ID

25768

Description

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)

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Versions (1)
  1. 9/18/17 9/18/17 -
Copyright Holder

GlaxoSmithKline

Uploaded on

September 18, 2017

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Creative Commons BY-NC-ND 3.0
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Serious Adverse Event (SAE) GSK Ropinirole Restless Legs Syndrome 101468

English

Serious Adverse Event (SAE) GSK Ropinirole Restless Legs Syndrome 101468

1 forms  
Patient Information
Description

Patient Information

Alias
UMLS CUI-1
C1955348
Patient Number
Description

Patient Number

Data type

text

Alias
UMLS CUI [1]
C1830427
Centre Number
Description

Centre Number

Data type

text

Alias
UMLS CUI [1,1]
C0600091
UMLS CUI [1,2]
C0019994
Visit Date
Description

Visit Date

Data type

date

Measurement units
  • dd-mmm-yyyy
Alias
UMLS CUI [1]
C1320303
dd-mmm-yyyy
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.
Description

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
Person Reporting SAE
Description

Investigator's Name

Data type

text

Alias
UMLS CUI [1]
C2826892
AEGIS Number
Description

Number

Data type

text

Alias
UMLS CUI [1]
C0237753
Serious Adverse Event
Description

Serious Adverse Event

Data type

text

Alias
UMLS CUI [1]
C1519255
Specify reason(s) for considering this a serious AE. Mark all that apply.
Description

Reason

Data type

text

Alias
UMLS CUI [1]
C0566251
Specify reason(s) for considering this a serious AE. Mark all that apply. If 'Other', please specify:
Description

Reason: Specification

Data type

text

Alias
UMLS CUI [1,1]
C0566251
UMLS CUI [1,2]
C2348235
Onset Date
Description

Onset Date

Data type

date

Measurement units
  • dd-mmm-yyyy
Alias
UMLS CUI [1]
C0574845
dd-mmm-yyyy
Onset Time
Description

Onset Time

Data type

time

Measurement units
  • 24hr:min
Alias
UMLS CUI [1]
C0449244
24hr:min
End Date (If ongoing please leave blank)
Description

End Date

Data type

date

Measurement units
  • dd-mmm-yyyy
Alias
UMLS CUI [1]
C0806020
dd-mmm-yyyy
End Time (If ongoing please leave blank)
Description

End Time

Data type

time

Measurement units
  • 24hr:min
24hr:min
Outcome
Description

* If subject died, please inform GSK within 24 hours and complete Form D

Data type

text

Alias
UMLS CUI [1,1]
C1705586
UMLS CUI [1,2]
C1519255
Event Course
Description

Event Course

Data type

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0750729
Event Course If Intermittent, specify No. of episodes
Description

Number of Episodes

Data type

float

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C4086638
Intensity (maximum)
Description

Intensity

Data type

text

Alias
UMLS CUI [1]
C1710066
Action Taken with Respect to Investigational Drug
Description

Action taken

Data type

text

Alias
UMLS CUI [1]
C2826626
Relationship to Investigational Drug
Description

Relationship

Data type

text

Alias
UMLS CUI [1]
C0439849
Relationship to Investigational Drug: If 'Not related', 'Unlikely', The SAE is probably associated with:
Description

Assessment

Data type

text

Alias
UMLS CUI [1]
C0220825
Relationship to Investigational Drug: If 'Not related', 'Unlikely', The SAE is probably associated with: Please specify
Description

Assessment Specification

Data type

text

Alias
UMLS CUI [1,1]
C0220825
UMLS CUI [1,2]
C2348235
Corrective Therapy
Description

If 'YES', Please record on Concomitant Medication form

Data type

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0087111
Was subject withdrawn due to this AE?
Description

Withdrawal

Data type

boolean

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C1519255
Did the SAE ablate?
Description

