ID

29117

Beschreibung

Study ID: 101468/249 Clinical Study ID: 101468/249 Study Title: A 12-Week, Double-Blind, Placebo Controlled, Parallel Group Study to Assess the Efficacy and Safety of Ropinirole in Patients Suffering from Restless Legs Syndrome (RLS) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00363857 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: N/A 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; Restless Legs Syndrome (RLS)

Stichworte

Versionen (1)
  1. 26.02.18 26.02.18 -
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GlaxoSmithKline (GSK)

Hochgeladen am

26. Februar 2018

DOI

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Clinical Study, Ropinirole in Patients Suffering from Restless Legs Syndrome (RLS), Study ID: 101468/249, NCT00363857

Englisch

Serious adverse events, Form D and Vitals

1 Formulare  
Administration
Beschreibung

Administration

Alias
UMLS CUI-1
C1320722
Center Number
Beschreibung

Center Number

Datentyp

integer

Alias
UMLS CUI [1,1]
C1301943
UMLS CUI [1,2]
C0600091
Patient number
Beschreibung

Patient number

Datentyp

integer

Alias
UMLS CUI [1]
C1830427
GSK Receipt Date
Beschreibung

GSK Receipt Date

Datentyp

date

Alias
UMLS CUI [1]
C2985846
Serious adverse experience
Beschreibung

Serious adverse experience

Alias
UMLS CUI-1
C1519255
Person Reporting SAE (Please print clearly)
Beschreibung

Person Reporting SAE

Datentyp

text

Alias
UMLS CUI [1,1]
C0008961
UMLS CUI [1,2]
C1519255
AEGIS Number
Beschreibung

AEGIS Number

Datentyp

integer

Alias
UMLS CUI [1,1]
C0237753
UMLS CUI [1,2]
C0600091
Onset Date and Time
Beschreibung

Onset Date and Time

Datentyp

datetime

Alias
UMLS CUI [1]
C2826806
End Date and Time (If ongoing please leave blank)
Beschreibung

End Date and Time

Datentyp

datetime

Alias
UMLS CUI [1]
C2826793
Outcome If patient died, please complete Form D
Beschreibung

Outcome

Datentyp

integer

Alias
UMLS CUI [1]
C1705586
Experience Course
Beschreibung

Experience Course

Datentyp

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0750729
If intermittent please specify No. of episodes
Beschreibung

Experience Course

Datentyp

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0750729
Intensity (maximum)
Beschreibung

Intensity (maximum)

Datentyp

integer

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

Action Taken

Datentyp

integer

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

Relationship to Investigational Drug

Datentyp

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0013230
UMLS CUI [1,3]
C0439849
Corrective Therapy
Beschreibung

If Yes’, record details in the Concomitant Medication section and/ or Healthcare Resource Utilisation form if appropriate

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0087111
Was patient withdrawn due to this specific AE?
Beschreibung

Patient withdrawal

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1710677
UMLS CUI [1,2]
C1518404
Specify reason(s) for considering this a serious AE. Mark all that apply.
Beschreibung

Serious adverse experience

Datentyp

integer

Alias
UMLS CUI [1]
C1519255
Did the SAE abate?
Beschreibung

Abatement of SAE

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0547047
Was investigational product reintroduced (or dose increased)?
Beschreibung

If investigational product was interrupted, stopped or dose reduced:

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0376495
UMLS CUI [1,2]
C0304229
UMLS CUI [1,3]
C1519255
If you answered the previous question with yes, did SAE recur?
Beschreibung

If investigational product was interrupted, stopped or dose reduced:

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0034897
Assessment The SAE is probably associated with:
Beschreibung

Assessment of SAE association

Datentyp

integer

Alias
UMLS CUI [1,1]
C0085978
UMLS CUI [1,2]
C1710056
Relevant Laboratory Data: Test
Beschreibung

Please provide relevant abnormal laboratory data below

Datentyp

text

Alias
UMLS CUI [1]
C0022885
Relevant Laboratory Data: Date
Beschreibung

Laboratory Data

Datentyp

date

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0011008
Relevant Laboratory Data: Value
Beschreibung

