ID

25033

Beskrivning

Study ID: 101468/166 Clinical Study ID: SKF-101468/166 Study Title: A Phase II, randomised, double-blind, active-controlled, dose-escalation study to determine the maximum well-tolerated starting dose of a new formulation of ropinirole in Parkinson's Disease patients not receiving other dopaminergic therapies 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: Parkinson Disease

Nyckelord

Versioner (2)
  1. 2017-08-24 2017-08-24 -
  2. 2017-09-04 2017-09-04 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

24 augusti 2017

DOI

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Licens

Creative Commons BY-NC 3.0
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end of study determination of the maximum well-tolerated starting dose of ropinirole in Parkinson's Disease 101468/166

Engelsk

end of study determination of the maximum well-tolerated starting dose of ropinirole in Parkinson's Disease 101468/166

1 Formulär  
Administrative Data
Beskrivning

Administrative Data

Alias
UMLS CUI-1
C1320722
Patient Initials
Beskrivning

patient's initials

Datatyp

text

Alias
UMLS CUI [1]
C2986440
Patient No.
Beskrivning

patient number

Datatyp

integer

Alias
UMLS CUI [1]
C1830427
Date of Visit
Beskrivning

date of visit

Datatyp

date

Alias
UMLS CUI [1]
C1320303
COMPLETION OF TREATMENT PHASE
Beskrivning

COMPLETION OF TREATMENT PHASE

Alias
UMLS CUI-1
C0580352
Date of termination
Beskrivning

date of study termination

Datatyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0008972
UMLS CUI [1,3]
C0013135
Did the patient remain on study drug through Day 7?
Beskrivning

patient's study participation status

Datatyp

integer

Did the patient remain on study drug through Day 7?
Beskrivning

If "NO, discontinued study drug prematurely"; tick the one most significant reason below

Datatyp

integer

COMPLETION THROUGH DAY 14
Beskrivning

COMPLETION THROUGH DAY 14

Alias
UMLS CUI-1
C2348568
Did the patient complete study visits/prodcedures through Day 14?
Beskrivning

patient's study participation status

Datatyp

integer

Did the patient complete study visits/prodcedures through Day 14?
Beskrivning

If "NO, check the one most significant reason below", choose a reason below.

Datatyp

integer

Date of last contact
Beskrivning

If "Lost to follow-up" above, record the date.

Datatyp

date

Alias
UMLS CUI [1]
C0805839
PATIENT DEATH
Beskrivning

PATIENT DEATH

Alias
UMLS CUI-1
C1306577
Date of death
Beskrivning

date of death

Datatyp

date

Alias
UMLS CUI [1]
C1148348
Was an autopsy performed?
Beskrivning

If YES, attach a copy of the autopsy report.

Datatyp

integer

Alias
UMLS CUI [1]
C0004398
Primary cause of death
Beskrivning

primary cause of death

Datatyp

text

Alias
UMLS CUI [1]
C0007465
Underlying cause(s) of death
Beskrivning

underlying causes of death

Datatyp

text

Alias
UMLS CUI [1]
C0007465
Was death related to study drug?
Beskrivning

death related to study drug

Datatyp

integer

Alias
UMLS CUI [1,1]
C0011065
UMLS CUI [1,2]
C0304229
INVESTIGATOR'S SIGNATURE
Beskrivning

INVESTIGATOR'S SIGNATURE

Alias
UMLS CUI-1
C2346576
Signature
Beskrivning

I have assumed reponsibility for completeness and accuracy of all data recorded on the case report forms.

Datatyp

text

Date
Beskrivning

I have assumed reponsibility for completeness and accuracy of all data recorded on the case report forms.

Datatyp

date

Alias
UMLS CUI [1]
C0807937
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Similar models

end of study determination of the maximum well-tolerated starting dose of ropinirole in Parkinson's Disease 101468/166

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
patient's initials
Item
Patient Initials
text
C2986440 (UMLS CUI [1])
patient number
Item
Patient No.
integer
C1830427 (UMLS CUI [1])
date of visit
Item
Date of Visit
date
C1320303 (UMLS CUI [1])
Item Group
COMPLETION OF TREATMENT PHASE
C0580352 (UMLS CUI-1)
date of study termination
Item
Date of termination
date
C0011008 (UMLS CUI [1,1])
C0008972 (UMLS CUI [1,2])
C0013135 (UMLS CUI [1,3])
Item
Did the patient remain on study drug through Day 7?
integer
patient's study participation status
Code List
Did the patient remain on study drug through Day 7?
CL Item
YES (1)
CL Item
NO, discontinued study drug prematurely (2)
Item
Did the patient remain on study drug through Day 7?
integer
patient's study participation status
Code List
Did the patient remain on study drug through Day 7?
CL Item
Adverse event, specify AE (Adverse event must be recorded on the Adverse Events CRF.) (1)
CL Item
Patientrequest (unrelated to AE), specify  (2)
CL Item
Non-compliance(unrelatedto an AE), specify (3)
CL Item
Investigatorjudgement, specify  (4)
CL Item
Termination of patient dosing by sponsor (5)
CL Item
Protocolviolation, specify  (6)
CL Item
Death, complete the Patient Death CRF (7)
CL Item
Other, specify (8)
Item Group
COMPLETION THROUGH DAY 14
C2348568 (UMLS CUI-1)
Item
Did the patient complete study visits/prodcedures through Day 14?
integer
patient's study participation status
Code List
Did the patient complete study visits/prodcedures through Day 14?
CL Item
YES (1)
CL Item
NO, check the one most significant reason below (2)
Item
Did the patient complete study visits/prodcedures through Day 14?
integer
patient's study participation status
Code List
Did the patient complete study visits/prodcedures through Day 14?
CL Item
Death, complete the Patient Death CRF  (1)
CL Item
Lost to follow-up  (2)
CL Item
Other, specify (3)
date of last contact
Item
Date of last contact
date
C0805839 (UMLS CUI [1])
Item Group
PATIENT DEATH
C1306577 (UMLS CUI-1)
date of death
Item
Date of death
date
C1148348 (UMLS CUI [1])
Item
Was an autopsy performed?
integer
C0004398 (UMLS CUI [1])
autopsy
Code List
Was an autopsy performed?
CL Item
YES (1)
CL Item
NO (2)
primary cause of death
Item
Primary cause of death
text
C0007465 (UMLS CUI [1])
underlying causes of death
Item
Underlying cause(s) of death
text
C0007465 (UMLS CUI [1])
Item
Was death related to study drug?
integer
C0011065 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
death related to study drug
Code List
Was death related to study drug?
CL Item
YES (1)
CL Item
NO (2)
Item Group
INVESTIGATOR'S SIGNATURE
C2346576 (UMLS CUI-1)
investigator's signature
Item
Signature
text
signature date
Item
Date
date
C0807937 (UMLS CUI [1])
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