ID

39234

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 (10)
  1. 10.12.19 10.12.19 -
  2. 11.12.19 11.12.19 -
  3. 11.12.19 11.12.19 -
  4. 11.12.19 11.12.19 -
  5. 11.12.19 11.12.19 -
  6. 11.12.19 11.12.19 -
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  8. 16.12.19 16.12.19 -
  9. 16.12.19 16.12.19 -
  10. 09.01.20 09.01.20 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

11. Dezember 2019

DOI

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Lizenz

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

Englisch

Visit 1; Visit 2; Visit 3; Visit 4; Visit 5; Visit 6; Visit 7; Visit 8; Maintenance 1+2; Early Withdrawal; Follow up - Diary; IP Compliance

1 Formulare  
Administrative
Beschreibung

Administrative

Alias
UMLS CUI-1
C1320722
Study Name
Beschreibung

Study Name

Datentyp

text

Alias
UMLS CUI [1]
C2348560
Subject ID
Beschreibung

Subject ID

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Study Site
Beschreibung

Study Site

Datentyp

text

Alias
UMLS CUI [1]
C2825164
Diary - Target Day 1
Beschreibung

Diary - Target Day 1

Alias
UMLS CUI-1
C3890583
UMLS CUI-2
C1521840
UMLS CUI-3
C0439228
Target Day 1 - Date of Study Medication
Beschreibung

Target Day 1 - Date of Study Medication

Datentyp

date

Alias
UMLS CUI [1,1]
C1521840
UMLS CUI [1,2]
C0439228
UMLS CUI [2,1]
C0011008
UMLS CUI [2,2]
C0013227
Target Day 1 - Time of Study Medication
Beschreibung

Target Day 1 - Time of Study Medication

Datentyp

text

Alias
UMLS CUI [1,1]
C1521840
UMLS CUI [1,2]
C0439228
UMLS CUI [2,1]
C0040223
UMLS CUI [2,2]
C0013227
Diary - Target Day 2
Beschreibung

Diary - Target Day 2

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

Target Day 2 - Date

Datentyp

date

Alias
UMLS CUI [1,1]
C1521840
UMLS CUI [1,2]
C0439228
UMLS CUI [1,3]
C0011008
Target Day 2 - Time of awakening
Beschreibung

Target Day 2 - Time of awakening

Datentyp

time

Alias
UMLS CUI [1,1]
C1521840
UMLS CUI [1,2]
C0439228
UMLS CUI [1,3]
C1720052
UMLS CUI [1,4]
C0040223
Target Day 2 - State on awakening
Beschreibung

State you woke up in, following your overnight sleep

Datentyp

integer

Alias
UMLS CUI [1,1]
C1521840
UMLS CUI [1,2]
C0439228
UMLS CUI [1,3]
C1720052
UMLS CUI [1,4]
C1442792
Target Day 2 - Time of Study Medication
Beschreibung

Time you took your study medication

Datentyp

time

Alias
UMLS CUI [1,1]
C1521840
UMLS CUI [1,2]
C0439228
UMLS CUI [1,3]
C0013227
UMLS CUI [1,4]
C0040223
Diary Day 2
Beschreibung

Diary Day 2

Alias
UMLS CUI-1
C3890583
UMLS CUI-2
C0439228
Timepoint
Beschreibung

Timepoint

Datentyp

integer

Alias
UMLS CUI [1]
C2348792
State
Beschreibung

State

Datentyp

integer

Alias
UMLS CUI [1]
C1442792
Troublesome dyskinesia
Beschreibung

Troublesome dyskinesia

Datentyp

integer

Alias
UMLS CUI [1]
C0013384
Target Day 3
Beschreibung

Target Day 3

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

Target Day 3 - Date

Datentyp

date

Alias
UMLS CUI [1,1]
C1521840
UMLS CUI [1,2]
C0439228
UMLS CUI [1,3]
C0011008
Target Day 3 - Time of awakening
Beschreibung

