ID
24042
Beskrivning
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
Nyckelord
Versioner (1)
- 2017-07-23 2017-07-23 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
23 juli 2017
DOI
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Licens
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
Beskrivning
Laboratory Evaluation
Alias
- UMLS CUI-1
- C0022877
Beskrivning
Date of blood sample
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0011008
Beskrivning
(Affix label only if sample was sent to Quest)
Datatyp
text
Alias
- UMLS CUI [1]
- C4273937
Beskrivning
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.
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C1704258
Beskrivning
Urine Dipstick
Alias
- UMLS CUI-1
- C0430370
Beskrivning
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.
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0430370
- UMLS CUI [1,2]
- C0456984
Beskrivning
Pregnancy dipstick
Alias
- UMLS CUI-1
- C0430056
Beskrivning
If ’Yes’, please perform a pregnancy dipstick test and record result below.
Datatyp
integer
Alias
- UMLS CUI [1]
- C1960468
Beskrivning
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.
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0430056
- UMLS CUI [1,2]
- C0456984
Beskrivning
Medical Procedures
Alias
- UMLS CUI-1
- C0199171
Beskrivning
If 'Yes', please record details below using standard medical terminology
Datatyp
integer
Alias
- UMLS CUI [1]
- C0199171
- UMLS CUI [2]
- C0087111
- UMLS CUI [3]
- C0430022
- UMLS CUI [4]
- C0543467
Beskrivning
Medical Procedures
Alias
- UMLS CUI-1
- C0199171
Beskrivning
Procedure
Datatyp
text
Alias
- UMLS CUI [1]
- C0199171
Beskrivning
Indication of medical procedure
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0199171
- UMLS CUI [1,2]
- C3146298
Beskrivning
Procedure Start Date
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0199171
- UMLS CUI [1,2]
- C0808070
Beskrivning
End Date Procedure
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0199171
- UMLS CUI [1,2]
- C0806020
Beskrivning
Prior and concomitant medication
Alias
- UMLS CUI-1
- C2826257
- UMLS CUI-2
- C2347852
Beskrivning
If ‘Yes’, please record details below (Please print clearly)
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C2826257
- UMLS CUI [1,2]
- C2347852
Beskrivning
prior and concomitant medication
Alias
- UMLS CUI-1
- C2826257
- UMLS CUI-2
- C2347852
Beskrivning
Drug name
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0919189
Beskrivning
eg. 500 mg
Datatyp
text
Alias
- UMLS CUI [1]
- C2348070
Beskrivning
or symptom in absence of diagnosis
Datatyp
text
Alias
- UMLS CUI [1]
- C0011900
Beskrivning
start date of medication
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0808070
Beskrivning
End Date of medication
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0806020
Beskrivning
medication is current
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0521116
Beskrivning
Baseline signs and symptoms
Alias
- UMLS CUI-1
- C0037088
- UMLS CUI-2
- C1442488
Beskrivning
Baseline adverse reaction
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0037088
- UMLS CUI [1,2]
- C1442488
Beskrivning
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.
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0559546
- UMLS CUI [1,2]
- C1442488
Beskrivning
Adverse Reaction Start Date Time
Datatyp
datetime
Alias
- UMLS CUI [1,1]
- C2981441
- UMLS CUI [1,2]
- C1442488
Beskrivning
(If ongoing please leave blank)
Datatyp
datetime
Alias
- UMLS CUI [1,1]
- C2981425
- UMLS CUI [1,2]
- C1442488
Beskrivning
If patient died, STOP: go to SAE section and follow instructions given there
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0559546
- UMLS CUI [1,2]
- C1624730
Beskrivning
adverse reaction course
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0559546
- UMLS CUI [1,2]
- C0750729
Beskrivning
only answer if previous answer was 'intermittent'
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0559546
- UMLS CUI [1,2]
- C4086638
Beskrivning
Intensity concerning the maximum
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0559546
- UMLS CUI [1,2]
- C0518690
Beskrivning
Relationship to study procedures
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C1510821
Beskrivning
If ‘Yes’, record details in Prior and Concomitant Medication section and/or Resource Utilisation section if appropriate
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0559546
- UMLS CUI [1,2]
- C0087111
Beskrivning
Study subject participation status due to adverse reaction
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C2348568
- UMLS CUI [1,2]
- C0559546
- UMLS CUI [1,3]
- C0424092
Beskrivning
Significant medical/surgical history and physical examination
Alias
- UMLS CUI-1
- C0262926
- UMLS CUI-3
- C0489540
- UMLS CUI-5
- C0031809
Beskrivning
If 'Yes' , please list below one diagnosis per line.
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0008976
- UMLS CUI [2,1]
- C0543467
- UMLS CUI [2,2]
- C0008976
Beskrivning
Significant medical/surgical history and physical examination
Alias
- UMLS CUI-1
- C0262926
- UMLS CUI-2
- C0489540
- UMLS CUI-3
- C0031809
Beskrivning
Diagnosis
Datatyp
text
Alias
- UMLS CUI [1]
- C0011900
Beskrivning
Year of diagnosis
Datatyp
partialDate
Alias
- UMLS CUI [1,1]
- C0011900
- UMLS CUI [1,2]
- C0439234
Beskrivning
Past and/or ongoing medical history
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0011900
- UMLS CUI [1,2]
- C0455458
- UMLS CUI [2]
- C2826680
Beskrivning
Patient continuation/ withdrawal
Alias
- UMLS CUI-1
- C2348568
Beskrivning
If ’Yes’, please place this Module in the CRF (Book 1) If ’No’, please mark the primary cause of withdrawal. (Mark one box only).
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C2348568
- UMLS CUI [1,2]
- C0549178
Beskrivning
Cause of withdrawal from study
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C0085978
Beskrivning
Other cause of withdrawal from study
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C0205394
Beskrivning
Investigator signature
Alias
- UMLS CUI-1
- C2346576
Beskrivning
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.
Datatyp
text
Alias
- UMLS CUI [1]
- C2346576
Beskrivning
Investigator Signature Date
Datatyp
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Beskrivning
Repeated Laboratory Evaluation
Alias
- UMLS CUI-1
- C0022877
- UMLS CUI-2
- C0205341
Beskrivning
Date of blood sample
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0011008
Beskrivning
Affix label only if sample was sent to Quest
Datatyp
text
Alias
- UMLS CUI [1]
- C4273937
Beskrivning
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.
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C1704258
Beskrivning
Repeated Urine dipstick
Alias
- UMLS CUI-1
- C0430370
- UMLS CUI-2
- C0205341
Beskrivning
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.
Datatyp
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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