ID

33379

Description

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 Concomitant Medications form. It has to be filled in if concomitant medications were taken by subject during study.

Link

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

Keywords

Versions (3)
  1. 12/4/18 12/4/18 -
  2. 12/7/18 12/7/18 -
  3. 12/10/18 12/10/18 - Sarah Riepenhausen
Copyright Holder

GlaxoSmithKline

Uploaded on

December 7, 2018

DOI

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License

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

English

Concomitant Medications

1 forms  
Administrative data
Description

Administrative data

Alias
UMLS CUI-1
C1320722
Subject identifier
Description

Subject identifier

Data type

text

Alias
UMLS CUI [1]
C2348585
Concomitant medication
Description

Concomitant medication

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

If Yes, record each medication on a separate line using Trade Names where possible in following items. .

Data type

text

Alias
UMLS CUI [1,1]
C1524063
UMLS CUI [1,2]
C2347852
Drug name
Description

(Trade name preferred)

Data type

text

Alias
UMLS CUI [1]
C0013227
Unit Dose
Description

Unit Dose

Data type

text

Alias
UMLS CUI [1]
C0869039
Units
Description

Units

Data type

text

Alias
UMLS CUI [1]
C1519795
Frequency
Description

Frequency

Data type

text

Alias
UMLS CUI [1]
C3476109
Route
Description

Route

Data type

text

Alias
UMLS CUI [1]
C0013153
Reason for medication
Description

Reason for medication

Data type

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0013227
Start Date of medication
Description

day month year

Data type

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0808070
Start time of medication
Description

00:00-23:59

Data type

time

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C1301880
Taken prior to study?
Description

Taken prior to study

Data type

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0332152
UMLS CUI [1,3]
C2347804
Stop Date of medication
Description

day month year

Data type

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0806020
Stop Time of medication
Description

00:00-23:59

Data type

time

Alias
UMLS CUI [1]
C2826659
Ongoing medication?
Description

Ongoing medication

Data type

text

Alias
UMLS CUI [1]
C2826666
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Similar models

Concomitant Medications

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Subject identifier
Item
Subject identifier
text
C2348585 (UMLS CUI [1])
Item Group
Concomitant medication
C2347852 (UMLS CUI-1)
Item
Were any concomitant medications taken by the subject during the study?
text
C1524063 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Use of concomitant medication
Code List
Were any concomitant medications taken by the subject during the study?
CL Item
Yes (Y)
CL Item
No (N)
Drug name
Item
Drug name
text
C0013227 (UMLS CUI [1])
Unit Dose
Item
Unit Dose
text
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
Mililitre (ML)
CL Item
Litre (L)
CL Item
Microgram (MCG)
CL Item
Miligram (MG)
CL Item
Gram (G)
Item
Frequency
text
C3476109 (UMLS CUI [1])
Frequency
Code List
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
Route
text
C0013153 (UMLS CUI [1])
Route
Code List
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])
Start date of medication
Item
Start Date of medication
date
C0013227 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Start time of medication
Item
Start time of medication
time
C0013227 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
Item
Taken prior to study?
text
C2347852 (UMLS CUI [1,1])
C0332152 (UMLS CUI [1,2])
C2347804 (UMLS CUI [1,3])
Taken prior to study
Code List
Taken prior to study?
CL Item
Yes (Y)
CL Item
No (N)
Stop Date of medication
Item
Stop Date of medication
date
C0013227 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Stop Time of medication
Item
Stop Time of medication
time
C2826659 (UMLS CUI [1])
Item
Ongoing medication?
text
C2826666 (UMLS CUI [1])
Ongoing medication
Code List
Ongoing medication?
CL Item
Yes (Y)
CL Item
No (N)
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