00%
0/201
|
0.97%
2/207 • Number of events 2
|
|
Nervous system disorders
Postural reflex impairment
|
0.49%
1/204 • Number of events 1
|
0.00%
0/201
|
0.00%
0/207
|
|
Nervous system disorders
Poor quality sleep
|
0.49%
1/204 • Number of events 1
|
0.00%
0/201
|
0.00%
0/207
|
|
Nervous system disorders
Parkinson's disease
|
0.98%
2/204 • Number of events 2
|
1.00%
2/201 • Number of events 2
|
0.97%
2/207 • Number of events 2
|
|
Nervous system disorders
Paraesthesia
|
0.49%
1/204 • Number of events 1
|
3.5%
7/201 • Number of events 7
|
2.4%
5/207 • Number of events 5
|
|
Nervous system disorders
Nerve root compression
|
0.00%
0/204
|
0.50%
1/201 • Number of events 1
|
0.00%
0/207
|
|
Nervous system disorders
Nerve compression
|
0.49%
1/204 • Number of events 1
|
0.00%
0/201
|
0.00%
0/207
|
|
Nervous system disorders
Migraine
|
0.49%
1/204 • Number of events 2
|
0.00%
0/201
|
0.00%
0/207
|
|
Nervous system disorders
Micrographia
|
0.00%
0/204
|
0.50%
1/201 • Number of events 1
|
0.00%
0/207
|
|
Nervous system disorders
Meralgia paraesthetica
|
0.00%
0/204
|
0.50%
1/201 • Number of events 1
|
0.00%
0/207
|
|
Nervous system disorders
Mental impairment
|
0.00%
0/204
|
0.50%
1/201 • Number of events 1
|
0.00%
0/207
|
|
Nervous system disorders
Lumbar radiculopathy
|
0.49%
1/204 • Number of events 1
|
0.00%
0/201
|
0.00%
0/207
|
|
Nervous system disorders
On and off phenomenon
|
4.4%
9/204 • Number of events 10
|
1.00%
2/201 • Number of events 2
|
2.9%
6/207 • Number of events 6
|
|
Nervous system disorders
Lethargy
|
0.00%
0/204
|
0.00%
0/201
|
0.48%
1/207 • Number of events 1
|
|
Nervous system disorders
Intercostal neuralgia
|
0.49%
1/204 • Number of events 1
|
0.00%
0/201
|
0.00%
0/207
|
|
Nervous system disorders
Hypoaesthesia
|
0.49%
1/204 • Number of events 1
|
0.50%
1/201 • Number of events 1
|
0.00%
0/207
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/204
|
0.50%
1/201 • Number of events 1
|
0.00%
0/207
|
|
Nervous system disorders
Headache
|
2.5%
5/204 • Number of events 5
|
2.0%
4/201 • Number of events 4
|
1.9%
4/207 • Number of events 4
|
|
Nervous system disorders
Freezing phenomenon
|
0.98%
2/204 • Number of events 2
|
0.00%
0/201
|
0.97%
2/207 • Number of events 2
|
|
Nervous system disorders
Dystonia
|
0.00%
0/204
|
0.50%
1/201 • Number of events 1
|
0.97%
2/207 • Number of events 3
|
|
Nervous system disorders
Dyskinesia
|
6.9%
14/204 • Number of events 14
|
11.4%
23/201 • Number of events 30
|
16.4%
34/207 • Number of events 37
|
|
Nervous system disorders
Sciatica
|
0.98%
2/204 • Number of events 2
|
0.50%
1/201 • Number of events 1
|
0.00%
0/207
|
|
Nervous system disorders
Tremor
|
0.98%
2/204 • Number of events 2
|
1.5%
3/201 • Number of events 3
|
0.97%
2/207 • Number of events 2
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/204
|
0.00%
0/201
|
0.48%
1/207 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
2.5%
5/204 • Number of events 5
|
3.0%
6/201 • Number of events 6
|
4.3%
9/207 • Number of events 11
|
|
Nervous system disorders
Disturbance in attention
|
0.49%
1/204 • Number of events 1
|
0.00%
0/201
|
0.97%
2/207 • Number of events 2
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/204
|
0.50%
1/201 • Number of events 1
|
0.48%
1/207 • Number of events 1
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.98%
2/204 • Number of events 2
|
0.00%
0/201
|
0.48%
1/207 • Number of events 1
|
|
