ID

29055

Description

Ropinirole Case Report Form GSK RRL100013 GSK Study ID: 100013 Clinical Study ID: RRL100013 A 12-Week, Double-Blind, Placebo-Controlled, Twice-Daily Dosing Study to Assess the Efficacy and Safety of Ropinirole in Patients Suffering from Restless Legs Syndrome (RLS) Requiring Extended Treatment Coverage

Keywords

Versions (5)
  1. 10/5/17 10/5/17 -
  2. 2/22/18 2/22/18 -
  3. 2/22/18 2/22/18 -
  4. 2/22/18 2/22/18 -
  5. 9/17/21 9/17/21 -
Copyright Holder

gsk

Uploaded on

February 22, 2018

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 Case Report Form GSK RRL100013

English

Vital signs descirptions

9 forms  
Vital signs
Description

Vital signs

ADVERSE EVENTS
Description

Record details of any new non-serious adverse events/serious adverse events observed or reported by the subject or any changes to ongoing non-serious adverse events in the appropriate Non-Serious Adverse Events/ Serious Adverse Event section.

Data type

text

Alias
UMLS CUI [1]
C0877248
International restless legs syndrome rating scale
Description

International restless legs syndrome rating scale

Data type

text

Alias
UMLS CUI [1,1]
C0449820
UMLS CUI [1,2]
C0035258
VITAL SIGNS instructions
Description

Semi-supine measurements must be taken first, followed straight away by the standing measurements. Blood pressure and pulse rate measurements must be recorded in both the semi-supine and standing position. Semi-supine will be defined as the subject lying flat with two pillows under his/her head. Semi-supine pulse and blood measurements will be made after the subject has been resting semi-supine for a period of at least 10 minutes. A standing blood pressure and pulse measurement will be taken after the subject has been standing for a period of one minute. Any clinically significant worsening will be recorded on the Adverse Event or SAE page of the CRF. Blood pressure measurements should not be conducted within 15 minutes of a blood sample. If the blood pressure measurement is conducted after the blood sample, you should ensure that the subject has recovered from the venepuncture before the blood pressure measurement. The blood pressure cuff must be placed on the same arm throughout the study. The same study nurse/medical professional should conduct all the blood pressure/pulse measurements for each clinic visit. Ideally, the same study nurse/medical professional should conduct all the blood pressure/pulse measurements for each patient throughout the study.

Data type

text

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C1442085
Insomnia severity index
Description

Insomnia severity index

Data type

text

Alias
UMLS CUI [1]
C0917801
CENTRAL LABORATORY
Description

CENTRAL LABORATORY

Data type

text

Alias
UMLS CUI [1]
C1880016
Heart rate
Description

Heart rate

Data type

integer

Measurement units
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
Blood pressure, systolic
Description

Blood pressure

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0005823
mmHg
Blood pressure, diastolic
Description

Blood pressure

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0005823
mmHg
Body weight
Description

Body weight

Data type

float

Measurement units
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Clinical global impression
Description

Clinical global impression

Data type

integer

Measurement units
  • cm
Alias
UMLS CUI [1]
C3639708
cm
CONCOMITANT MEDICATIONS
Description

Record any changes to the subject's concomitant medications or any new medications taken since the last visit in the appropriate Concomitant Medications section.

Data type

text

Alias
UMLS CUI [1]
C2347852
Back to the top of the page

Similar models

Vital signs descirptions

9 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Vital signs
ADVERSE EVENTS
Item
ADVERSE EVENTS
text
C0877248 (UMLS CUI [1])
International restless legs syndrome rating scale
Item
International restless legs syndrome rating scale
text
C0449820 (UMLS CUI [1,1])
C0035258 (UMLS CUI [1,2])
VITAL SIGNS instructions
Item
VITAL SIGNS instructions
text
C0518766 (UMLS CUI [1,1])
C1442085 (UMLS CUI [1,2])
Insomnia severity index
Item
Insomnia severity index
text
C0917801 (UMLS CUI [1])
CENTRAL LABORATORY
Item
CENTRAL LABORATORY
text
C1880016 (UMLS CUI [1])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Blood pressure
Item
Blood pressure, systolic
integer
C0005823 (UMLS CUI [1])
Blood pressure
Item
Blood pressure, diastolic
integer
C0005823 (UMLS CUI [1])
Body weight
Item
Body weight
float
C0005910 (UMLS CUI [1])
Clinical global impression
Item
Clinical global impression
integer
C3639708 (UMLS CUI [1])
CONCOMITANT MEDICATIONS
Item
CONCOMITANT MEDICATIONS
text
C2347852 (UMLS CUI [1])
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