ID

41757

Beschreibung

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

Stichworte

Versionen (1)
  1. 13.01.21 13.01.21 -
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GlaxoSmithKline

Hochgeladen am

13. Januar 2021

DOI

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Effect of one week repeat dosing of GW685698X and FP on serum cortisol (103096)

Englisch

Running Logs and End of Study - Status of Treatment Blind; Pharmacogenetic Research; Concomitant Medications

1 Formulare  
Administrative
Beschreibung

Administrative

Alias
UMLS CUI-1
C1320722
Volunteer Identifier
Beschreibung

Volunteer Identifier

Datentyp

text

Alias
UMLS CUI [1,1]
C1300638
UMLS CUI [1,2]
C0020155
Subject Identifier
Beschreibung

Subject Identifier

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Centre Number
Beschreibung

Centre Number

Datentyp

text

Alias
UMLS CUI [1,1]
C0600091
UMLS CUI [1,2]
C0019994
Status of Treatment Blind
Beschreibung

Status of Treatment Blind

Alias
UMLS CUI-1
C0749659
UMLS CUI-2
C2347038
Was the treatment blind broken during the study?
Beschreibung

Was the treatment blind broken during the study?

Datentyp

boolean

Alias
UMLS CUI [1]
C3897431
Date blind broken
Beschreibung

Date blind broken

Datentyp

date

Alias
UMLS CUI [1,1]
C3897431
UMLS CUI [1,2]
C0011008
Reason blind broken
Beschreibung

Check one Complete Non-Serious Adverse Events, Serious Adverse Event and/or Investigational Product pages, as appropriate.

Datentyp

integer

Alias
UMLS CUI [1,1]
C3897431
UMLS CUI [1,2]
C0392360
Specify other reason blind broken
Beschreibung

Specify other reason blind broken

Datentyp

text

Alias
UMLS CUI [1,1]
C3897431
UMLS CUI [1,2]
C0392360
UMLS CUI [1,3]
C0205394
UMLS CUI [1,4]
C2348235
Pharmacogenetic Research - Consent for PGx-Pharmacogenetic Research
Beschreibung

Pharmacogenetic Research - Consent for PGx-Pharmacogenetic Research

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

Has informed consent been obtained for PGx-Pharmacogenetic research?

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

If yes, record the date informed consent obtained for PGx-Pharmacogenetic research

Datentyp

date

Alias
UMLS CUI [1,1]
C2347500
UMLS CUI [1,2]
C0021430
UMLS CUI [1,3]
C0011008
If no informed consent obtained, check one reason
Beschreibung

If no informed consent obtained, check one reason

Datentyp

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0021430
UMLS CUI [1,3]
C1882120
Specify other reason for informed consent not been obtained
Beschreibung

Specify other reason for informed consent not been obtained

Datentyp

text

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1882120
UMLS CUI [2,1]
C0392360
UMLS CUI [2,2]
C0205394
UMLS CUI [2,3]
C2348235
Pharmacogenetic Research - Blood Sample Collection (DNA)
Beschreibung

Pharmacogenetic Research - Blood Sample Collection (DNA)

Alias
UMLS CUI-1
C0005834
UMLS CUI-2
C2347500
Has a blood sample been collected for pGx-pharmacogenetic research?
Beschreibung

Has a blood sample been collected for pGx-pharmacogenetic research?

Datentyp

boolean

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

If yes, record the date sample taken

Datentyp

date

Alias
UMLS CUI [1,1]
C2347500
UMLS CUI [1,2]
C0005834
UMLS CUI [1,3]
C0011008
Pharmacogenetic Research - Withdrawal of consent
Beschreibung

Pharmacogenetic Research - Withdrawal of consent

Alias
UMLS CUI-1
C2347500
UMLS CUI-2
C0021430
UMLS CUI-3
C2349954
Has subject withdrawn consent for PGx-Pharmacogenetic research?
Beschreibung

Has subject withdrawn consent for PGx-Pharmacogenetic research?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2347500
UMLS CUI [1,2]
C0021430
UMLS CUI [1,3]
C2349954
Pharmacogenetic Research - Blood Sample Destruction
Beschreibung

Pharmacogenetic Research - Blood Sample Destruction

Alias
UMLS CUI-1
C2347500
UMLS CUI-2
C1948029
UMLS CUI-3
C0178913
Has a request been made for sample destruction?
Beschreibung

Has a request been made for sample destruction?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1948029
UMLS CUI [1,2]
C0178913
UMLS CUI [1,3]
C1272683
If request for blood sample destruction has been made, check one reason
Beschreibung

If request for blood sample destruction has been made, check one reason

Datentyp

text

Alias
UMLS CUI [1,1]
C1948029
UMLS CUI [1,2]
C0178913
UMLS CUI [1,3]
C1272683
UMLS CUI [1,4]
C0392360
Specify other reason for request for blood sample destruction.
Beschreibung

Specify other reason for request for blood sample destruction.