Nervous system disorders
Bradykinesia
|
0.49%
1/204 • Number of events 1
|
1.5%
3/201 • Number of events 3
|
0.00%
0/207
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/204
|
1.00%
2/201 • Number of events 2
|
0.48%
1/207 • Number of events 1
|
|
Nervous system disorders
Akinesia
|
0.00%
0/204
|
0.00%
0/201
|
0.97%
2/207 • Number of events 2
|
|
Psychiatric disorders
Bipolar disorder
|
0.00%
0/204
|
0.50%
1/201 • Number of events 1
|
0.00%
0/207
|
|
Psychiatric disorders
Apathy
|
0.98%
2/204 • Number of events 2
|
0.50%
1/201 • Number of events 1
|
0.00%
0/207
|
|
Psychiatric disorders
Anxiety
|
1.5%
3/204 • Number of events 3
|
1.00%
2/201 • Number of events 2
|
2.4%
5/207 • Number of events 6
|
|
Psychiatric disorders
Abnormal dreams
|
0.00%
0/204
|
0.50%
1/201 • Number of events 1
|
1.9%
4/207 • Number of events 4
|
|
Psychiatric disorders
Terminal insomnia
|
0.49%
1/204 • Number of events 1
|
0.00%
0/201
|
0.48%
1/207 • Number of events 1
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/204
|
0.50%
1/201 • Number of events 1
|
0.00%
0/207
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/204
|
1.5%
3/201 • Number of events 3
|
0.48%
1/207 • Number of events 1
|
|
Psychiatric disorders
Restlessness
|
0.49%
1/204 • Number of events 1
|
1.00%
2/201 • Number of events 2
|
0.48%
1/207 • Number of events 1
|
|
Psychiatric disorders
Rapid eye movements sleep abnormal
|
0.00%
0/204
|
0.50%
1/201 • Number of events 1
|
0.97%
2/207 • Number of events 2
|
|
Psychiatric disorders
Paranoia
|
0.00%
0/204
|
0.00%
0/201
|
0.48%
1/207 • Number of events 1
|
|
Psychiatric disorders
Mood altered
|
0.00%
0/204
|
0.00%
0/201
|
0.48%
1/207 • Number of events 1
|
|
Psychiatric disorders
Middle insomnia
|
0.49%
1/204 • Number of events 1
|
0.00%
0/201
|
0.48%
1/207 • Number of events 1
|
|
Psychiatric disorders
Mania
|
0.00%
0/204
|
0.00%
0/201
|
0.48%
1/207 • Number of events 1
|
|
Psychiatric disorders
Libido increased
|
0.00%
0/204
|
0.50%
1/201 • Number of events 1
|
0.00%
0/207
|
|
Psychiatric disorders
Insomnia
|
2.5%
5/204 • Number of events 6
|
5.0%
10/201 • Number of events 10
|
3.4%
7/207 • Number of events 7
|
|
Psychiatric disorders
Initial insomnia
|
0.00%
0/204
|
0.50%
1/201 • Number of events 1
|
0.00%
0/207
|
|
Psychiatric disorders
Impulse-control disorder
|
0.00%
0/204
|
0.50%
1/201 • Number of events 1
|
0.48%
1/207 • Number of events 1
|
|
Psychiatric disorders
Illusion
|
0.00%
0/204
|
0.00%
0/201
|
0.48%
1/207 • Number of events 1
|
|
Psychiatric disorders
Hypomania
|
0.00%
0/204
|
0.00%
0/201
|
0.48%
1/207 • Number of events 1
|
|
Psychiatric disorders
Hypersexuality
|
0.00%
0/204
|
0.50%
1/201 • Number of events 1
|
0.48%
1/207 • Number of events 1
|
|
Psychiatric disorders
Hallucination, visual
|
0.98%
2/204 • Number of events 2
|
1.00%
2/201 • Number of events 2
|
0.00%
0/207
|
|
Psychiatric disorders
Hallucination, auditory
|
0.00%
0/204
|
0.50%
1/201 • Number of events 1
|
0.48%
1/207 • Number of events 1
|
|
Psychiatric disorders
Hallucination
|
0.98%
2/204 • Number of events 2
|
0.50%
1/201 • Number of events 1
|
1.9%
4/207 • Number of events 5
|
|
Psychiatric disorders
Depression
|
0.98%
2/204 • Number of events 2
|
1.5%
3/201 • Number of events 3
|
0.97%
2/207 • Number of events 2
|
|
Psychiatric disorders
Depressed mood
|
0.00%
0/204
|
0.00%
0/201
|
0.48%
1/207 • Number of events 1
|
|
Psychiatric disorders
Delusion
|
0.49%
