ID

42070

Descripción

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

Palabras clave

Versiones (3)
  1. 24/8/17 24/8/17 -
  2. 4/9/17 4/9/17 -
  3. 15/3/21 15/3/21 - Dr. rer. medic Philipp Neuhaus
Subido en

15 de marzo de 2021

DOI

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Licencia

Creative Commons BY-NC 3.0
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inital & follow-up report serious adverse events starting dose of ropinirole Parkinson's Disease 101468/166

Inglés

inital & follow-up report serious adverse events starting dose of ropinirole Parkinson's Disease 101468/166

1 formularios  
Time of documentation
Descripción

Time of documentation

Alias
UMLS CUI-1
C0040223
UMLS CUI-2
C0920316
time of documentation, check one.
Descripción

time of documentation

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0920316
Date
Descripción

date of documentation

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0920316
PATIENT INFORMATION
Descripción

PATIENT INFORMATION

Alias
UMLS CUI-1
C1955348
Patient No.
Descripción

patient number

Tipo de datos

integer

Alias
UMLS CUI [1]
C1830427
Patient Initials
Descripción

patient initials

Tipo de datos

text

Alias
UMLS CUI [1]
C2986440
Date of Birth
Descripción

date of birth

Tipo de datos

date

Alias
UMLS CUI [1]
C0421451
ADVERSE EVENT
Descripción

ADVERSE EVENT

Alias
UMLS CUI-1
C0877248
Adverse Event
Descripción

Check All Items Appropriate to the Adverse Event If "Death", record the date.

Tipo de datos

text

Alias
UMLS CUI [1]
C0877248
Was the patient an in-patient when the adverse event occurred?
Descripción

patient in-patient during adverse event

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0021562
UMLS CUI [1,2]
C0877248
Date of Report
Descripción

date of report

Tipo de datos

date

Alias
UMLS CUI [1]
C1302584
Start Date and Time
Descripción

start date and time of adverse event

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C2697888
UMLS CUI [1,2]
C2697889
Stop Date and Time
Descripción

stop date and time of adverse event

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C2697886
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C1522314
Severity of Event
Descripción

severity of adverse event

Tipo de datos

text

Alias
UMLS CUI [1]
C1710066
DESCRIBE EVENT
Descripción

symptoms/signs/time course/onset and end of evenVrelevant tests/laboratory data/treatment of evenVresidual effect. Chronological description of the medical situation including all experiences which might have led to the serious adverse event. If possible, give diagnosis/syndrome.

Tipo de datos

text

Alias
UMLS CUI [1]
C0877248
STUDY DRUG
Descripción

STUDY DRUG

Alias
UMLS CUI-1
C0304229
Dose Frequency
Descripción

total daily dose

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C2982514
UMLS CUI [1,2]
C3854006
Route
Descripción

drug administration route

Tipo de datos

text

Alias
UMLS CUI [1]
C0013153
Indication
Descripción

indication of medication

Tipo de datos

text

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0013227
Therapy Start Date
Descripción

start date of study drug

Tipo de datos

date

Alias
UMLS CUI [1]
C3173309
Therapy StopDate
Descripción

stop date of study drug

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C0304229
DRUG/EVENT RELATIONSHIP
Descripción

adverse event related to study drug

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0304229
Did event resolve after study treatment stopped?
Descripción

event resolve after study treatment stop

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1514893
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C1531784
Did reaction reappear after reintroduction?
Descripción

adverse event repeat

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0376495
UMLS CUI [1,2]
C0877248
MEDICAL HISTORY/ COEXISTING DISEASES
Descripción

medical history

Tipo de datos

text

Alias
UMLS CUI [1]
C0262926
PATIENT INFORMATION
Descripción

PATIENT INFORMATION

Alias
UMLS CUI-1
C1955348
RELEVANT TESTS/LABORATORY DATA (including dates)/DIAGNOSIS/TREATMENT/AUTOPSY FINDINGS
Descripción

relevant laboratory data/ diagnosis/ concomitant medication/ autopsy finding

Tipo de datos

text

Alias
UMLS CUI [1]
C1115972
UMLS CUI [2]
C0011900
UMLS CUI [3]
C0011900
UMLS CUI [4]
C1706864
FINAL OUTCOME
Descripción

check the worst outcome If "Death", record the date of death.

