ID

25946

Beskrivning

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

Nyckelord

Versioner (1)
  1. 2017-09-30 2017-09-30 -
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gsk

Uppladdad den

30 september 2017

DOI

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

Tysk Engelsk

MEDICAL CONDITIONS Ropinirole Case Report Form GSK

1 Formulär  
Zeitplan
Beskrivning

Zeitplan

Date of birth
Beskrivning

Date of birth

Datatyp

date

Alias
UMLS CUI [1]
C0421451
Gender
Beskrivning

Gender

Datatyp

integer

Alias
UMLS CUI [1]
C0079399
Ethnicity
Beskrivning

Ethnicity

Datatyp

integer

Alias
UMLS CUI [1]
C0015031
Race
Beskrivning

Race

Datatyp

integer

Alias
UMLS CUI [1]
C0034510
VITAL SIGNS
Beskrivning

VITAL SIGNS

Height
Beskrivning

Height

Datatyp

integer

Måttenheter
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Weight
Beskrivning

Weight

Datatyp

integer

Måttenheter
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Blood pressure Semi-Supine
Beskrivning

Blood pressure Semi-Supine

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1,1]
C0005823
UMLS CUI [1,2]
C0038846
Blood pressure Standing position
Beskrivning

Blood pressure Standing position

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1,1]
C0005823
UMLS CUI [1,2]
C0231472
Heart rate standing position
Beskrivning

Heart rate standing position

Datatyp

integer

Måttenheter
  • beats/minute
Alias
UMLS CUI [1,1]
C0018810
UMLS CUI [1,2]
C0231472
beats/minute
Heart rate Semi-Supine
Beskrivning

Heart rate Semi-Supine

Datatyp

integer

Måttenheter
  • beats/minute
Alias
UMLS CUI [1,1]
C0018810
UMLS CUI [1,2]
C0038846
beats/minute
MEDICAL CONDITIONS
Beskrivning

MEDICAL CONDITIONS

Blood and lymphatic system disorders
Beskrivning

Blood and lymphatic system disorders

Datatyp

integer

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

Ear and labyrinth disorders

Datatyp

integer

Alias
UMLS CUI [1]
C0851354
endocrine disorders
Beskrivning

endocrine disorders

Datatyp

integer

Alias
UMLS CUI [1]
C0014130
Eye disorders
Beskrivning

Eye disorders

Datatyp

integer

Alias
UMLS CUI [1]
C0015397
Gastrointestinal disorders
Beskrivning

Gastrointestinal disorders

Datatyp

integer

Alias
UMLS CUI [1]
C0017178
Hepatobiliary disorders
Beskrivning

Hepatobiliary disorders

Datatyp

integer

Alias
UMLS CUI [1]
C0267792
Immune system disorders
Beskrivning

Immune system disorders

Datatyp

integer

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

Metabolism and nutrition disorders

Datatyp

integer

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

Musculoskeletal and connective tissue disorders

Datatyp

integer

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

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

Datatyp

integer

Alias
UMLS CUI [1]
C1882062
Nervous system disorders
Beskrivning

Nervous system disorders

Datatyp

integer

Alias
UMLS CUI [1]
C0810273
Psychiatric disorders
Beskrivning

Psychiatric disorders

Datatyp

integer

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

Renal and urinary disorders

Datatyp

integer

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

Reproductive system and breast disorders

Datatyp

integer

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

Respiratory, thoracic and mediastinal disorders

Datatyp

integer

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

Skin and subcutaneous tissue disorders

Datatyp

integer

Alias
UMLS CUI [1]
C0178301
Vascular disorders
Beskrivning

Vascular disorders

Datatyp

integer

Alias
UMLS CUI [1]
C0042373
Infections and infestations
Beskrivning

Infections and infestations

Datatyp

integer

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

Congenital, familial and genetic disorders

Datatyp

integer

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

General disorders and administration site conditions

Datatyp

integer

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

Injury, poisoning and procedural complications

Datatyp

integer

Alias
UMLS CUI [1]
C0947733
Investigations
Beskrivning

Investigations

Datatyp

integer

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

MEDICATIONS OF SPECIAL INTEREST

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

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

Datatyp

boolean

Alias
UMLS CUI [1]
C0013227
methysergide
Beskrivning

methysergide

Datatyp

integer

Alias
UMLS CUI [1]
C0025842
fenfluramine
Beskrivning

fenfluramine

Datatyp

integer

Alias
UMLS CUI [1]
C0015827
dexfenfluramine
Beskrivning

dexfenfluramine

Datatyp

integer

phentermine
Beskrivning

phentermine

Datatyp

integer

Alias
UMLS CUI [1]
C0031447
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Similar models