1/204 • Number of events 1
|
0.50%
1/201 • Number of events 1
|
0.48%
1/207 • Number of events 1
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/204
|
0.50%
1/201 • Number of events 1
|
0.48%
1/207 • Number of events 1
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/204
|
0.00%
0/201
|
0.48%
1/207 • Number of events 1
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/204
|
0.00%
0/201
|
0.48%
1/207 • Number of events 1
|
|
Renal and urinary disorders
Urinary hesitation
|
0.00%
0/204
|
0.50%
1/201 • Number of events 1
|
0.00%
0/207
|
|
Renal and urinary disorders
Urge incontinence
|
0.49%
1/204 • Number of events 1
|
0.00%
0/201
|
0.00%
0/207
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/204
|
0.50%
1/201 • Number of events 2
|
0.00%
0/207
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/204
|
0.00%
0/201
|
0.48%
1/207 • Number of events 1
|
|
Renal and urinary disorders
Proteinuria
|
0.49%
1/204 • Number of events 1
|
0.00%
0/201
|
0.48%
1/207 • Number of events 1
|
|
Renal and urinary disorders
Pollakiuria
|
0.49%
1/204 • Number of events 1
|
0.00%
0/201
|
0.00%
0/207
|
|
Renal and urinary disorders
Nephritis
|
0.49%
1/204 • Number of events 2
|
0.00%
0/201
|
0.00%
0/207
|
|
Renal and urinary disorders
Micturition urgency
|
0.98%
2/204 • Number of events 2
|
0.00%
0/201
|
0.97%
2/207 • Number of events 2
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/204
|
0.50%
1/201 • Number of events 1
|
0.00%
0/207
|
|
Renal and urinary disorders
Azotaemia
|
0.49%
1/204 • Number of events 1
|
0.00%
0/201
|
0.00%
0/207
|
|
Reproductive system and breast disorders
Breast tenderness
|
0.49%
1/204 • Number of events 1
|
0.00%
0/201
|
0.00%
0/207
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/204
|
0.50%
1/201 • Number of events 1
|
0.00%
0/207
|
|
Respiratory, thoracic and mediastinal disorders
Sputum discoloured
|
0.49%
1/204 • Number of events 1
|
0.00%
0/201
|
0.00%
0/207
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.49%
1/204 • Number of events 1
|
0.00%
0/201
|
0.00%
0/207
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/204
|
1.00%
2/201 • Number of events 2
|
0.00%
0/207
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.49%
1/204 • Number of events 1
|
0.50%
1/201 • Number of events 1
|
0.00%
0/207
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/204
|
0.00%
0/201
|
0.48%
1/207 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
0.49%
1/204 • Number of events 1
|
0.00%
0/201
|
0.48%
1/207 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.00%
0/204
|
0.50%
1/201 • Number of events 1
|
0.00%
0/207
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/204
|
0.00%
0/201
|
0.48%
1/207 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.98%
2/204 • Number of events 2
|
1.5%
3/201 • Number of events 3
|
0.00%
0/207
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/204
|
1.00%
2/201 • Number of events 2
|
0.48%
1/207 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.49%
1/204 • Number of events 1
|
0.00%
0/201
|
0.00%
0/207
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.5%
3/204 • Number of events 3
|
1.5%
3/201 • Number of events 3
|
0.48%
1/207 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.98%
2/204 • Number of events 2
|
1.5%
3/201 • Number of events 4
|
1.4%
3/207 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Choking
|
0.49%
1/204 • Number of events 1
|
0.50%
