ID

39435

Description

Study ID: 111569 Clinical Study ID: 111569 Study Title: A fixed dose, dose-response study for ropinirole prolonged release (PR) as adjunctive treatment to L-Dopa in patients with advanced Parkinson's disease Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01494532 Sponsor: GlaxoSmithKline Phase: Phase 4 Study Recruitment Status: Completed Generic Name: Ropinirole, placebo Study Indication: Parkinson's Disease

Keywords

Versions (2)
  1. 1/8/20 1/8/20 -
  2. 1/9/20 1/9/20 -
Copyright Holder

GlaxoSmithKline

Uploaded on

January 9, 2020

DOI

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License

Creative Commons BY-NC 3.0
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Ropinirole prolonged release (PR) as adjunctive treatment to L-Dopa in patients with advanced Parkinson's disease (NCT01494532)

English

Diary Card

1 forms  
  1. StudyEvent: ODM
    1. Diary Card
Administrative
Description

Administrative

Alias
UMLS CUI-1
C1320722
Subject Identifier
Description

Subject Identifier

Data type

text

Alias
UMLS CUI [1]
C2348585
Target Day 1
Description

Target Day 1

Alias
UMLS CUI-1
C3890583
UMLS CUI-2
C1521840
UMLS CUI-3
C0439228
Diary Date - Day 1
Description

Diary Date - Day 1

Data type

date

Alias
UMLS CUI [1,1]
C3890583
UMLS CUI [1,2]
C0011008
Time you took your study medication
Description

Time you took your study medication

Data type

time

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0040223
Time you took your study medication
Description

Time you took your study medication

Data type

integer

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0040223
Target Day 2
Description

Target Day 2

Alias
UMLS CUI-1
C3890583
UMLS CUI-2
C1521840
UMLS CUI-3
C0439228
Diary Date - Day 2
Description

Diary Date - Day 2

Data type

date

Alias
UMLS CUI [1,1]
C3890583
UMLS CUI [1,2]
C0011008
Time of awakening - Target Day 2
Description

This is when you are ready to get up out of bed and start the day, after your main night time sleep and/or rest

Data type

time

Alias
UMLS CUI [1,1]
C1720052
UMLS CUI [1,2]
C0040223
UMLS CUI [2,1]
C1521840
UMLS CUI [2,2]
C0439228
Time of awakening - Target Day 2
Description

This is when you are ready to get up out of bed and start the day, after your main night time sleep and/or rest +

Data type

integer

Alias
UMLS CUI [1,1]
C1720052
UMLS CUI [1,2]
C0040223
UMLS CUI [2,1]
C1521840
UMLS CUI [2,2]
C0439228
State you woke up in, following your overnight sleep - Target Day 2
Description

State you woke up in, following your overnight sleep - Target Day 2

Data type

integer

Alias
UMLS CUI [1,1]
C1720052
UMLS CUI [1,2]
C1442792
UMLS CUI [2,1]
C1521840
UMLS CUI [2,2]
C0439228
Time you took your study medication - Target Day 2
Description

Time you took your study medication - Target Day 2

Data type

time

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0040223
UMLS CUI [2,1]
C1521840
UMLS CUI [2,2]
C0439228
Time you took your study medication - Target Day 2
Description

Time you took your study medication - Target Day 2

Data type

integer

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0040223
UMLS CUI [2,1]
C1521840
UMLS CUI [2,2]
C0439228
Diary Day 2
Description

Diary Day 2

Alias
UMLS CUI-1
C3890583
UMLS CUI-2
C0439228
Time - Diary Day 2
Description

Time - Diary Day 2

Data type

integer

Alias
UMLS CUI [1]
C0040223
UMLS CUI [2,1]
C3890583
UMLS CUI [2,2]
C0439228
State - Diary Day 2
Description

State - Diary Day 2

Data type

integer

Alias
UMLS CUI [1]
C1442792
UMLS CUI [2,1]
C3890583
UMLS CUI [2,2]
C0439228
Target Day 3
Description

Target Day 3

Alias
UMLS CUI-1
C3890583
UMLS CUI-2
C1521840
UMLS CUI-3
C0439228
Diary Date - Day 3
Description

Diary Date - Day 3

Data type

date

Alias
UMLS CUI [1,1]
C3890583
UMLS CUI [1,2]
C0011008
Time of awakening - Target Day 3
Description

This is when you are ready to get up out of bed and start the day, after your main night time sleep and/or rest

Data type

time

Alias
UMLS CUI [1,1]
C1720052
UMLS CUI [1,2]
C0040223
UMLS CUI [2,1]
C1521840
UMLS CUI [2,2]
C0439228
Time of awakening - Target Day 3
Description

This is when you are ready to get up out of bed and start the day, after your main night time sleep and/or rest +

Data type

integer

Alias
UMLS CUI [1,1]
C1720052
UMLS CUI [1,2]
C0040223
UMLS CUI [2,1]
C1521840
UMLS CUI [2,2]
C0439228
State you woke up in, following your overnight sleep - Target Day 3
Description

