ID

35553

Description

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 This document contains the Pregnancy Dipstick form. It has to be filled in for Screening (+Baseline), Week 24, Week 52 and fpr early withdrawal.

Keywords

Versions (1)
  1. 3/8/19 3/8/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

March 8, 2019

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License

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

English

Pregnancy Dipstick

1 forms  
  1. StudyEvent: ODM
    1. Pregnancy Dipstick
Administrative data
Description

Administrative data

Alias
UMLS CUI-1
C1320722 (Administrative documentation)
SNOMED
405624007
Centre Number
Description

Centre Number

Data type

integer

Alias
UMLS CUI [1,1]
C0600091 (Identifier)
SNOMED
118522005
LOINC
LP31795-5
UMLS CUI [1,2]
C0019994 (Hospitals)
Patient Initials
Description

Patient Initials

Data type

text

Alias
UMLS CUI [1]
C2986440 (Person Initials)
Patient Number
Description

Patient Number

Data type

text

Alias
UMLS CUI [1]
C2348585 (Clinical Trial Subject Unique Identifier)
Visit type
Description

Visit type

Data type

integer

Alias
UMLS CUI [1,1]
C0545082 (Visit)
UMLS CUI [1,2]
C0332307 (Type - attribute)
SNOMED
261664005
Pregnancy Dipstick
Description

Pregnancy Dipstick

Alias
UMLS CUI-1
C0430056 (Urine pregnancy test)
SNOMED
167252002
Is the patient a female of child-bearing potential?
Description

child-bearing potential

Data type

boolean

Alias
UMLS CUI [1]
C1960468 (Female of child bearing age)
SNOMED
427504007
Pregnancy Dipstick Result
Description

If patient is of child-bearing potential, please perform a pregnancy dipstick test and record result below. If ’Positive’, please record details on the Pregnancy Notification Form and withdraw the patient.

Data type

text

Alias
UMLS CUI [1,1]
C0430056 (Urine pregnancy test)
SNOMED
167252002
UMLS CUI [1,2]
C0456984 (Test Result)
SNOMED
277775005
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Similar models

Pregnancy Dipstick

1 forms
  1. StudyEvent: ODM
    1. Pregnancy Dipstick
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Centre Number
Item
Centre Number
integer
C0600091 (UMLS CUI [1,1])
C0019994 (UMLS CUI [1,2])
Patient Initials
Item
Patient Initials
text
C2986440 (UMLS CUI [1])
Patient Number
Item
Patient Number
text
C2348585 (UMLS CUI [1])
Item
Visit type
integer
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Visit type
Code List
Visit type
CL Item
Screening (+Baseline) (1)
CL Item
Week 24  (2)
CL Item
Week 52 (3)
CL Item
Early withdrawal (4)
Item Group
Pregnancy Dipstick
C0430056 (UMLS CUI-1)
child-bearing potential
Item
Is the patient a female of child-bearing potential?
boolean
C1960468 (UMLS CUI [1])
Item
Pregnancy Dipstick Result
text
C0430056 (UMLS CUI [1,1])
C0456984 (UMLS CUI [1,2])
Pregnancy Dipstick Result
Code List
Pregnancy Dipstick Result
CL Item
Positive (P)
CL Item
Negative (N)
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