ID

42305

Beskrivning

Study ID: 111406 Clinical Study ID: 111406 Study Title: A First-Time-in-Human Study to Evaluate the Safety, Tolerability and Pharmacokinetics of GSK1399686 After Single and Repeated Oral Dosing in Healthy Volunteers using a Dose- Escalating, Randomized, Placebo-Controlled Study Design Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00721812 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Placebo, locally-acting anti-inflammatory compound GSK1399686 Study Indication: Inflammatory Bowel Diseases

Nyckelord

Versioner (1)
  1. 2021-05-26 2021-05-26 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

26 maj 2021

DOI

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Licens

Creative Commons BY 4.0
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Safety, Tolerability and Pharmacokinetics of GSK1399686 After Single and Repeated Oral Dosing NCT00721812

Engelsk

Concomitant Medications

1 Formulär  
Administrative
Beskrivning

Administrative

Alias
UMLS CUI-1
C1320722
Subject Identifier
Beskrivning

Subject Identifier

Datatyp

text

Alias
UMLS CUI [1]
C2348585
Concomitant Medications
Beskrivning

Concomitant Medications

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

Were any concomitant medications taken by the subject during the study?

Datatyp

boolean

Alias
UMLS CUI [1]
C2347852
Concomitant Medications
Beskrivning

Concomitant Medications

Alias
UMLS CUI-1
C2347852
Drug Name
Beskrivning

(Trade Name preferred)

Datatyp

text

Alias
UMLS CUI [1]
C2360065
Unit Dose
Beskrivning

Unit Dose

Datatyp

float

Alias
UMLS CUI [1]
C0869039
Units
Beskrivning

Units

Datatyp

text

Alias
UMLS CUI [1]
C1519795
Medication Frequency
Beskrivning

Medication Frequency

Datatyp

text

Alias
UMLS CUI [1]
C3476109
Medication Route
Beskrivning

Medication Route

Datatyp

text

Alias
UMLS CUI [1]
C0013153
Reason for Medication
Beskrivning

Reason for Medication

Datatyp

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0013227
Medication Start Date
Beskrivning

Medication Start Date

Datatyp

date

Alias
UMLS CUI [1]
C2826734
Medication Start Time
Beskrivning

Medication Start Time

Datatyp

time

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

Medication Taken Prior to Study?

Datatyp

boolean

Alias
UMLS CUI [1]
C2826667
Medication Stop Date
Beskrivning

Medication Stop Date

Datatyp

date

Alias
UMLS CUI [1]
C2826744
Medication Stop Time
Beskrivning

Medication Stop Time

Datatyp

time

Alias
UMLS CUI [1]
C2826659
Ongoing Medication?
Beskrivning

Ongoing Medication?

Datatyp

boolean

Alias
UMLS CUI [1]
C2826666
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Similar models

Concomitant Medications

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
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
C2360065 (UMLS CUI [1])
Unit Dose
Item
Unit Dose
float
C0869039 (UMLS CUI [1])
Item
Units
text
C1519795 (UMLS CUI [1])
Units
Code List
Units
CL Item
Tablet  (TAB)
CL Item
Microlitre  (MCL)
CL Item
Millilitre  (ML)
CL Item
Litre  (L)
CL Item
Microgram  (MCG)
CL Item
Milligram (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)
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 Medication
Item
Reason for Medication
text
C0392360 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Medication Start Date
Item
Medication Start Date
date
C2826734 (UMLS CUI [1])
Medication Start Time
Item
Medication Start Time
time
C1301880 (UMLS CUI [1,1])
C2347852 (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])
Tillbaka till toppen 

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