ID
25471
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)
- 24/8/17 24/8/17 -
- 4/9/17 4/9/17 -
- 15/3/21 15/3/21 - Dr. rer. medic Philipp Neuhaus
Subido en
4 de septiembre de 2017
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
inital & follow-up report serious adverse events starting dose of ropinirole Parkinson's Disease 101468/166
Descripción
PATIENT INFORMATION
Alias
- UMLS CUI-1
- C1955348
Descripción
ADVERSE EVENT
Alias
- UMLS CUI-1
- C0877248
Descripción
Check All Items Appropriate to the Adverse Event If "Death", record the date.
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0877248
Descripción
patient in-patient during adverse event
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0021562
- UMLS CUI [1,2]
- C0877248
Descripción
date of report
Tipo de datos
date
Alias
- UMLS CUI [1]
- C1302584
Descripción
start date and time of adverse event
Tipo de datos
datetime
Alias
- UMLS CUI [1,1]
- C2697888
- UMLS CUI [1,2]
- C2697889
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
Descripción
severity of adverse event
Tipo de datos
text
Alias
- UMLS CUI [1]
- C1710066
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
Descripción
STUDY DRUG
Alias
- UMLS CUI-1
- C0304229
Descripción
total daily dose
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C2982514
- UMLS CUI [1,2]
- C3854006
Descripción
drug administration route
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0013153
Descripción
indication of medication
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C3146298
- UMLS CUI [1,2]
- C0013227
Descripción
start date of study drug
Tipo de datos
date
Alias
- UMLS CUI [1]
- C1531783
Descripción
stop date of study drug
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0806020
- UMLS CUI [1,2]
- C0304229
Descripción
adverse event related to study drug
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0304229
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
Descripción
adverse event repeat
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0376495
- UMLS CUI [1,2]
- C0877248
Descripción
medical history
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0262926
Descripción
PATIENT INFORMATION
Alias
- UMLS CUI-1
- C1955348
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
Descripción
check the worst outcome If "Death", record the date of death.
Tipo de datos
text
Alias
- UMLS CUI [1]
- C1705586
Descripción
IN CASE OF DEATH check all relevant boxes
Tipo de datos
text
Alias
- UMLS CUI [1]
- C1306577
Descripción
autopsy
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0004398
Descripción
code broken
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C3846431
Descripción
Describe the most probable cause(s) of death (ranked by decreasing probability)
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0007465
Descripción
PRINCIPAL INVESTIGATOR
Alias
- UMLS CUI-1
- C1521895
Descripción
name of principal investigator
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1547383
- UMLS CUI [1,2]
- C1521895
Descripción
address of principal investigator
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1442065
- UMLS CUI [1,2]
- C1521895
Descripción
telephone number of principal investigator
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C1515258
Descripción
principal investigator's signature
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1519316
- UMLS CUI [1,2]
- C1521895
Descripción
date of signature
Tipo de datos
date
Alias
- UMLS CUI [1]
- C0807937
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inital & follow-up report serious adverse events starting dose of ropinirole Parkinson's Disease 101468/166
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