ID

25946

Description

MEDICAL CONDITIONS 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. 9/30/17 9/30/17 -
Copyright Holder

gsk

Uploaded on

September 30, 2017

DOI

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License

Creative Commons BY-NC 3.0
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MEDICAL CONDITIONS Ropinirole Case Report Form GSK RRL100013

German English

MEDICAL CONDITIONS Ropinirole Case Report Form GSK

1 forms  
DEMOGRAPHY
Description

DEMOGRAPHY

Date of birth
Description

Date of birth

Data type

date

Alias
UMLS CUI [1]
C0421451
Gender
Description

Gender

Data type

integer

Alias
UMLS CUI [1]
C0079399
Ethnicity
Description

Ethnicity

Data type

integer

Alias
UMLS CUI [1]
C0015031
Race
Description

Race

Data type

integer

Alias
UMLS CUI [1]
C0034510
VITAL SIGNS
Description

VITAL SIGNS

Height
Description

Height

Data type

integer

Measurement units
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Weight
Description

Weight

Data type

integer

Measurement units
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Blood pressure Semi-Supine
Description

Blood pressure Semi-Supine

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1,1]
C0005823
UMLS CUI [1,2]
C0038846
Blood pressure Standing position
Description

Blood pressure Standing position

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1,1]
C0005823
UMLS CUI [1,2]
C0231472
Heart rate standing position
Description

Heart rate standing position

Data type

integer

Measurement units
  • beats/minute
Alias
UMLS CUI [1,1]
C0018810
UMLS CUI [1,2]
C0231472
beats/minute
Heart rate Semi-Supine
Description

Heart rate Semi-Supine

Data type

integer

Measurement units
  • beats/minute
Alias
UMLS CUI [1,1]
C0018810
UMLS CUI [1,2]
C0038846
beats/minute
MEDICAL CONDITIONS
Description

MEDICAL CONDITIONS

Blood and lymphatic system disorders
Description

Blood and lymphatic system disorders

Data type

integer

Alias
UMLS CUI [1]
C0851353
Ear and labyrinth disorders
Description

Ear and labyrinth disorders

Data type

integer

Alias
UMLS CUI [1]
C0851354
endocrine disorders
Description

endocrine disorders

Data type

integer

Alias
UMLS CUI [1]
C0014130
Eye disorders
Description

Eye disorders

Data type

integer

Alias
UMLS CUI [1]
C0015397
Gastrointestinal disorders
Description

Gastrointestinal disorders

Data type

integer

Alias
UMLS CUI [1]
C0017178
Hepatobiliary disorders
Description

Hepatobiliary disorders

Data type

integer

Alias
UMLS CUI [1]
C0267792
Immune system disorders
Description

Immune system disorders

Data type

integer

Alias
UMLS CUI [1]
C1334156
Metabolism and nutrition disorders
Description

Metabolism and nutrition disorders

Data type

integer

Alias
UMLS CUI [1]
C0851358
Musculoskeletal and connective tissue disorders
Description

Musculoskeletal and connective tissue disorders

Data type

integer

Alias
UMLS CUI [1]
C0263660
Neoplasms benign, malignant and unspecified (including cysts and polyps)
Description

Neoplasms benign, malignant and unspecified (including cysts and polyps)

Data type

integer

Alias
UMLS CUI [1]
C1882062
Nervous system disorders
Description

Nervous system disorders

Data type

integer

Alias
UMLS CUI [1]
C0810273
Psychiatric disorders
Description

Psychiatric disorders

Data type

integer

Alias
UMLS CUI [1]
C0004936
Renal and urinary disorders
Description

Renal and urinary disorders

Data type

integer

Alias
UMLS CUI [1]
C0042075
Reproductive system and breast disorders
Description

Reproductive system and breast disorders

Data type

integer

Alias
UMLS CUI [1]
C0851366
Respiratory, thoracic and mediastinal disorders
Description

Respiratory, thoracic and mediastinal disorders

Data type

integer

Alias
UMLS CUI [1]
C0851355
Skin and subcutaneous tissue disorders
Description

Skin and subcutaneous tissue disorders

Data type

integer

Alias
UMLS CUI [1]
C0178301
Vascular disorders
Description

Vascular disorders

Data type

integer

Alias
UMLS CUI [1]
C0042373
Infections and infestations
Description

Infections and infestations

Data type

integer

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0851341
Congenital, familial and genetic disorders
Description

