ID
42070
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 (3)
- 2017-08-24 2017-08-24 -
- 2017-09-04 2017-09-04 -
- 2021-03-15 2021-03-15 - Dr. rer. medic Philipp Neuhaus
Uppladdad den
15 mars 2021
DOI
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Licens
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
inital & follow-up report serious adverse events starting dose of ropinirole Parkinson's Disease 101468/166
Beskrivning
PATIENT INFORMATION
Alias
- UMLS CUI-1
- C1955348
Beskrivning
ADVERSE EVENT
Alias
- UMLS CUI-1
- C0877248
Beskrivning
Check All Items Appropriate to the Adverse Event If "Death", record the date.
Datatyp
text
Alias
- UMLS CUI [1]
- C0877248
Beskrivning
patient in-patient during adverse event
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0021562
- UMLS CUI [1,2]
- C0877248
Beskrivning
date of report
Datatyp
date
Alias
- UMLS CUI [1]
- C1302584
Beskrivning
start date and time of adverse event
Datatyp
datetime
Alias
- UMLS CUI [1,1]
- C2697888
- UMLS CUI [1,2]
- C2697889
Beskrivning
stop date and time of adverse event
Datatyp
datetime
Alias
- UMLS CUI [1,1]
- C2697886
- UMLS CUI [1,2]
- C0877248
- UMLS CUI [1,3]
- C1522314
Beskrivning
severity of adverse event
Datatyp
text
Alias
- UMLS CUI [1]
- C1710066
Beskrivning
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.
Datatyp
text
Alias
- UMLS CUI [1]
- C0877248
Beskrivning
STUDY DRUG
Alias
- UMLS CUI-1
- C0304229
Beskrivning
total daily dose
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C2982514
- UMLS CUI [1,2]
- C3854006
Beskrivning
drug administration route
Datatyp
text
Alias
- UMLS CUI [1]
- C0013153
Beskrivning
indication of medication
Datatyp
text
Alias
- UMLS CUI [1,1]
- C3146298
- UMLS CUI [1,2]
- C0013227
Beskrivning
start date of study drug
Datatyp
date
Alias
- UMLS CUI [1]
- C3173309
Beskrivning
stop date of study drug
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0806020
- UMLS CUI [1,2]
- C0304229
Beskrivning
adverse event related to study drug
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0304229
Beskrivning
event resolve after study treatment stop
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1514893
- UMLS CUI [1,2]
- C0877248
- UMLS CUI [1,3]
- C1531784
Beskrivning
adverse event repeat
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0376495
- UMLS CUI [1,2]
- C0877248
Beskrivning
medical history
Datatyp
text
Alias
- UMLS CUI [1]
- C0262926
Beskrivning
PATIENT INFORMATION
Alias
- UMLS CUI-1
- C1955348
Beskrivning
relevant laboratory data/ diagnosis/ concomitant medication/ autopsy finding
Datatyp
text
Alias
- UMLS CUI [1]
- C1115972
- UMLS CUI [2]
- C0011900
- UMLS CUI [3]
- C0011900
- UMLS CUI [4]
- C1706864
Beskrivning
check the worst outcome If "Death", record the date of death.
Datatyp
text
Alias
- UMLS CUI [1]
- C1705586
Beskrivning
IN CASE OF DEATH check all relevant boxes
Datatyp
text
Alias
- UMLS CUI [1]
- C1306577
Beskrivning
autopsy
Datatyp
text
Alias
- UMLS CUI [1]
- C0004398
Beskrivning
code broken
Datatyp
boolean
Alias
- UMLS CUI [1]
- C3846431
Beskrivning
Describe the most probable cause(s) of death (ranked by decreasing probability)
Datatyp
text
Alias
- UMLS CUI [1]
- C0007465
Beskrivning
PRINCIPAL INVESTIGATOR
Alias
- UMLS CUI-1
- C1521895
Beskrivning
name of principal investigator
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1547383
- UMLS CUI [1,2]
- C1521895
Beskrivning
address of principal investigator
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1442065
- UMLS CUI [1,2]
- C1521895
Beskrivning
telephone number of principal investigator
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1515258
Beskrivning
principal investigator's signature
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519316
- UMLS CUI [1,2]
- C1521895
Beskrivning
date of signature
Datatyp
date
Alias
- UMLS CUI [1]
- C0807937
Similar models
inital & follow-up report serious adverse events starting dose of ropinirole 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])
C0011900 (UMLS CUI [2])
C0011900 (UMLS CUI [3])
C1706864 (UMLS CUI [4])
C1521895 (UMLS CUI [1,2])
C1521895 (UMLS CUI [1,2])
C1521895 (UMLS CUI [1,2])