ID

42066

Beschrijving

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

Trefwoorden

Versies (3)
  1. 09-12-19 09-12-19 -
  2. 09-01-20 09-01-20 -
  3. 15-03-21 15-03-21 - Dr. rer. medic Philipp Neuhaus
Houder van rechten

GlaxoSmithKline

Geüploaded op

15 maart 2021

DOI

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Licentie

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)

Engels

Baseline - PR/ Conmeds; Pregnancy; Sudden Onset of Sleep Questionnaire

1 Formulieren  
Administrative
Beschrijving

Administrative

Alias
UMLS CUI-1
C1320722
Study Name
Beschrijving

Study Name

Datatype

text

Alias
UMLS CUI [1]
C2348560
Subject ID
Beschrijving

Subject ID

Datatype

text

Alias
UMLS CUI [1]
C2348585
Study Site
Beschrijving

Study Site

Datatype

text

Alias
UMLS CUI [1]
C2825164
Prior/ Current Concomitant Medications
Beschrijving

Prior/ Current Concomitant Medications

Alias
UMLS CUI-1
C2347852
UMLS CUI-2
C1514463
UMLS CUI-3
C0521116
Concomitant Medication Sequence Number
Beschrijving

Concomitant Medication Sequence Number

Datatype

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C2348184
Concomitant Medication - Drug Name
Beschrijving

(Trade name preferred)

Datatype

text

Alias
UMLS CUI [1]
C2347852
UMLS CUI [2]
C2360065
Concomitant Medication - Total daily dose
Beschrijving

Concomitant Medication - Total daily dose

Datatype

float

Alias
UMLS CUI [1]
C2347852
UMLS CUI [2,1]
C2348070
UMLS CUI [2,2]
C0439810
Concomitant Medication - Unit
Beschrijving

Concomitant Medication - Unit

Datatype

text

Alias
UMLS CUI [1]
C2347852
UMLS CUI [2]
C1519795
Concomitant Medication - Indication
Beschrijving

Concomitant Medication - Indication

Datatype

text

Alias
UMLS CUI [1]
C2826696
Concomitant Medication - Start date - Complete Date Unknown
Beschrijving

Concomitant Medication - Start date - Complete Date Unknown

Datatype

integer

Alias
UMLS CUI [1,1]
C2826734
UMLS CUI [1,2]
C0439673
Concomitant Medication - Start date/ time
Beschrijving

Concomitant Medication - Start date/ time

Datatype

datetime

Alias
UMLS CUI [1]
C2826734
UMLS CUI [2,1]
C1301880
UMLS CUI [2,2]
C2347852
Concomitant Medication - Taken prior to sudy?
Beschrijving

Concomitant Medication - Taken prior to sudy?

Datatype

boolean

Alias
UMLS CUI [1]
C2826667
Concomitant Medication - Ongoing?
Beschrijving

Concomitant Medication - Ongoing?

Datatype

boolean

Alias
UMLS CUI [1]
C2826666
Concomitant Medication - End date - Complete Date unknown
Beschrijving

Concomitant Medication - End date - Complete Date unknown

Datatype

integer

Alias
UMLS CUI [1,1]
C2826744
UMLS CUI [1,2]
C0439673
Concomitant Medication - End date/ time
Beschrijving

Concomitant Medication - End date/ time

Datatype

datetime

Alias
UMLS CUI [1]
C2826744
UMLS CUI [2,1]
C2347852
UMLS CUI [2,2]
C1522314
AE/ SAE related?
Beschrijving

AE/ SAE related?

Datatype

boolean

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0869014
UMLS CUI [2,1]
C1519255
UMLS CUI [2,2]
C0869014
Prior/ current non-drug therapies
Beschrijving

Prior/ current non-drug therapies

Alias
UMLS CUI-1
C1514463
UMLS CUI-2
C0033082
UMLS CUI-3
C2827774
UMLS CUI-4
C0033082
Did the subject participate in any Non-Drug therapies prior to screening and/or during the study?
Beschrijving

Did the subject participate in any Non-Drug therapies prior to screening and/or during the study?

