ID

39435

Beschreibung

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

Stichworte

Versionen (2)
  1. 08.01.20 08.01.20 -
  2. 09.01.20 09.01.20 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

9. Januar 2020

DOI

Für eine Beantragung loggen Sie sich ein.

Lizenz

Creative Commons BY-NC 3.0
Modell Kommentare :

Hier können Sie das Modell kommentieren. Über die Sprechblasen an den Itemgruppen und Items können Sie diese spezifisch kommentieren.

Zurück zu Modell Kommentaren
Itemgroup Kommentare für :

Item Kommentare für :

Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.

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

Englisch

Diary Card

1 Formulare  
  1. StudyEvent: ODM
    1. Diary Card
Administrative
Beschreibung

Administrative

Alias
UMLS CUI-1
C1320722
Subject Identifier
Beschreibung

Subject Identifier

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Target Day 1
Beschreibung

Target Day 1

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

Diary Date - Day 1

Datentyp

date

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

Time you took your study medication

Datentyp

time

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

Time you took your study medication

Datentyp

integer

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

Target Day 2

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

Diary Date - Day 2

Datentyp

date

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

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

Datentyp

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
Beschreibung

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 +

Datentyp

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
Beschreibung

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

Datentyp

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
Beschreibung

Time you took your study medication - Target Day 2

Datentyp

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
Beschreibung

Time you took your study medication - Target Day 2

Datentyp

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
Beschreibung

Diary Day 2

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

Time - Diary Day 2

Datentyp

integer

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

State - Diary Day 2

Datentyp

integer

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

Target Day 3

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

Diary Date - Day 3

Datentyp

date

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

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

Datentyp

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
Beschreibung

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 +

Datentyp

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
Beschreibung

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

Datentyp

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
Beschreibung

Time you took your study medication - Target Day 3

Datentyp

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
Beschreibung

Time you took your study medication - Target Day 3

Datentyp

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
Beschreibung

Diary Day 3

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

Time - Diary Day 3

Datentyp

integer

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

State - Diary Day 3

Datentyp

integer

Alias
UMLS CUI [1]
C1442792
UMLS CUI [2,1]
C3890583
UMLS CUI [2,2]
C0439228
Zum Seitenanfang zurückkehren

Ähnliche Modelle

Diary Card

1 Formulare
  1. StudyEvent: ODM
    1. Diary Card
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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)
Zum Seitenanfang zurückkehren 

Kontakt

Benutzen Sie dieses Formular für Rückmeldungen, Fragen und Verbesserungsvorschläge.

Mit * gekennzeichnete Felder sind notwendig.

Hilfe

Benötigen Sie Hilfe bei der Suche? Um mehr Details zu erfahren und die Suche effektiver nutzen zu können schauen Sie sich doch das entsprechende Video auf unserer Tutorial Seite an.

Zum Video