Congenital, familial and genetic disorders

Data type

integer

Alias
UMLS CUI [1]
C0851352
General disorders and administration site conditions
Description

General disorders and administration site conditions

Data type

integer

Alias
UMLS CUI [1]
C0851362
Injury, poisoning and procedural complications
Description

Injury, poisoning and procedural complications

Data type

integer

Alias
UMLS CUI [1]
C0947733
Investigations
Description

Investigations

Data type

integer

Alias
UMLS CUI [1]
C0841577
MEDICATIONS OF SPECIAL INTEREST
Description

MEDICATIONS OF SPECIAL INTEREST

Were any of the following medications taken by the subject prior to entering this study?
Description

Were any of the following medications taken by the subject prior to entering this study?

Data type

boolean

Alias
UMLS CUI [1]
C0013227
methysergide
Description

methysergide

Data type

integer

Alias
UMLS CUI [1]
C0025842
fenfluramine
Description

fenfluramine

Data type

integer

Alias
UMLS CUI [1]
C0015827
dexfenfluramine
Description

dexfenfluramine

Data type

integer

phentermine
Description

phentermine

Data type

integer

Alias
UMLS CUI [1]
C0031447
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Similar models

MEDICAL CONDITIONS Ropinirole Case Report Form GSK

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
DEMOGRAPHY
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Item
Gender
integer
C0079399 (UMLS CUI [1])
endocrine disorders
Code List
Gender
CL Item
current (1)
C0521116 (UMLS CUI-1)
(Comment:en)
CL Item
past (2)
C1444637 (UMLS CUI-1)
(Comment:en)
CL Item
no medical history (3)
C0262926 (UMLS CUI-1)
(Comment:en)
CL Item
not assessed (4)
C3846720 (UMLS CUI-1)
(Comment:en)
Item
Ethnicity
integer
C0015031 (UMLS CUI [1])
Ear and labyrinth disorders
Code List
Ethnicity
CL Item
current (1)
CL Item
past (2)
CL Item
no medical history (3)
CL Item
not assessed (4)
Item
Race
integer
C0034510 (UMLS CUI [1])
Blood and lymphatic system disorders
Code List
Race
CL Item
current (1)
C0521116 (UMLS CUI-1)
(Comment:en)
CL Item
past (2)
C1444637 (UMLS CUI-1)
(Comment:en)
CL Item
no medical history (3)
C0262926 (UMLS CUI-1)
(Comment:en)
CL Item
not assessed (4)
C3846720 (UMLS CUI-1)
(Comment:en)
Item Group
VITAL SIGNS
Height
Item
Height
integer
C0005890 (UMLS CUI [1])
Weight
Item
Weight
integer
C0005910 (UMLS CUI [1])
Item
Blood pressure Semi-Supine
integer
C0005823 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
Ear and labyrinth disorders
Code List
Blood pressure Semi-Supine
CL Item
current (1)
C0521116 (UMLS CUI-1)
(Comment:en)
CL Item
past (2)
C1444637 (UMLS CUI-1)
(Comment:en)
CL Item
no medical history (3)
C0262926 (UMLS CUI-1)
(Comment:en)
CL Item
not assessed (4)
C3846720 (UMLS CUI-1)
(Comment:en)
Item
Blood pressure Standing position
integer
C0005823 (UMLS CUI [1,1])
C0231472 (UMLS CUI [1,2])
endocrine disorders
Code List
Blood pressure Standing position
CL Item
current (1)
C0521116 (UMLS CUI-1)
(Comment:en)
CL Item
past (2)
C1444637 (UMLS CUI-1)
(Comment:en)
CL Item
no medical history (3)
C0262926 (UMLS CUI-1)
(Comment:en)
CL Item
not assessed (4)
C3846720 (UMLS CUI-1)
(Comment:en)
Heart rate standing position