Datatype

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0033082
UMLS CUI [2,1]
C2827774
UMLS CUI [2,2]
C0033082
Non-drug therapies
Beschrijving

Non-drug therapies

Alias
UMLS CUI-1
C0087111
UMLS CUI-2
C0033082
Non-Drug Sequence Number
Beschrijving

Non-Drug Sequence Number

Datatype

integer

Alias
UMLS CUI [1,1]
C0033082
UMLS CUI [1,2]
C2348184
Non-Drug Therapy Name
Beschrijving

Non-Drug Therapy Name

Datatype

text

Alias
UMLS CUI [1,1]
C0033082
UMLS CUI [1,2]
C2826274
Non-Drug Indication
Beschrijving

Non-Drug Indication

Datatype

text

Alias
UMLS CUI [1,1]
C0033082
UMLS CUI [1,2]
C3146298
Non-Drug Therapy - Start Date - Complete Date unknown
Beschrijving

Non-Drug Therapy - Start Date - Complete Date unknown

Datatype

integer

Alias
UMLS CUI [1,1]
C0033082
UMLS CUI [1,2]
C3173309
UMLS CUI [2,1]
C0011008
UMLS CUI [2,2]
C0439673
Non-Drug Therapy - Start Date
Beschrijving

Non-Drug Therapy - Start Date

Datatype

date

Alias
UMLS CUI [1,1]
C0033082
UMLS CUI [1,2]
C3173309
Non-Drug Therapy - Taken prior to study?
Beschrijving

Non-Drug Therapy - Taken prior to study?

Datatype

boolean

Alias
UMLS CUI [1,1]
C0033082
UMLS CUI [1,2]
C2603343
UMLS CUI [1,3]
C0332152
Non-Drug Therapy ongoing?
Beschrijving

Non-Drug Therapy ongoing?

Datatype

boolean

Alias
UMLS CUI [1,1]
C0033082
UMLS CUI [1,2]
C0549178
Non-Drug Therapy - End Date - Complete Date unknown
Beschrijving

Non-Drug Therapy - End Date - Complete Date unknown

Datatype

integer

Alias
UMLS CUI [1,1]
C0033082
UMLS CUI [1,2]
C1531784
UMLS CUI [2,1]
C0011008
UMLS CUI [2,2]
C0439673
Non-Drug Therapy - End Date/Time
Beschrijving

Non-Drug Therapy - End Date/Time

Datatype

datetime

Alias
UMLS CUI [1,1]
C0033082
UMLS CUI [1,2]
C1531784
UMLS CUI [2,1]
C0033082
UMLS CUI [2,2]
C1522314
Non-Drug Therapy - AE/ SAE related?
Beschrijving

Non-Drug Therapy - AE/ SAE related?

Datatype

boolean

Alias
UMLS CUI [1,1]
C0033082
UMLS CUI [1,2]
C0439849
UMLS CUI [1,3]
C0877248
UMLS CUI [2,1]
C0033082
UMLS CUI [2,2]
C0439849
UMLS CUI [2,3]
C1519255
Pregnancy
Beschrijving

Pregnancy

Alias
UMLS CUI-1
C0032961
Did a female partner of a male subject become pregnant during the study?
Beschrijving

Did a female partner of a male subject become pregnant during the study?

Datatype

boolean

Alias
UMLS CUI [1]
C0919624
Did the subject become pregnant during the study?
Beschrijving

Did the subject become pregnant during the study?

Datatype

boolean

Alias
UMLS CUI [1]
C3828490
Sudden Onset of Sleep Questionnaire
Beschrijving

Sudden Onset of Sleep Questionnaire

Alias
UMLS CUI-1
C1272517
UMLS CUI-2
C0037313
UMLS CUI-3
C0034394
Date of event
Beschrijving

Date of event

Datatype

date

Alias
UMLS CUI [1,1]
C0441471
UMLS CUI [1,2]
C0011008
Time of day
Beschrijving

Time of day

Datatype

integer

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0439228
1. What were you doing at the time of this event?
Beschrijving

1. What were you doing at the time of this event?

Datatype

integer

Alias
UMLS CUI [1,1]
C2828361
UMLS CUI [1,2]
C0441471
UMLS CUI [1,3]
C0040223
If you were doing something different, specify
Beschrijving

If you were doing something different, specify

Datatype

text

Alias
UMLS CUI [1,1]
C2828361
UMLS CUI [1,2]
C0441471
UMLS CUI [1,3]
C0040223
UMLS CUI [1,4]
C0205394
UMLS CUI [1,5]
C2348235
2. Prior to this event, did you experience any sleepiness or drowsiness?
Beschrijving

2. Prior to this event, did you experience any sleepiness or drowsiness?

Datatype

boolean

Alias
UMLS CUI [1,1]
C0441471
UMLS CUI [1,2]
C0332152
UMLS CUI [2]
C2830004
UMLS CUI [3]
C0013144
2A. If yes, please explain/clarify:
Beschrijving

2A. If yes, please explain/clarify:

Datatype

text

Alias
UMLS CUI [1]
C2830004
UMLS CUI [2]
C0013144
UMLS CUI [3]
C0681841
3. What specifically happened?
Beschrijving

3. What specifically happened?

Datatype

text

Alias
UMLS CUI [1,1]
C2348235
UMLS CUI [1,2]
C0441471
4. How long did this event last?
Beschrijving

4. How long did this event last?

Datatype

integer

Alias
UMLS CUI [1,1]
C0441471
UMLS CUI [1,2]
C0449238
Event duration unit
Beschrijving