Ablation

Data type

boolean

Alias
UMLS CUI [1]
C0547070
If study medication was interrupted, stopped or dose reduced: Was study medication reintroduced (or dose increased)?
Description

Retreatment with study medication

Data type

boolean

Alias
UMLS CUI [1,1]
C0376495
UMLS CUI [1,2]
C0304229
If 'YES', did SAE recur?
Description

Recurrence

Data type

boolean

Alias
UMLS CUI [1]
C0034897
Serious Adverse Event (SAE) - Relevant Laboratory Data (Please provide relevant abnormal laboratory data below)
Description

Serious Adverse Event (SAE) - Relevant Laboratory Data (Please provide relevant abnormal laboratory data below)

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0587081
Test
Description

Laboratory Test

Data type

text

Alias
UMLS CUI [1]
C0022885
Date
Description

Laboratory Test Date

Data type

date

Measurement units
  • dd-mmm-yyyy
Alias
UMLS CUI [1]
C2826641
dd-mmm-yyyy
Value
Description

Laboratory Value

Data type

text

Alias
UMLS CUI [1]
C0587081
Units
Description

Measurement Unit

Data type

text

Alias
UMLS CUI [1]
C1519795
Normal Range
Description

Normal Range

Data type

text

Alias
UMLS CUI [1]
C0086715
Remarks (Please provide a brief narrative description of the SAE, attaching extra eg. hospital discharge summary if necessary)
Description

Remarks

Data type

text

If applicable, was randomisation code broken at investigational site?
Description

Randomization

Data type

boolean

Alias
UMLS CUI [1]
C0034656
Randomisation/Study Medication Number:
Description

Randomization Number

Data type

float

Alias
UMLS CUI [1]
C2986235
Investigator's Signature (confirming that the above data are accurate and complete)
Description

Investigator's Name

Data type

text

Alias
UMLS CUI [1]
C2826892
Date
Description

Date of Report

Data type

date

Measurement units
  • dd-mmm-yyyy
Alias
UMLS CUI [1]
C1302584
dd-mmm-yyyy
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Similar models