State you woke up in, following your overnight sleep - Target Day 3

Data type

integer

Alias
UMLS CUI [1,1]
C1720052
UMLS CUI [1,2]
C1442792
UMLS CUI [2,1]
C1521840
UMLS CUI [2,2]
C0439228
Time you took your study medication - Target Day 3
Description

Time you took your study medication - Target Day 3

Data type

time

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0040223
UMLS CUI [2,1]
C1521840
UMLS CUI [2,2]
C0439228
Time you took your study medication - Target Day 3
Description

Time you took your study medication - Target Day 3

Data type

integer

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0040223
UMLS CUI [2,1]
C1521840
UMLS CUI [2,2]
C0439228
Diary Day 3
Description

Diary Day 3

Alias
UMLS CUI-1
C3890583
UMLS CUI-2
C0439228
Time - Diary Day 3
Description

Time - Diary Day 3

Data type

integer

Alias
UMLS CUI [1]
C0040223
UMLS CUI [2,1]
C3890583
UMLS CUI [2,2]
C0439228
State - Diary Day 3
Description

State - Diary Day 3

Data type

integer

Alias
UMLS CUI [1]
C1442792
UMLS CUI [2,1]
C3890583
UMLS CUI [2,2]
C0439228
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Similar models

Diary Card

1 forms
  1. StudyEvent: ODM
    1. Diary Card
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Item Group
Target Day 1
C3890583 (UMLS CUI-1)
C1521840 (UMLS CUI-2)
C0439228 (UMLS CUI-3)
Diary Date - Day 1
Item
Diary Date - Day 1
date
C3890583 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Time you took your study medication
Item
Time you took your study medication
time
C0013227 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Item
Time you took your study medication
integer
C0013227 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Time you took your study medication
Code List
Time you took your study medication
CL Item
am (1)
CL Item
pm (2)
Item Group
Target Day 2
C3890583 (UMLS CUI-1)
C1521840 (UMLS CUI-2)
C0439228 (UMLS CUI-3)
Diary Date - Day 2
Item
Diary Date - Day 2
date
C3890583 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Time of awakening - Target Day 2
Item
Time of awakening - Target Day 2
time
C1720052 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C1521840 (UMLS CUI [2,1])
C0439228 (UMLS CUI [2,2])
Item
Time of awakening - Target Day 2
integer
C1720052 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C1521840 (UMLS CUI [2,1])
C0439228 (UMLS CUI [2,2])
Time of awakening
Code List
Time of awakening - Target Day 2
CL Item
am (1)
CL Item
pm (2)
Item
State you woke up in, following your overnight sleep - Target Day 2
integer
C1720052 (UMLS CUI [1,1])
C1442792 (UMLS CUI [1,2])
C1521840 (UMLS CUI [2,1])
C0439228 (UMLS CUI [2,2])
State you woke up in, following your overnight sleep
Code List
State you woke up in, following your overnight sleep - Target Day 2
CL Item
OFF (1)
CL Item
ON (2)
CL Item
Troublesome dyskinesias during this ON time (3)
Time you took your study medication - Target Day 2
Item
Time you took your study medication - Target Day 2
time
C0013227 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C1521840 (UMLS CUI [2,1])
C0439228 (UMLS CUI [2,2])
Item
Time you took your study medication - Target Day 2
integer
C0013227 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C1521840 (UMLS CUI [2,1])
C0439228 (UMLS CUI [2,2])
Time you took your study medication
Code List
Time you took your study medication - Target Day 2
CL Item
am (1)
CL Item
pm (2)
Item Group
Diary Day 2
C3890583 (UMLS CUI-1)
C0439228 (UMLS CUI-2)
Item
Time - Diary Day 2
integer
C0040223 (UMLS CUI [1])
C3890583 (UMLS CUI [2,1])
C0439228 (UMLS CUI [2,2])
Time
Code List
Time - Diary Day 2
CL Item
12:00 am (1)
CL Item
12:30 am (2)
CL Item
1:00 am (3)
CL Item
1:30 am (4)
CL Item
2:00 am (5)
CL Item
2:30 am (6)
CL Item
3:00 am (7)
CL Item
3:30 am (8)
CL Item
4:00 am (9)
CL Item
4:30 am (10)
CL Item
5:00 am (11)
CL Item
5:30 am (12)
CL Item
6:00 am (13)
CL Item
6:30 am (14)
CL Item
7:00 am (15)
CL Item
7:30 am (16)
CL Item
8:00 am (17)
CL Item
8:30 am (18)
CL Item
9:00 am (19)
CL Item
9:30 am (20)
CL Item
10:00 am (21)
CL Item
10:30 am (22)
CL Item
11:00 am (23)
CL Item
11:30 am (24)
CL Item
12:00 pm (25)
CL Item
12:30 pm (26)
CL Item
1:00 pm (27)
CL Item
1:30 pm (28)
CL Item
2:00 pm (29)
CL Item
2:30 pm (30)
CL Item
3:00 pm (31)
CL Item
3:30 pm (32)
CL Item
4:00 pm (33)
CL Item
4:30 pm (34)
CL Item
5:00 pm (35)
CL Item
5:30 pm (36)
CL Item
6:00 pm (37)
CL Item
6:30 pm (38)
CL Item
7:00 pm (39)
CL Item
7:30 pm (40)
CL Item
8:00 pm (41)
CL Item
8:30 pm (42)
CL Item
9:00 pm (43)
CL Item
9:30 pm (44)
CL Item
10:00 pm (45)
CL Item
10:30 pm (46)
CL Item
11:00 pm (47)
CL Item
11:30 pm (48)
Item
State - Diary Day 2
integer
C1442792 (UMLS CUI [1])
C3890583 (UMLS CUI [2,1])
C0439228 (UMLS CUI [2,2])
State
Code List
State - Diary Day 2
CL Item
Asleep (1)
CL Item
OFF (2)
CL Item
ON (3)
CL Item
Troublesome dyskinesias during this ON time (4)
Item Group
Target Day 3
C3890583 (UMLS CUI-1)
C1521840 (UMLS CUI-2)
C0439228 (UMLS CUI-3)
Diary Date - Day 3
Item
Diary Date - Day 3
date
C3890583 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Time of awakening - Target Day 3
Item
Time of awakening - Target Day 3
time
C1720052 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C1521840 (UMLS CUI [2,1])
C0439228 (UMLS CUI [2,2])
Item
Time of awakening - Target Day 3
integer
C1720052 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C1521840 (UMLS CUI [2,1])
C0439228 (UMLS CUI [2,2])
Time of awakening - Target Day 3
Code List
Time of awakening - Target Day 3
CL Item
am (1)
CL Item
pm (2)
Item
State you woke up in, following your overnight sleep - Target Day 3
integer
C1720052 (UMLS CUI [1,1])
C1442792 (UMLS CUI [1,2])
C1521840 (UMLS CUI [2,1])
C0439228 (UMLS CUI [2,2])
State you woke up in, following your overnight sleep - Target Day 3
Code List
State you woke up in, following your overnight sleep - Target Day 3
CL Item
OFF (1)
CL Item
ON (2)
CL Item
Troublesome dyskinesias during this ON time (3)
Time you took your study medication - Target Day 3
Item
Time you took your study medication - Target Day 3
time
C0013227 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C1521840 (UMLS CUI [2,1])
C0439228 (UMLS CUI [2,2])
Item
Time you took your study medication - Target Day 3
integer
C0013227 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C1521840 (UMLS CUI [2,1])
C0439228 (UMLS CUI [2,2])
Time you took your study medication - Target Day 3
Code List
Time you took your study medication - Target Day 3
CL Item
am  (1)
CL Item
pm (2)
Item Group
Diary Day 3
C3890583 (UMLS CUI-1)
C0439228 (UMLS CUI-2)
Item
Time - Diary Day 3
integer
C0040223 (UMLS CUI [1])
C3890583 (UMLS CUI [2,1])
C0439228 (UMLS CUI [2,2])
Time - Diary Day 3
Code List
Time - Diary Day 3
CL Item
12:00 am (1)
CL Item
12:30 am (2)
CL Item
1:00 am (3)
CL Item
1:30 am (4)
CL Item
2:00 am (5)
CL Item
2:30 am (6)
CL Item
3:00 am (7)
CL Item
3:30 am (8)
CL Item
4:00 am (9)
CL Item
4:30 am (10)
CL Item
5:00 am (11)
CL Item
5:30 am (12)
CL Item
6:00 am (13)
CL Item
6:30 am (14)
CL Item
7:00 am (15)
CL Item
7:30 am (16)
CL Item
8:00 am (17)
CL Item
8:30 am (18)
CL Item
9:00 am (19)
CL Item
9:30 am (20)
CL Item
10:00 am (21)
CL Item
10:30 am (22)
CL Item
11:00 am (23)
CL Item
11:30 am (24)
CL Item
12:00 pm (25)
CL Item
12:30 pm (26)
CL Item
1:00 pm (27)
CL Item
1:30 pm (28)
CL Item
2:00 pm (29)
CL Item
2:30 pm (30)
CL Item
3:00 pm (31)
CL Item
3:30 pm (32)
CL Item
4:00 pm (33)
CL Item
4:30 pm (34)
CL Item
5:00 pm (35)
CL Item
5:30 pm (36)
CL Item
6:00 pm (37)
CL Item
6:30 pm (38)
CL Item
7:00 pm (39)
CL Item
7:30 pm (40)
CL Item
8:00 pm (41)
CL Item
8:30 pm (42)
CL Item
9:00 pm (43)
CL Item
9:30 pm (44)
CL Item
10:00 pm (45)
CL Item
10:30 pm (46)
CL Item
11:00 pm (47)
CL Item
11:30 pm (48)
Item
State - Diary Day 3
integer
C1442792 (UMLS CUI [1])
C3890583 (UMLS CUI [2,1])
C0439228 (UMLS CUI [2,2])
State - Diary Day 3
Code List
State - Diary Day 3
CL Item
Asleep (1)
CL Item
OFF (2)
CL Item
ON (3)
CL Item
Troublesome dyskinesias during this ON time (4)
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