ID

33285

Beschreibung

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.

Link

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

Stichworte

Versionen (2)
  1. 30.11.18 30.11.18 -
  2. 04.12.18 04.12.18 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

4. Dezember 2018

DOI

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Lizenz

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

Englisch

Tobacco use, HIV screen

1 Formulare  
Administrative data
Beschreibung

Administrative data

Alias
UMLS CUI-1
C1320722
Subject identifier
Beschreibung

Subject identifier

Datentyp

text

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

HISTORY OF TOBACCO USE

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

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

Datentyp

integer

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

day month year

Datentyp

date

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

SEROLOGY - HIV SCREEN

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

day month year

Datentyp

date

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

Tick appropriate box(es)

Datentyp

integer

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

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

Datentyp

text

Alias
UMLS CUI [1,1]
C0036743
UMLS CUI [1,2]
C0521026
UMLS CUI [1,3]
C3714514
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Ähnliche Modelle

Tobacco use, HIV screen

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