Informatie:
Fout:
ID
35024
Beschrijving
Study ID: 101468/205 Clinical Study ID: 101468/205 Study Title:A 12-Week, Double-Blind, Placebo Controlled, Parallel Group Study to Assess the Efficacy and Safety of Ropinirole XR (Extended Release) in Patients with Restless Legs Syndrome Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00197080 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Modutab,ZIPEREVE,ZEPREVE,REPREVE,ADARTREL,REQUIP,Zygara; Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication: Restless Legs Syndrome
Trefwoorden
Versies (1)
- 10-02-19 10-02-19 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
10 februari 2019
DOI
Voor een aanvraag inloggen.
Licentie
Creative Commons BY-NC 3.0
Model Commentaren :
Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.
Itemgroep Commentaren voor :
Item Commentaren voor :
U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.
Efficacy and Safety of Ropinirole XR (Extended Release) in Patients with Restless Legs Syndrome NCT00197080
Screening - Demography; Vital Signs; Cardiovascular medical Conditions; Cardiovascular surgical Procedures; Medical Conditions
Similar models
Screening - Demography; Vital Signs; Cardiovascular medical Conditions; Cardiovascular surgical Procedures; Medical Conditions
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Subject Identifier
Item
Subject Identifier
integer
C2348585 (UMLS CUI [1])
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
CL Item
Male (M)
CL Item
Female (F)
CL Item
Hispanic or Latino (1)
CL Item
Not Hispanic or Latino (2)
CL Item
African American/ African Heritage (11)
CL Item
American Indian or Alaskan Native (12)
CL Item
Asian - Central/South Asian Heritage (13)
CL Item
Asian - East Asian Heritage (14)
CL Item
Asian - Japanese Heritage (15)
CL Item
Asian - South East Asian Heritage (16)
CL Item
Native Hawaiian or Other Pacific Islander (17)
CL Item
White - Arabic/North African Heritage (18)
CL Item
White - White/Caucasian/European Heritage (19)
Height
Item
Height
integer
C0005890 (UMLS CUI [1])
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Item Group
Blood Pressure and Heart Rate
C0005823 (UMLS CUI-1)
C0018810 (UMLS CUI-2)
C0018810 (UMLS CUI-2)
Systolic Blood Pressure
Item
Systolic Blood Pressure
float
C0871470 (UMLS CUI [1])
Diastolic Blood Pressure
Item
Diastolic Blood Pressure
integer
C0428883 (UMLS CUI [1])
CL Item
Supine (1)
CL Item
Sitting (2)
CL Item
Standing (3)
CL Item
Semi-supine (4)
Heart Rate
Item
Heart Rate
integer
C0018810 (UMLS CUI [1])
Item Group
Cardiovascular Medical Conditions
C0007222 (UMLS CUI-1)
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Conditions (5)
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Conditions (5)
Item
3. Stable angina pectoris
integer
C0002962 (UMLS CUI [1,1])
C0340288 (UMLS CUI [1,2])
C0340288 (UMLS CUI [1,2])
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Conditions (5)
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Conditions (5)
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Conditions (5)
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Conditions (5)
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Conditions (5)
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Conditions (5)
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Conditions (5)
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Conditions (5)
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Conditions (5)
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Conditions (5)
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Conditions (5)
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Conditions (5)
Item
15. Left ventricular dysfunction
integer
C0242698 (UMLS CUI [1])
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Conditions (5)
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Conditions (5)
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Conditions (5)
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Conditions (5)
Item
19. Left ventricular hypertrophy
integer
C0149721 (UMLS CUI [1])
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Conditions (5)
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Conditions (5)
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Conditions (5)
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Conditions (5)
Item Group
Cardiovascular Surgical Procedures
C1320716 (UMLS CUI-1)
C0543467 (UMLS CUI-2)
C0543467 (UMLS CUI-2)
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Unknown (U)
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Unknown (U)
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Unknown (U)
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Unknown (U)
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Unknown (U)
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Unknown (U)
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Unknown (U)
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Unknown (U)
Item
1. Blood and lymphatic system disorders
integer
C0851353 (UMLS CUI [1])
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical History (3)
CL Item
Not Assessed (4)
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical History (3)
CL Item
Not Assessed (4)
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical History (3)
CL Item
Not Assessed (4)
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical History (3)
CL Item
Not Assessed (4)
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical History (3)
CL Item
Not Assessed (4)
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical History (3)
CL Item
Not Assessed (4)
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical History (3)
CL Item
Not Assessed (4)
Item
8. Metabolism and nutrition disorders
integer
C0851358 (UMLS CUI [1])
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical History (3)
CL Item
Not Assessed (4)
Item
9. Musculoskeletal and connective tissue disorders
integer
C0263660 (UMLS CUI [1])
Code List
9. Musculoskeletal and connective tissue disorders
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical History (3)
CL Item
Not Assessed (4)
Item
10. Neoplasms benign, malignant and unspecified (including cysts and polyps)
integer
C1882062 (UMLS CUI [1,1])
C0205183 (UMLS CUI [1,2])
C0006826 (UMLS CUI [2])
C1882062 (UMLS CUI [3,1])
C0205370 (UMLS CUI [3,2])
C0010709 (UMLS CUI [4])
C0032584 (UMLS CUI [5])
C0205183 (UMLS CUI [1,2])
C0006826 (UMLS CUI [2])
C1882062 (UMLS CUI [3,1])
C0205370 (UMLS CUI [3,2])
C0010709 (UMLS CUI [4])
C0032584 (UMLS CUI [5])
Code List
10. Neoplasms benign, malignant and unspecified (including cysts and polyps)
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical History (3)
CL Item
Not Assessed (4)
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical History (3)
CL Item
Not Assessed (4)
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical History (3)
CL Item
Not Assessed (4)
Item
13. Renal and urinary disorders
integer
C0042075 (UMLS CUI [1])
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical History (3)
CL Item
Not Assessed (4)
Item
14. Reproductive system and breast disorders
integer
C0851366 (UMLS CUI [1])
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical History (3)
CL Item
Not Assessed (4)
Item
15. Respiratory, thoracic and mediastinal disorders
integer
C0851355 (UMLS CUI [1])
Code List
15. Respiratory, thoracic and mediastinal disorders
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical History (3)
CL Item
Not Assessed (4)
Item
16. Skin and subcutaneous tissue disorders
integer
C0178301 (UMLS CUI [1])
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical History (3)
CL Item
Not Assessed (4)
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical History (3)
CL Item
Not Assessed (4)
Item
18. Infections and infestations
integer
C0009450 (UMLS CUI [1,1])
C0851341 (UMLS CUI [1,2])
C0851341 (UMLS CUI [1,2])
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical History (3)
CL Item
Not Assessed (4)
Item
19. Congenital, familial and genetic disorders
integer
C0851352 (UMLS CUI [1])
Code List
19. Congenital, familial and genetic disorders
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical History (3)
CL Item
Not Assessed (4)
Item
20. General disorders and administration site conditions
integer
C0851362 (UMLS CUI [1])
Code List
20. General disorders and administration site conditions
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical History (3)
CL Item
Not Assessed (4)
Item
21. Injury, poisoning and procedural complications
integer
C0947733 (UMLS CUI [1])
Code List
21. Injury, poisoning and procedural complications
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical History (3)
CL Item
Not Assessed (4)