MEDICAL CONDITIONS Ropinirole Case Report Form GSK

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Zeitplan
Date of birth
Item
date
C0421451 (UMLS CUI [1])
Item
integer
C0079399 (UMLS CUI [1])
endocrine disorders
Code List
Gender
CL Item
 (1)
C0521116 (UMLS CUI-1)
(Comment:en)
CL Item
 (2)
C1444637 (UMLS CUI-1)
(Comment:en)
CL Item
 (3)
C0262926 (UMLS CUI-1)
(Comment:en)
CL Item
 (4)
C3846720 (UMLS CUI-1)
(Comment:en)
Item
integer
C0015031 (UMLS CUI [1])
Ear and labyrinth disorders
Code List
Ethnicity
CL Item
 (1)
CL Item
 (2)
CL Item
 (3)
CL Item
 (4)
Item
integer
C0034510 (UMLS CUI [1])
Blood and lymphatic system disorders
Code List
Race
CL Item
 (1)
C0521116 (UMLS CUI-1)
(Comment:en)
CL Item
 (2)
C1444637 (UMLS CUI-1)
(Comment:en)
CL Item
 (3)
C0262926 (UMLS CUI-1)
(Comment:en)
CL Item
 (4)
C3846720 (UMLS CUI-1)
(Comment:en)
Item Group
Height
Item
integer
C0005890 (UMLS CUI [1])
Weight
Item
integer
C0005910 (UMLS CUI [1])
Item
integer
C0005823 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
Ear and labyrinth disorders
Code List
Blood pressure Semi-Supine
CL Item
 (1)
C0521116 (UMLS CUI-1)
(Comment:en)
CL Item
 (2)
C1444637 (UMLS CUI-1)
(Comment:en)
CL Item
 (3)
C0262926 (UMLS CUI-1)
(Comment:en)
CL Item
 (4)
C3846720 (UMLS CUI-1)
(Comment:en)
Item
integer
C0005823 (UMLS CUI [1,1])
C0231472 (UMLS CUI [1,2])
endocrine disorders
Code List
Blood pressure Standing position
CL Item
 (1)
C0521116 (UMLS CUI-1)
(Comment:en)
CL Item
 (2)
C1444637 (UMLS CUI-1)
(Comment:en)
CL Item
 (3)
C0262926 (UMLS CUI-1)
(Comment:en)
CL Item
 (4)
C3846720 (UMLS CUI-1)
(Comment:en)
Heart rate standing position
Item
integer
C0018810 (UMLS CUI [1,1])
C0231472 (UMLS CUI [1,2])
Heart rate Semi-Supine
Item
integer
C0018810 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
Item
integer
C0851353 (UMLS CUI [1])
Blood and lymphatic system disorders
Code List
Blood and lymphatic system disorders
CL Item
 (1)
C0521116 (UMLS CUI-1)
(Comment:en)
CL Item
 (2)
C1444637 (UMLS CUI-1)
(Comment:en)
CL Item
 (3)
C0262926 (UMLS CUI-1)
(Comment:en)
CL Item
 (4)
C3846720 (UMLS CUI-1)
(Comment:en)
Item
integer
C0851354 (UMLS CUI [1])
Ear and labyrinth disorders
Code List
Ear and labyrinth disorders
CL Item
 (1)
C0521116 (UMLS CUI-1)
(Comment:en)
CL Item
 (2)
C1444637 (UMLS CUI-1)
(Comment:en)
CL Item
 (3)
C0262926 (UMLS CUI-1)
(Comment:en)
CL Item
 (4)
C3846720 (UMLS CUI-1)
(Comment:en)
Item
integer
C0014130 (UMLS CUI [1])
endocrine disorders
Code List
endocrine disorders
CL Item
 (1)
C0521116 (UMLS CUI-1)
(Comment:en)
CL Item
 (2)
C1444637 (UMLS CUI-1)
(Comment:en)
CL Item
 (3)
C0262926 (UMLS CUI-1)
(Comment:en)
CL Item
 (4)
C3846720 (UMLS CUI-1)
(Comment:en)
Item
integer
C0015397 (UMLS CUI [1])
Eye disorders
Code List
Eye disorders
CL Item
 (1)
C0521116 (UMLS CUI-1)
(Comment:en)
CL Item
 (2)
C1444637 (UMLS CUI-1)
(Comment:en)
CL Item
 (3)
C0262926 (UMLS CUI-1)
(Comment:en)
CL Item
 (4)
C3846720 (UMLS CUI-1)
(Comment:en)
Item
integer
C0017178 (UMLS CUI [1])