Datentyp

text

Alias
UMLS CUI [1,1]
C1948029
UMLS CUI [1,2]
C0178913
UMLS CUI [1,3]
C1272683
UMLS CUI [2,1]
C0392360
UMLS CUI [2,2]
C0205394
UMLS CUI [3]
C2348235
Concomitant Medications
Beschreibung

Concomitant Medications

Alias
UMLS CUI-1
C2347852
Were any concomitant medications taken by the subject during the study?
Beschreibung

If yes, record each medication on a separate line using Trade Names where possible. If the medication is related to a Non-Serious Adverse Event or Serious Adverse Event, details should be expressed using the same terminology.

Datentyp

boolean

Alias
UMLS CUI [1]
C2347852
Concomitant Medications
Beschreibung

Concomitant Medications

Alias
UMLS CUI-1
C2347852
Drug Name
Beschreibung

Trade Name preferred

Datentyp

text

Alias
UMLS CUI [1]
C0013227
Medication Unit Dose
Beschreibung

Medication Unit Dose

Datentyp

float

Alias
UMLS CUI [1]
C2826646
Medication Units
Beschreibung

Medication Units

Datentyp

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C1519795
Medication Frequency
Beschreibung

Medication Frequency

Datentyp

text

Alias
UMLS CUI [1]
C3476109
Medication Route
Beschreibung

Medication Route

Datentyp

text

Alias
UMLS CUI [1]
C0013153
Reason for Medications
Beschreibung

Reason for Medications

Datentyp

text

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C2347852
Medication Start Date
Beschreibung

Medication Start Date

Datentyp

date

Alias
UMLS CUI [1]
C2826734
Medication Start Time
Beschreibung

Medication Start Time

Datentyp

time

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C1301880
Medication Taken Prior to Study?
Beschreibung

Medication Taken Prior to Study?

Datentyp

boolean

Alias
UMLS CUI [1]
C2826667
Medication Stop Date
Beschreibung

Medication Stop Date

Datentyp

date

Alias
UMLS CUI [1]
C2826744
Medication Stop Time
Beschreibung

Medication Stop Time

Datentyp

time

Alias
UMLS CUI [1]
C2826659
Ongoing Medication?
Beschreibung

Ongoing Medication?

Datentyp

boolean

Alias
UMLS CUI [1]
C2826666
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Ähnliche Modelle

Running Logs and End of Study - Status of Treatment Blind; Pharmacogenetic Research; Concomitant Medications

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Volunteer Identifier
Item
Volunteer Identifier
text
C1300638 (UMLS CUI [1,1])
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])
Item Group
Status of Treatment Blind
C0749659 (UMLS CUI-1)
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])
Item
Reason blind broken
integer
C3897431 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Reason blind broken
Code List
Reason blind broken
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])
Item Group
Pharmacogenetic Research - Consent for PGx-Pharmacogenetic Research
C0021430 (UMLS CUI-1)
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])
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])
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])
If no informed consent obtained, check one reason
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])
Item Group
Pharmacogenetic Research - Blood Sample Collection (DNA)
C0005834 (UMLS CUI-1)
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])
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])
Item Group
Pharmacogenetic Research - Withdrawal of consent
C2347500 (UMLS CUI-1)
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])
Item Group
Pharmacogenetic Research - Blood Sample Destruction
C2347500 (UMLS CUI-1)
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])
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])
If request for blood sample destruction has been made, check one reason
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])
Item Group
Concomitant Medications
C2347852 (UMLS CUI-1)
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])
Item Group
Concomitant Medications
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])
Item
Medication Units
text
C0013227 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
Units
Code List
Medication Units
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)
Item
Medication Frequency
text
C3476109 (UMLS CUI [1])
Medication Frequency
Code List
Medication Frequency
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)
Item
Medication Route
text
C0013153 (UMLS CUI [1])
Medication Route
Code List
Medication Route
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])
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])
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])
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