ID

33285

Beskrivning

Study ID: 107806 Clinical Study ID: RA3107806 Study Title: An open label study to determine the safety, tolerability, excretion balance and pharmacokinetics of Losmapimod, administered as a single dose of an oral solution to healthy adult male subjects Patient Level Data: Clinicaltrials.gov Identifier: NCT00599612 https://clinicaltrials.gov/ct2/show/NCT00599612 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: losmapimod Trade Name: losmapimod Study Indication: Pulmonary Disease, Chronic Obstructive The study consists of a screening, study visit and follow-up. The protocol identifier for all: RA3107806 This document contains the history of tobacco use and the serology - HIV screen form. It has to be filled in for screening.

Länk

https://clinicaltrials.gov/ct2/show/NCT00599612

Nyckelord

Versioner (2)
  1. 2018-11-30 2018-11-30 -
  2. 2018-12-04 2018-12-04 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

4 december 2018

DOI

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Licens

Creative Commons BY-NC 3.0
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Safety, tolerability, excretion balance and pharmacokinetics of Losmapimod in healthy males, NCT00599612

Engelsk

Tobacco use, HIV screen

1 Formulär  
Administrative data
Beskrivning

Administrative data

Alias
UMLS CUI-1
C1320722
Subject identifier
Beskrivning

Subject identifier

Datatyp

text

Alias
UMLS CUI [1]
C2348585
HISTORY OF TOBACCO USE
Beskrivning

HISTORY OF TOBACCO USE

Alias
UMLS CUI-1
C0543414
What is the subject's history of smoking use (includes all tobacco products)?
Beskrivning

If current smoker, Exclude subject from study. DEFINITIONS: Never smoked: Never smoked Current smoker: Currently smoking or has smoked within 6 months of screening visit Former smoker: Previously smoked and has not smoked for at least 6 months prior to screening visit

Datatyp

integer

Alias
UMLS CUI [1]
C1519384
If former smoker, when did the subject last smoke?
Beskrivning

day month year

Datatyp

date

Alias
UMLS CUI [1,1]
C0425310
UMLS CUI [1,2]
C0011008
SEROLOGY - HIV SCREEN
Beskrivning

SEROLOGY - HIV SCREEN

Alias
UMLS CUI-1
C0459958
UMLS CUI-2
C0036743
Date sample taken
Beskrivning

day month year

Datatyp

date

Alias
UMLS CUI [1]
C1302413
Serology for viral infections
Beskrivning

Tick appropriate box(es)

Datatyp

integer

Alias
UMLS CUI [1,1]
C0036743
UMLS CUI [1,2]
C0521026
UMLS CUI [1,3]
C3714514
Serology for viral infections, result
Beskrivning

If any screen are positive, exclude subject from the study.

Datatyp

text

Alias
UMLS CUI [1,1]
C0036743
UMLS CUI [1,2]
C0521026
UMLS CUI [1,3]
C3714514
Tillbaka till toppen

Similar models

Tobacco use, HIV screen

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Subject identifier
Item
Subject identifier
text
C2348585 (UMLS CUI [1])
Item Group
HISTORY OF TOBACCO USE
C0543414 (UMLS CUI-1)
Item
What is the subject's history of smoking use (includes all tobacco products)?
integer
C1519384 (UMLS CUI [1])
History of smoking use
Code List
What is the subject's history of smoking use (includes all tobacco products)?
CL Item
Never smoked (1)
CL Item
Current smoker (2)
CL Item
Former smoker (3)
Date stopped smoking
Item
If former smoker, when did the subject last smoke?
date
C0425310 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
SEROLOGY - HIV SCREEN
C0459958 (UMLS CUI-1)
C0036743 (UMLS CUI-2)
Date sample taken
Item
Date sample taken
date
C1302413 (UMLS CUI [1])
Item
Serology for viral infections
integer
C0036743 (UMLS CUI [1,1])
C0521026 (UMLS CUI [1,2])
C3714514 (UMLS CUI [1,3])
HIV screen
Code List
Serology for viral infections
CL Item
HIV antibody (1)
CL Item
Hepatitis B surface antigen (2)
CL Item
Hepatitis C antibody (3)
Item
Serology for viral infections, result
text
C0036743 (UMLS CUI [1,1])
C0521026 (UMLS CUI [1,2])
C3714514 (UMLS CUI [1,3])
HIV screen, result
Code List
Serology for viral infections, result
CL Item
Positive (P)
CL Item
Negative (N)
Tillbaka till toppen 

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