ID

34362

Description

Study ID: 101682 Clinical Study ID: B2E101682 Study Title: A randomised, double-blind, placebo-controlled, parallel group study to examine the safety, tolerability, and pharmacokinetics of repeat inhaled doses of GSK159797 in healthy subjects. Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: milveterol Trade Name: milveterol Study Indication: Pulmonary Disease, Chronic Obstructive. This form contains information about concomitant medications and should be completed only in case of concomitant medication.

Keywords

Versions (2)
  1. 1/16/19 1/16/19 -
  2. 1/16/19 1/16/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

January 16, 2019

DOI

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License

Creative Commons BY-NC 3.0
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Safety, tolerability and pharmacokinetics of repeat inhaled doses of milveterol in healthy subjects (Study ID: 101682)

English

Concomitant Medications

1 forms  
Administrative data
Description

Administrative data

Alias
UMLS CUI-1
C1320722
Subject number
Description

Subject number

Data type

text

Alias
UMLS CUI [1]
C2348585
Concomitant Medications
Description

Concomitant Medications

Alias
UMLS CUI-1
C1704627
Were any concomitant medications taken by the subject during the study?
Description

concomitant medications during study

Data type

boolean

Alias
UMLS CUI [1]
C1707479
Drug (Trade name preferred)
Description

If medication is given to treat an adverse event, then the ADVERSE EVENT must be recorded on the NON-SERIOUS ADVERSE EVENT or SERIOUS ADVERSE EVENT page(s).

Data type

text

Alias
UMLS CUI [1]
C2347852
Dose
Description

Dose

Data type

float

Alias
UMLS CUI [1]
C2826638
Unit
Description

Unit

Data type

text

Alias
UMLS CUI [1]
C2826646
Frequency
Description

Frequency

Data type

text

Alias
UMLS CUI [1]
C2826654
Route
Description

Route

Data type

text

Alias
UMLS CUI [1]
C2826730
Date started
Description

Start Date

Data type

date

Measurement units
  • dd.mm.yyyy
Alias
UMLS CUI [1]
C2826734
dd.mm.yyyy
Started pre-study
Description

Started pre-study

Data type

boolean

Alias
UMLS CUI [1]
C2981448
Start time
Description

Start time

Data type

time

Measurement units
  • hh:mm
Alias
UMLS CUI [1]
C2826740
hh:mm
Date stopped
Description

Stop Date

Data type

date

Measurement units
  • dd.mm.yyyy
Alias
UMLS CUI [1]
C2826744
dd.mm.yyyy
Medication continued post-study
Description

Ongoing Medication

Data type

boolean

Alias
UMLS CUI [1]
C2826666
Stop time
Description

Stop time

Data type

time

Measurement units
  • hh:mm
Alias
UMLS CUI [1]
C2826659
hh:mm
Conditions treated/indication
Description

Reason for Medication

Data type

text

Alias
UMLS CUI [1]
C2826696
Was drug administered for an adverse event?
Description

drug administered for an adverse event

Data type

boolean

Alias
UMLS CUI [1,1]
C2826696
UMLS CUI [1,2]
C0877248
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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 number
Item
Subject number
text
C2348585 (UMLS CUI [1])
Item Group
Concomitant Medications
C1704627 (UMLS CUI-1)
concomitant medications during study
Item
Were any concomitant medications taken by the subject during the study?
boolean
C1707479 (UMLS CUI [1])
Drug Name
Item
Drug (Trade name preferred)
text
C2347852 (UMLS CUI [1])
Dose
Item
Dose
float
C2826638 (UMLS CUI [1])
Unit
Item
Unit
text
C2826646 (UMLS CUI [1])
Frequency
Item
Frequency
text
C2826654 (UMLS CUI [1])
Route
Item
Route
text
C2826730 (UMLS CUI [1])
Start Date
Item
Date started
date
C2826734 (UMLS CUI [1])
Started pre-study
Item
Started pre-study
boolean
C2981448 (UMLS CUI [1])
Start time
Item
Start time
time
C2826740 (UMLS CUI [1])
Stop Date
Item
Date stopped
date
C2826744 (UMLS CUI [1])
Ongoing Medication
Item
Medication continued post-study
boolean
C2826666 (UMLS CUI [1])
Stop time
Item
Stop time
time
C2826659 (UMLS CUI [1])
Reason for Medication
Item
Conditions treated/indication
text
C2826696 (UMLS CUI [1])
drug administered for an adverse event
Item
Was drug administered for an adverse event?
boolean
C2826696 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
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