Item
Heart rate standing position
integer
C0018810 (UMLS CUI [1,1])
C0231472 (UMLS CUI [1,2])
Heart rate Semi-Supine
Item
Heart rate Semi-Supine
integer
C0018810 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
Item Group
MEDICAL CONDITIONS
Item
Blood and lymphatic system disorders
integer
C0851353 (UMLS CUI [1])
Blood and lymphatic system disorders
Code List
Blood and lymphatic system disorders
CL Item
current (1)
C0521116 (UMLS CUI-1)
(Comment:en)
CL Item
past (2)
C1444637 (UMLS CUI-1)
(Comment:en)
CL Item
no medical history (3)
C0262926 (UMLS CUI-1)
(Comment:en)
CL Item
not assessed (4)
C3846720 (UMLS CUI-1)
(Comment:en)
Item
Ear and labyrinth disorders
integer
C0851354 (UMLS CUI [1])
Ear and labyrinth disorders
Code List
Ear and labyrinth disorders
CL Item
current (1)
C0521116 (UMLS CUI-1)
(Comment:en)
CL Item
past (2)
C1444637 (UMLS CUI-1)
(Comment:en)
CL Item
no medical history (3)
C0262926 (UMLS CUI-1)
(Comment:en)
CL Item
not assessed (4)
C3846720 (UMLS CUI-1)
(Comment:en)
Item
endocrine disorders
integer
C0014130 (UMLS CUI [1])
endocrine disorders
Code List
endocrine disorders
CL Item
current (1)
C0521116 (UMLS CUI-1)
(Comment:en)
CL Item
past (2)
C1444637 (UMLS CUI-1)
(Comment:en)
CL Item
no medical history (3)
C0262926 (UMLS CUI-1)
(Comment:en)
CL Item
not assessed (4)
C3846720 (UMLS CUI-1)
(Comment:en)
Item
Eye disorders
integer
C0015397 (UMLS CUI [1])
Eye disorders
Code List
Eye disorders
CL Item
current (1)
C0521116 (UMLS CUI-1)
(Comment:en)
CL Item
past (2)
C1444637 (UMLS CUI-1)
(Comment:en)
CL Item
no medical history (3)
C0262926 (UMLS CUI-1)
(Comment:en)
CL Item
not assessed (4)
C3846720 (UMLS CUI-1)
(Comment:en)
Item
Gastrointestinal disorders
integer
C0017178 (UMLS CUI [1])
Gastrointestinal disorders
Code List
Gastrointestinal disorders
CL Item
current (1)
C0521116 (UMLS CUI-1)
(Comment:en)
CL Item
past (2)
C1444637 (UMLS CUI-1)
(Comment:en)
CL Item
no medical history (3)
C0262926 (UMLS CUI-1)
(Comment:en)
CL Item
not assessed (4)
C3846720 (UMLS CUI-1)
(Comment:en)
Item
Hepatobiliary disorders
integer
C0267792 (UMLS CUI [1])
Hepatobiliary disorders
Code List
Hepatobiliary disorders
CL Item
current (1)
C0521116 (UMLS CUI-1)
(Comment:en)
CL Item
past (2)
C1444637 (UMLS CUI-1)
(Comment:en)
CL Item
no medical history (3)
C0262926 (UMLS CUI-1)
(Comment:en)
CL Item
not assessed (4)
C3846720 (UMLS CUI-1)
(Comment:en)
Item
Immune system disorders
integer
C1334156 (UMLS CUI [1])
Immune system disorders
Code List
Immune system disorders
CL Item
current (1)
C0521116 (UMLS CUI-1)
(Comment:en)
CL Item
past (2)
C1444637 (UMLS CUI-1)
(Comment:en)
CL Item
no medical history (3)
C0262926 (UMLS CUI-1)
(Comment:en)
CL Item
not assessed (4)
C3846720 (UMLS CUI-1)
(Comment:en)
Item
Metabolism and nutrition disorders
integer
C0851358 (UMLS CUI [1])
Metabolism and nutrition disorders
Code List
Metabolism and nutrition disorders
CL Item
current (1)
C0521116 (UMLS CUI-1)
(Comment:en)
CL Item
past (2)
C1444637 (UMLS CUI-1)
(Comment:en)
CL Item
no medical history (3)
C0262926 (UMLS CUI-1)
(Comment:en)
CL Item
not assessed (4)
C3846720 (UMLS CUI-1)
(Comment:en)
Item
Musculoskeletal and connective tissue disorders
