ID

33378

Beschreibung

Study ID: 107806 Clinical Study ID: RA3107806 Study Title: An open label study to determine the safety, tolerability, excretion balance and pharmacokinetics of Losmapimod, administered as a single dose of an oral solution to healthy adult male subjects Patient Level Data: Clinicaltrials.gov Identifier: NCT00599612 https://clinicaltrials.gov/ct2/show/NCT00599612 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: losmapimod Trade Name: losmapimod Study Indication: Pulmonary Disease, Chronic Obstructive The study consists of a screening, study visit and follow-up. The protocol identifier for all: RA3107806 This document contains the Pharmacogenetic (PGx) research form. It has to be filled in if a PGx was done during study.

Link

https://clinicaltrials.gov/ct2/show/NCT00599612

Stichworte

Versionen (2)
  1. 04.12.18 04.12.18 -
  2. 07.12.18 07.12.18 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

7. Dezember 2018

DOI

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Creative Commons BY-NC 3.0
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Safety, tolerability, excretion balance and pharmacokinetics of Losmapimod in healthy males, NCT00599612

Englisch

Pharmacogenetic (PGx) research

1 Formulare  
Administrative data
Beschreibung

Administrative data

Alias
UMLS CUI-1
C1320722
Subject identifier
Beschreibung

Subject identifier

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Consent for pharmacogenetic (PGx) research (DNA)
Beschreibung

Consent for pharmacogenetic (PGx) research (DNA)

Alias
UMLS CUI-1
C0021430
UMLS CUI-2
C2347500
Has informed consent been obtained for PGx research?
Beschreibung

Informed consent for PGx

Datentyp

text

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C2347500
If you ticked yes in "informed consent for PGx", record the date informed consent obtained for PGx research
Beschreibung

day month year

Datentyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0009797
If you ticked no in "informed consent for PGx", please tick one reason
Beschreibung

No informed consent, reason

Datentyp

text

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1272696
UMLS CUI [1,3]
C0566251
If other reason, please specify
Beschreibung

Other reason for none informed consent

Datentyp

text

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1272696
UMLS CUI [1,3]
C0205394
UMLS CUI [1,4]
C0566251
Blood sample collection
Beschreibung

Blood sample collection

Alias
UMLS CUI-1
C0005834
Has a blood sample been collected for PGx research?
Beschreibung

Blood sample collection for PGx

Datentyp

text

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0031325
If you ticked yes in "blood sample collection for PGx" record the date sample taken
Beschreibung

day month year

Datentyp

date

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0031325
UMLS CUI [1,3]
C0011008
Withdrawl of consent
Beschreibung

Withdrawl of consent

Alias
UMLS CUI-1
C1707492
Has subject withdrawn consent for PGx research?
Beschreibung

Withdrawn consent for PGx

Datentyp

text

Alias
UMLS CUI [1,1]
C1707492
UMLS CUI [1,2]
C0031325
If you ticked yes in "withdrawn consent for PGx", record the date informed consent withdrawn for PGx research
Beschreibung

Date of informed consent withdraw

Datentyp

date

Alias
UMLS CUI [1,1]
C1707492
UMLS CUI [1,2]
C0031325
UMLS CUI [1,3]
C0011008
Blood sample destruction
Beschreibung

Blood sample destruction

Alias
UMLS CUI-1
C1948029
UMLS CUI-2
C0178913
Has a request been made for blood sample destruction?
Beschreibung

Request for blood sample destruction

Datentyp

text

Alias
UMLS CUI [1,1]
C1948029
UMLS CUI [1,2]
C0178913
UMLS CUI [1,3]
C1272683
If request, please tick one reason
Beschreibung

Reason for request

Datentyp

text

Alias
UMLS CUI [1,1]
C0566251
UMLS CUI [1,2]
C1272683
If other reason, please specify
Beschreibung

Other reason for request

Datentyp

text

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C0566251
UMLS CUI [1,3]
C1272683
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Ähnliche Modelle

Pharmacogenetic (PGx) research

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Subject identifier
Item
Subject identifier
text
C2348585 (UMLS CUI [1])
Item Group
Consent for pharmacogenetic (PGx) research (DNA)
C0021430 (UMLS CUI-1)
C2347500 (UMLS CUI-2)
Item
Has informed consent been obtained for PGx research?
text
C0021430 (UMLS CUI [1,1])
C2347500 (UMLS CUI [1,2])
Informed consent for PGx
Code List
Has informed consent been obtained for PGx research?
CL Item
Yes (Y)
CL Item
No (N)
Date of informed consent
Item
If you ticked yes in "informed consent for PGx", record the date informed consent obtained for PGx research
date
C0011008 (UMLS CUI [1,1])
C0009797 (UMLS CUI [1,2])
Item
If you ticked no in "informed consent for PGx", please tick one reason
text
C0021430 (UMLS CUI [1,1])
C1272696 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
No informed consent, reason
Code List
If you ticked no in "informed consent for PGx", please tick one reason
CL Item
Subject declined (1)
CL Item
Subject not asked by Investigator (2)
CL Item
Other (Z)
Item
If other reason, please specify
text
C0021430 (UMLS CUI [1,1])
C1272696 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,4])
No informed consent, reason
Code List
If other reason, please specify
Item Group
Blood sample collection
C0005834 (UMLS CUI-1)
Item
Has a blood sample been collected for PGx research?
text
C0005834 (UMLS CUI [1,1])
C0031325 (UMLS CUI [1,2])
Blood sample collection for PGx
Code List
Has a blood sample been collected for PGx research?
CL Item
Yes (Y)
CL Item
No (N)
Date of blood sample collection
Item
If you ticked yes in "blood sample collection for PGx" record the date sample taken
date
C0005834 (UMLS CUI [1,1])
C0031325 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item Group
Withdrawl of consent
C1707492 (UMLS CUI-1)
Item
Has subject withdrawn consent for PGx research?
text
C1707492 (UMLS CUI [1,1])
C0031325 (UMLS CUI [1,2])
Withdrawn consent for PGx
Code List
Has subject withdrawn consent for PGx research?
CL Item
Yes (Y)
CL Item
No (N)
Date of informed consent withdraw
Item
If you ticked yes in "withdrawn consent for PGx", record the date informed consent withdrawn for PGx research
date
C1707492 (UMLS CUI [1,1])
C0031325 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item Group
Blood sample destruction
C1948029 (UMLS CUI-1)
C0178913 (UMLS CUI-2)
Item
Has a request been made for blood sample destruction?
text
C1948029 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
C1272683 (UMLS CUI [1,3])
Request for blood sample destruction
Code List
Has a request been made for blood sample destruction?
CL Item
Yes (Y)
CL Item
No (N)
Item
If request, please tick one reason
text
C0566251 (UMLS CUI [1,1])
C1272683 (UMLS CUI [1,2])
Reason for request
Code List
If request, please tick one reason
CL Item
Subject withdrew consent for PGx (1)
CL Item
Screen failure (2)
CL Item
Other (Z)
Other reason for request
Item
If other reason, please specify
text
C0205394 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
C1272683 (UMLS CUI [1,3])
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