Gastrointestinal disorders
Code List
Gastrointestinal disorders
CL Item
 (1)
C0521116 (UMLS CUI-1)
(Comment:en)
CL Item
 (2)
C1444637 (UMLS CUI-1)
(Comment:en)
CL Item
 (3)
C0262926 (UMLS CUI-1)
(Comment:en)
CL Item
 (4)
C3846720 (UMLS CUI-1)
(Comment:en)
Item
integer
C0267792 (UMLS CUI [1])
Hepatobiliary disorders
Code List
Hepatobiliary disorders
CL Item
 (1)
C0521116 (UMLS CUI-1)
(Comment:en)
CL Item
 (2)
C1444637 (UMLS CUI-1)
(Comment:en)
CL Item
 (3)
C0262926 (UMLS CUI-1)
(Comment:en)
CL Item
 (4)
C3846720 (UMLS CUI-1)
(Comment:en)
Item
integer
C1334156 (UMLS CUI [1])
Immune system disorders
Code List
Immune system disorders
CL Item
 (1)
C0521116 (UMLS CUI-1)
(Comment:en)
CL Item
 (2)
C1444637 (UMLS CUI-1)
(Comment:en)
CL Item
 (3)
C0262926 (UMLS CUI-1)
(Comment:en)
CL Item
 (4)
C3846720 (UMLS CUI-1)
(Comment:en)
Item
integer
C0851358 (UMLS CUI [1])
Metabolism and nutrition disorders
Code List
Metabolism and nutrition disorders
CL Item
 (1)
C0521116 (UMLS CUI-1)
(Comment:en)
CL Item
 (2)
C1444637 (UMLS CUI-1)
(Comment:en)
CL Item
 (3)
C0262926 (UMLS CUI-1)
(Comment:en)
CL Item
 (4)
C3846720 (UMLS CUI-1)
(Comment:en)
Item
integer
C0263660 (UMLS CUI [1])
Musculoskeletal and connective tissue disorders
Code List
Musculoskeletal and connective tissue disorders
CL Item
 (1)
C0521116 (UMLS CUI-1)
(Comment:en)
CL Item
 (2)
C1444637 (UMLS CUI-1)
(Comment:en)
CL Item
 (3)
C0262926 (UMLS CUI-1)
(Comment:en)
CL Item
 (4)
C3846720 (UMLS CUI-1)
(Comment:en)
Neoplasms benign, malignant and unspecified (including cysts and polyps)
Code List
Neoplasms benign, malignant and unspecified (including cysts and polyps)
CL Item
 (1)
C0521116 (UMLS CUI-1)
(Comment:en)
CL Item
 (2)
C1444637 (UMLS CUI-1)
(Comment:en)
CL Item
 (3)
C0262926 (UMLS CUI-1)
(Comment:en)
CL Item
 (4)
C3846720 (UMLS CUI-1)
(Comment:en)
Item
integer
C0810273 (UMLS CUI [1])
Nervous system disorders
Code List
Nervous system disorders
CL Item
 (1)
C0521116 (UMLS CUI-1)
(Comment:en)
CL Item
 (2)
C1444637 (UMLS CUI-1)
(Comment:en)
CL Item
 (3)
C0262926 (UMLS CUI-1)
(Comment:en)
CL Item
 (4)
C3846720 (UMLS CUI-1)
(Comment:en)
Item
integer
C0004936 (UMLS CUI [1])
Psychiatric disorders
Code List
Psychiatric disorders
CL Item
 (1)
CL Item
 (2)
CL Item
 (3)
CL Item
 (4)
Item
integer
C0042075 (UMLS CUI [1])
Renal and urinary disorders
Code List
Renal and urinary disorders
CL Item
 (1)
CL Item
 (2)
CL Item
 (3)
CL Item
 (4)
Item
integer
C0851366 (UMLS CUI [1])
Reproductive system and breast disorders
Code List
Reproductive system and breast disorders
CL Item
 (1)
CL Item
 (2)
CL Item
 (3)
CL Item
 (4)
Item
integer
C0851355 (UMLS CUI [1])
Respiratory, thoracic and mediastinal disorders
Code List
Respiratory, thoracic and mediastinal disorders
CL Item
 (1)
C0521116 (UMLS CUI-1)
(Comment:en)
CL Item
 (2)
C1444637 (UMLS CUI-1)
(Comment:en)
CL Item
 (3)
C0262926 (UMLS CUI-1)
(Comment:en)
CL Item
 (4)
C3846720 (UMLS CUI-1)
(Comment:en)
Item
integer
C0178301 (UMLS CUI [1])
