ID
24042
Beschrijving
Module 2 - Screening & Repeat Tests 101468/243 Study ID: 101468/243 Clinical Study ID: 101468/243 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: N/A 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)
- 23-07-17 23-07-17 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
23 juli 2017
DOI
Voor een aanvraag inloggen.
Licentie
Creative Commons BY-NC 3.0
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GSK study: Ropinirole in RLS patients 101468/243 - Screening & Repeat Tests
GSK study: Ropinirole in RLS patients 101468/243 - Screening & Repeat Tests
Beschrijving
Laboratory Evaluation
Alias
- UMLS CUI-1
- C0022877
Beschrijving
Date of blood sample
Datatype
date
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0011008
Beschrijving
(Affix label only if sample was sent to Quest)
Datatype
text
Alias
- UMLS CUI [1]
- C4273937
Beschrijving
If "Yes", please record the diagnosis on the Baseline Signs and Symptoms page in this module and/or SAE page in separate pad and exclude the patient from the study.
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C1704258
Beschrijving
Urine Dipstick
Alias
- UMLS CUI-1
- C0430370
Beschrijving
If ’Positive’, please record details on the Significant Medical/Surgical History and Physical Examination or Baseline Signs and Symptom/SAE pages and send a sample to Quest Diagnostics for further evaluation.
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0430370
- UMLS CUI [1,2]
- C0456984
Beschrijving
Pregnancy dipstick
Alias
- UMLS CUI-1
- C0430056
Beschrijving
If ’Yes’, please perform a pregnancy dipstick test and record result below.
Datatype
integer
Alias
- UMLS CUI [1]
- C1960468
Beschrijving
If previous question was answered "yes", please perform a pregnancy dipstick test and record result below. If ’Positive’, please record details on the pregnancy form and exclude the patient.
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0430056
- UMLS CUI [1,2]
- C0456984
Beschrijving
Medical Procedures
Alias
- UMLS CUI-1
- C0199171
Beschrijving
If 'Yes', please record details below using standard medical terminology
Datatype
integer
Alias
- UMLS CUI [1]
- C0199171
- UMLS CUI [2]
- C0087111
- UMLS CUI [3]
- C0430022
- UMLS CUI [4]
- C0543467
Beschrijving
Medical Procedures
Alias
- UMLS CUI-1
- C0199171
Beschrijving
Procedure
Datatype
text
Alias
- UMLS CUI [1]
- C0199171
Beschrijving
Indication of medical procedure
Datatype
text
Alias
- UMLS CUI [1,1]
- C0199171
- UMLS CUI [1,2]
- C3146298
Beschrijving
Procedure Start Date
Datatype
date
Alias
- UMLS CUI [1,1]
- C0199171
- UMLS CUI [1,2]
- C0808070
Beschrijving
End Date Procedure
Datatype
date
Alias
- UMLS CUI [1,1]
- C0199171
- UMLS CUI [1,2]
- C0806020
Beschrijving
Prior and concomitant medication
Alias
- UMLS CUI-1
- C2826257
- UMLS CUI-2
- C2347852
Beschrijving
If ‘Yes’, please record details below (Please print clearly)
Datatype
integer
Alias
- UMLS CUI [1,1]
- C2826257
- UMLS CUI [1,2]
- C2347852
Beschrijving
prior and concomitant medication
Alias
- UMLS CUI-1
- C2826257
- UMLS CUI-2
- C2347852
Beschrijving
Drug name
Datatype
text
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0919189
Beschrijving
eg. 500 mg
Datatype
text
Alias
- UMLS CUI [1]
- C2348070
Beschrijving
or symptom in absence of diagnosis
Datatype
text
Alias
- UMLS CUI [1]
- C0011900
Beschrijving
start date of medication
Datatype
date
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0808070
Beschrijving
End Date of medication
Datatype
date
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0806020
Beschrijving
medication is current
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0521116
Beschrijving
Baseline signs and symptoms
Alias
- UMLS CUI-1
- C0037088
- UMLS CUI-2
- C1442488
Beschrijving
Baseline adverse reaction
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0037088
- UMLS CUI [1,2]
- C1442488
Beschrijving
Record any baseline events (using standard medical terminology) observed or elicited by the following direct question to patient: “Have you felt different in any way in the last 7 days?” Provide the diagnosis, not symptoms where possible. One baseline event per column.
