ID

28173

Beschreibung

Double blind, randomised, prospective placebo controlled parallel group phase III study to investigate the effect of EGCG supplementation on disease progression of patients with Multiple System Atrophy (MSA) NCT02008721 Short title: Progression Rate of MSA under EGCG Supplementation as anti-Aggregation-Approach Study Code: PROMESA EudraCT-Number: 2012-000928-18 NCT02008721 Sponsor: Klinikum Großhadern Medical Center University of Munich,Represented by the Medical Director Prof. Dr. med. Burkhard Göke, Marchioninistraße 15 D-81377 Munich Principal Investigator: Prof. Dr. med. Günter Höglinger Department of Neurology, Klinikum rechts der Isar Technische Universität München Ismaninger Str. 22 D-81675 Munich; Contact: Yvonne Rödenbeck Trial Monitoring: Münchner Studienzentrum Klinikum rechts der Isar ,Technische Universität München, Ismaninger Str.22 D-81675 Munich Trial Monitoring: Prof. Dr. rer. nat. Ulrich Masnmann, Institute for Medical Informatics, Biometry and Epidemiology (IBE), Marchioninistraße 15 D-81377 Munich Trial Office: Deutsches Zentrum für Neurodegenerative Erkrankungen e.V., Max-Lebsche Platz 30, D-81377 Munich Source: Priv.-Doz. Dr. med. Johannes Levin Neurologische Klinik Ludwig-Maximilians-Universität München

Stichworte

Versionen (1)
  1. 26.12.17 26.12.17 -
Rechteinhaber

Priv.-Doz. Dr. med. Johannes Levin

Hochgeladen am

26. Dezember 2017

DOI

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Lizenz

Creative Commons BY-NC 3.0
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PROMESA NCT02008721

Englisch

Concomitant Medication Record and Adverse Event Form

1 Formulare  
Concomitant Medication Record
Beschreibung

Concomitant Medication Record

Alias
UMLS CUI-1
C2347852
Code
Beschreibung

Medication code

Datentyp

integer

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0009219
Brand name
Beschreibung

Concomitant medication Brand name

Datentyp

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0592503
Dosage
Beschreibung

e.g. 20mg

Datentyp

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0178602
Regimen
Beschreibung

e.g. 1-0-1

Datentyp

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0237125
Application
Beschreibung

Concomitant medication application

Datentyp

integer

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0013153
Indication
Beschreibung

Concomitant medication indication

Datentyp

text

Alias
UMLS CUI [1]
C2826696
Date started
Beschreibung

Concomitant medication started

Datentyp

date

Alias
UMLS CUI [1]
C2826734
Not known
Beschreibung

Start date not known

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C0439673
Date stopped
Beschreibung

Concomitant medication end date

Datentyp

date

Alias
UMLS CUI [1]
C2826744
Not known
Beschreibung

End date not known

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2826744
UMLS CUI [1,2]
C0439673
Ongoing
Beschreibung

Concomitant Medication Ongoing

Datentyp

boolean

Alias
UMLS CUI [1]
C2826666
Due to AE, if yes give AE no.
Beschreibung

AE number

Datentyp

text

Alias
UMLS CUI [1]
C2826275
Signature of investigator - Concomitant Medication
Beschreibung

Signature of investigator - Concomitant Medication

Alias
UMLS CUI-1
C2346576
UMLS CUI-2
C2347852
Date of Investigator Signature
Beschreibung

Investigator Signature Date

Datentyp

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
Name of investigator
Beschreibung

Investigator name

Datentyp

text

Alias
UMLS CUI [1]
C2826892
Investigator signature
Beschreibung

Investigator signature

Datentyp

text

Alias
UMLS CUI [1]
C2346576
Adverse event form
Beschreibung

Adverse event form

Alias
UMLS CUI-1
C0877248
AE Number
Beschreibung

AE Number

Datentyp

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0237753
Adverse event
Beschreibung

diagnosis (if known) or signs/symptoms

Datentyp

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0011900
UMLS CUI [2,1]
C0877248
UMLS CUI [2,2]
C0037088
Start Date
Beschreibung

Adverse event start date

Datentyp

date

Alias
UMLS CUI [1]
C2697888
Stop date
Beschreibung

Adverse event end date

Datentyp

date

Alias
UMLS CUI [1]
C2697886
Specific
Beschreibung

No SAE reporting as per study protocol, chapter 6.4

Datentyp

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C2348235
Severity
Beschreibung

adverse event severity

Datentyp

integer

Alias
UMLS CUI [1]
C1710066
Serious
Beschreibung

If YES, please complete SAE form

Datentyp

boolean

Alias
UMLS CUI [1]
C1519255
Outcome
Beschreibung

adverse event outcome

Datentyp

integer

Alias
UMLS CUI [1]
C1705586
Concomitant medication given
Beschreibung

If YES, please fill in concomitant medication record.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C2347852
Relationship to study drug
Beschreibung

adverse event Relationship to study drug

Datentyp

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0304229
Action taken with study drug
Beschreibung

Adverse event action taken with study drug

Datentyp

integer

Alias
UMLS CUI [1]
C2826626
Signatur of investigator - adverse event
Beschreibung

Signatur of investigator - adverse event

Alias
UMLS CUI-1
C0877248
UMLS CUI-2
C2346576
Date of Investigator Signature
Beschreibung

Investigator Signature Date

Datentyp

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
Name of investigator
Beschreibung

Investigator name

Datentyp

text

Alias
UMLS CUI [1]
C2826892
Investigator signature
Beschreibung

Investigator signature

Datentyp

text

Alias
UMLS CUI [1]
C2346576
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Ähnliche Modelle

Concomitant Medication Record and Adverse Event Form

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Concomitant Medication Record
C2347852 (UMLS CUI-1)
Item
Code
integer
C0013227 (UMLS CUI [1,1])
C0009219 (UMLS CUI [1,2])
Medication code
Code List
Code
CL Item
Levodopa preparation (1)
CL Item
Dopamine Agonists (2)
CL Item
Amantadine (3)
CL Item
Anticholinergic drugs (4)
CL Item
MAO inhibitors (5)
CL Item
COMT inhibitors (Exclusion!) (6)
CL Item
other (7)
Concomitant medication Brand name
Item
Brand name
text
C2347852 (UMLS CUI [1,1])
C0592503 (UMLS CUI [1,2])
Concomitant medication dosage
Item
Dosage
text
C2347852 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
Concomitant medication Regimen
Item
Regimen
text
C2347852 (UMLS CUI [1,1])
C0237125 (UMLS CUI [1,2])
Item
Application
integer
C2347852 (UMLS CUI [1,1])
C0013153 (UMLS CUI [1,2])
Concomitant medication application
Code List
Application
CL Item
p.o. (1)
CL Item
i.v. (2)
CL Item
i.m. (3)
CL Item
rectal (4)
CL Item
p.inh. (5)
CL Item
transdermal (6)
CL Item
other (7)
Concomitant medication indication
Item
Indication
text
C2826696 (UMLS CUI [1])
Concomitant medication started
Item
Date started
date
C2826734 (UMLS CUI [1])
Start date not known
Item
Not known
boolean
C0808070 (UMLS CUI [1,1])
C0439673 (UMLS CUI [1,2])
Concomitant medication end date
Item
Date stopped
date
C2826744 (UMLS CUI [1])
End date not known
Item
Not known
boolean
C2826744 (UMLS CUI [1,1])
C0439673 (UMLS CUI [1,2])
Concomitant Medication Ongoing
Item
Ongoing
boolean
C2826666 (UMLS CUI [1])
AE number
Item
Due to AE, if yes give AE no.
text
C2826275 (UMLS CUI [1])
Item Group
Signature of investigator - Concomitant Medication
C2346576 (UMLS CUI-1)
C2347852 (UMLS CUI-2)
Investigator Signature Date
Item
Date of Investigator Signature
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Investigator name
Item
Name of investigator
text
C2826892 (UMLS CUI [1])
Investigator signature
Item
Investigator signature
text
C2346576 (UMLS CUI [1])
Item Group
Adverse event form
C0877248 (UMLS CUI-1)
AE Number
Item
AE Number
integer
C0877248 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Adverse event diagnosis or signs and symptoms
Item
Adverse event
text
C0877248 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C0877248 (UMLS CUI [2,1])
C0037088 (UMLS CUI [2,2])
Adverse event start date
Item
Start Date
date
C2697888 (UMLS CUI [1])
Adverse event end date
Item
Stop date
date
C2697886 (UMLS CUI [1])
Item
Specific
integer
C0877248 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
adverse event specification
Code List
Specific
CL Item
falls (due to postural instability, ataxia, orthostatic hypotension) (1)
CL Item
swallowing problems, pneumonia due to aspiration (2)
CL Item
dysarthria, dysphagia (3)
CL Item
orthostatic hypotension and blood pressure changes due to vegetative dysfunction (4)
CL Item
urinary tract infections due to vegetative dysfunction (5)
CL Item
progression of disease with hypo kinetic rigid symptoms, ataxia or vegetative dysfunction (6)
Item
Severity
integer
C1710066 (UMLS CUI [1])
adverse event severity
Code List
Severity
CL Item
mild (1)
CL Item
moderate (2)
CL Item
severe (3)
Serious adverse event
Item
Serious
boolean
C1519255 (UMLS CUI [1])
Item
Outcome
integer
C1705586 (UMLS CUI [1])
adverse event outcome
Code List
Outcome
CL Item
recovered (1)
CL Item
recovered with sequelae (2)
CL Item
not recovered (3)
CL Item
fatal (4)
CL Item
unknown (5)
adverse event concomitant medication
Item
Concomitant medication given
boolean
C0877248 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Item
Relationship to study drug
integer
C0877248 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
adverse event Relationship to study drug
Code List
Relationship to study drug
CL Item
definite (1)
CL Item
probable (2)
CL Item
possible (3)
CL Item
unlikely (4)
CL Item
not related (5)
CL Item
unknown (6)
Item
Action taken with study drug
integer
C2826626 (UMLS CUI [1])
Adverse event action taken with study drug
Code List
Action taken with study drug
CL Item
dose not changed (1)
CL Item
dose reduced (2)
CL Item
dose increased (3)
CL Item
drug temporarily discontinued (4)
CL Item
drug permanently discontinued (4)
Item Group
Signatur of investigator - adverse event
C0877248 (UMLS CUI-1)
C2346576 (UMLS CUI-2)
Investigator Signature Date
Item
Date of Investigator Signature
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Investigator name
Item
Name of investigator
text
C2826892 (UMLS CUI [1])
Investigator signature
Item
Investigator signature
text
C2346576 (UMLS CUI [1])
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