ID

34364

Beschreibung

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 non-serious adverse events and should only be completed in case of occurence of non-serious adverse events.

Stichworte

Versionen (2)
  1. 16.01.19 16.01.19 -
  2. 16.01.19 16.01.19 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

16. Januar 2019

DOI

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Lizenz

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)

Englisch

Non-Serious Adverse Events

1 Formulare  
Administrative data
Beschreibung

Administrative data

Alias
UMLS CUI-1
C1320722
Subject number
Beschreibung

Subject number

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Non-Serious adverse events
Beschreibung

Non-Serious adverse events

Alias
UMLS CUI-1
C1518404
Did the subject experience any non-serious adverse events during the study?
Beschreibung

If YES, indicate below

Datentyp

boolean

Alias
UMLS CUI [1]
C1518404
Diagnosis only (if known) or signs/symptoms
Beschreibung

Diagnosis or signs/symptoms of NSAE

Datentyp

text

Alias
UMLS CUI [1,1]
C0011900
UMLS CUI [1,2]
C0037088
UMLS CUI [1,3]
C1518404
Date of onset
Beschreibung

Date of onset NSAE

Datentyp

date

Maßeinheiten
  • dd.mm.yyyy
Alias
UMLS CUI [1,1]
C0574845
UMLS CUI [1,2]
C1518404
dd.mm.yyyy
Time of onset
Beschreibung

Time of onset NSAE

Datentyp

time

Maßeinheiten
  • hh:mm
Alias
UMLS CUI [1,1]
C0449244
UMLS CUI [1,2]
C1518404
hh:mm
Maximum Intensity
Beschreibung

Maximum Intensity NSAE

Datentyp

integer

Alias
UMLS CUI [1,1]
C0518690
UMLS CUI [1,2]
C1518404
Outcome
Beschreibung

Outcome SAE

Datentyp

integer

Alias
UMLS CUI [1,1]
C1705586
UMLS CUI [1,2]
C1518404
Date of resolution
Beschreibung

Date of resolution

Datentyp

date

Maßeinheiten
  • dd.mm.yyyy
Alias
UMLS CUI [1,1]
C2985918
UMLS CUI [1,2]
C1518404
dd.mm.yyyy
Time of resolution
Beschreibung

Time of resolution

Datentyp

time

Maßeinheiten
  • hh:mm
Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C2699488
UMLS CUI [1,3]
C1518404
hh:mm
Action taken with investigational product(s) as a result of the non-serious AE
Beschreibung

Investigational drug, change of dose as a result of NSAE

Datentyp

integer

Alias
UMLS CUI [1,1]
C0013230
UMLS CUI [1,2]
C1608430
UMLS CUI [1,3]
C1518404
Did the subject withdraw from study as a result of this non-serious AE?
Beschreibung

Withdrawal from study as result of NSAE

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1710677
UMLS CUI [1,2]
C1518404
Is there a reasonable possibility the non-serious AE may have been caused by the investigational product(s)?
Beschreibung

Relationship to investigational product

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0085978
UMLS CUI [1,3]
C0013230
Does the AE meet the definition of serious?
Beschreibung

In this study, the answer 'No' was preselected.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1704788
UMLS CUI [1,2]
C1710056
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Ähnliche Modelle

Non-Serious Adverse Events

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Subject number
Item
Subject number
text
C2348585 (UMLS CUI [1])
Item Group
Non-Serious adverse events
C1518404 (UMLS CUI-1)
non-serious adverse events
Item
Did the subject experience any non-serious adverse events during the study?
boolean
C1518404 (UMLS CUI [1])
Diagnosis or signs/symptoms of NSAE
Item
Diagnosis only (if known) or signs/symptoms
text
C0011900 (UMLS CUI [1,1])
C0037088 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
Date of onset NSAE
Item
Date of onset
date
C0574845 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Time of onset NSAE
Item
Time of onset
time
C0449244 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Item
Maximum Intensity
integer
C0518690 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Maximum Intensity SAE
Code List
Maximum Intensity
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Not applicable (4)
Item
Outcome
integer
C1705586 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Outcome
Code List
Outcome
CL Item
Resolved (1)
CL Item
Resolved with Sequelae (2)
CL Item
Not Resolved (3)
Date of resolution
Item
Date of resolution
date
C2985918 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Time of resolution
Item
Time of resolution
time
C0040223 (UMLS CUI [1,1])
C2699488 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
Item
Action taken with investigational product(s) as a result of the non-serious AE
integer
C0013230 (UMLS CUI [1,1])
C1608430 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
Investigational drug, change of dose
Code List
Action taken with investigational product(s) as a result of the non-serious AE
CL Item
None (1)
CL Item
Dose adjusted (2)
CL Item
Temporarily interrupted (3)
CL Item
Permanently discontinued (4)
CL Item
Not applicable (5)
Withdrawal from study as result of NSAE
Item
Did the subject withdraw from study as a result of this non-serious AE?
boolean
C1710677 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Relationship to investigational product
Item
Is there a reasonable possibility the non-serious AE may have been caused by the investigational product(s)?
boolean
C1518404 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C0013230 (UMLS CUI [1,3])
Definition of Seriousness
Item
Does the AE meet the definition of serious?
boolean
C1704788 (UMLS CUI [1,1])
C1710056 (UMLS CUI [1,2])
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