ID

24685

Description

Study part: Ambulatory Blood Pressure Monitoring Diary. A 52-Week, Open-Label Study to Assess the Long-Term Safety of Ropinirole Extended Release (XR) in Patients with Restless Legs Syndrome (RLS). Patient Level Data: Study Listed on ClinicalStudyDataRequest.com. Clinicaltrials.gov Identifier: NCT00355641. 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. Study ID: 101468/206. Clinical Study ID: 101468/206.

Keywords

Versions (1)
  1. 8/13/17 8/13/17 -
Copyright Holder

GlaxoSmithKline

Uploaded on

August 13, 2017

DOI

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License

Creative Commons BY-NC 3.0
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Ambulatory Blood Pressure Monitoring Diary Restless Legs Syndrom NCT00355641

English

Ambulatory Blood Pressure Monitoring Diary

1 forms  
General Information
Description

General Information

Alias
UMLS CUI-1
C1508263
Visit week
Description

Visit week

Data type

integer

Alias
UMLS CUI [1]
C0439230
Doctor’s Name:
Description

Physician 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
Subject Identifier
Description

Subject Identifier

Data type

text

Alias
UMLS CUI [1]
C2348585
AMBULATORY BLOOD PRESSURE MONITORING DIARY
Description

AMBULATORY BLOOD PRESSURE MONITORING DIARY

Alias
UMLS CUI-1
C0430452
Date of assessment:
Description

Date of assessment

Data type

date

Alias
UMLS CUI [1]
C2985720
Arm
Description

Arm

Data type

text

Alias
UMLS CUI [1]
C1140618
What time did you take your study medication:
Description

Please record time to the nearest minute.

Data type

time

Measurement units
  • min
Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C1512806
min
Activity at time of Blood Pressure Measurement- Pre-dose
Description

Blood Pressure Monitoring Ambulatory Pre-dose

Data type

integer

Alias
UMLS CUI [1,1]
C0026426
UMLS CUI [1,2]
C0439841
UMLS CUI [1,3]
C0439565
1 Hour Post-dose
Description

Blood Pressure Monitoring Ambulatory 1 hour post-dose

Data type

integer

Alias
UMLS CUI [1,1]
C0026426
UMLS CUI [1,2]
C0439841
UMLS CUI [1,3]
C0439571
2 Hours Post-dose
Description

Blood Pressure Monitoring Ambulatory 2 hour post-dose

Data type

integer

Alias
UMLS CUI [1,1]
C0026426
UMLS CUI [1,2]
C0439841
UMLS CUI [1,3]
C0439572
3 Hours Post-dose
Description

Blood Pressure Monitoring Ambulatory 3 Hours Post-dose

Data type

integer

Alias
UMLS CUI [1,1]
C0026426
UMLS CUI [1,2]
C0439841
UMLS CUI [1,3]
C0439573
4 Hours Post-dose
Description

Blood Pressure Monitoring Ambulatory 4 Hours Post-dose

Data type

integer

Alias
UMLS CUI [1,1]
C0026426
UMLS CUI [1,2]
C0439841
UMLS CUI [1,3]
C0439574
5 Hours Post-dose
Description

Blood Pressure Monitoring Ambulatory Post-dose

Data type

integer

Alias
UMLS CUI [1,1]
C0026426
UMLS CUI [1,2]
C0439841
UMLS CUI [1,3]
C0439568
6 Hours Post-dose
Description

Blood Pressure Monitoring Ambulatory Post-dose

Data type

integer

Alias
UMLS CUI [1,1]
C0026426
UMLS CUI [1,2]
C0439841
UMLS CUI [1,3]
C0439568
7 Hours Post-dose
Description

Blood Pressure Monitoring Ambulatory Post-dose

Data type

integer

Alias
UMLS CUI [1,1]
C0026426
UMLS CUI [1,2]
C0439841
UMLS CUI [1,3]
C0439568
8 Hours Post-dose
Description