Laboratory Data

Datentyp

float

Alias
UMLS CUI [1]
C0022885
UMLS CUI [2]
C0587081
Relevant Laboratory Data: Units
Beschreibung

Laboratory Data

Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C1519795
Relevant Laboratory Data: Normal Range
Beschreibung

Laboratory Data

Datentyp

float

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0086715
Remarks (Please provide a brief narrative description of the SAE, attaching extra pages eg. hospital discharge summary if necessary)
Beschreibung

Remarks

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0947611
If applicable, was randomization code broken at investigational site?
Beschreibung

Randomization code

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0805701
Randomization Number (please do NOT enter the container number):
Beschreibung

Randomization Number

Datentyp

integer

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0805701
Investigator’s Signature (confirming that the above data are accurate and complete)
Beschreibung

Investigator’s Signature

Datentyp

text

Alias
UMLS CUI [1]
C2346576
Date
Beschreibung

Date

Datentyp

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
Please PRINT Name
Beschreibung

Investigator's name

Datentyp

text

Alias
UMLS CUI [1]
C2826892
GSK Medical Monitor’s Signature:
Beschreibung

GSK Medical Monitor’s Signature

Datentyp

text

Alias
UMLS CUI [1,1]
C1519316
UMLS CUI [1,2]
C1708968
Date
Beschreibung

Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1519316
UMLS CUI [1,3]
C1521743
Please PRINT Name:
Beschreibung

Monitor's Name

Datentyp

text

Alias
UMLS CUI [1,1]
C0027365
UMLS CUI [1,2]
C1708968
Form D
Beschreibung

Form D

Alias
UMLS CUI-1
C1306577
Certified Cause of Death
Beschreibung

Cause of Death

Datentyp

text

Alias
UMLS CUI [1]
C0007465
Date of death
Beschreibung

Date of death

Datentyp

date

Alias
UMLS CUI [1]
C1148348
Was a post-mortem carried out?
Beschreibung

Post-mortem

Datentyp

boolean

Alias
UMLS CUI [1]
C0004398
If ‘Yes’ please summarise findings (include diagnosis):
Beschreibung

Post-mortem findings

Datentyp

text

Alias
UMLS CUI [1]
C0004398
Reporting Physician’s Signature
Beschreibung

Physician’s Signature

Datentyp

text

Alias
UMLS CUI [1]
C0807938
Date
Beschreibung

Date

Datentyp

date

Alias
UMLS CUI [1]
C0011008
Orthostatic vital signs
Beschreibung

Orthostatic vital signs

Alias
UMLS CUI-1
C0518766
Orthostatic vital signs
Beschreibung

Orthostatic vital signs

Datentyp

integer

Alias
UMLS CUI [1]
C0518766
Time Vitals Taken
Beschreibung

Time Vitals Taken

Datentyp

time

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0040223
Blood pressure systolic/diastolic
Beschreibung

Blood pressure

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1]
C0005823
mmHg
Pulse
Beschreibung

Pulse

Datentyp

integer

Maßeinheiten
  • beats/min
Alias
UMLS CUI [1]
C0232117
beats/min
Dose and meal information
Beschreibung

Dose and meal information

Alias
UMLS CUI-1
C3174092
UMLS CUI-2
C0034869
UMLS CUI-4
C1998602
UMLS CUI-5
C0034869
Time of last dose of study medication prior to the Week 12 Visit or the Early Withdrawal Visit:
Beschreibung

Time of last dose of study medication

Datentyp

time

Alias
UMLS CUI [1]
C0946444
Date and time of last meal prior to ECG Visit:
Beschreibung

Date and time of last meal

Datentyp

datetime

Alias
UMLS CUI [1,1]
C0578574
UMLS CUI [1,2]
C0011008
Time of in-clinic study medication dose:
Beschreibung

Time of in-clinic study medication dose

Datentyp

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0013227
Medical Procedures
Beschreibung