Target Day 3 - Time of awakening

Datentyp

time

Alias
UMLS CUI [1,1]
C1521840
UMLS CUI [1,2]
C0439228
UMLS CUI [1,3]
C1720052
UMLS CUI [1,4]
C0040223
Target Day 3 - State on awakening
Beschreibung

State you woke up in, following your overnight sleep

Datentyp

integer

Alias
UMLS CUI [1,1]
C1521840
UMLS CUI [1,2]
C0439228
UMLS CUI [1,3]
C1720052
UMLS CUI [1,4]
C1442792
Target Day 3 - Time of Study Medication
Beschreibung

Time you took your study medication

Datentyp

time

Alias
UMLS CUI [1,1]
C1521840
UMLS CUI [1,2]
C0439228
UMLS CUI [1,3]
C0013227
UMLS CUI [1,4]
C0040223
Diary Day 3
Beschreibung

Diary Day 3

Alias
UMLS CUI-1
C3890583
UMLS CUI-2
C0439228
Timepoint
Beschreibung

Timepoint

Datentyp

integer

Alias
UMLS CUI [1]
C2348792
State
Beschreibung

State

Datentyp

integer

Alias
UMLS CUI [1]
C1442792
Troublesome dyskinesia
Beschreibung

Troublesome dyskinesia

Datentyp

integer

Alias
UMLS CUI [1]
C0013384
Investigational Product - Study drug returned
Beschreibung

Investigational Product - Study drug returned

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0332156
Was study drug returned?
Beschreibung

Was study drug returned?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0332156
Investigational Product #
Beschreibung

Investigational Product #

Datentyp

text

Alias
UMLS CUI [1]
C0304229
Date investigational product returned
Beschreibung

Date investigational product returned

Datentyp

date

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0332156
UMLS CUI [1,3]
C0011008
Investigational Product - Total # tablets returned
Beschreibung

Investigational Product - Total # tablets returned

Datentyp

integer

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C2699071
Investigational Product - Additional bottle(s) returned?
Beschreibung

Investigational Product - Additional bottle(s) returned?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0332156
UMLS CUI [1,3]
C0179376
UMLS CUI [1,4]
C1524062
Additional bottle(s) returned
Beschreibung

Additional bottle(s) returned

Alias
UMLS CUI-1
C0332156
UMLS CUI-2
C0179376
UMLS CUI-3
C1524062
Additional bottle(s) returned - Sequence Number
Beschreibung

Additional bottle(s) returned - Sequence Number

Datentyp

integer

Alias
UMLS CUI [1,1]
C0332156
UMLS CUI [1,2]
C0179376
UMLS CUI [1,3]
C1524062
UMLS CUI [2]
C2348184
Additional bottle(s) returned - Investigational Product #
Beschreibung

Additional bottle(s) returned - Investigational Product #

Datentyp

integer

Alias
UMLS CUI [1,1]
C0332156
UMLS CUI [1,2]
C0179376
UMLS CUI [1,3]
C1524062
UMLS CUI [2,1]
C0304229
UMLS CUI [2,2]
C0237753
Additional bottle(s) returned - Date returned
Beschreibung

Additional bottle(s) returned - Date returned

Datentyp

date

Alias
UMLS CUI [1,1]
C0332156
UMLS CUI [1,2]
C0179376
UMLS CUI [1,3]
C1524062
UMLS CUI [2,1]
C0947323
UMLS CUI [2,2]
C0011008
Additional bottle(s) returned - Total # tablets returned
Beschreibung

Additional bottle(s) returned - Total # tablets returned

Datentyp

integer

Alias
UMLS CUI [1,1]
C0332156
UMLS CUI [1,2]
C0179376
UMLS CUI [1,3]
C1524062
UMLS CUI [2]
C2699071
Investigational Product - Study drug dispensed
Beschreibung

Investigational Product - Study drug dispensed

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0947323
Was study drug dispensed?
Beschreibung

Was study drug dispensed?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0947323
Investigational Product #
Beschreibung