Blood Pressure Monitoring Ambulatory Post-dose

Data type

integer

Alias
UMLS CUI [1,1]
C0026426
UMLS CUI [1,2]
C0439841
UMLS CUI [1,3]
C0439568
9 Hours Post-dose
Description

Blood Pressure Monitoring Ambulatory Post-dose

Data type

integer

Alias
UMLS CUI [1,1]
C0026426
UMLS CUI [1,2]
C0439841
UMLS CUI [1,3]
C0439568
10 Hours Post-dose
Description

Blood Pressure Monitoring Ambulatory Post-dose

Data type

integer

Alias
UMLS CUI [1,1]
C0026426
UMLS CUI [1,2]
C0439841
UMLS CUI [1,3]
C0439568
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Similar models

Ambulatory Blood Pressure Monitoring Diary

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
General Information
C1508263 (UMLS CUI-1)
Visit week
Item
Visit week
integer
C0439230 (UMLS CUI [1])
Physician 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])
Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Item Group
AMBULATORY BLOOD PRESSURE MONITORING DIARY
C0430452 (UMLS CUI-1)
Date of assessment
Item
Date of assessment:
date
C2985720 (UMLS CUI [1])
Arm
Item
Arm
text
C1140618 (UMLS CUI [1])
time medication intake
Item
What time did you take your study medication:
time
C0040223 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C1512806 (UMLS CUI [1,3])
Item
Activity at time of Blood Pressure Measurement- Pre-dose
integer
C0026426 (UMLS CUI [1,1])
C0439841 (UMLS CUI [1,2])
C0439565 (UMLS CUI [1,3])
Blood Pressure Measurement Pre-dose
Code List
Activity at time of Blood Pressure Measurement- Pre-dose
CL Item
Sedentary (or not very active) (For example, napping, reading, watching TV, listening to music, etc.) (1)
C0205254 (UMLS CUI-1)
(Comment:en)
CL Item
Low (activity) (For example, using computer, cooking, eating, etc.)  (2)
C0851791 (UMLS CUI-1)
(Comment:en)
CL Item
Moderate (activity) (For example, shopping at the mall, walking at a comfortable pace, etc.) (3)
C0851791 (UMLS CUI-1)
(Comment:en)
CL Item
High (activity) (For example, running, cycling, etc.) (4)
C0851792 (UMLS CUI-1)
(Comment:en)
CL Item
Device not worn (5)
(Comment:en)
Item
1 Hour Post-dose
integer
C0026426 (UMLS CUI [1,1])
C0439841 (UMLS CUI [1,2])
C0439571 (UMLS CUI [1,3])
Blood Pressure Measurement Pre-dose
Code List
1 Hour Post-dose
CL Item
Sedentary (or not very active) (For example, napping, reading, watching TV, listening to music, etc.) (1)
C0205254 (UMLS CUI-1)
(Comment:en)
CL Item
Low (activity) (For example, using computer, cooking, eating, etc.)  (2)
C0851791 (UMLS CUI-1)
(Comment:en)
CL Item
Moderate (activity) (For example, shopping at the mall, walking at a comfortable pace, etc.) (3)
C0851791 (UMLS CUI-1)
(Comment:en)
CL Item
High (activity) (For example, running, cycling, etc.) (4)
C0851792 (UMLS CUI-1)
(Comment:en)
CL Item
Device not worn (5)
(Comment:en)
Item
2 Hours Post-dose
integer
C0026426 (UMLS CUI [1,1])
C0439841 (UMLS CUI [1,2])
C0439572 (UMLS CUI [1,3])
Blood Pressure Measurement Pre-dose
Code List
2 Hours Post-dose
CL Item
Sedentary (or not very active) (For example, napping, reading, watching TV, listening to music, etc.) (1)
C0205254 (UMLS CUI-1)
(Comment:en)
CL Item
