ID

25946

Beschreibung

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

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  1. 30.09.17 30.09.17 -
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30. September 2017

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MEDICAL CONDITIONS Ropinirole Case Report Form GSK RRL100013

Deutsch Englisch

MEDICAL CONDITIONS Ropinirole Case Report Form GSK

1 Formulare  
Zeitplan
Beschreibung

Zeitplan

Date of birth
Beschreibung

Date of birth

Datentyp

date

Alias
UMLS CUI [1]
C0421451
Gender
Beschreibung

Gender

Datentyp

integer

Alias
UMLS CUI [1]
C0079399
Ethnicity
Beschreibung

Ethnicity

Datentyp

integer

Alias
UMLS CUI [1]
C0015031
Race
Beschreibung

Race

Datentyp

integer

Alias
UMLS CUI [1]
C0034510
VITAL SIGNS
Beschreibung

VITAL SIGNS

Height
Beschreibung

Height

Datentyp

integer

Maßeinheiten
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Weight
Beschreibung

Weight

Datentyp

integer

Maßeinheiten
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Blood pressure Semi-Supine
Beschreibung

Blood pressure Semi-Supine

Datentyp

integer

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

Blood pressure Standing position

Datentyp

integer

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

Heart rate standing position

Datentyp

integer

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

Heart rate Semi-Supine

Datentyp

integer

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

MEDICAL CONDITIONS

Blood and lymphatic system disorders
Beschreibung

Blood and lymphatic system disorders

Datentyp

integer

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

Ear and labyrinth disorders

Datentyp

integer

Alias
UMLS CUI [1]
C0851354
endocrine disorders
Beschreibung

endocrine disorders

Datentyp

integer

Alias
UMLS CUI [1]
C0014130
Eye disorders
Beschreibung

Eye disorders

Datentyp

integer

Alias
UMLS CUI [1]
C0015397
Gastrointestinal disorders
Beschreibung

Gastrointestinal disorders

Datentyp

integer

Alias
UMLS CUI [1]
C0017178
Hepatobiliary disorders
Beschreibung

Hepatobiliary disorders

Datentyp

integer

Alias
UMLS CUI [1]
C0267792
Immune system disorders
Beschreibung

Immune system disorders

Datentyp

integer

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

Metabolism and nutrition disorders

Datentyp

integer

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

Musculoskeletal and connective tissue disorders

Datentyp

integer

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

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

Datentyp

integer

Alias
UMLS CUI [1]
C1882062
Nervous system disorders
Beschreibung

Nervous system disorders

Datentyp

integer

Alias
UMLS CUI [1]
C0810273
Psychiatric disorders
Beschreibung

Psychiatric disorders

Datentyp

integer

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

Renal and urinary disorders

Datentyp

integer

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

Reproductive system and breast disorders

Datentyp

integer

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

Respiratory, thoracic and mediastinal disorders

Datentyp

integer

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

Skin and subcutaneous tissue disorders

Datentyp

integer

Alias
UMLS CUI [1]
C0178301
Vascular disorders
Beschreibung

Vascular disorders

Datentyp

integer

Alias
UMLS CUI [1]
C0042373
Infections and infestations
Beschreibung

Infections and infestations

Datentyp

integer

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

Congenital, familial and genetic disorders

Datentyp

integer

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

General disorders and administration site conditions

Datentyp

integer

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

Injury, poisoning and procedural complications

Datentyp

integer

Alias
UMLS CUI [1]
C0947733
Investigations
Beschreibung

Investigations

Datentyp

integer

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

MEDICATIONS OF SPECIAL INTEREST

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

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

Datentyp

boolean

Alias
UMLS CUI [1]
C0013227
methysergide
Beschreibung

methysergide

Datentyp

integer

Alias
UMLS CUI [1]
C0025842
fenfluramine
Beschreibung

fenfluramine

Datentyp

integer

Alias
UMLS CUI [1]
C0015827
dexfenfluramine
Beschreibung

dexfenfluramine

Datentyp

integer

phentermine
Beschreibung

phentermine

Datentyp

integer

Alias
UMLS CUI [1]
C0031447
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Ähnliche Modelle

MEDICAL CONDITIONS Ropinirole Case Report Form GSK

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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