ID
24042
Descripción
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
Palabras clave
Versiones (1)
- 23/7/17 23/7/17 -
Titular de derechos de autor
GlaxoSmithKline
Subido en
23 de julio de 2017
DOI
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Licencia
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
Descripción
Laboratory Evaluation
Alias
- UMLS CUI-1
- C0022877
Descripción
Date of blood sample
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0011008
Descripción
(Affix label only if sample was sent to Quest)
Tipo de datos
text
Alias
- UMLS CUI [1]
- C4273937
Descripción
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.
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C1704258
Descripción
Urine Dipstick
Alias
- UMLS CUI-1
- C0430370
Descripción
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.
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0430370
- UMLS CUI [1,2]
- C0456984
Descripción
Pregnancy dipstick
Alias
- UMLS CUI-1
- C0430056
Descripción
If ’Yes’, please perform a pregnancy dipstick test and record result below.
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C1960468
Descripción
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.
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0430056
- UMLS CUI [1,2]
- C0456984
Descripción
Medical Procedures
Alias
- UMLS CUI-1
- C0199171
Descripción
If 'Yes', please record details below using standard medical terminology
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0199171
- UMLS CUI [2]
- C0087111
- UMLS CUI [3]
- C0430022
- UMLS CUI [4]
- C0543467
Descripción
Medical Procedures
Alias
- UMLS CUI-1
- C0199171
Descripción
Procedure
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0199171
Descripción
Indication of medical procedure
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0199171
- UMLS CUI [1,2]
- C3146298
Descripción
Procedure Start Date
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0199171
- UMLS CUI [1,2]
- C0808070
Descripción
End Date Procedure
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0199171
- UMLS CUI [1,2]
- C0806020
Descripción
Prior and concomitant medication
Alias
- UMLS CUI-1
- C2826257
- UMLS CUI-2
- C2347852
Descripción
If ‘Yes’, please record details below (Please print clearly)
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C2826257
- UMLS CUI [1,2]
- C2347852
Descripción
prior and concomitant medication
Alias
- UMLS CUI-1
- C2826257
- UMLS CUI-2
- C2347852
Descripción
Drug name
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0919189
Descripción
eg. 500 mg
Tipo de datos
text
Alias
- UMLS CUI [1]
- C2348070
Descripción
or symptom in absence of diagnosis
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0011900
Descripción
start date of medication
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0808070
Descripción
End Date of medication
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0806020
Descripción
medication is current
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0521116
Descripción
Baseline signs and symptoms
Alias
- UMLS CUI-1
- C0037088
- UMLS CUI-2
- C1442488
Descripción
Baseline adverse reaction
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0037088
- UMLS CUI [1,2]
- C1442488
Descripción
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.
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0559546
- UMLS CUI [1,2]
- C1442488
Descripción
Adverse Reaction Start Date Time
Tipo de datos
datetime
Alias
- UMLS CUI [1,1]
- C2981441
- UMLS CUI [1,2]
- C1442488
Descripción
(If ongoing please leave blank)
Tipo de datos
datetime
Alias
- UMLS CUI [1,1]
- C2981425
- UMLS CUI [1,2]
- C1442488
Descripción
If patient died, STOP: go to SAE section and follow instructions given there
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0559546
- UMLS CUI [1,2]
- C1624730
Descripción
adverse reaction course
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0559546
- UMLS CUI [1,2]
- C0750729
Descripción
only answer if previous answer was 'intermittent'
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0559546
- UMLS CUI [1,2]
- C4086638
Descripción
Intensity concerning the maximum
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0559546
- UMLS CUI [1,2]
- C0518690
Descripción
Relationship to study procedures
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C1510821
Descripción
If ‘Yes’, record details in Prior and Concomitant Medication section and/or Resource Utilisation section if appropriate
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0559546
- UMLS CUI [1,2]
- C0087111
Descripción
Study subject participation status due to adverse reaction
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C2348568
- UMLS CUI [1,2]
- C0559546
- UMLS CUI [1,3]
- C0424092
Descripción
Significant medical/surgical history and physical examination
Alias
- UMLS CUI-1
- C0262926
- UMLS CUI-3
- C0489540
- UMLS CUI-5
- C0031809
Descripción
If 'Yes' , please list below one diagnosis per line.
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0008976
- UMLS CUI [2,1]
- C0543467
- UMLS CUI [2,2]
- C0008976
Descripción
Significant medical/surgical history and physical examination
Alias
- UMLS CUI-1
- C0262926
- UMLS CUI-2
- C0489540
- UMLS CUI-3
- C0031809
Descripción
Diagnosis
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0011900
Descripción
Year of diagnosis
Tipo de datos
partialDate
Alias
- UMLS CUI [1,1]
- C0011900
- UMLS CUI [1,2]
- C0439234
Descripción
Past and/or ongoing medical history
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0011900
- UMLS CUI [1,2]
- C0455458
- UMLS CUI [2]
- C2826680
Descripción
Patient continuation/ withdrawal
Alias
- UMLS CUI-1
- C2348568
Descripción
If ’Yes’, please place this Module in the CRF (Book 1) If ’No’, please mark the primary cause of withdrawal. (Mark one box only).
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C2348568
- UMLS CUI [1,2]
- C0549178
Descripción
Cause of withdrawal from study
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C0085978
Descripción
Other cause of withdrawal from study
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C0205394
Descripción
Investigator signature
Alias
- UMLS CUI-1
- C2346576
Descripción
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.
Tipo de datos
text
Alias
- UMLS CUI [1]
- C2346576
Descripción
Investigator Signature Date
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Descripción
Repeated Laboratory Evaluation
Alias
- UMLS CUI-1
- C0022877
- UMLS CUI-2
- C0205341
Descripción
Date of blood sample
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0011008
Descripción
Affix label only if sample was sent to Quest
Tipo de datos
text
Alias
- UMLS CUI [1]
- C4273937
Descripción
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.
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C1704258
Descripción
Repeated Urine dipstick
Alias
- UMLS CUI-1
- C0430370
- UMLS CUI-2
- C0205341
Descripción
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.
Tipo de datos
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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