ID

33286

Beschrijving

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 Electronically transferred laboratory data form (Clinial chemistry, haematology, urinanalysis). It has to be filled in for sceening, study visit and follow up. If the laboratory results meet the protocol definition of an adverse event, record the details in the Non-Serious Adverse Events or Serious Adverse Event section(s).

Link

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

Trefwoorden

  1. 04-12-18 04-12-18 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

4 december 2018

DOI

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Licentie

Creative Commons BY-NC 3.0

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Safety, tolerability, excretion balance and pharmacokinetics of Losmapimod in healthy males, NCT00599612

Electronically transferred laboratory data

Administrative data
Beschrijving

Administrative data

Alias
UMLS CUI-1
C1320722
Subject identifier
Beschrijving

Subject identifier

Datatype

text

Alias
UMLS CUI [1]
C2348585
Visit type
Beschrijving

Visit type

Datatype

integer

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0332307
Electronically transferred laboratory data
Beschrijving

Electronically transferred laboratory data

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0008000
Date Sample Taken
Beschrijving

day month year

Datatype

date

Alias
UMLS CUI [1,1]
C1302413
UMLS CUI [1,2]
C0008000
Actual time
Beschrijving

00:00-23:59

Datatype

time

Alias
UMLS CUI [1]
C0040223
Dosing
Beschrijving

Only for Study visit

Datatype

integer

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C0008000
Electronically transferred laboratory data - Haematology
Beschrijving

Electronically transferred laboratory data - Haematology

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0018941
Date Sample Taken
Beschrijving

day month year

Datatype

date

Alias
UMLS CUI [1,1]
C1302413
UMLS CUI [1,2]
C0018941
Actual time
Beschrijving

00:00-23:59

Datatype

time

Alias
UMLS CUI [1]
C0040223
Dosing
Beschrijving

Only for study visit

Datatype

integer

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C0018941
Electronically transferred laboratory data - Urinalysis
Beschrijving

Electronically transferred laboratory data - Urinalysis

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0042014
Date Sample Taken
Beschrijving

day month year

Datatype

date

Alias
UMLS CUI [1,1]
C1302413
UMLS CUI [1,2]
C0042014
Actual time
Beschrijving

00:00-23:59

Datatype

time

Alias
UMLS CUI [1]
C0040223
Dosing
Beschrijving

Only for study visit

Datatype

integer

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C0042014

Similar models

Electronically transferred laboratory data

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Subject identifier
Item
Subject identifier
text
C2348585 (UMLS CUI [1])
Item
Visit type
integer
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Code List
Visit type
CL Item
Screening (1)
CL Item
Study visit (2)
CL Item
Follow-up (3)
Item Group
Electronically transferred laboratory data
C0022885 (UMLS CUI-1)
C0008000 (UMLS CUI-2)
Date Sample Taken, clinical chemistry
Item
Date Sample Taken
date
C1302413 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
Actual time
Item
Actual time
time
C0040223 (UMLS CUI [1])
Item
Dosing
integer
C0178602 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
Code List
Dosing
CL Item
Pre-dose (1)
CL Item
48hrs post-dose (2)
Item Group
Electronically transferred laboratory data - Haematology
C0022885 (UMLS CUI-1)
C0018941 (UMLS CUI-2)
Date Sample Taken, haematology
Item
Date Sample Taken
date
C1302413 (UMLS CUI [1,1])
C0018941 (UMLS CUI [1,2])
Actual time
Item
Actual time
time
C0040223 (UMLS CUI [1])
Item
Dosing
integer
C0178602 (UMLS CUI [1,1])
C0018941 (UMLS CUI [1,2])
Code List
Dosing
CL Item
Pre-dose (1)
CL Item
48hrs post-dose (2)
Item Group
Electronically transferred laboratory data - Urinalysis
C0022885 (UMLS CUI-1)
C0042014 (UMLS CUI-2)
Date Sample Taken, urinalysis
Item
Date Sample Taken
date
C1302413 (UMLS CUI [1,1])
C0042014 (UMLS CUI [1,2])
Actual time
Item
Actual time
time
C0040223 (UMLS CUI [1])
Item
Dosing
integer
C0178602 (UMLS CUI [1,1])
C0042014 (UMLS CUI [1,2])
Code List
Dosing
CL Item
Pre-dose (1)
CL Item
48hrs post-dose (2)

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