Skin and subcutaneous tissue disorders
Code List
Skin and subcutaneous tissue disorders
CL Item
 (1)
C0521116 (UMLS CUI-1)
(Comment:en)
CL Item
 (2)
C1444637 (UMLS CUI-1)
(Comment:en)
CL Item
 (3)
C0262926 (UMLS CUI-1)
(Comment:en)
CL Item
 (4)
C3846720 (UMLS CUI-1)
(Comment:en)
Item
integer
C0042373 (UMLS CUI [1])
Vascular disorders
Code List
Vascular disorders
CL Item
 (1)
C0521116 (UMLS CUI-1)
(Comment:en)
CL Item
 (2)
C1444637 (UMLS CUI-1)
(Comment:en)
CL Item
 (3)
C0262926 (UMLS CUI-1)
(Comment:en)
CL Item
 (4)
C3846720 (UMLS CUI-1)
(Comment:en)
Item
integer
C0009450 (UMLS CUI [1,1])
C0851341 (UMLS CUI [1,2])
Infections and infestations
Code List
Infections and infestations
CL Item
 (1)
C0521116 (UMLS CUI-1)
(Comment:en)
CL Item
 (2)
C1444637 (UMLS CUI-1)
(Comment:en)
CL Item
 (3)
C0262926 (UMLS CUI-1)
(Comment:en)
CL Item
 (4)
C3846720 (UMLS CUI-1)
(Comment:en)
Item
integer
C0851352 (UMLS CUI [1])
Congenital, familial and genetic disorders
Code List
Congenital, familial and genetic disorders
CL Item
 (1)
C0521116 (UMLS CUI-1)
(Comment:en)
CL Item
 (2)
C1444637 (UMLS CUI-1)
(Comment:en)
CL Item
 (3)
C0262926 (UMLS CUI-1)
(Comment:en)
CL Item
 (4)
C3846720 (UMLS CUI-1)
(Comment:en)
Item
integer
C0851362 (UMLS CUI [1])
General disorders and administration site conditions
Code List
General disorders and administration site conditions
CL Item
 (1)
C0521116 (UMLS CUI-1)
(Comment:en)
CL Item
 (2)
C1444637 (UMLS CUI-1)
(Comment:en)
CL Item
 (3)
C0262926 (UMLS CUI-1)
(Comment:en)
CL Item
 (4)
C3846720 (UMLS CUI-1)
(Comment:en)
Item
integer
C0947733 (UMLS CUI [1])
Injury, poisoning and procedural complications
Code List
Injury, poisoning and procedural complications
CL Item
 (1)
C0521116 (UMLS CUI-1)
(Comment:en)
CL Item
 (2)
C1444637 (UMLS CUI-1)
(Comment:en)
CL Item
 (3)
C0262926 (UMLS CUI-1)
(Comment:en)
CL Item
 (4)
C3846720 (UMLS CUI-1)
(Comment:en)
Item
integer
C0841577 (UMLS CUI [1])
Investigations
Code List
Investigations
CL Item
 (1)
C0521116 (UMLS CUI-1)
(Comment:en)
CL Item
 (2)
C1444637 (UMLS CUI-1)
(Comment:en)
CL Item
 (3)
C0262926 (UMLS CUI-1)
(Comment:en)
CL Item
 (4)
C3846720 (UMLS CUI-1)
(Comment:en)
Were any of the following medications taken by the subject prior to entering this study?
Item
boolean
C0013227 (UMLS CUI [1])
Item
integer
C0025842 (UMLS CUI [1])
methysergide
Code List
methysergide
CL Item
 (1)
C2239127 (UMLS CUI-1)
(Comment:en)
CL Item
 (2)
C1549995 (UMLS CUI-1)
(Comment:en)
Item
integer
C0015827 (UMLS CUI [1])
fenfluramine
Code List
fenfluramine
CL Item
 (1)
C2239127 (UMLS CUI-1)
(Comment:en)
CL Item
 (2)
C1549995 (UMLS CUI-1)
(Comment:en)
Item
integer
dexfenfluramine
Code List
dexfenfluramine
CL Item
 (1)
C2239127 (UMLS CUI-1)
(Comment:en)
CL Item
 (2)
C1549995 (UMLS CUI-1)
(Comment:en)
Item
integer
C0031447 (UMLS CUI [1])
phentermine
Code List
phentermine
CL Item
 (1)
C2239127 (UMLS CUI-1)
(Comment:en)
CL Item
 (2)
C1549995 (UMLS CUI-1)
(Comment:en)
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