integer
C0263660 (UMLS CUI [1])
Musculoskeletal and connective tissue disorders
Code List
Musculoskeletal and connective tissue disorders
CL Item
current (1)
C0521116 (UMLS CUI-1)
(Comment:en)
CL Item
past (2)
C1444637 (UMLS CUI-1)
(Comment:en)
CL Item
no medical history (3)
C0262926 (UMLS CUI-1)
(Comment:en)
CL Item
not assessed (4)
C3846720 (UMLS CUI-1)
(Comment:en)
Item
Neoplasms benign, malignant and unspecified (including cysts and polyps)
integer
C1882062 (UMLS CUI [1])
Neoplasms benign, malignant and unspecified (including cysts and polyps)
Code List
Neoplasms benign, malignant and unspecified (including cysts and polyps)
CL Item
current (1)
C0521116 (UMLS CUI-1)
(Comment:en)
CL Item
past (2)
C1444637 (UMLS CUI-1)
(Comment:en)
CL Item
no medical history (3)
C0262926 (UMLS CUI-1)
(Comment:en)
CL Item
not assessed (4)
C3846720 (UMLS CUI-1)
(Comment:en)
Item
Nervous system disorders
integer
C0810273 (UMLS CUI [1])
Nervous system disorders
Code List
Nervous system disorders
CL Item
current (1)
C0521116 (UMLS CUI-1)
(Comment:en)
CL Item
past (2)
C1444637 (UMLS CUI-1)
(Comment:en)
CL Item
no medical history (3)
C0262926 (UMLS CUI-1)
(Comment:en)
CL Item
not assessed (4)
C3846720 (UMLS CUI-1)
(Comment:en)
Item
Psychiatric disorders
integer
C0004936 (UMLS CUI [1])
Psychiatric disorders
Code List
Psychiatric disorders
CL Item
current (1)
CL Item
past (2)
CL Item
no medical history (3)
CL Item
not assessed (4)
Item
Renal and urinary disorders
integer
C0042075 (UMLS CUI [1])
Renal and urinary disorders
Code List
Renal and urinary disorders
CL Item
current (1)
CL Item
past (2)
CL Item
no medical history (3)
CL Item
not assessed (4)
Item
Reproductive system and breast disorders
integer
C0851366 (UMLS CUI [1])
Reproductive system and breast disorders
Code List
Reproductive system and breast disorders
CL Item
current (1)
CL Item
past (2)
CL Item
no medical history (3)
CL Item
not assessed (4)
Item
Respiratory, thoracic and mediastinal disorders
integer
C0851355 (UMLS CUI [1])
Respiratory, thoracic and mediastinal disorders
Code List
Respiratory, thoracic and mediastinal disorders
CL Item
current (1)
C0521116 (UMLS CUI-1)
(Comment:en)
CL Item
past (2)
C1444637 (UMLS CUI-1)
(Comment:en)
CL Item
no medical history (3)
C0262926 (UMLS CUI-1)
(Comment:en)
CL Item
not assessed (4)
C3846720 (UMLS CUI-1)
(Comment:en)
Item
Skin and subcutaneous tissue disorders
integer
C0178301 (UMLS CUI [1])
Skin and subcutaneous tissue disorders
Code List
Skin and subcutaneous tissue disorders
CL Item
current (1)
C0521116 (UMLS CUI-1)
(Comment:en)
CL Item
past (2)
C1444637 (UMLS CUI-1)
(Comment:en)
CL Item
no medical history (3)
C0262926 (UMLS CUI-1)
(Comment:en)
CL Item
not assessed (4)
C3846720 (UMLS CUI-1)
(Comment:en)
Item
Vascular disorders
integer
C0042373 (UMLS CUI [1])
Vascular disorders
Code List
Vascular disorders
CL Item
current (1)
C0521116 (UMLS CUI-1)
(Comment:en)
CL Item
past (2)
C1444637 (UMLS CUI-1)
(Comment:en)
CL Item
no medical history (3)
C0262926 (UMLS CUI-1)
(Comment:en)
CL Item
not assessed (4)
C3846720 (UMLS CUI-1)
(Comment:en)
Item
Infections and infestations
integer
C0009450 (UMLS CUI [1,1])