Tipo de datos

text

Alias
UMLS CUI [1]
C1705586
Patient Death
Descripción

IN CASE OF DEATH check all relevant boxes

Tipo de datos

text

Alias
UMLS CUI [1]
C1306577
AUTOPSY
Descripción

autopsy

Tipo de datos

text

Alias
UMLS CUI [1]
C0004398
CODE BROKEN
Descripción

code broken

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3846431
Cause of Death
Descripción

Describe the most probable cause(s) of death (ranked by decreasing probability)

Tipo de datos

text

Alias
UMLS CUI [1]
C0007465
PRINCIPAL INVESTIGATOR
Descripción

PRINCIPAL INVESTIGATOR

Alias
UMLS CUI-1
C1521895
Name
Descripción

name of principal investigator

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1547383
UMLS CUI [1,2]
C1521895
Address
Descripción

address of principal investigator

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1442065
UMLS CUI [1,2]
C1521895
Telephone Number
Descripción

telephone number of principal investigator

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1515258
Principal Investigator's Signature
Descripción

principal investigator's signature

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1519316
UMLS CUI [1,2]
C1521895
Date
Descripción

date of signature

Tipo de datos

date

Alias
UMLS CUI [1]
C0807937
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Similar models

inital & follow-up report serious adverse events starting dose of ropinirole Parkinson's Disease 101468/166

