Informações:
Falhas:
ID
41757
Descrição
Study ID: 103096 Clinical Study ID: 103096 Study Title: A randomised, double blind, placebo controlled, incomplete block, five-way cross-over study to investigate the effect of one week repeat dosing of GW685698X and FP on twenty-four hour serum cortisol in healthy subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Fluticasone Furoate;Fluticasone Propionate Trade Name: Fluticasone Furoate;Fluticasone Propionate Study Indication: Asthma
Palavras-chave
Versões (1)
- 13/01/2021 13/01/2021 -
Titular dos direitos
GlaxoSmithKline
Transferido a
13 de janeiro de 2021
DOI
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Licença
Creative Commons BY 4.0
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Effect of one week repeat dosing of GW685698X and FP on serum cortisol (103096)
Running Logs and End of Study - Status of Treatment Blind; Pharmacogenetic Research; Concomitant Medications
Similar models
Running Logs and End of Study - Status of Treatment Blind; Pharmacogenetic Research; Concomitant Medications
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Volunteer Identifier
Item
Volunteer Identifier
text
C1300638 (UMLS CUI [1,1])
C0020155 (UMLS CUI [1,2])
C0020155 (UMLS CUI [1,2])
Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Centre Number
Item
Centre Number
text
C0600091 (UMLS CUI [1,1])
C0019994 (UMLS CUI [1,2])
C0019994 (UMLS CUI [1,2])
Item Group
Status of Treatment Blind
C0749659 (UMLS CUI-1)
C2347038 (UMLS CUI-2)
C2347038 (UMLS CUI-2)
Was the treatment blind broken during the study?
Item
Was the treatment blind broken during the study?
boolean
C3897431 (UMLS CUI [1])
Date blind broken
Item
Date blind broken
date
C3897431 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Item
Reason blind broken
integer
C3897431 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,2])
CL Item
Medical emergency requiring identification of investigational product for further treatment (1)
CL Item
Other, specify (2)
Specify other reason blind broken
Item
Specify other reason blind broken
text
C3897431 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
C0392360 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
Item Group
Pharmacogenetic Research - Consent for PGx-Pharmacogenetic Research
C0021430 (UMLS CUI-1)
C2347500 (UMLS CUI-2)
C2347500 (UMLS CUI-2)
Has informed consent been obtained for PGx-Pharmacogenetic research?
Item
Has informed consent been obtained for PGx-Pharmacogenetic research?
boolean
C0021430 (UMLS CUI [1,1])
C2347500 (UMLS CUI [1,2])
C2347500 (UMLS CUI [1,2])
If yes, record the date informed consent obtained for PGx-Pharmacogenetic research
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])
C0021430 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item
If no informed consent obtained, check one reason
text
C0392360 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
C1882120 (UMLS CUI [1,3])
C0021430 (UMLS CUI [1,2])
C1882120 (UMLS CUI [1,3])
Code List
If no informed consent obtained, check one reason
CL Item
Subject declined (1)
CL Item
Subject not asked by Investigator (2)
CL Item
Other, specify (Z)
Specify other reason for informed consent not been obtained
Item
Specify other reason for informed consent not been obtained
text
C0021430 (UMLS CUI [1,1])
C1882120 (UMLS CUI [1,2])
C0392360 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C2348235 (UMLS CUI [2,3])
C1882120 (UMLS CUI [1,2])
C0392360 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C2348235 (UMLS CUI [2,3])
Item Group
Pharmacogenetic Research - Blood Sample Collection (DNA)
C0005834 (UMLS CUI-1)
C2347500 (UMLS CUI-2)
C2347500 (UMLS CUI-2)
Has a blood sample been collected for pGx-pharmacogenetic research?