Datatype
text
Alias
- UMLS CUI [1,1]
- C0559546
- UMLS CUI [1,2]
- C1442488
Beschrijving
Adverse Reaction Start Date Time
Datatype
datetime
Alias
- UMLS CUI [1,1]
- C2981441
- UMLS CUI [1,2]
- C1442488
Beschrijving
(If ongoing please leave blank)
Datatype
datetime
Alias
- UMLS CUI [1,1]
- C2981425
- UMLS CUI [1,2]
- C1442488
Beschrijving
If patient died, STOP: go to SAE section and follow instructions given there
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0559546
- UMLS CUI [1,2]
- C1624730
Beschrijving
adverse reaction course
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0559546
- UMLS CUI [1,2]
- C0750729
Beschrijving
only answer if previous answer was 'intermittent'
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0559546
- UMLS CUI [1,2]
- C4086638
Beschrijving
Intensity concerning the maximum
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0559546
- UMLS CUI [1,2]
- C0518690
Beschrijving
Relationship to study procedures
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C1510821
Beschrijving
If ‘Yes’, record details in Prior and Concomitant Medication section and/or Resource Utilisation section if appropriate
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0559546
- UMLS CUI [1,2]
- C0087111
Beschrijving
Study subject participation status due to adverse reaction
Datatype
integer
Alias
- UMLS CUI [1,1]
- C2348568
- UMLS CUI [1,2]
- C0559546
- UMLS CUI [1,3]
- C0424092
Beschrijving
Significant medical/surgical history and physical examination
Alias
- UMLS CUI-1
- C0262926
- UMLS CUI-3
- C0489540
- UMLS CUI-5
- C0031809
Beschrijving
If 'Yes' , please list below one diagnosis per line.
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0008976
- UMLS CUI [2,1]
- C0543467
- UMLS CUI [2,2]
- C0008976
Beschrijving
Significant medical/surgical history and physical examination
Alias
- UMLS CUI-1
- C0262926
- UMLS CUI-2
- C0489540
- UMLS CUI-3
- C0031809
Beschrijving
Diagnosis
Datatype
text
Alias
- UMLS CUI [1]
- C0011900
Beschrijving
Year of diagnosis
Datatype
partialDate
Alias
- UMLS CUI [1,1]
- C0011900
- UMLS CUI [1,2]
- C0439234
Beschrijving
Past and/or ongoing medical history
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0011900
- UMLS CUI [1,2]
- C0455458
- UMLS CUI [2]
- C2826680
Beschrijving
Patient continuation/ withdrawal
Alias
- UMLS CUI-1
- C2348568
Beschrijving
If ’Yes’, please place this Module in the CRF (Book 1) If ’No’, please mark the primary cause of withdrawal. (Mark one box only).
Datatype
integer
Alias
- UMLS CUI [1,1]
- C2348568
- UMLS CUI [1,2]
- C0549178
Beschrijving
Cause of withdrawal from study
Datatype
text
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C0085978
Beschrijving
Other cause of withdrawal from study
Datatype
text
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C0205394
Beschrijving
Investigator signature
Alias
- UMLS CUI-1
- C2346576
Beschrijving
I certify that I have reviewed the data in this Case Report Form, including laboratory data and that in the Baseline Signs and Symptoms and Serious Adverse Experience sections (if appropriate) and that all information is complete and accurate.
Datatype
text
Alias
- UMLS CUI [1]
- C2346576
Beschrijving
Investigator Signature Date
Datatype
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Beschrijving
Repeated Laboratory Evaluation
Alias
- UMLS CUI-1
- C0022877
- UMLS CUI-2
- C0205341
Beschrijving
Date of blood sample
Datatype
date
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0011008
Beschrijving
Affix label only if sample was sent to Quest
Datatype
text
Alias
- UMLS CUI [1]
- C4273937
Beschrijving
If "Yes", please record the diagnosis on the Baseline Signs and Symptoms page in this module and/or SAE page in separate pad and exclude the patient from the study.
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C1704258
Beschrijving
Repeated Urine dipstick
Alias
- UMLS CUI-1
- C0430370
- UMLS CUI-2
- C0205341
Beschrijving
If ’Positive’, please record details on the Significant Medical/Surgical History and Physical Examination or Baseline Signs and Symptom/SAE pages and send a sample to Quest Diagnostics for further evaluation.
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0430370
- UMLS CUI [1,2]
- C0456984
Similar models
GSK study: Ropinirole in RLS patients 101468/243 - Screening & Repeat Tests
C0277814 (UMLS CUI [1,2])
C0277814 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,2])
C0456984 (UMLS CUI [1,2])
C0456984 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2])
C0430022 (UMLS CUI [3])
C0543467 (UMLS CUI [4])
C3146298 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
C2347852 (UMLS CUI-2)
C2347852 (UMLS CUI [1,2])
C2347852 (UMLS CUI-2)
C0919189 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
C0521116 (UMLS CUI [1,2])
C1442488 (UMLS CUI-2)
C1442488 (UMLS CUI [1,2])
C1442488 (UMLS CUI [1,2])
C1442488 (UMLS CUI [1,2])
C1442488 (UMLS CUI [1,2])
C0750729 (UMLS CUI [1,2])
C4086638 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,2])
C1510821 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,2])
C0559546 (UMLS CUI [1,2])
C0424092 (UMLS CUI [1,3])
C0489540 (UMLS CUI-3)
C0031809 (UMLS CUI-5)
C0008976 (UMLS CUI [1,2])
C0543467 (UMLS CUI [2,1])
C0008976 (UMLS CUI [2,2])
C0489540 (UMLS CUI-2)
C0031809 (UMLS CUI-3)
C0439234 (UMLS CUI [1,2])
C0455458 (UMLS CUI [1,2])
C2826680 (UMLS CUI [2])
C0549178 (UMLS CUI [1,2])
C0085978 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0205341 (UMLS CUI-2)
C0011008 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,2])
C0205341 (UMLS CUI-2)
C0456984 (UMLS CUI [1,2])
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