C0851341 (UMLS CUI [1,2])
Infections and infestations
Code List
Infections and infestations
CL Item
current (1)
C0521116 (UMLS CUI-1)
(Comment:en)
CL Item
past (2)
C1444637 (UMLS CUI-1)
(Comment:en)
CL Item
no medical history (3)
C0262926 (UMLS CUI-1)
(Comment:en)
CL Item
not assessed (4)
C3846720 (UMLS CUI-1)
(Comment:en)
Item
Congenital, familial and genetic disorders
integer
C0851352 (UMLS CUI [1])
Congenital, familial and genetic disorders
Code List
Congenital, familial and genetic disorders
CL Item
current (1)
C0521116 (UMLS CUI-1)
(Comment:en)
CL Item
past (2)
C1444637 (UMLS CUI-1)
(Comment:en)
CL Item
no medical history (3)
C0262926 (UMLS CUI-1)
(Comment:en)
CL Item
not assessed (4)
C3846720 (UMLS CUI-1)
(Comment:en)
Item
General disorders and administration site conditions
integer
C0851362 (UMLS CUI [1])
General disorders and administration site conditions
Code List
General disorders and administration site conditions
CL Item
current (1)
C0521116 (UMLS CUI-1)
(Comment:en)
CL Item
past (2)
C1444637 (UMLS CUI-1)
(Comment:en)
CL Item
no medical history (3)
C0262926 (UMLS CUI-1)
(Comment:en)
CL Item
not assessed (4)
C3846720 (UMLS CUI-1)
(Comment:en)
Item
Injury, poisoning and procedural complications
integer
C0947733 (UMLS CUI [1])
Injury, poisoning and procedural complications
Code List
Injury, poisoning and procedural complications
CL Item
current (1)
C0521116 (UMLS CUI-1)
(Comment:en)
CL Item
past (2)
C1444637 (UMLS CUI-1)
(Comment:en)
CL Item
no medical history (3)
C0262926 (UMLS CUI-1)
(Comment:en)
CL Item
not assessed (4)
C3846720 (UMLS CUI-1)
(Comment:en)
Item
Investigations
integer
C0841577 (UMLS CUI [1])
Investigations
Code List
Investigations
CL Item
current (1)
C0521116 (UMLS CUI-1)
(Comment:en)
CL Item
past (2)
C1444637 (UMLS CUI-1)
(Comment:en)
CL Item
no medical history (3)
C0262926 (UMLS CUI-1)
(Comment:en)
CL Item
not assessed (4)
C3846720 (UMLS CUI-1)
(Comment:en)
Item Group
MEDICATIONS OF SPECIAL INTEREST
Were any of the following medications taken by the subject prior to entering this study?
Item
Were any of the following medications taken by the subject prior to entering this study?
boolean
C0013227 (UMLS CUI [1])
Item
methysergide
integer
C0025842 (UMLS CUI [1])
methysergide
Code List
methysergide
CL Item
Was drug ever used? (1)
C2239127 (UMLS CUI-1)
(Comment:en)
CL Item
Primary Reason Medication Started (2)
C1549995 (UMLS CUI-1)
(Comment:en)
Item
fenfluramine
integer
C0015827 (UMLS CUI [1])
fenfluramine
Code List
fenfluramine
CL Item
Was drug ever used? (1)
C2239127 (UMLS CUI-1)
(Comment:en)
CL Item
Primary Reason Medication Started (2)
C1549995 (UMLS CUI-1)
(Comment:en)
Item
dexfenfluramine
integer
dexfenfluramine
Code List
dexfenfluramine
CL Item
Was drug ever used? (1)
C2239127 (UMLS CUI-1)
(Comment:en)
CL Item
Primary Reason Medication Started (2)
C1549995 (UMLS CUI-1)
(Comment:en)
Item
phentermine
integer
C0031447 (UMLS CUI [1])
phentermine
Code List
phentermine
CL Item
Was drug ever used? (1)
C2239127 (UMLS CUI-1)
(Comment:en)
CL Item
Primary Reason Medication Started (2)
C1549995 (UMLS CUI-1)
(Comment:en)
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