Event duration unit

Datatype

integer

Alias
UMLS CUI [1,1]
C0441471
UMLS CUI [1,2]
C0449238
UMLS CUI [1,3]
C1519795
5. Did you suffer any "bad" outcome/problem from this falling asleep event?
Beschrijving

5. Did you suffer any

Datatype

boolean

Alias
UMLS CUI [1,1]
C1624730
UMLS CUI [1,2]
C0037313
Please explain/clarify "bad" outcome/problem
Beschrijving

Please explain/clarify

Datatype

text

Alias
UMLS CUI [1,1]
C1624730
UMLS CUI [1,2]
C0681841
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Similar models

Baseline - PR/ Conmeds; Pregnancy; Sudden Onset of Sleep Questionnaire

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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
Prior/ Current Concomitant Medications
C2347852 (UMLS CUI-1)
C1514463 (UMLS CUI-2)
C0521116 (UMLS CUI-3)
Concomitant Medication Sequence Number
Item
Concomitant Medication Sequence Number
text
C2347852 (UMLS CUI [1,1])
C2348184 (UMLS CUI [1,2])
Concomitant Medication - Drug Name
Item
Concomitant Medication - Drug Name
text
C2347852 (UMLS CUI [1])
C2360065 (UMLS CUI [2])
Concomitant Medication - Total daily dose
Item
Concomitant Medication - Total daily dose
float
C2347852 (UMLS CUI [1])
C2348070 (UMLS CUI [2,1])
C0439810 (UMLS CUI [2,2])
Concomitant Medication - Unit
Item
Concomitant Medication - Unit
text
C2347852 (UMLS CUI [1])
C1519795 (UMLS CUI [2])
Concomitant Medication - Indication
Item
Concomitant Medication - Indication
text
C2826696 (UMLS CUI [1])
Item
Concomitant Medication - Start date - Complete Date Unknown
integer
C2826734 (UMLS CUI [1,1])
C0439673 (UMLS CUI [1,2])
Concomitant Medication - Start date - Complete Date Unknown
Code List
Concomitant Medication - Start date - Complete Date Unknown
CL Item
Complete Date Unknown (1)
Concomitant Medication - Start date/ time
Item
Concomitant Medication - Start date/ time
datetime
C2826734 (UMLS CUI [1])
C1301880 (UMLS CUI [2,1])
C2347852 (UMLS CUI [2,2])
Concomitant Medication - Taken prior to sudy?
Item
Concomitant Medication - Taken prior to sudy?
boolean
C2826667 (UMLS CUI [1])
Concomitant Medication - Ongoing?
Item
Concomitant Medication - Ongoing?
boolean
C2826666 (UMLS CUI [1])
Item
Concomitant Medication - End date - Complete Date unknown
integer
C2826744 (UMLS CUI [1,1])
C0439673 (UMLS CUI [1,2])
Concomitant Medication - End date - Complete Date unknown
Code List
Concomitant Medication - End date - Complete Date unknown
CL Item
Complete Date Unknown (1)
Concomitant Medication - End date/ time
Item
Concomitant Medication - End date/ time
datetime
C2826744 (UMLS CUI [1])
C2347852 (UMLS CUI [2,1])
C1522314 (UMLS CUI [2,2])
AE/ SAE related?
Item
AE/ SAE related?
boolean
C1518404 (UMLS CUI [1,1])
C0869014 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2,1])
C0869014 (UMLS CUI [2,2])
Item Group
Prior/ current non-drug therapies
C1514463 (UMLS CUI-1)
C0033082 (UMLS CUI-2)
C2827774 (UMLS CUI-3)
C0033082 (UMLS CUI-4)
Did the subject participate in any Non-Drug therapies prior to screening and/or during the study?
Item
Did the subject participate in any Non-Drug therapies prior to screening and/or during the study?
boolean
C1514463 (UMLS CUI [1,1])
C0033082 (UMLS CUI [1,2])
C2827774 (UMLS CUI [2,1])
C0033082 (UMLS CUI [2,2])
Item Group
Non-drug therapies
C0087111 (UMLS CUI-1)
C0033082 (UMLS CUI-2)
Non-Drug Sequence Number
Item
Non-Drug Sequence Number
integer
C0033082 (UMLS CUI [1,1])
C2348184 (UMLS CUI [1,2])
Non-Drug Therapy Name
Item
Non-Drug Therapy Name
text
C0033082 (UMLS CUI [1,1])
C2826274 (UMLS CUI [1,2])
Non-Drug Indication
Item
Non-Drug Indication
text
C0033082 (UMLS CUI [1,1])
C3146298 (UMLS CUI [1,2])
Item
Non-Drug Therapy - Start Date - Complete Date unknown
integer
C0033082 (UMLS CUI [1,1])
C3173309 (UMLS CUI [1,2])
C0011008 (UMLS CUI [2,1])
C0439673 (UMLS CUI [2,2])
Non-Drug Therapy - Start Date - Complete Date unknown
Code List
