ID

39425

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 (10)
  1. 12/10/19 12/10/19 -
  2. 12/11/19 12/11/19 -
  3. 12/11/19 12/11/19 -
  4. 12/11/19 12/11/19 -
  5. 12/11/19 12/11/19 -
  6. 12/11/19 12/11/19 -
  7. 12/11/19 12/11/19 -
  8. 12/16/19 12/16/19 -
  9. 12/16/19 12/16/19 -
  10. 1/9/20 1/9/20 -
Copyright Holder

GlaxoSmithKline

Uploaded on

January 9, 2020

DOI

To request one please log in.

License

Creative Commons BY-NC 3.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

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

English

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

1 forms  
Administrative
Description

Administrative

Alias
UMLS CUI-1
C1320722
Study Name
Description

Study Name

Data type

text

Alias
UMLS CUI [1]
C2348560
Subject ID
Description

Subject ID

Data type

text

Alias
UMLS CUI [1]
C2348585
Study Site
Description

Study Site

Data type

text

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

Diary - Target Day 1

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

Target Day 1 - Date of Study Medication

Data type

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
Description

Target Day 1 - Time of Study Medication

Data type

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
Description

Diary - Target Day 2

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

Target Day 2 - Date

Data type

date

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

Target Day 2 - Time of awakening

Data type

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
Description

State you woke up in, following your overnight sleep

Data type

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
Description

Time you took your study medication

Data type

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
Description

Diary Day 2

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

Timepoint

Data type

integer

Alias
UMLS CUI [1]
C2348792
State
Description

State

Data type

integer

Alias
UMLS CUI [1]
C1442792
Troublesome dyskinesia
Description

Troublesome dyskinesia

Data type

integer

Alias
UMLS CUI [1]
C0013384
Target Day 3
Description

Target Day 3

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

Target Day 3 - Date

Data type

date

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

Target Day 3 - Time of awakening

Data type

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
Description

State you woke up in, following your overnight sleep

Data type

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
Description

Time you took your study medication

Data type

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
Description

Diary Day 3

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

Timepoint

Data type

integer

Alias
UMLS CUI [1]
C2348792
State
Description

State

Data type

integer

Alias
UMLS CUI [1]
C1442792
Troublesome dyskinesia
Description

Troublesome dyskinesia

Data type

integer

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

Investigational Product - Study drug returned

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

Was study drug returned?

Data type

boolean

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

Investigational Product #

Data type

text

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

Date investigational product returned

Data type

date

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

Investigational Product - Total # tablets returned

Data type

integer

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

Investigational Product - Additional bottle(s) returned?

Data type

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
Description

Additional bottle(s) returned

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

Additional bottle(s) returned - Sequence Number

Data type

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 #
Description

Additional bottle(s) returned - Investigational Product #

Data type

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
Description

Additional bottle(s) returned - Date returned

Data type

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
Description

Additional bottle(s) returned - Total # tablets returned

Data type

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
Description

Investigational Product - Study drug dispensed

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

Was study drug dispensed?

Data type

boolean

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

Investigational Product #

Data type

text

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

Date investigational product dispensed

Data type

date

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

Investigational Product - Total # tablets dispensed

Data type

integer

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

Investigational Product - Additional bottle(s) disepensed?

Data type

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
Description

Additional bottle(s) dispensed

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

Additional bottle(s) dispensed - Sequence Number

Data type

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 #
Description

Additional bottle(s) dispensed - Investigational Product #

Data type

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
Description

Additional bottle(s) dispensed - Date disepensed

Data type

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
Description

Additional bottle(s) dispensed - Total # tablets dispensed

Data type

integer

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

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?
Description

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

Data type

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
Description

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

Data type

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
Description

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

Data type

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?
Description

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

Data type

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
Description

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

Data type

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
Description

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

Data type

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:
Description

Current Investigational Product Level:

Data type

integer

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

L-Dopa Medication

Alias
UMLS CUI-1
C0023570
L-dopa dose
Description

L-dopa dose

Data type

float

Measurement units
  • mg
Alias
UMLS CUI [1,1]
C0023570
UMLS CUI [1,2]
C0178602
mg
L-dopa release
Description

L-dopa release

Data type

integer

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

Controlled release amt

Data type

float

Measurement units
  • mg
Alias
UMLS CUI [1,1]
C1707506
UMLS CUI [1,2]
C1561574
mg
Immediate release amt
Description

Immediate release amt

Data type

float

Measurement units
  • mg
Alias
UMLS CUI [1,1]
C1708470
UMLS CUI [1,2]
C1561574
mg
Was L-dopa dose reduced?
Description

Was L-dopa dose reduced?

Data type

integer

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

Date L-dopa dose reduced

Data type

date

Alias
UMLS CUI [1,1]
C0023570
UMLS CUI [1,2]
C1707814
UMLS CUI [1,3]
C0011008
Back to the top of the page

Similar models

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

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial