ID

26066

Description

Inclusion Ropinirole Case Report Form Concomitant Medication Ropinirole Case Report Form 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 (1)
  1. 10/5/17 10/5/17 -
Copyright Holder

gsk

Uploaded on

October 5, 2017

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License

Creative Commons BY-NC 3.0
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Inclusion Ropinirole Case Report Form GSK RRL10001

English

Inclusion Ropinirole Case Report Form GSK RRL10001

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
1. Is the subject a healthy, male or female subject between 18 and 50 years of age (both inclusive)?
Description

Healthy adult

Data type

boolean

Alias
UMLS CUI [1]
C0686750
2. Is the subject's body mass index of 19 to 29 kg/m^2, with a body weight ≥50 kg?
Description

BMI and weight

Data type

boolean

Alias
UMLS CUI [1]
C1305855
UMLS CUI [2]
C0005910
3. Is the subject healthy as judged by responsible physician and no abnormality identified on the clinical examination?
Description

A subject with a clinical abnormality may be included only if the Principal Investigator, in agreement with the Sponsor, considers that the abnormality will not introduce additional risk factors and will not interfere with the study procedures.

Data type

boolean

Alias
UMLS CUI [1]
C0855737
4. Is the subject healthy as judged by resposible physician and no abnormality revealed by the clinical laboratory parameters examination at the pre-study medical examination?
Description

Subjects with laboratory values outside the reference range for this age group will only be included if the Principal Investigator, in agreement with the Sponsor, considers that such findings will not introduce additional risk factors.

Data type

boolean

Alias
UMLS CUI [1]
C0438214
5. Is the 12-lead ECG at the pre-study screening normal?
Description

Normal 12-lead ECG

Data type

boolean

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0459422
6. Does the subject have normal systolic (100-140 mmHg) and diastolic (<90 mmHg) blood pressure (semi-supine) at prestudy screening?
Description

Normal systolic and diastolic blood pressure

Data type

boolean

Alias
UMLS CUI [1]
C0277882
UMLS CUI [2]
C0277887
7. Does the subject give a written informed consent prior to admission to the study?
Description

Written informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
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Similar models

Inclusion Ropinirole Case Report Form GSK RRL10001

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
Healthy adult
Item
1. Is the subject a healthy, male or female subject between 18 and 50 years of age (both inclusive)?
boolean
C0686750 (UMLS CUI [1])
BMI and weight
Item
2. Is the subject's body mass index of 19 to 29 kg/m^2, with a body weight ≥50 kg?
boolean
C1305855 (UMLS CUI [1])
C0005910 (UMLS CUI [2])
Physical examination normal
Item
3. Is the subject healthy as judged by responsible physician and no abnormality identified on the clinical examination?
boolean
C0855737 (UMLS CUI [1])
Normal laboratory parameters
Item
4. Is the subject healthy as judged by resposible physician and no abnormality revealed by the clinical laboratory parameters examination at the pre-study medical examination?
boolean
C0438214 (UMLS CUI [1])
Normal 12-lead ECG
Item
5. Is the 12-lead ECG at the pre-study screening normal?
boolean
C0430456 (UMLS CUI [1,1])
C0459422 (UMLS CUI [1,2])
Normal systolic and diastolic blood pressure
Item
6. Does the subject have normal systolic (100-140 mmHg) and diastolic (<90 mmHg) blood pressure (semi-supine) at prestudy screening?
boolean
C0277882 (UMLS CUI [1])
C0277887 (UMLS CUI [2])
Written informed consent
Item
7. Does the subject give a written informed consent prior to admission to the study?
boolean
C0021430 (UMLS CUI [1])
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