ID

40852

Beschreibung

Study ID: 103933 Clinical Study ID: NKV103933 Study Title: A non-randomised, open label, two period cross-over study to determine the excretion balance and metabolic disposition of [14C]-GW679769, administered as single doses of an oral solution and an intravenous infusion to healthy male subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier:N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: casopitant Trade Name: Rezonic,Zunrisa; Zunrisa,Rezonic Study Indication: Nausea and Vomiting, Chemotherapy-Induced Protocol ID: NKV103933 The eligibility to participate was determined during a screening visit within 21 days prior to first dosing day. The study consisted of two dosing periods, each consisting of predose visit, monitoring after dose administration and prior to discharge visit. Dosing periods were separated by a wash-out period of 43 days. The Pharmacogenetic Research Form is used to record the state of informed consent for the pharmacogenetic research at the moments when the state changes. See the form sections for more details.

Stichworte

Versionen (1)
  1. 26.05.20 26.05.20 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

26. Mai 2020

DOI

Für eine Beantragung loggen Sie sich ein.

Lizenz

Creative Commons BY-NC 4.0
Modell Kommentare :

Hier können Sie das Modell kommentieren. Über die Sprechblasen an den Itemgruppen und Items können Sie diese spezifisch kommentieren.

Zurück zu Modell Kommentaren
Itemgroup Kommentare für :

Item Kommentare für :

Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.

Study of Casopitant Pharmacokinetics in Healthy Males, NKV103933

Englisch

PGx - Pharmacogenetic 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
Visit Date
Beschreibung

Visit Date

Datentyp

date

Alias
UMLS CUI [1]
C1320303
CONSENT FOR PGx-PHARMACOGENETIC RESEARCH
Beschreibung

CONSENT FOR PGx-PHARMACOGENETIC RESEARCH

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

informed consent Pharmacogenetic Test

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C2347500
If Yes, record the date informed consent obtained for PGx-Pharmacogenetic research
Beschreibung

Pharmacogenetic test Informed consent Date

Datentyp

date

Alias
UMLS CUI [1,1]
C2347500
UMLS CUI [1,2]
C0021430
UMLS CUI [1,3]
C0011008
If No, check one reason:
Beschreibung

Pharmacogenetic test Informed consent Reason

Datentyp

text

Alias
UMLS CUI [1,1]
C2347500
UMLS CUI [1,2]
C0021430
UMLS CUI [1,3]
C0566251
Other, specify
Beschreibung

other reason for no consent for PGx obtained

Datentyp

text

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C0566251
UMLS CUI [1,3]
C0021430
UMLS CUI [1,4]
C2347500
UMLS CUI [1,5]
C1882120
BLOOD SAMPLE COLLECTION (DNA)
Beschreibung

BLOOD SAMPLE COLLECTION (DNA)

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

Blood Sample Collection Pharmacogenetic research

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C2347500
If Yes, record the date sample taken
Beschreibung

Date Blood sample collection Pharmacogenetic research

Datentyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0005834
UMLS CUI [1,3]
C02347500
WITHDRAWAL OF CONSENT
Beschreibung

WITHDRAWAL OF CONSENT

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

Withdrawal of consent Pharmacogenetic research

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1707492
UMLS CUI [1,2]
C0031325
BLOOD SAMPLE DESTRUCTION
Beschreibung

BLOOD SAMPLE DESTRUCTION

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

Blood Sample Destruction

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1948029
UMLS CUI [1,2]
C0178913
If Yes, check one reason:
Beschreibung

Reason Blood sample destruction

Datentyp

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C1948029
UMLS CUI [1,3]
C0178913
If other, please specify
Beschreibung

other reason for blood sample destruction

Datentyp

text

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C0566251
UMLS CUI [1,3]
C1948029
UMLS CUI [1,4]
C0178913
Zum Seitenanfang zurückkehren

Ähnliche Modelle

PGx - Pharmacogenetic 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])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item Group
CONSENT FOR PGx-PHARMACOGENETIC RESEARCH
C0021430 (UMLS CUI-1)
C2347500 (UMLS CUI-2)
informed consent Pharmacogenetic Test
Item
Has informed consent been obtained for PGx-Pharmacogenetic research?
boolean
C0021430 (UMLS CUI [1,1])
C2347500 (UMLS CUI [1,2])
Pharmacogenetic test Informed consent Date
Item
If Yes, record the date informed consent obtained for PGx-Pharmacogenetic research
date
C2347500 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item
If No, check one reason:
text
C2347500 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
reason
Code List
If No, check one reason:
CL Item
Subject declined (1)
CL Item
Subject not asked by Investigator (2)
CL Item
Other, specify (Z)
other reason for no consent for PGx obtained
Item
Other, specify
text
C0205394 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
C0021430 (UMLS CUI [1,3])
C2347500 (UMLS CUI [1,4])
C1882120 (UMLS CUI [1,5])
Item Group
BLOOD SAMPLE COLLECTION (DNA)
C0005834 (UMLS CUI-1)
Blood Sample Collection Pharmacogenetic research
Item
Has a blood sample been collected for PGx-pharmacogenetic research?
boolean
C0005834 (UMLS CUI [1,1])
C2347500 (UMLS CUI [1,2])
Date Blood sample collection Pharmacogenetic research
Item
If Yes, record the date sample taken
date
C0011008 (UMLS CUI [1,1])
C0005834 (UMLS CUI [1,2])
C02347500 (UMLS CUI [1,3])
Item Group
WITHDRAWAL OF CONSENT
C1707492 (UMLS CUI-1)
Withdrawal of consent Pharmacogenetic research
Item
Has subject withdrawn consent for PGx-Pharmacogenetic research?
boolean
C1707492 (UMLS CUI [1,1])
C0031325 (UMLS CUI [1,2])
Item Group
BLOOD SAMPLE DESTRUCTION
C1948029 (UMLS CUI-1)
C0178913 (UMLS CUI-2)
Blood Sample Destruction
Item
Has a request been made for sample destruction?
boolean
C1948029 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
Item
If Yes, check one reason:
text
C0392360 (UMLS CUI [1,1])
C1948029 (UMLS CUI [1,2])
C0178913 (UMLS CUI [1,3])
reason BLOOD SAMPLE DESTRUCTION
Code List
If Yes, check one reason:
CL Item
Subject requested (1)
CL Item
Screen failure (2)
CL Item
Other, specify (Z)
other reason for blood sample destruction
Item
If other, please specify
text
C0205394 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
C1948029 (UMLS CUI [1,3])
C0178913 (UMLS CUI [1,4])
Zum Seitenanfang zurückkehren 

Kontakt

Benutzen Sie dieses Formular für Rückmeldungen, Fragen und Verbesserungsvorschläge.

Mit * gekennzeichnete Felder sind notwendig.

Hilfe

Benötigen Sie Hilfe bei der Suche? Um mehr Details zu erfahren und die Suche effektiver nutzen zu können schauen Sie sich doch das entsprechende Video auf unserer Tutorial Seite an.

Zum Video