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Time of documentation
C0040223 (UMLS CUI-1)
C0920316 (UMLS CUI-2)
Item
time of documentation, check one.
text
C0040223 (UMLS CUI [1,1])
C0920316 (UMLS CUI [1,2])
time of documentation
Code List
time of documentation, check one.
CL Item
Initial Report (Inital Report)
CL Item
Follow-Up Report (Follow-Up Report)
date of documentation
Item
Date
date
C0011008 (UMLS CUI [1,1])
C0920316 (UMLS CUI [1,2])
Item Group
PATIENT INFORMATION
C1955348 (UMLS CUI-1)
patient number
Item
Patient No.
integer
C1830427 (UMLS CUI [1])
patient initials
Item
Patient Initials
text
C2986440 (UMLS CUI [1])
date of birth
Item
Date of Birth
date
C0421451 (UMLS CUI [1])
Item Group
ADVERSE EVENT
C0877248 (UMLS CUI-1)
Item
Adverse Event
text
C0877248 (UMLS CUI [1])
adverse event
Code List
Adverse Event
CL Item
Death (Death)
CL Item
Life-threatening (Life-threatening)
CL Item
Hospitalization/prolonged hospitalization  (Hospitalization/prolonged hospitalization)
CL Item
Disabling/incapacitating  (Disabling/incapacitating)
CL Item
Congenital anomaly/birth defect (Congenital anomaly/birth defect)
CL Item
Important medical event (please explain below)  (Important medical event (please explain below))
CL Item
Other, specify (Other, specify)
Item
Was the patient an in-patient when the adverse event occurred?
integer
C0021562 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
patient in-patient during adverse event
Code List
Was the patient an in-patient when the adverse event occurred?
CL Item
YES (1)
CL Item
NO (2)
date of report
Item
Date of Report
date
C1302584 (UMLS CUI [1])
start date and time of adverse event
Item
Start Date and Time
datetime
C2697888 (UMLS CUI [1,1])
C2697889 (UMLS CUI [1,2])
stop date and time of adverse event
Item
Stop Date and Time
datetime
C2697886 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,3])
Item
Severity of Event
text
C1710066 (UMLS CUI [1])
severity of adverse event
Code List
Severity of Event
CL Item
Mild (Mild)
CL Item
Moderare (Moderate)
CL Item
Severe (Severe)
describe adverse event
Item
DESCRIBE EVENT
text
C0877248 (UMLS CUI [1])
Item Group
STUDY DRUG
C0304229 (UMLS CUI-1)
dose frequency of study drug
Item
Dose Frequency
integer
C2982514 (UMLS CUI [1,1])
C3854006 (UMLS CUI [1,2])
drug administration route
Item
Route
text
C0013153 (UMLS CUI [1])
indication of medication
Item
Indication
text
C3146298 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
start date of study drug
Item
Therapy Start Date
date
C3173309 (UMLS CUI [1])
stop date of study drug
Item
Therapy StopDate
date
C0806020 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Item
DRUG/EVENT RELATIONSHIP
text
C0877248 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
adverse event related to study drug
Code List
DRUG/EVENT RELATIONSHIP
CL Item
Not related (Not related)
CL Item
Suspected  (Suspected)
CL Item
Unlikely (Unlikely)
CL Item
Probable (Probable)
Item
Did event resolve after study treatment stopped?
text
C1514893 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1531784 (UMLS CUI [1,3])
event resolve after study treatment stop
Code List
Did event resolve after study treatment stopped?
CL Item
Yes (Yes)
CL Item
No (No)
CL Item
Not applicable (Not applicable)
Item
Did reaction reappear after reintroduction?
text
C0376495 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
event resolve after study treatment stop
Code List
Did reaction reappear after reintroduction?
CL Item
Yes (Yes)
CL Item
No (No)
CL Item
Not applicable (Not applicable)
medical history
Item
MEDICAL HISTORY/ COEXISTING DISEASES
text
C0262926 (UMLS CUI [1])
Item Group
PATIENT INFORMATION
C1955348 (UMLS CUI-1)
relevant laboratory data/ diagnosis/ concomitant medication/ autopsy finding
Item
RELEVANT TESTS/LABORATORY DATA (including dates)/DIAGNOSIS/TREATMENT/AUTOPSY FINDINGS
text
C1115972 (UMLS CUI [1])
C0011900 (UMLS CUI [2])
C0011900 (UMLS CUI [3])
C1706864 (UMLS CUI [4])
Item
FINAL OUTCOME
text
C1705586 (UMLS CUI [1])
adverse event outcome
Code List
FINAL OUTCOME
CL Item
Resolved, no residual effects (Resolved, no residual effects)
CL Item
Resolved, residual effects  (Resolved, residual effects)
CL Item
Continuing (Continuing)
CL Item
Death (Death)
Item
Patient Death
text
C1306577 (UMLS CUI [1])
patient's death
Code List
Patient Death
CL Item
Disease for which the patient was given study treatment (e.g. disease progression, treatment failure) (Disease for which the patient was given study treatment (e.g. disease progression, treatment failure))
CL Item
Other pre-existing condition/disease  (Other pre-existing condition/disease)
CL Item
SAE not related to study drug  (SAE not related to study drug)
CL Item
SAE related to study drug  (SAE related to study drug)
CL Item
Unknown (further information will be requested) (Unknown (further information will be requested))
Item
AUTOPSY
text
C0004398 (UMLS CUI [1])
autopsy
Code List
AUTOPSY
CL Item
Yes (provide report if possible) (Yes (provide report if possible))
CL Item
No (No)
CL Item
Planned (Planned)
code broken
Item
CODE BROKEN
boolean
C3846431 (UMLS CUI [1])
cause of death
Item
Cause of Death
text
C0007465 (UMLS CUI [1])
Item Group
PRINCIPAL INVESTIGATOR
C1521895 (UMLS CUI-1)
name of principal investigator
Item
Name
text
C1547383 (UMLS CUI [1,1])
C1521895 (UMLS CUI [1,2])
address of principal investigator
Item
Address
text
C1442065 (UMLS CUI [1,1])
C1521895 (UMLS CUI [1,2])
telephone number of principal investigator
Item
Telephone Number
integer
C1515258 (UMLS CUI [1,1])
principal investigator's signature
Item
Principal Investigator's Signature
text
C1519316 (UMLS CUI [1,1])
C1521895 (UMLS CUI [1,2])
date of signature
Item
Date
date
C0807937 (UMLS CUI [1])
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