ID
25768
Descripción
Study ID: 101468/207 Clinical Study ID: SKF-101468/207 Study Title:A double-blind, randomized, placebo-controlled, parallel-group study to investigate the tolerability of a dose-escalating regimen of ropinirole in patients suffering from Restless Legs Syndrome (RLS). Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 2 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Requip Study Indication : Restless Legs Syndrome Serious Adverse Event (SAE)
Palabras clave
Versiones (1)
- 18/9/17 18/9/17 -
Titular de derechos de autor
GlaxoSmithKline
Subido en
18 de septiembre de 2017
DOI
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Licencia
Creative Commons BY-NC-ND 3.0
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Serious Adverse Event (SAE) GSK Ropinirole Restless Legs Syndrome 101468
Serious Adverse Event (SAE) GSK Ropinirole Restless Legs Syndrome 101468
Descripción
Serious Adverse Event - Complete the SAE Pages. Please complete these pages fully and accurately as possible in order to minimise the time you spend dealing with data queries. If the SAE is still ongoing at the time of reporting, please leave 'Event Course' blank and update it later. Sign and date the SAE page. Please ensure that all of the information on the following CRF pages is complete (Demography, significant Medical/Surgical History and Physiology Examination, Study Medication Record, Concomitant Medication, Form D (if applicable). Photocophy the SAE pages and the CRF pages specified above (Do not separate the NCR pages). Fax a copy of the SAE pages and all of the CRF pages specified above to: Your local GSK CRA/Medical Monitor (see Investigator Site File for appropriate fax number). If no photocopier OR fax is available please telephone your local GSK CRA/Medical monitor within 24 hours.
Alias
- UMLS CUI-1
- C1519255
Descripción
Investigator's Name
Tipo de datos
text
Alias
- UMLS CUI [1]
- C2826892
Descripción
Number
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0237753
Descripción
Serious Adverse Event
Tipo de datos
text
Alias
- UMLS CUI [1]
- C1519255
Descripción
Reason
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0566251
Descripción
Reason: Specification
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0566251
- UMLS CUI [1,2]
- C2348235
Descripción
Onset Date
Tipo de datos
date
Unidades de medida
- dd-mmm-yyyy
Alias
- UMLS CUI [1]
- C0574845
Descripción
Onset Time
Tipo de datos
time
Unidades de medida
- 24hr:min
Alias
- UMLS CUI [1]
- C0449244
Descripción
End Date
Tipo de datos
date
Unidades de medida
- dd-mmm-yyyy
Alias
- UMLS CUI [1]
- C0806020
Descripción
End Time
Tipo de datos
time
Unidades de medida
- 24hr:min
Descripción
* If subject died, please inform GSK within 24 hours and complete Form D
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1705586
- UMLS CUI [1,2]
- C1519255
Descripción
Event Course
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0750729
Descripción
Number of Episodes
Tipo de datos
float
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C4086638
Descripción
Intensity
Tipo de datos
text
Alias
- UMLS CUI [1]
- C1710066
Descripción
Action taken
Tipo de datos
text
Alias
- UMLS CUI [1]
- C2826626
Descripción
Relationship
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0439849
Descripción
Assessment
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0220825
Descripción
Assessment Specification
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0220825
- UMLS CUI [1,2]
- C2348235
Descripción
If 'YES', Please record on Concomitant Medication form
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0087111
Descripción
Withdrawal
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C2349954
- UMLS CUI [1,2]
- C1519255
Descripción
Ablation
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0547070
Descripción
Retreatment with study medication
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0376495
- UMLS CUI [1,2]
- C0304229
Descripción
Recurrence
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0034897
Descripción
Serious Adverse Event (SAE) - Relevant Laboratory Data (Please provide relevant abnormal laboratory data below)
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0587081
Descripción
Laboratory Test
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0022885
Descripción
Laboratory Test Date
Tipo de datos
date
Unidades de medida
- dd-mmm-yyyy
Alias
- UMLS CUI [1]
- C2826641
Descripción
Laboratory Value
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0587081
Descripción
Measurement Unit
Tipo de datos
text
Alias
- UMLS CUI [1]
- C1519795
Descripción
Normal Range
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0086715
Descripción
Remarks
Tipo de datos
text
Descripción
Randomization
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0034656
Descripción
Randomization Number
Tipo de datos
float
Alias
- UMLS CUI [1]
- C2986235
Descripción
Investigator's Name
Tipo de datos
text
Alias
- UMLS CUI [1]
- C2826892
Descripción
Date of Report
Tipo de datos
date
Unidades de medida
- dd-mmm-yyyy
Alias
- UMLS CUI [1]
- C1302584
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Serious Adverse Event (SAE) GSK Ropinirole Restless Legs Syndrome 101468
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