ID
25042
Beschrijving
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
Trefwoorden
Versies (3)
- 24-08-17 24-08-17 -
- 04-09-17 04-09-17 -
- 15-03-21 15-03-21 - Dr. rer. medic Philipp Neuhaus
Houder van rechten
GlaxoSmithKline
Geüploaded op
24 augustus 2017
DOI
Voor een aanvraag inloggen.
Licentie
Creative Commons BY-NC 3.0
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serious adverse events determination of the maximum well-tolerated starting dose of ropinirole in Parkinson's Disease 101468/166
serious adverse events determination of the maximum well-tolerated starting dose of ropinirole in Parkinson's Disease 101468/166
Beschrijving
PATIENT INFORMATION
Alias
- UMLS CUI-1
- C1955348
Beschrijving
ADVERSE EVENT
Alias
- UMLS CUI-1
- C0877248
Beschrijving
Check All Items Appropriate to the Adverse Event If "Death", record the date.
Datatype
text
Alias
- UMLS CUI [1]
- C0877248
Beschrijving
patient in-patient during adverse event
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0021562
- UMLS CUI [1,2]
- C0877248
Beschrijving
date of report
Datatype
date
Alias
- UMLS CUI [1]
- C1302584
Beschrijving
start date and time of adverse event
Datatype
datetime
Alias
- UMLS CUI [1,1]
- C2697888
- UMLS CUI [1,2]
- C2697889
Beschrijving
stop date and time of adverse event
Datatype
datetime
Alias
- UMLS CUI [1,1]
- C2697886
- UMLS CUI [1,2]
- C0877248
- UMLS CUI [1,3]
- C1522314
Beschrijving
severity of adverse event
Datatype
text
Alias
- UMLS CUI [1]
- C1710066
Beschrijving
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.
Datatype
text
Alias
- UMLS CUI [1]
- C0877248
Beschrijving
STUDY DRUG
Alias
- UMLS CUI-1
- C0304229
Beschrijving
total daily dose
Datatype
integer
Alias
- UMLS CUI [1,1]
- C2982514
- UMLS CUI [1,2]
- C3854006
Beschrijving
drug administration route
Datatype
text
Alias
- UMLS CUI [1]
- C0013153
Beschrijving
indication of medication
Datatype
text
Alias
- UMLS CUI [1,1]
- C3146298
- UMLS CUI [1,2]
- C0013227
Beschrijving
start date of study drug
Datatype
date
Alias
- UMLS CUI [1]
- C1531783
Beschrijving
stop date of study drug
Datatype
date
Alias
- UMLS CUI [1,1]
- C0806020
- UMLS CUI [1,2]
- C0304229
Beschrijving
adverse event related to study drug
Datatype
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0304229
Beschrijving
event resolve after study treatment stop
Datatype
text
Alias
- UMLS CUI [1,1]
- C1514893
- UMLS CUI [1,2]
- C0877248
- UMLS CUI [1,3]
- C1531784
Beschrijving
adverse event repeat
Datatype
text
Alias
- UMLS CUI [1,1]
- C0376495
- UMLS CUI [1,2]
- C0877248
Beschrijving
medical history
Datatype
text
Alias
- UMLS CUI [1]
- C0262926
Beschrijving
PATIENT INFORMATION
Alias
- UMLS CUI-1
- C1955348
Beschrijving
relevant laboratory data/ diagnosis/ concomitant medication/ autopsy finding
Datatype
text
Alias
- UMLS CUI [1]
- C1115972
- UMLS CUI [2]
- C0011900
- UMLS CUI [3]
- C0011900
- UMLS CUI [4]
- C1706864
Beschrijving
check the worst outcome If "Death", record the date of death.
Datatype
text
Alias
- UMLS CUI [1]
- C1705586
Beschrijving
IN CASE OF DEATH check all relevant boxes
Datatype
text
Alias
- UMLS CUI [1]
- C1306577
Beschrijving
autopsy
Datatype
text
Alias
- UMLS CUI [1]
- C0004398
Beschrijving
code broken
Datatype
boolean
Alias
- UMLS CUI [1]
- C3846431
Beschrijving
Describe the most probable cause(s) of death (ranked by decreasing probability)
Datatype
text
Alias
- UMLS CUI [1]
- C0007465
Beschrijving
PRINCIPAL INVESTIGATOR
Alias
- UMLS CUI-1
- C1521895
Beschrijving
name of principal investigator
Datatype
text
Alias
- UMLS CUI [1,1]
- C1547383
- UMLS CUI [1,2]
- C1521895
Beschrijving
address of principal investigator
Datatype
text
Alias
- UMLS CUI [1,1]
- C1442065
- UMLS CUI [1,2]
- C1521895
Beschrijving
telephone number of principal investigator
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1515258
Beschrijving
principal investigator's signature
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519316
- UMLS CUI [1,2]
- C1521895
Beschrijving
date of signature
Datatype
date
Alias
- UMLS CUI [1]
- C0807937
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serious adverse events determination of the maximum well-tolerated starting dose of ropinirole in Parkinson's Disease 101468/166
C0920316 (UMLS CUI [1,2])
C0920316 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,2])
C2697889 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,3])
C3854006 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,2])
C1531784 (UMLS CUI [1,3])
C0877248 (UMLS CUI [1,2])
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C0011900 (UMLS CUI [3])
C1706864 (UMLS CUI [4])
C1521895 (UMLS CUI [1,2])
C1521895 (UMLS CUI [1,2])
C1521895 (UMLS CUI [1,2])