ID

44255

Description

Study ID: 101468/205 Clinical Study ID: 101468/205 Study Title:A 12-Week, Double-Blind, Placebo Controlled, Parallel Group Study to Assess the Efficacy and Safety of Ropinirole XR (Extended Release) in Patients with Restless Legs Syndrome Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00197080 Sponsor: GlaxoSmithKline Phase: phase 3 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Modutab,ZIPEREVE,ZEPREVE,REPREVE,ADARTREL,REQUIP,Zygara; Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication: Restless Legs Syndrome

Keywords

Versions (2)
  1. 2/19/19 2/19/19 -
  2. 9/20/21 9/20/21 -
Copyright Holder

GlaxoSmithKline

Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY-NC 3.0
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Efficacy and Safety of Ropinirole XR (Extended Release) in Patients with Restless Legs Syndrome NCT00197080

English

Ambulatory Blood Pressuure Monitoring Diary; Equipment Request

1 forms  
When dispensed?
Description

When dispensed?

Alias
UMLS CUI-1
C1880359
Dispensed at the End of which Week Visit?
Description

Dispensed at the End of which Week Visit?

Data type

integer

Alias
UMLS CUI [1,1]
C1880359
UMLS CUI [1,2]
C0545082
Administrative
Description

Administrative

Alias
UMLS CUI-1
C1320722
Subject Identifier
Description

Subject Identifier

Data type

integer

Alias
UMLS CUI [1]
C2348585
Doctor’s Name:
Description

Doctor’s Name:

Data type

text

Alias
UMLS CUI [1]
C2361125
Telephone Number:
Description

Telephone Number:

Data type

integer

Alias
UMLS CUI [1]
C1515258
Study Contact:
Description

Study Contact:

Data type

text

Alias
UMLS CUI [1]
C0337611
Ambulatory Blood Pressure Monitoring Diary
Description

Ambulatory Blood Pressure Monitoring Diary

Alias
UMLS CUI-1
C0430452
Date and time of dose:
Description

Date and time of dose:

Data type

datetime

Alias
UMLS CUI [1]
C1986447
Date of Assessment:
Description

Date of Assessment:

Data type

date

Alias
UMLS CUI [1]
C2985720
Blood Pressure Measurement
Description

Blood Pressure Measurement

Alias
UMLS CUI-1
C0005823
Time of Blood Pressure Measurement
Description

Time of Blood Pressure Measurement

Data type

integer

Alias
UMLS CUI [1,1]
C0005823
UMLS CUI [1,2]
C0040223
Activity at time of Blood Pressure Measurement
Description

Check one activity level for each time point

Data type

integer

Alias
UMLS CUI [1,1]
C0005824
UMLS CUI [1,2]
C0040223
UMLS CUI [1,3]
C0026606
Equipment Request
Description

Equipment Request

Alias
UMLS CUI-1
C0014672
UMLS CUI-2
C1272683
Date of Request:
Description

Date of Request:

Data type

date

Alias
UMLS CUI [1,1]
C1272683
UMLS CUI [1,2]
C0011008
Investigator’s name:
Description

Investigator’s name:

Data type

text

Alias
UMLS CUI [1]
C2826892
Site Number:
Description

Site Number:

Data type

integer

Alias
UMLS CUI [1,1]
C2825164
UMLS CUI [1,2]
C0237753
Requestor’s name:
Description

Requestor’s name:

Data type

text

Alias
UMLS CUI [1,1]
C1272683
UMLS CUI [1,2]
C0027365
Requestor’s phone number:
Description

Requestor’s phone number:

Data type

integer

Alias
UMLS CUI [1,1]
C1272683
UMLS CUI [1,2]
C1515258
Number of ABP 90207 monitors:
Description

Number of ABP 90207 monitors:

Data type

integer

Alias
UMLS CUI [1,1]
C0237753
UMLS CUI [1,2]
C0181904
Cuff Size(s):
Description

Cuff Size(s):

Data type

integer

Alias
UMLS CUI [1]
C0489480
Time Zone at the site:
Description

Time Zone at the site:

Data type

text

Alias
UMLS CUI [1,1]
C2825194
UMLS CUI [1,2]
C2825164
Equipment needed by:
Description

Equipment needed by:

Data type

date

Alias
UMLS CUI [1,1]
C0014672
UMLS CUI [1,2]
C0686904
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Similar models

Ambulatory Blood Pressuure Monitoring Diary; Equipment Request

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
When dispensed?
C1880359 (UMLS CUI-1)
Dispensed at the End of which Week Visit?
Item
Dispensed at the End of which Week Visit?
integer
C1880359 (UMLS CUI [1,1])
C0545082 (UMLS CUI [1,2])
Item Group
Administrative
C1320722 (UMLS CUI-1)
Subject Identifier
Item
Subject Identifier
integer
C2348585 (UMLS CUI [1])
Doctor’s Name:
Item
Doctor’s Name:
text
C2361125 (UMLS CUI [1])
Telephone Number:
Item
Telephone Number:
integer
C1515258 (UMLS CUI [1])
Study Contact:
Item
Study Contact:
text
C0337611 (UMLS CUI [1])
Item Group
Ambulatory Blood Pressure Monitoring Diary
C0430452 (UMLS CUI-1)
Date and time of dose:
Item
Date and time of dose:
datetime
C1986447 (UMLS CUI [1])
Date of Assessment:
Item
Date of Assessment:
date
C2985720 (UMLS CUI [1])
Item Group
Blood Pressure Measurement
C0005823 (UMLS CUI-1)
Item
Time of Blood Pressure Measurement
integer
C0005823 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Time of Blood Pressure Measurement
Code List
Time of Blood Pressure Measurement
CL Item
Pre-dose (1)
CL Item
1 Hour Post-dose (2)
CL Item
2 Hours Post-dose (3)
CL Item
3 Hours Post-dose (4)
CL Item
4 Hours Post-dose (5)
CL Item
5 Hours Post-dose (6)
CL Item
6 Hours Post-dose (7)
CL Item
7 Hours Post-dose (8)
CL Item
8 Hours Post-dose (9)
CL Item
9 Hours Post-dose (10)
CL Item
10 Hours Post-dose (11)
Item
Activity at time of Blood Pressure Measurement
integer
C0005824 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0026606 (UMLS CUI [1,3])
Activity at time of Blood Pressure Measurement
Code List
Activity at time of Blood Pressure Measurement
CL Item
Sedentary (or not very active) (1)
CL Item
(For example, napping, reading, watching TV, listening to music, etc.) (2)
CL Item
Low (activity) (2)
CL Item
(For example, using computer, cooking, eating, etc.) (4)
CL Item
Moderate (activity) (3)
CL Item
(For example, shopping at the mall, walking at a comfortable pace, etc.) (6)
CL Item
High (activity) (4)
CL Item
(For example, running, cycling, etc.) (8)
CL Item
Device not worn (5)
Item Group
Equipment Request
C0014672 (UMLS CUI-1)
C1272683 (UMLS CUI-2)
Date of Request:
Item
Date of Request:
date
C1272683 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Investigator’s name:
Item
Investigator’s name:
text
C2826892 (UMLS CUI [1])
Site Number:
Item
Site Number:
integer
C2825164 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Requestor’s name:
Item
Requestor’s name:
text
C1272683 (UMLS CUI [1,1])
C0027365 (UMLS CUI [1,2])
Requestor’s phone number:
Item
Requestor’s phone number:
integer
C1272683 (UMLS CUI [1,1])
C1515258 (UMLS CUI [1,2])
Number of ABP 90207 monitors:
Item
Number of ABP 90207 monitors:
integer
C0237753 (UMLS CUI [1,1])
C0181904 (UMLS CUI [1,2])
Item
Cuff Size(s):
integer
C0489480 (UMLS CUI [1])
Cuff Size(s):
Code List
Cuff Size(s):
CL Item
Small (17 - 24 cm) (1)
CL Item
Medium (24 - 32cm) (2)
CL Item
Large (32 - 42 cm) (3)
CL Item
Extra Large (38 - 50 cm) (4)
Time Zone at the site:
Item
Time Zone at the site:
text
C2825194 (UMLS CUI [1,1])
C2825164 (UMLS CUI [1,2])
Equipment needed by:
Item
Equipment needed by:
date
C0014672 (UMLS CUI [1,1])
C0686904 (UMLS CUI [1,2])
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