Investigational Product #

Datentyp

text

Alias
UMLS CUI [1]
C0304229
Date investigational product dispensed
Beschreibung

Date investigational product dispensed

Datentyp

date

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0947323
UMLS CUI [1,3]
C0011008
Investigational Product - Total # tablets dispensed
Beschreibung

Investigational Product - Total # tablets dispensed

Datentyp

integer

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0805077
Investigational Product - Additional bottle(s) disepensed?
Beschreibung

Investigational Product - Additional bottle(s) disepensed?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0947323
UMLS CUI [1,3]
C0179376
UMLS CUI [1,4]
C1524062
Additional bottle(s) dispensed
Beschreibung

Additional bottle(s) dispensed

Alias
UMLS CUI-1
C0947323
UMLS CUI-2
C0179376
UMLS CUI-3
C1524062
Additional bottle(s) dispensed - Sequence Number
Beschreibung

Additional bottle(s) dispensed - Sequence Number

Datentyp

integer

Alias
UMLS CUI [1,1]
C0947323
UMLS CUI [1,2]
C0179376
UMLS CUI [1,3]
C1524062
UMLS CUI [2]
C2348184
Additional bottle(s) dispensed - Investigational Product #
Beschreibung

Additional bottle(s) dispensed - Investigational Product #

Datentyp

integer

Alias
UMLS CUI [1,1]
C0947323
UMLS CUI [1,2]
C0179376
UMLS CUI [1,3]
C1524062
UMLS CUI [2,1]
C0304229
UMLS CUI [2,2]
C0237753
Additional bottle(s) dispensed - Date disepensed
Beschreibung

Additional bottle(s) dispensed - Date disepensed

Datentyp

date

Alias
UMLS CUI [1,1]
C0947323
UMLS CUI [1,2]
C0179376
UMLS CUI [1,3]
C1524062
UMLS CUI [2,1]
C0947323
UMLS CUI [2,2]
C0011008
Additional bottle(s) dispensed - Total # tablets dispensed
Beschreibung

Additional bottle(s) dispensed - Total # tablets dispensed

Datentyp

integer

Alias
UMLS CUI [1,1]
C0947323
UMLS CUI [1,2]
C0179376
UMLS CUI [1,3]
C1524062
UMLS CUI [2]
C0805077
Study Drug Compliance
Beschreibung

Study Drug Compliance

Alias
UMLS CUI-1
C1321605
UMLS CUI-2
C0304229
Did the subject take between 80% - 120% of their allocated tablets since the last visit?
Beschreibung

Did the subject take between 80% - 120% of their allocated tablets since the last visit?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0039225
UMLS CUI [1,2]
C1706778
UMLS CUI [1,3]
C1512806
UMLS CUI [2,1]
C0545082
UMLS CUI [2,2]
C1517741
UMLS CUI [2,3]
C1711239
If the subject did not take between 80% - 120% of their allocated tablets since the last visit, record reason
Beschreibung

If the subject did not take between 80% - 120% of their allocated tablets since the last visit, record reason

Datentyp

integer

Alias
UMLS CUI [1,1]
C0039225
UMLS CUI [1,2]
C1706778
UMLS CUI [1,3]
C1512806
UMLS CUI [2,1]
C0545082
UMLS CUI [2,2]
C1517741
UMLS CUI [2,3]
C1711239
UMLS CUI [3]
C0392360
If other reason for subject did not take between 80% - 120% of their allocated tablets since the last visit, specify
Beschreibung

If other reason for subject did not take between 80% - 120% of their allocated tablets since the last visit, specify

Datentyp

text

Alias
UMLS CUI [1,1]
C0039225
UMLS CUI [1,2]
C1706778
UMLS CUI [1,3]
C1512806
UMLS CUI [2,1]
C0545082
UMLS CUI [2,2]
C1517741
UMLS CUI [2,3]
C1711239
UMLS CUI [3,1]
C3840932
UMLS CUI [3,2]
C2348235
Did the subject miss more than 3 consecutive days of medication since the last visit?
Beschreibung

If the subject is non-compliant for any reason other than poor tolerability, the subject must be withdrawn

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0304229
If the subject did miss more than 3 consecutive days of medication since the last visit, record reason
Beschreibung

If the subject did miss more than 3 consecutive days of medication since the last visit, record reason

Datentyp

integer

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0304229
UMLS CUI [2]
C0392360
If other reason for subject missing more than 3 consecutive days of medication since the last visit, specify
Beschreibung

If other reason for subject missing more than 3 consecutive days of medication since the last visit, specify

Datentyp

text

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0304229
UMLS CUI [2,1]
C3840932
UMLS CUI [2,2]
C2348235
Current Investigational Product Level:
Beschreibung

Current Investigational Product Level:

Datentyp

integer

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0441889
UMLS CUI [1,3]
C0521116
L-Dopa Medication
Beschreibung

L-Dopa Medication

Alias
UMLS CUI-1
C0023570
L-dopa dose
Beschreibung

L-dopa dose

Datentyp

float

Maßeinheiten
  • mg
Alias
UMLS CUI [1,1]
C0023570
UMLS CUI [1,2]
C0178602
mg
L-dopa release
Beschreibung

L-dopa release

Datentyp

integer

Alias
UMLS CUI [1,1]
C0023570
UMLS CUI [1,2]
C0391871
Controlled release amt
Beschreibung

Controlled release amt

Datentyp

float

Maßeinheiten
  • mg
Alias
UMLS CUI [1,1]
C1707506
UMLS CUI [1,2]
C1561574
mg
Immediate release amt
Beschreibung

Immediate release amt

Datentyp

float

Maßeinheiten
  • mg
Alias
UMLS CUI [1,1]
C1708470
UMLS CUI [1,2]
C1561574
mg
Was L-dopa dose reduced?
Beschreibung

Was L-dopa dose reduced?

Datentyp

integer

Alias
UMLS CUI [1,1]
C0023570
UMLS CUI [1,2]
C1707814
Date L-dopa dose reduced
Beschreibung

Date L-dopa dose reduced

Datentyp

date

Alias
UMLS CUI [1,1]
C0023570
UMLS CUI [1,2]
C1707814
UMLS CUI [1,3]
C0011008
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Ähnliche Modelle

Visit 1; Visit 2; Visit 3; Visit 4; Visit 5; Visit 6; Visit 7; Visit 8; Maintenance 1+2; Early Withdrawal; Follow up - Diary; IP Compliance

