ID

35679

Beschrijving

Study ID: 101468/192 Clinical Study ID: 101468/192 Study Title:A 52 Week Open-Label Extension Study of the Long-Term Safety of Ropinirole in Subjects Suffering from Restless Legs Syndrome (RLS) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: 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 The study consists of 16 visits which are devided in 3 study books: Book 1: Screening (+Baseline), Day 2, Week 1, Week 2 , Week 3 , Week 4, Week 5, Week 6, Week 7, Week 8 Book 2: Week 12, Week 24, Week 36, Week 48, Week 52, Follow-up Book 3: Early withdrawal and Follow-up Each follow-up Visit takes place 7 +/- 3 days after last dose Tthis document contains the vital signs document. It has to be filled in for Baseline, Week 52 and Early Withdrawal.

Trefwoorden

  1. 15-03-19 15-03-19 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

15 maart 2019

DOI

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Licentie

Creative Commons BY-NC 3.0

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Long-Term Safety of Ropinirole in Subjects Suffering from Restless Legs Syndrome (RLS), 101468/192

Vital Signs (Baseline, Week 52, Early Withdrawal)

Administrative data
Beschrijving

Administrative data

Alias
UMLS CUI-1
C1320722
Patient Number
Beschrijving

Patient Number

Datatype

text

Alias
UMLS CUI [1]
C2348585
Patient initials
Beschrijving

Patient initials

Datatype

text

Alias
UMLS CUI [1]
C2986440
Centre Number
Beschrijving

Centre Number

Datatype

integer

Alias
UMLS CUI [1,1]
C0600091
UMLS CUI [1,2]
C0019994
Visit Date
Beschrijving

day month year

Datatype

date

Alias
UMLS CUI [1]
C1320303
Visit type
Beschrijving

Visit type

Datatype

integer

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0332307
Vital Signs
Beschrijving

Vital Signs

Alias
UMLS CUI-1
C0518766
Weight
Beschrijving

(without shoes)

Datatype

float

Alias
UMLS CUI [1]
C0005910
Units of weight
Beschrijving

Units of weight

Datatype

integer

Alias
UMLS CUI [1,1]
C0005910
UMLS CUI [1,2]
C1519795
Pulse (after 5 minutes sitting)
Beschrijving

Pulse

Datatype

integer

Maateenheden
  • beats/min
Alias
UMLS CUI [1]
C0232117
beats/min
Blood Pressure systolic
Beschrijving

(after 5 minutes sitting)

Datatype

integer

Maateenheden
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Blood Pressure diastolic
Beschrijving

(after 5 minutes sitting)

Datatype

integer

Maateenheden
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg

Similar models

Vital Signs (Baseline, Week 52, Early Withdrawal)

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Patient Number
Item
Patient Number
text
C2348585 (UMLS CUI [1])
Patient initials
Item
Patient initials
text
C2986440 (UMLS CUI [1])
Centre Number
Item
Centre Number
integer
C0600091 (UMLS CUI [1,1])
C0019994 (UMLS CUI [1,2])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item
Visit type
integer
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Code List
Visit type
CL Item
Baseline (1)
CL Item
Week 52 (2)
CL Item
Early withdrawal (3)
Item Group
Vital Signs
C0518766 (UMLS CUI-1)
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Item
Units of weight
integer
C0005910 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
Code List
Units of weight
CL Item
kg (1)
CL Item
Ibs (2)
Pulse
Item
Pulse (after 5 minutes sitting)
integer
C0232117 (UMLS CUI [1])
Blood Pressure systolic
Item
Blood Pressure systolic
integer
C0871470 (UMLS CUI [1])
Blood Pressure diastolic
Item
Blood Pressure diastolic
integer
C0428883 (UMLS CUI [1])

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