Serious Adverse Event (SAE) GSK Ropinirole Restless Legs Syndrome 101468

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Patient Information
C1955348 (UMLS CUI-1)
Patient Number
Item
Patient Number
text
C1830427 (UMLS CUI [1])
Centre Number
Item
Centre Number
text
C0600091 (UMLS CUI [1,1])
C0019994 (UMLS CUI [1,2])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item Group
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.
C1519255 (UMLS CUI-1)
Investigator's Name
Item
Person Reporting SAE
text
C2826892 (UMLS CUI [1])
Number
Item
AEGIS Number
text
C0237753 (UMLS CUI [1])
Serious Adverse Event
Item
Serious Adverse Event
text
C1519255 (UMLS CUI [1])
Item
Specify reason(s) for considering this a serious AE. Mark all that apply.
text
C0566251 (UMLS CUI [1])
Reason
Code List
Specify reason(s) for considering this a serious AE. Mark all that apply.
CL Item
results in Death (A)
CL Item
life threatening (B)
CL Item
requires hospitalisation or prolongation existing hospitalization (C)
CL Item
results in disability/incapacity (D)
CL Item
congenital anomaly/birth defect (E)
CL Item
other (F)
Reason: Specification
Item
Specify reason(s) for considering this a serious AE. Mark all that apply. If 'Other', please specify:
text
C0566251 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Onset Date
Item
Onset Date
date
C0574845 (UMLS CUI [1])
Onset Time
Item
Onset Time
time
C0449244 (UMLS CUI [1])
End Date
Item
End Date (If ongoing please leave blank)
date
C0806020 (UMLS CUI [1])
End Time
Item
End Time (If ongoing please leave blank)
time
Item
Outcome
text
C1705586 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Serious Adverse Event Outcome
Code List
Outcome
CL Item
Resolved (Resolved)
CL Item
Ongoing (Ongoing)
CL Item
Died* (Died*)
Item
Event Course
text
C0877248 (UMLS CUI [1,1])
C0750729 (UMLS CUI [1,2])
Event Course
Code List
Event Course
CL Item
Intermittent (Intermittent)
CL Item
Constant (Constant)
Number of Episodes
Item
Event Course If Intermittent, specify No. of episodes
float
C0877248 (UMLS CUI [1,1])
C4086638 (UMLS CUI [1,2])
Item
Intensity (maximum)
text
C1710066 (UMLS CUI [1])
Intensity
Code List
Intensity (maximum)
CL Item
Mild (Mild)
CL Item
Moderate (Moderate)
CL Item
Severe (Severe)
Item
Action Taken with Respect to Investigational Drug
text
C2826626 (UMLS CUI [1])
action taken
Code List
Action Taken with Respect to Investigational Drug
CL Item
Dose increased (Dose increased)
CL Item
Dose reduced (Dose reduced)
CL Item
Drug interrupted/restarted (Drug interrupted/restarted)
CL Item
Drug stopped (Drug stopped)
CL Item
None (None)
Item
Relationship to Investigational Drug
text
C0439849 (UMLS CUI [1])
Relationship
Code List
Relationship to Investigational Drug
CL Item
Not related (Not related)
CL Item
Unlikely (Unlikely)
CL Item
Suspected (reasonable possibility) (Suspected (reasonable possibility))
CL Item
Probable (Probable)
Item
Relationship to Investigational Drug: If 'Not related', 'Unlikely', The SAE is probably associated with:
text
C0220825 (UMLS CUI [1])
Assessment
Code List
Relationship to Investigational Drug: If 'Not related', 'Unlikely', The SAE is probably associated with:
CL Item
Protocol design or procedures (Protocol design or procedures)
CL Item
Another condition (e.g., condition under study, intercurrent illness) (Another condition (e.g., condition under study, intercurrent illness))
CL Item
Another drug (Another drug)
Assessment Specification
Item
Relationship to Investigational Drug: If 'Not related', 'Unlikely', The SAE is probably associated with: Please specify
text
C0220825 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Corrective Therapy
Item
Corrective Therapy
boolean
C0877248 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
Withdrawal
Item
Was subject withdrawn due to this AE?
boolean
C2349954 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Ablation
Item
Did the SAE ablate?
boolean
C0547070 (UMLS CUI [1])
Retreatment with study medication
Item
If study medication was interrupted, stopped or dose reduced: Was study medication reintroduced (or dose increased)?
boolean
C0376495 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Recurrence
Item
If 'YES', did SAE recur?
boolean
C0034897 (UMLS CUI [1])
Item Group
Serious Adverse Event (SAE) - Relevant Laboratory Data (Please provide relevant abnormal laboratory data below)
C1519255 (UMLS CUI-1)
C0587081 (UMLS CUI-2)
Laboratory Test
Item
Test
text
C0022885 (UMLS CUI [1])
Laboratory Test Date
Item
Date
date
C2826641 (UMLS CUI [1])
Laboratory Value
Item
Value
text
C0587081 (UMLS CUI [1])
Measurement Unit
Item
Units
text
C1519795 (UMLS CUI [1])
Normal Range
Item
Normal Range
text
C0086715 (UMLS CUI [1])
Remarks
Item
Remarks (Please provide a brief narrative description of the SAE, attaching extra eg. hospital discharge summary if necessary)
text
Randomization
Item
If applicable, was randomisation code broken at investigational site?
boolean
C0034656 (UMLS CUI [1])
Randomization Number
Item
Randomisation/Study Medication Number:
float
C2986235 (UMLS CUI [1])
Investigator's Name
Item
Investigator's Signature (confirming that the above data are accurate and complete)
text
C2826892 (UMLS CUI [1])
Date of Report
Item
Date
date
C1302584 (UMLS CUI [1])
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