Medical Procedures

Alias
UMLS CUI-1
C0199171
Concomitant Medication
Beschreibung

Concomitant Medication

Alias
UMLS CUI-1
C2347852
Adverse experiences
Beschreibung

Adverse experiences

Alias
UMLS CUI-1
C0877248
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Ähnliche Modelle

Serious adverse events, Form D and Vitals

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administration
C1320722 (UMLS CUI-1)
Center Number
Item
Center Number
integer
C1301943 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Patient number
Item
Patient number
integer
C1830427 (UMLS CUI [1])
GSK Receipt Date
Item
GSK Receipt Date
date
C2985846 (UMLS CUI [1])
Item Group
Serious adverse experience
C1519255 (UMLS CUI-1)
Person Reporting SAE
Item
Person Reporting SAE (Please print clearly)
text
C0008961 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
AEGIS Number
Item
AEGIS Number
integer
C0237753 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Onset Date and Time
Item
Onset Date and Time
datetime
C2826806 (UMLS CUI [1])
End Date and Time
Item
End Date and Time (If ongoing please leave blank)
datetime
C2826793 (UMLS CUI [1])
Item
Outcome If patient died, please complete Form D
integer
C1705586 (UMLS CUI [1])
Outcome
Code List
Outcome If patient died, please complete Form D
CL Item
Resolved (1)
CL Item
Ongoing (2)
CL Item
Died (3)
Item
Experience Course
integer
C0877248 (UMLS CUI [1,1])
C0750729 (UMLS CUI [1,2])
Experience Course
Code List
Experience Course
CL Item
Intermittent  ( 1)
CL Item
Constant (2)
Experience Course
Item
If intermittent please specify No. of episodes
integer
C0877248 (UMLS CUI [1,1])
C0750729 (UMLS CUI [1,2])
Item
Intensity (maximum)
integer
C1710066 (UMLS CUI [1])
Intensity (maximum)
Code List
Intensity (maximum)
CL Item
Mild 2=Moderate 3=Severe (1)
Item
Action Taken with Respect to Investigational Drug
integer
C2826626 (UMLS CUI [1])
Action Taken
Code List
Action Taken with Respect to Investigational Drug
CL Item
None 2=Dose reduced 3=Dose increased 4=Drug interrupted/restarted 5=Drug stopped (1)
Item
Relationship to Investigational Drug
integer
C1518404 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
Relationship to Investigational Drug
Code List
Relationship to Investigational Drug
CL Item
Related 2=Possibly related 3=Probably unrelated 4=Unrelated (1)
Corrective Therapy
Item
Corrective Therapy
boolean
C0877248 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
Patient withdrawal
Item
Was patient withdrawn due to this specific AE?
boolean
C1710677 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Item
Specify reason(s) for considering this a serious AE. Mark all that apply.
integer
C1519255 (UMLS CUI [1])
Serious adverse experience
Code List
Specify reason(s) for considering this a serious AE. Mark all that apply.
CL Item
results in death (1)
CL Item
life threatening (2)
CL Item
results in hospitalization or prolongation of existing hospitalization (3)
CL Item
results in disability/incapacity (4)
CL Item
congenital abnormality/birth defect (5)
CL Item
other (see definition) (6)
Abatement of SAE
Item
Did the SAE abate?
boolean
C1519255 (UMLS CUI [1,1])
C0547047 (UMLS CUI [1,2])
Product reintroduction
Item
Was investigational product reintroduced (or dose increased)?
boolean
C0376495 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
Recurrence of SAE
Item
If you answered the previous question with yes, did SAE recur?
boolean
C0877248 (UMLS CUI [1,1])
C0034897 (UMLS CUI [1,2])
Item
Assessment The SAE is probably associated with:
integer
C0085978 (UMLS CUI [1,1])
C1710056 (UMLS CUI [1,2])
Assessment of SAE association
Code List
Assessment The SAE is probably associated with:
CL Item
Protocol design or procedures (but not to study drug): Please specify _ _ _ _ _ _ _ _ _ _ _ _ _ _ (1)
CL Item
Another condition (eg, condition under study, intercurrent illness): Please specify _ _ _ _ _ _ _ _ _ _ _ _ _ _ (2)
CL Item
Another drug: Please specify _ _ _ _ _ _ _ _ _ _ _ _ _ _ (3)
Laboratory Data
Item
Relevant Laboratory Data: Test
text
C0022885 (UMLS CUI [1])
Laboratory Data
Item
Relevant Laboratory Data: Date
date
C0022885 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Laboratory Data
Item
Relevant Laboratory Data: Value
float
C0022885 (UMLS CUI [1])
C0587081 (UMLS CUI [2])
Laboratory Data
Item
Relevant Laboratory Data: Units
text
C0022885 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
Laboratory Data
Item
Relevant Laboratory Data: Normal Range
float
C0022885 (UMLS CUI [1,1])
C0086715 (UMLS CUI [1,2])
Remarks
Item
Remarks (Please provide a brief narrative description of the SAE, attaching extra pages eg. hospital discharge summary if necessary)
text
C1519255 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
Randomization code
Item
If applicable, was randomization code broken at investigational site?
boolean
C0034656 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
Randomization Number
Item
Randomization Number (please do NOT enter the container number):
integer
C0034656 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
Investigator’s Signature
Item
Investigator’s Signature (confirming that the above data are accurate and complete)
text
C2346576 (UMLS CUI [1])
Date
Item
Date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Investigator's name
Item
Please PRINT Name
text
C2826892 (UMLS CUI [1])
GSK Medical Monitor’s Signature
Item
GSK Medical Monitor’s Signature:
text
C1519316 (UMLS CUI [1,1])
C1708968 (UMLS CUI [1,2])
Date
Item
Date
date
C0011008 (UMLS CUI [1,1])
C1519316 (UMLS CUI [1,2])
C1521743 (UMLS CUI [1,3])
Monitor's Name
Item
Please PRINT Name:
text
C0027365 (UMLS CUI [1,1])
C1708968 (UMLS CUI [1,2])
Item Group
Form D
C1306577 (UMLS CUI-1)
Cause of Death
Item
Certified Cause of Death
text
C0007465 (UMLS CUI [1])
Date of death
Item
Date of death
date
C1148348 (UMLS CUI [1])
Post-mortem
Item
Was a post-mortem carried out?
boolean
C0004398 (UMLS CUI [1])
Post-mortem findings
Item
If ‘Yes’ please summarise findings (include diagnosis):
text
C0004398 (UMLS CUI [1])
Physician’s Signature
Item
Reporting Physician’s Signature
text
C0807938 (UMLS CUI [1])
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Item Group
Orthostatic vital signs
C0518766 (UMLS CUI-1)
Item
Orthostatic vital signs
integer
C0518766 (UMLS CUI [1])
Orthostatic vital signs
Code List
Orthostatic vital signs
CL Item
After 10 minutes semi-supine (1)
CL Item
After erect for 1 minute (2)
Time Vitals Taken
Item
Time Vitals Taken
time
C0518766 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Blood pressure
Item
Blood pressure systolic/diastolic
integer
C0005823 (UMLS CUI [1])
Pulse
Item
Pulse
integer
C0232117 (UMLS CUI [1])
Item Group
Dose and meal information
C3174092 (UMLS CUI-1)
C0034869 (UMLS CUI-2)
C1998602 (UMLS CUI-4)
C0034869 (UMLS CUI-5)
Time of last dose of study medication
Item
Time of last dose of study medication prior to the Week 12 Visit or the Early Withdrawal Visit:
time
C0946444 (UMLS CUI [1])
Date and time of last meal
Item
Date and time of last meal prior to ECG Visit:
datetime
C0578574 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Time of in-clinic study medication dose
Item
Time of in-clinic study medication dose:
time
C0040223 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Item Group
Medical Procedures
C0199171 (UMLS CUI-1)
Item Group
Concomitant Medication
C2347852 (UMLS CUI-1)
Item Group
Adverse experiences
C0877248 (UMLS CUI-1)
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