Non-Drug Therapy - Start Date - Complete Date unknown
CL Item
Complete Date Unknown (1)
Non-Drug Therapy - Start Date
Item
Non-Drug Therapy - Start Date
date
C0033082 (UMLS CUI [1,1])
C3173309 (UMLS CUI [1,2])
Non-Drug Therapy - Taken prior to study?
Item
Non-Drug Therapy - Taken prior to study?
boolean
C0033082 (UMLS CUI [1,1])
C2603343 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
Non-Drug Therapy ongoing?
Item
Non-Drug Therapy ongoing?
boolean
C0033082 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Item
Non-Drug Therapy - End Date - Complete Date unknown
integer
C0033082 (UMLS CUI [1,1])
C1531784 (UMLS CUI [1,2])
C0011008 (UMLS CUI [2,1])
C0439673 (UMLS CUI [2,2])
Non-Drug Therapy - Stop Date - Complete Date unknown
Code List
Non-Drug Therapy - End Date - Complete Date unknown
CL Item
Complete Date Unknown (1)
Non-Drug Therapy - End Date/Time
Item
Non-Drug Therapy - End Date/Time
datetime
C0033082 (UMLS CUI [1,1])
C1531784 (UMLS CUI [1,2])
C0033082 (UMLS CUI [2,1])
C1522314 (UMLS CUI [2,2])
Non-Drug Therapy - AE/ SAE related?
Item
Non-Drug Therapy - AE/ SAE related?
boolean
C0033082 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,3])
C0033082 (UMLS CUI [2,1])
C0439849 (UMLS CUI [2,2])
C1519255 (UMLS CUI [2,3])
Item Group
Pregnancy
C0032961 (UMLS CUI-1)
Did a female partner of a male subject become pregnant during the study?
Item
Did a female partner of a male subject become pregnant during the study?
boolean
C0919624 (UMLS CUI [1])
Did the subject become pregnant during the study?
Item
Did the subject become pregnant during the study?
boolean
C3828490 (UMLS CUI [1])
Item Group
Sudden Onset of Sleep Questionnaire
C1272517 (UMLS CUI-1)
C0037313 (UMLS CUI-2)
C0034394 (UMLS CUI-3)
Date of event
Item
Date of event
date
C0441471 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Time of day
integer
C0040223 (UMLS CUI [1,1])
C0439228 (UMLS CUI [1,2])
Time of day
Code List
Time of day
CL Item
Morning (1)
CL Item
Afternoon (2)
CL Item
Early evening (3)
CL Item
Late evening (4)
CL Item
Night (5)
Item
1. What were you doing at the time of this event?
integer
C2828361 (UMLS CUI [1,1])
C0441471 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
1. What were you doing at the time of this event?
Code List
1. What were you doing at the time of this event?
CL Item
Eating (1)
CL Item
Driving (2)
CL Item
Passenger in car (3)
CL Item
Talking (4)
CL Item
Other (5)
If you were doing something different, specify
Item
If you were doing something different, specify
text
C2828361 (UMLS CUI [1,1])
C0441471 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
C2348235 (UMLS CUI [1,5])
2. Prior to this event, did you experience any sleepiness or drowsiness?
Item
2. Prior to this event, did you experience any sleepiness or drowsiness?
boolean
C0441471 (UMLS CUI [1,1])
C0332152 (UMLS CUI [1,2])
C2830004 (UMLS CUI [2])
C0013144 (UMLS CUI [3])
2A. If yes, please explain/clarify:
Item
2A. If yes, please explain/clarify:
text
C2830004 (UMLS CUI [1])
C0013144 (UMLS CUI [2])
C0681841 (UMLS CUI [3])
3. What specifically happened?
Item
3. What specifically happened?
text
C2348235 (UMLS CUI [1,1])
C0441471 (UMLS CUI [1,2])
4. How long did this event last?
Item
4. How long did this event last?
integer
C0441471 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Item
Event duration unit
integer
C0441471 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
C1519795 (UMLS CUI [1,3])
Event duration unit
Code List
Event duration unit
CL Item
Seconds (1)
CL Item
Minutes (2)
CL Item
Hours (3)
5. Did you suffer any
Item
5. Did you suffer any "bad" outcome/problem from this falling asleep event?
boolean
C1624730 (UMLS CUI [1,1])
C0037313 (UMLS CUI [1,2])
Please explain/clarify
Item
Please explain/clarify "bad" outcome/problem
text
C1624730 (UMLS CUI [1,1])
C0681841 (UMLS CUI [1,2])
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