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Study Name
Item
Study Name
text
C2348560 (UMLS CUI [1])
Subject ID
Item
Subject ID
text
C2348585 (UMLS CUI [1])
Study Site
Item
Study Site
text
C2825164 (UMLS CUI [1])
Item Group
Diary - Target Day 1
C3890583 (UMLS CUI-1)
C1521840 (UMLS CUI-2)
C0439228 (UMLS CUI-3)
Target Day 1 - Date of Study Medication
Item
Target Day 1 - Date of Study Medication
date
C1521840 (UMLS CUI [1,1])
C0439228 (UMLS CUI [1,2])
C0011008 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
Target Day 1 - Time of Study Medication
Item
Target Day 1 - Time of Study Medication
text
C1521840 (UMLS CUI [1,1])
C0439228 (UMLS CUI [1,2])
C0040223 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
Item Group
Diary - Target Day 2
C3890583 (UMLS CUI-1)
C1521840 (UMLS CUI-2)
C0439228 (UMLS CUI-3)
Target Day 2 - Date
Item
Target Day 2 - Date
date
C1521840 (UMLS CUI [1,1])
C0439228 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Target Day 2 - Time of awakening
Item
Target Day 2 - Time of awakening
time
C1521840 (UMLS CUI [1,1])
C0439228 (UMLS CUI [1,2])
C1720052 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Item
Target Day 2 - State on awakening
integer
C1521840 (UMLS CUI [1,1])
C0439228 (UMLS CUI [1,2])
C1720052 (UMLS CUI [1,3])
C1442792 (UMLS CUI [1,4])
Target Day 2 - State on awakening
Code List
Target Day 2 - State on awakening
CL Item
OFF (1)
CL Item
ON (2)
CL Item
Troublesome dyskinesias during this ON time (3)
Target Day 2 - Time of Study Medication
Item
Target Day 2 - Time of Study Medication
time
C1521840 (UMLS CUI [1,1])
C0439228 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Item Group
Diary Day 2
C3890583 (UMLS CUI-1)
C0439228 (UMLS CUI-2)
Item
Timepoint
integer
C2348792 (UMLS CUI [1])
Timepoint
Code List
Timepoint
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)
Item
State
integer
C1442792 (UMLS CUI [1])
State
Code List
State
CL Item
Asleep  (1)
CL Item
OFF  (2)
CL Item
ON (3)
Item
Troublesome dyskinesia
integer
C0013384 (UMLS CUI [1])
Troublesome dyskinesia
Code List
Troublesome dyskinesia
CL Item
Troublesome dyskinesia (1)
Item Group
Target Day 3
C1521840 (UMLS CUI-1)
C0439228 (UMLS CUI-2)
Target Day 3 - Date
Item
Target Day 3 - Date
date
C1521840 (UMLS CUI [1,1])
C0439228 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Target Day 3 - Time of awakening
Item
Target Day 3 - Time of awakening
time
C1521840 (UMLS CUI [1,1])
C0439228 (UMLS CUI [1,2])
C1720052 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Item
Target Day 3 - State on awakening
integer
C1521840 (UMLS CUI [1,1])
C0439228 (UMLS CUI [1,2])
C1720052 (UMLS CUI [1,3])
C1442792 (UMLS CUI [1,4])
Target Day 3 - State on awakening
Code List
Target Day 3 - State on awakening
CL Item
OFF  (1)
CL Item
ON  (2)
CL Item
Troublesome dyskinesias during this ON time (3)
Target Day 3 - Time of Study Medication
Item
Target Day 3 - Time of Study Medication
time
C1521840 (UMLS CUI [1,1])
C0439228 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Item Group
Diary Day 3
C3890583 (UMLS CUI-1)
C0439228 (UMLS CUI-2)
Item
Timepoint
integer
C2348792 (UMLS CUI [1])
Timepoint
Code List
Timepoint
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)
Item
State
integer
C1442792 (UMLS CUI [1])
State
Code List
State
CL Item
Asleep  (1)
CL Item
OFF  (2)
CL Item
ON (3)
Item
Troublesome dyskinesia
integer
C0013384 (UMLS CUI [1])
Troublesome dyskinesia
Code List
Troublesome dyskinesia
CL Item
Troublesome dyskinesia (1)
Item Group
Investigational Product - Study drug returned
C0304229 (UMLS CUI-1)
C0332156 (UMLS CUI-2)
Was study drug returned?
Item
Was study drug returned?
boolean
C0304229 (UMLS CUI [1,1])
C0332156 (UMLS CUI [1,2])
Investigational Product #
Item
Investigational Product #
text
C0304229 (UMLS CUI [1])
Date investigational product returned
Item
Date investigational product returned
date
C0304229 (UMLS CUI [1,1])
C0332156 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Investigational Product - Total # tablets returned
Item
Investigational Product - Total # tablets returned
integer
C0304229 (UMLS CUI [1,1])
C2699071 (UMLS CUI [1,2])
Investigational Product - Additional bottle(s) returned?
Item
Investigational Product - Additional bottle(s) returned?
boolean
C0304229 (UMLS CUI [1,1])
C0332156 (UMLS CUI [1,2])
C0179376 (UMLS CUI [1,3])
C1524062 (UMLS CUI [1,4])
Item Group
Additional bottle(s) returned
C0332156 (UMLS CUI-1)
C0179376 (UMLS CUI-2)
C1524062 (UMLS CUI-3)
Additional bottle(s) returned - Sequence Number
Item
Additional bottle(s) returned - Sequence Number
integer
C0332156 (UMLS CUI [1,1])
C0179376 (UMLS CUI [1,2])
C1524062 (UMLS CUI [1,3])
C2348184 (UMLS CUI [2])
Additional bottle(s) returned - Investigational Product #
Item
Additional bottle(s) returned - Investigational Product #
integer
C0332156 (UMLS CUI [1,1])
C0179376 (UMLS CUI [1,2])
C1524062 (UMLS CUI [1,3])
C0304229 (UMLS CUI [2,1])
C0237753 (UMLS CUI [2,2])
Additional bottle(s) returned - Date returned
Item
Additional bottle(s) returned - Date returned
date
C0332156 (UMLS CUI [1,1])
C0179376 (UMLS CUI [1,2])
C1524062 (UMLS CUI [1,3])
C0947323 (UMLS CUI [2,1])
C0011008 (UMLS CUI [2,2])
Additional bottle(s) returned - Total # tablets returned
Item
Additional bottle(s) returned - Total # tablets returned
integer
C0332156 (UMLS CUI [1,1])
C0179376 (UMLS CUI [1,2])
C1524062 (UMLS CUI [1,3])
C2699071 (UMLS CUI [2])
Item Group
Investigational Product - Study drug dispensed
C0304229 (UMLS CUI-1)
C0947323 (UMLS CUI-2)
Was study drug dispensed?
Item
Was study drug dispensed?
boolean
C0304229 (UMLS CUI [1,1])
C0947323 (UMLS CUI [1,2])
Investigational Product #
Item
Investigational Product #
text
C0304229 (UMLS CUI [1])
Date investigational product dispensed
Item
Date investigational product dispensed
date
C0304229 (UMLS CUI [1,1])
C0947323 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Investigational Product - Total # tablets dispensed
Item
Investigational Product - Total # tablets dispensed
integer
C0304229 (UMLS CUI [1,1])
C0805077 (UMLS CUI [1,2])
Investigational Product - Additional bottle(s) disepensed?
Item
Investigational Product - Additional bottle(s) disepensed?
boolean
C0304229 (UMLS CUI [1,1])
C0947323 (UMLS CUI [1,2])
C0179376 (UMLS CUI [1,3])
C1524062 (UMLS CUI [1,4])
Item Group
Additional bottle(s) dispensed
C0947323 (UMLS CUI-1)
C0179376 (UMLS CUI-2)
C1524062 (UMLS CUI-3)
Additional bottle(s) dispensed - Sequence Number
Item
Additional bottle(s) dispensed - Sequence Number
integer
C0947323 (UMLS CUI [1,1])
C0179376 (UMLS CUI [1,2])
C1524062 (UMLS CUI [1,3])
C2348184 (UMLS CUI [2])
Additional bottle(s) dispensed - Investigational Product #
Item
Additional bottle(s) dispensed - Investigational Product #
integer
C0947323 (UMLS CUI [1,1])
C0179376 (UMLS CUI [1,2])
C1524062 (UMLS CUI [1,3])
C0304229 (UMLS CUI [2,1])
C0237753 (UMLS CUI [2,2])
Additional bottle(s) dispensed - Date disepensed
Item
Additional bottle(s) dispensed - Date disepensed
date
C0947323 (UMLS CUI [1,1])
C0179376 (UMLS CUI [1,2])
C1524062 (UMLS CUI [1,3])
C0947323 (UMLS CUI [2,1])
C0011008 (UMLS CUI [2,2])
Additional bottle(s) dispensed - Total # tablets dispensed
Item
Additional bottle(s) dispensed - Total # tablets dispensed
integer
C0947323 (UMLS CUI [1,1])
C0179376 (UMLS CUI [1,2])
C1524062 (UMLS CUI [1,3])
C0805077 (UMLS CUI [2])
Item Group
Study Drug Compliance
C1321605 (UMLS CUI-1)
C0304229 (UMLS CUI-2)
Did the subject take between 80% - 120% of their allocated tablets since the last visit?
