ID

42305

Beschreibung

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

Stichworte

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  1. 26.05.21 26.05.21 -
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GlaxoSmithKline

Hochgeladen am

26. Mai 2021

DOI

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

Englisch

Concomitant Medications

1 Formulare  
Administrative
Beschreibung

Administrative

Alias
UMLS CUI-1
C1320722 (Administrative documentation)
SNOMED
405624007
Subject Identifier
Beschreibung

Subject Identifier

Datentyp

text

Alias
UMLS CUI [1]
C2348585 (Clinical Trial Subject Unique Identifier)
Concomitant Medications
Beschreibung

Concomitant Medications

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

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

Datentyp

boolean

Alias
UMLS CUI [1]
C2347852 (Concomitant Agent)
Concomitant Medications
Beschreibung

Concomitant Medications

Alias
UMLS CUI-1
C2347852 (Concomitant Agent)
Drug Name
Beschreibung

(Trade Name preferred)

Datentyp

text

Alias
UMLS CUI [1]
C2360065 (Medication name)
LOINC
MTHU027854
Unit Dose
Beschreibung

Unit Dose

Datentyp

float

Alias
UMLS CUI [1]
C0869039 (Unit dose)
SNOMED
408102007
Units
Beschreibung

Units

Datentyp

text

Alias
UMLS CUI [1]
C1519795 (Unit of Measure)
SNOMED
767524001
Medication Frequency
Beschreibung

Medication Frequency

Datentyp

text

Alias
UMLS CUI [1]
C3476109 (Medication frequency)
LOINC
LP149758-7
Medication Route
Beschreibung

Medication Route

Datentyp

text

Alias
UMLS CUI [1]
C0013153 (Drug Administration Routes)
SNOMED
410675002
LOINC
LP40261-7
Reason for Medication
Beschreibung

Reason for Medication

Datentyp

text

Alias
UMLS CUI [1,1]
C0392360 (Indication of (contextual qualifier))
SNOMED
230165009
LOINC
MTHU008319
UMLS CUI [1,2]
C0013227 (Pharmaceutical Preparations)
SNOMED
763158003
LOINC
LP100609-9
Medication Start Date
Beschreibung

Medication Start Date

Datentyp

date

Alias
UMLS CUI [1]
C2826734 (Concomitant Medication Start Date)
Medication Start Time
Beschreibung

Medication Start Time

Datentyp

time

Alias
UMLS CUI [1,1]
C1301880 (Start time)
SNOMED
398201009
LOINC
LP102339-1
UMLS CUI [1,2]
C2347852 (Concomitant Agent)
Medication Taken Prior to Study?
Beschreibung

Medication Taken Prior to Study?

Datentyp

boolean

Alias
UMLS CUI [1]
C2826667 (Concomitant Medication Previous Occurrence)
Medication Stop Date
Beschreibung

Medication Stop Date

Datentyp

date

Alias
UMLS CUI [1]
C2826744 (Concomitant Medication End Date)
Medication Stop Time
Beschreibung

Medication Stop Time

Datentyp

time

Alias
UMLS CUI [1]
C2826659 (Concomitant Medication End Time)
Ongoing Medication?
Beschreibung

Ongoing Medication?

Datentyp

boolean

Alias
UMLS CUI [1]
C2826666 (Concomitant Medication Ongoing)
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Ähnliche Modelle

Concomitant Medications

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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])
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