1/201 • Number of events 1
|
0.00%
0/207
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.49%
1/204 • Number of events 1
|
0.50%
1/201 • Number of events 1
|
0.00%
0/207
|
|
Skin and subcutaneous tissue disorders
Skin necrosis
|
0.00%
0/204
|
0.00%
0/201
|
0.48%
1/207 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rosacea
|
0.00%
0/204
|
0.50%
1/201 • Number of events 1
|
0.00%
0/207
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/204
|
0.50%
1/201 • Number of events 1
|
0.00%
0/207
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/204
|
0.50%
1/201 • Number of events 1
|
1.4%
3/207 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/204
|
0.00%
0/201
|
0.48%
1/207 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Livedo reticularis
|
0.00%
0/204
|
0.00%
0/201
|
0.48%
1/207 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.98%
2/204 • Number of events 2
|
0.50%
1/201 • Number of events 1
|
0.48%
1/207 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Hand dermatitis
|
0.00%
0/204
|
0.50%
1/201 • Number of events 1
|
0.00%
0/207
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/204
|
1.00%
2/201 • Number of events 2
|
0.00%
0/207
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/204
|
0.50%
1/201 • Number of events 1
|
0.00%
0/207
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/204
|
0.50%
1/201 • Number of events 1
|
0.48%
1/207 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.49%
1/204 • Number of events 1
|
0.00%
0/201
|
0.48%
1/207 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Cold sweat
|
0.00%
0/204
|
0.00%
0/201
|
0.48%
1/207 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/204
|
0.50%
1/201 • Number of events 1
|
0.00%
0/207
|
|
Vascular disorders
Venous thrombosis limb
|
0.00%
0/204
|
0.50%
1/201 • Number of events 1
|
0.00%
0/207
|
|
Vascular disorders
Raynaud's phenomenon
|
0.00%
0/204
|
0.50%
1/201 • Number of events 2
|
0.00%
0/207
|
|
Vascular disorders
Peripheral coldness
|
0.00%
0/204
|
0.50%
1/201 • Number of events 1
|
0.00%
0/207
|
|
Vascular disorders
Orthostatic hypotension
|
0.49%
1/204 • Number of events 2
|
3.5%
7/201 • Number of events 8
|
1.4%
3/207 • Number of events 3
|
|
Vascular disorders
Orthostatic hypertension
|
0.00%
0/204
|
0.50%
1/201 • Number of events 1
|
0.00%
0/207
|
|
Vascular disorders
Hypotension
|
1.5%
3/204 • Number of events 3
|
1.00%
2/201 • Number of events 2
|
0.00%
0/207
|
|
Vascular disorders
Hypoperfusion
|
0.00%
0/204
|
0.50%
1/201 • Number of events 1
|
0.00%
0/207
|
|
Vascular disorders
Hypertension
|
0.49%
1/204 • Number of events 1
|
0.50%
1/201 • Number of events 1
|
1.9%
4/207 • Number of events 5
|
|
Vascular disorders
Hot flush
|
0.49%
1/204 • Number of events 1
|
1.5%
3/201 • Number of events 3
|
0.97%
2/207 • Number of events 2
|
|
Vascular disorders
Haematoma
|
0.49%
1/204 • Number of events 1
|
0.00%
0/201
|
0.48%
1/207 • Number of events 1
|
|
Vascular disorders
Flushing
|
0.00%
0/204
|
0.00%
0/201
|
0.48%
1/207 • Number of events 1
|
|
Vascular disorders
Blood pressure fluctuation
|
0.00%
0/204
|
1.00%
2/201 • Number of events 2
|
0.00%
0/207
|
|
Vascular disorders
Accelerated hypertension
|
0.00%
0/204
|
0.50%
1/201 • Number of events 1
|
0.00%
0/207
|
Additional Information
Kyowa Kirin Pharmaceutical Development
Kyowa Kirin Pharmaceutical Development
Phone: 609-919-1100
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60