Item
Did the subject take between 80% - 120% of their allocated tablets since the last visit?
boolean
C0039225 (UMLS CUI [1,1])
C1706778 (UMLS CUI [1,2])
C1512806 (UMLS CUI [1,3])
C0545082 (UMLS CUI [2,1])
C1517741 (UMLS CUI [2,2])
C1711239 (UMLS CUI [2,3])
Item
If the subject did not take between 80% - 120% of their allocated tablets since the last visit, record reason
integer
C0039225 (UMLS CUI [1,1])
C1706778 (UMLS CUI [1,2])
C1512806 (UMLS CUI [1,3])
C0545082 (UMLS CUI [2,1])
C1517741 (UMLS CUI [2,2])
C1711239 (UMLS CUI [2,3])
C0392360 (UMLS CUI [3])
If the subject did not take between 80% - 120% of their allocated tablets since the last visit, record reason
Code List
If the subject did not take between 80% - 120% of their allocated tablets since the last visit, record reason
CL Item
Poor tolerability (1)
CL Item
Other (2)
If other reason for subject did not take between 80% - 120% of their allocated tablets since the last visit, specify
Item
If other reason for subject did not take between 80% - 120% of their allocated tablets since the last visit, specify
text
C0039225 (UMLS CUI [1,1])
C1706778 (UMLS CUI [1,2])
C1512806 (UMLS CUI [1,3])
C0545082 (UMLS CUI [2,1])
C1517741 (UMLS CUI [2,2])
C1711239 (UMLS CUI [2,3])
C3840932 (UMLS CUI [3,1])
C2348235 (UMLS CUI [3,2])
Did the subject miss more than 3 consecutive days of medication since the last visit?
Item
Did the subject miss more than 3 consecutive days of medication since the last visit?
boolean
C1321605 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Item
If the subject did miss more than 3 consecutive days of medication since the last visit, record reason
integer
C1321605 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0392360 (UMLS CUI [2])
If the subject did miss more than 3 consecutive days of medication since the last visit, record reason
Code List
If the subject did miss more than 3 consecutive days of medication since the last visit, record reason
CL Item
Poor tolerability (1)
CL Item
Other (2)
If other reason for subject missing more than 3 consecutive days of medication since the last visit, specify
Item
If other reason for subject missing more than 3 consecutive days of medication since the last visit, specify
text
C1321605 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C3840932 (UMLS CUI [2,1])
C2348235 (UMLS CUI [2,2])
Item
Current Investigational Product Level:
integer
C0304229 (UMLS CUI [1,1])
C0441889 (UMLS CUI [1,2])
C0521116 (UMLS CUI [1,3])
Current Investigational Product Level:
Code List
Current Investigational Product Level:
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
CL Item
5 (5)
CL Item
6 (6)
CL Item
7 (7)
CL Item
8 (8)
Item Group
L-Dopa Medication
C0023570 (UMLS CUI-1)
L-dopa dose
Item
L-dopa dose
float
C0023570 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
Item
L-dopa release
integer
C0023570 (UMLS CUI [1,1])
C0391871 (UMLS CUI [1,2])
L-dopa release
Code List
L-dopa release
CL Item
Controlled-release (prolonged release)  (1)
CL Item
Immediate-release (conventional release)  (2)
CL Item
Both (3)
Controlled release amt
Item
Controlled release amt
float
C1707506 (UMLS CUI [1,1])
C1561574 (UMLS CUI [1,2])
Immediate release amt
Item
Immediate release amt
float
C1708470 (UMLS CUI [1,1])
C1561574 (UMLS CUI [1,2])
Item
Was L-dopa dose reduced?
integer
C0023570 (UMLS CUI [1,1])
C1707814 (UMLS CUI [1,2])
Was L-dopa dose reduced?
Code List
Was L-dopa dose reduced?
CL Item
Yes  (1)
CL Item
No  (2)
CL Item
half tablet  (3)
CL Item
whole tablet (4)
Date L-dopa dose reduced
Item
Date L-dopa dose reduced
date
C0023570 (UMLS CUI [1,1])
C1707814 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
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