Low (activity) (For example, using computer, cooking, eating, etc.)  (2)
C0851791 (UMLS CUI-1)
(Comment:en)
CL Item
Moderate (activity) (For example, shopping at the mall, walking at a comfortable pace, etc.) (3)
C0851791 (UMLS CUI-1)
(Comment:en)
CL Item
High (activity) (For example, running, cycling, etc.) (4)
C0851792 (UMLS CUI-1)
(Comment:en)
CL Item
Device not worn (5)
(Comment:en)
Item
3 Hours Post-dose
integer
C0026426 (UMLS CUI [1,1])
C0439841 (UMLS CUI [1,2])
C0439573 (UMLS CUI [1,3])
Blood Pressure Measurement Pre-dose
Code List
3 Hours Post-dose
CL Item
Sedentary (or not very active) (For example, napping, reading, watching TV, listening to music, etc.) (1)
C0205254 (UMLS CUI-1)
(Comment:en)
CL Item
Low (activity) (For example, using computer, cooking, eating, etc.)  (2)
C0851791 (UMLS CUI-1)
(Comment:en)
CL Item
Moderate (activity) (For example, shopping at the mall, walking at a comfortable pace, etc.) (3)
C0851791 (UMLS CUI-1)
(Comment:en)
CL Item
High (activity) (For example, running, cycling, etc.) (4)
C0851792 (UMLS CUI-1)
(Comment:en)
CL Item
Device not worn (5)
(Comment:en)
Item
4 Hours Post-dose
integer
C0026426 (UMLS CUI [1,1])
C0439841 (UMLS CUI [1,2])
C0439574 (UMLS CUI [1,3])
Blood Pressure Measurement Pre-dose
Code List
4 Hours Post-dose
CL Item
Sedentary (or not very active) (For example, napping, reading, watching TV, listening to music, etc.) (1)
C0205254 (UMLS CUI-1)
(Comment:en)
CL Item
Low (activity) (For example, using computer, cooking, eating, etc.)  (2)
C0851791 (UMLS CUI-1)
(Comment:en)
CL Item
Moderate (activity) (For example, shopping at the mall, walking at a comfortable pace, etc.) (3)
C0851791 (UMLS CUI-1)
(Comment:en)
CL Item
High (activity) (For example, running, cycling, etc.) (4)
C0851792 (UMLS CUI-1)
(Comment:en)
CL Item
Device not worn (5)
(Comment:en)
Item
5 Hours Post-dose
integer
C0026426 (UMLS CUI [1,1])
C0439841 (UMLS CUI [1,2])
C0439568 (UMLS CUI [1,3])
Blood Pressure Measurement Pre-dose
Code List
5 Hours Post-dose
CL Item
Sedentary (or not very active) (For example, napping, reading, watching TV, listening to music, etc.) (1)
C0205254 (UMLS CUI-1)
(Comment:en)
CL Item
Low (activity) (For example, using computer, cooking, eating, etc.)  (2)
C0851791 (UMLS CUI-1)
(Comment:en)
CL Item
Moderate (activity) (For example, shopping at the mall, walking at a comfortable pace, etc.) (3)
C0851791 (UMLS CUI-1)
(Comment:en)
CL Item
High (activity) (For example, running, cycling, etc.) (4)
C0851792 (UMLS CUI-1)
(Comment:en)
CL Item
Device not worn (5)
(Comment:en)
Item
6 Hours Post-dose
integer
C0026426 (UMLS CUI [1,1])
C0439841 (UMLS CUI [1,2])
C0439568 (UMLS CUI [1,3])
Blood Pressure Measurement Pre-dose
Code List
6 Hours Post-dose
CL Item
Sedentary (or not very active) (For example, napping, reading, watching TV, listening to music, etc.) (1)
C0205254 (UMLS CUI-1)
(Comment:en)
CL Item
Low (activity) (For example, using computer, cooking, eating, etc.)  (2)
C0851791 (UMLS CUI-1)
(Comment:en)
CL Item
Moderate (activity) (For example, shopping at the mall, walking at a comfortable pace, etc.) (3)
C0851791 (UMLS CUI-1)
(Comment:en)
CL Item
High (activity) (For example, running, cycling, etc.) (4)
C0851792 (UMLS CUI-1)
(Comment:en)
CL Item
Device not worn (5)
(Comment:en)
Item
7 Hours Post-dose
integer
C0026426 (UMLS CUI [1,1])
C0439841 (UMLS CUI [1,2])
C0439568 (UMLS CUI [1,3])
Blood Pressure Measurement Pre-dose
Code List
7 Hours Post-dose
CL Item
Sedentary (or not very active) (For example, napping, reading, watching TV, listening to music, etc.) (1)
C0205254 (UMLS CUI-1)
(Comment:en)
CL Item
Low (activity) (For example, using computer, cooking, eating, etc.)  (2)
C0851791 (UMLS CUI-1)
(Comment:en)
CL Item
Moderate (activity) (For example, shopping at the mall, walking at a comfortable pace, etc.) (3)
C0851791 (UMLS CUI-1)
(Comment:en)
CL Item
High (activity) (For example, running, cycling, etc.) (4)
C0851792 (UMLS CUI-1)
(Comment:en)
CL Item
Device not worn (5)
(Comment:en)
Item
8 Hours Post-dose
integer
C0026426 (UMLS CUI [1,1])
C0439841 (UMLS CUI [1,2])
C0439568 (UMLS CUI [1,3])
Blood Pressure Measurement Pre-dose
Code List
8 Hours Post-dose
CL Item
Sedentary (or not very active) (For example, napping, reading, watching TV, listening to music, etc.) (1)
C0205254 (UMLS CUI-1)
(Comment:en)
CL Item
Low (activity) (For example, using computer, cooking, eating, etc.)  (2)
C0851791 (UMLS CUI-1)
(Comment:en)
CL Item
Moderate (activity) (For example, shopping at the mall, walking at a comfortable pace, etc.) (3)
C0851791 (UMLS CUI-1)
(Comment:en)
CL Item
High (activity) (For example, running, cycling, etc.) (4)
C0851792 (UMLS CUI-1)
(Comment:en)
CL Item
Device not worn (5)
(Comment:en)
Item
9 Hours Post-dose
integer
C0026426 (UMLS CUI [1,1])
C0439841 (UMLS CUI [1,2])
C0439568 (UMLS CUI [1,3])
Blood Pressure Measurement Pre-dose
Code List
9 Hours Post-dose
CL Item
Sedentary (or not very active) (For example, napping, reading, watching TV, listening to music, etc.) (1)
C0205254 (UMLS CUI-1)
(Comment:en)
CL Item
Low (activity) (For example, using computer, cooking, eating, etc.)  (2)
C0851791 (UMLS CUI-1)
(Comment:en)
CL Item
Moderate (activity) (For example, shopping at the mall, walking at a comfortable pace, etc.) (3)
C0851791 (UMLS CUI-1)
(Comment:en)
CL Item
High (activity) (For example, running, cycling, etc.) (4)
C0851792 (UMLS CUI-1)
(Comment:en)
CL Item
Device not worn (5)
(Comment:en)
Item
10 Hours Post-dose
integer
C0026426 (UMLS CUI [1,1])
C0439841 (UMLS CUI [1,2])
C0439568 (UMLS CUI [1,3])
Blood Pressure Measurement Pre-dose
Code List
10 Hours Post-dose
CL Item
Sedentary (or not very active) (For example, napping, reading, watching TV, listening to music, etc.) (1)
C0205254 (UMLS CUI-1)
(Comment:en)
CL Item
Low (activity) (For example, using computer, cooking, eating, etc.)  (2)
C0851791 (UMLS CUI-1)
(Comment:en)
CL Item
Moderate (activity) (For example, shopping at the mall, walking at a comfortable pace, etc.) (3)
C0851791 (UMLS CUI-1)
(Comment:en)
CL Item
High (activity) (For example, running, cycling, etc.) (4)
C0851792 (UMLS CUI-1)
(Comment:en)
CL Item
Device not worn (5)
(Comment:en)
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