Item
Has a blood sample been collected for pGx-pharmacogenetic research?
boolean
C0005834 (UMLS CUI [1,1])
C2347500 (UMLS CUI [1,2])
C2347500 (UMLS CUI [1,2])
If yes, record the date sample taken
Item
If yes, record the date sample taken
date
C2347500 (UMLS CUI [1,1])
C0005834 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0005834 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item Group
Pharmacogenetic Research - Withdrawal of consent
C2347500 (UMLS CUI-1)
C0021430 (UMLS CUI-2)
C2349954 (UMLS CUI-3)
C0021430 (UMLS CUI-2)
C2349954 (UMLS CUI-3)
Has subject withdrawn consent for PGx-Pharmacogenetic research?
Item
Has subject withdrawn consent for PGx-Pharmacogenetic research?
boolean
C2347500 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
C2349954 (UMLS CUI [1,3])
C0021430 (UMLS CUI [1,2])
C2349954 (UMLS CUI [1,3])
Item Group
Pharmacogenetic Research - Blood Sample Destruction
C2347500 (UMLS CUI-1)
C1948029 (UMLS CUI-2)
C0178913 (UMLS CUI-3)
C1948029 (UMLS CUI-2)
C0178913 (UMLS CUI-3)
Has a request been made for sample destruction?
Item
Has a request been made for sample destruction?
boolean
C1948029 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
C1272683 (UMLS CUI [1,3])
C0178913 (UMLS CUI [1,2])
C1272683 (UMLS CUI [1,3])
Item
If request for blood sample destruction has been made, check one reason
text
C1948029 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
C1272683 (UMLS CUI [1,3])
C0392360 (UMLS CUI [1,4])
C0178913 (UMLS CUI [1,2])
C1272683 (UMLS CUI [1,3])
C0392360 (UMLS CUI [1,4])
Code List
If request for blood sample destruction has been made, check one reason
CL Item
Subject requested (1)
CL Item
Other, specify (Z)
Specify other reason for request for blood sample destruction.
Item
Specify other reason for request for blood sample destruction.
text
C1948029 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
C1272683 (UMLS CUI [1,3])
C0392360 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C2348235 (UMLS CUI [3])
C0178913 (UMLS CUI [1,2])
C1272683 (UMLS CUI [1,3])
C0392360 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C2348235 (UMLS CUI [3])
Were any concomitant medications taken by the subject during the study?
Item
Were any concomitant medications taken by the subject during the study?
boolean
C2347852 (UMLS CUI [1])
Drug Name
Item
Drug Name
text
C0013227 (UMLS CUI [1])
Medication Unit Dose
Item
Medication Unit Dose
float
C2826646 (UMLS CUI [1])
CL Item
Tablet (TAB)
CL Item
Microlitre (MCL)
CL Item
Mililitre (ML)
CL Item
Litre (L)
CL Item
Microgram (MCG)
CL Item
Miligram (MG)
CL Item
Gram (G)
CL Item
1 x Daily (OD/QD)
CL Item
2 x Daily (BID)
CL Item
3 x Daily (TID)
CL Item
4 x Daily (QID)
CL Item
As required (PRN)
CL Item
Single dose (ONCE)
CL Item
Intramuscular (IM)
CL Item
Inhalation (IH)
CL Item
Intravenous (IV)
CL Item
Nasal (NS)
CL Item
Topical (TP)
CL Item
Oral (PO)
CL Item
Vaginal (VG)
Reason for Medications
Item
Reason for Medications
text
C3146298 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,2])
Medication Start Date
Item
Medication Start Date
date
C2826734 (UMLS CUI [1])
Medication Start Time
Item
Medication Start Time
time
C2347852 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,2])
Medication Taken Prior to Study?
Item
Medication Taken Prior to Study?
boolean
C2826667 (UMLS CUI [1])
Medication Stop Date
Item
Medication Stop Date
date
C2826744 (UMLS CUI [1])
Medication Stop Time
Item
Medication Stop Time
time
C2826659 (UMLS CUI [1])
Ongoing Medication?
Item
Ongoing Medication?
boolean
C2826666 (UMLS CUI [1])