ID
25471
Description
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
Mots-clés
Versions (3)
- 24/08/2017 24/08/2017 -
- 04/09/2017 04/09/2017 -
- 15/03/2021 15/03/2021 - Dr. rer. medic Philipp Neuhaus
Téléchargé le
4 septembre 2017
DOI
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Licence
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
Description
PATIENT INFORMATION
Alias
- UMLS CUI-1
- C1955348
Description
ADVERSE EVENT
Alias
- UMLS CUI-1
- C0877248
Description
Check All Items Appropriate to the Adverse Event If "Death", record the date.
Type de données
text
Alias
- UMLS CUI [1]
- C0877248
Description
patient in-patient during adverse event
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0021562
- UMLS CUI [1,2]
- C0877248
Description
date of report
Type de données
date
Alias
- UMLS CUI [1]
- C1302584
Description
start date and time of adverse event
Type de données
datetime
Alias
- UMLS CUI [1,1]
- C2697888
- UMLS CUI [1,2]
- C2697889
Description
stop date and time of adverse event
Type de données
datetime
Alias
- UMLS CUI [1,1]
- C2697886
- UMLS CUI [1,2]
- C0877248
- UMLS CUI [1,3]
- C1522314
Description
severity of adverse event
Type de données
text
Alias
- UMLS CUI [1]
- C1710066
Description
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.
Type de données
text
Alias
- UMLS CUI [1]
- C0877248
Description
STUDY DRUG
Alias
- UMLS CUI-1
- C0304229
Description
total daily dose
Type de données
integer
Alias
- UMLS CUI [1,1]
- C2982514
- UMLS CUI [1,2]
- C3854006
Description
drug administration route
Type de données
text
Alias
- UMLS CUI [1]
- C0013153
Description
indication of medication
Type de données
text
Alias
- UMLS CUI [1,1]
- C3146298
- UMLS CUI [1,2]
- C0013227
Description
start date of study drug
Type de données
date
Alias
- UMLS CUI [1]
- C1531783
Description
stop date of study drug
Type de données
date
Alias
- UMLS CUI [1,1]
- C0806020
- UMLS CUI [1,2]
- C0304229
Description
adverse event related to study drug
Type de données
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0304229
Description
event resolve after study treatment stop
Type de données
text
Alias
- UMLS CUI [1,1]
- C1514893
- UMLS CUI [1,2]
- C0877248
- UMLS CUI [1,3]
- C1531784
Description
adverse event repeat
Type de données
text
Alias
- UMLS CUI [1,1]
- C0376495
- UMLS CUI [1,2]
- C0877248
Description
medical history
Type de données
text
Alias
- UMLS CUI [1]
- C0262926
Description
PATIENT INFORMATION
Alias
- UMLS CUI-1
- C1955348
Description
relevant laboratory data/ diagnosis/ concomitant medication/ autopsy finding
Type de données
text
Alias
- UMLS CUI [1]
- C1115972
- UMLS CUI [2]
- C0011900
- UMLS CUI [3]
- C0011900
- UMLS CUI [4]
- C1706864
Description
check the worst outcome If "Death", record the date of death.
Type de données
text
Alias
- UMLS CUI [1]
- C1705586
Description
IN CASE OF DEATH check all relevant boxes
Type de données
text
Alias
- UMLS CUI [1]
- C1306577
Description
autopsy
Type de données
text
Alias
- UMLS CUI [1]
- C0004398
Description
code broken
Type de données
boolean
Alias
- UMLS CUI [1]
- C3846431
Description
Describe the most probable cause(s) of death (ranked by decreasing probability)
Type de données
text
Alias
- UMLS CUI [1]
- C0007465
Description
PRINCIPAL INVESTIGATOR
Alias
- UMLS CUI-1
- C1521895
Description
name of principal investigator
Type de données
text
Alias
- UMLS CUI [1,1]
- C1547383
- UMLS CUI [1,2]
- C1521895
Description
address of principal investigator
Type de données
text
Alias
- UMLS CUI [1,1]
- C1442065
- UMLS CUI [1,2]
- C1521895
Description
telephone number of principal investigator
Type de données
integer
Alias
- UMLS CUI [1,1]
- C1515258
Description
principal investigator's signature
Type de données
text
Alias
- UMLS CUI [1,1]
- C1519316
- UMLS CUI [1,2]
- C1521895
Description
date of signature
Type de données
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])