ID

25946

Descripción

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

Palabras clave

Versiones (1)
  1. 30/9/17 30/9/17 -
Titular de derechos de autor

gsk

Subido en

30 de septiembre de 2017

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

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

Alemán Inglés

MEDICAL CONDITIONS Ropinirole Case Report Form GSK

1 formularios  
Zeitplan
Descripción

Zeitplan

Date of birth
Descripción

Date of birth

Tipo de datos

date

Alias
UMLS CUI [1]
C0421451
Gender
Descripción

Gender

Tipo de datos

integer

Alias
UMLS CUI [1]
C0079399
Ethnicity
Descripción

Ethnicity

Tipo de datos

integer

Alias
UMLS CUI [1]
C0015031
Race
Descripción

Race

Tipo de datos

integer

Alias
UMLS CUI [1]
C0034510
VITAL SIGNS
Descripción

VITAL SIGNS

Height
Descripción

Height

Tipo de datos

integer

Unidades de medida
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Weight
Descripción

Weight

Tipo de datos

integer

Unidades de medida
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Blood pressure Semi-Supine
Descripción

Blood pressure Semi-Supine

Tipo de datos

integer

Unidades de medida
  • mmHg
Alias
UMLS CUI [1,1]
C0005823
UMLS CUI [1,2]
C0038846
Blood pressure Standing position
Descripción

Blood pressure Standing position

Tipo de datos

integer

Unidades de medida
  • mmHg
Alias
UMLS CUI [1,1]
C0005823
UMLS CUI [1,2]
C0231472
Heart rate standing position
Descripción

Heart rate standing position

Tipo de datos

integer

Unidades de medida
  • beats/minute
Alias
UMLS CUI [1,1]
C0018810
UMLS CUI [1,2]
C0231472
beats/minute
Heart rate Semi-Supine
Descripción

Heart rate Semi-Supine

Tipo de datos

integer

Unidades de medida
  • beats/minute
Alias
UMLS CUI [1,1]
C0018810
UMLS CUI [1,2]
C0038846
beats/minute
MEDICAL CONDITIONS
Descripción

MEDICAL CONDITIONS

Blood and lymphatic system disorders
Descripción

Blood and lymphatic system disorders

Tipo de datos

integer

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

Ear and labyrinth disorders

Tipo de datos

integer

Alias
UMLS CUI [1]
C0851354
endocrine disorders
Descripción

endocrine disorders

Tipo de datos

integer

Alias
UMLS CUI [1]
C0014130
Eye disorders
Descripción

Eye disorders

Tipo de datos

integer

Alias
UMLS CUI [1]
C0015397
Gastrointestinal disorders
Descripción

Gastrointestinal disorders

Tipo de datos

integer

Alias
UMLS CUI [1]
C0017178
Hepatobiliary disorders
Descripción

Hepatobiliary disorders

Tipo de datos

integer

Alias
UMLS CUI [1]
C0267792
Immune system disorders
Descripción

Immune system disorders

Tipo de datos

integer

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

Metabolism and nutrition disorders

Tipo de datos

integer

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

Musculoskeletal and connective tissue disorders

Tipo de datos

integer

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

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

Tipo de datos

integer

Alias
UMLS CUI [1]
C1882062
Nervous system disorders
Descripción

Nervous system disorders

Tipo de datos

integer

Alias
UMLS CUI [1]
C0810273
Psychiatric disorders
Descripción

Psychiatric disorders

Tipo de datos

integer

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

Renal and urinary disorders

Tipo de datos

integer

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

Reproductive system and breast disorders

Tipo de datos

integer

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

Respiratory, thoracic and mediastinal disorders

Tipo de datos

integer

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

Skin and subcutaneous tissue disorders

Tipo de datos

integer

Alias
UMLS CUI [1]
C0178301
Vascular disorders
Descripción

Vascular disorders

Tipo de datos

integer

Alias
UMLS CUI [1]
C0042373
Infections and infestations
Descripción

Infections and infestations

Tipo de datos

integer

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

Congenital, familial and genetic disorders

Tipo de datos

integer

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

General disorders and administration site conditions

Tipo de datos

integer

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

Injury, poisoning and procedural complications

Tipo de datos

integer

Alias
UMLS CUI [1]
C0947733
Investigations
Descripción

Investigations

Tipo de datos

integer

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

MEDICATIONS OF SPECIAL INTEREST

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

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

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0013227
methysergide
Descripción

methysergide

Tipo de datos

integer

Alias
UMLS CUI [1]
C0025842
fenfluramine
Descripción

fenfluramine

Tipo de datos

integer

Alias
UMLS CUI [1]
C0015827
dexfenfluramine
Descripción

dexfenfluramine

Tipo de datos

integer

phentermine
Descripción

phentermine

Tipo de datos

integer

Alias
UMLS CUI [1]
C0031447
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Similar models

MEDICAL CONDITIONS Ropinirole Case Report Form GSK

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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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