ID
34377
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 serious adverse events and should be completed only in case of occurrence of serious adverse events.
Keywords
Versions (1)
- 1/17/19 1/17/19 -
Copyright Holder
GlaxoSmithKline
Uploaded on
January 17, 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)
Serious Adverse Event (SAE)
- StudyEvent: ODM
Description
Experience of any serious adverse events during the study
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C2347804
Description
Demography
Alias
- UMLS CUI-1
- C0011298
Description
Date of birth
Data type
date
Measurement units
- dd.mm.yyyy
Alias
- UMLS CUI [1]
- C0421451
Description
Gender
Data type
integer
Alias
- UMLS CUI [1]
- C0079399
Description
Race
Data type
integer
Alias
- UMLS CUI [1]
- C0034510
Description
Weight
Data type
float
Measurement units
- kg
Alias
- UMLS CUI [1]
- C0005910
Description
Height
Data type
integer
Measurement units
- cm
Alias
- UMLS CUI [1]
- C0005890
Description
Serious adverse events
Alias
- UMLS CUI-1
- C1519255
Description
Diagnosis or serious signs/symptoms of SAE
Data type
text
Alias
- UMLS CUI [1,1]
- C0011900
- UMLS CUI [1,2]
- C0037088
- UMLS CUI [1,3]
- C1519255
Description
Date of onset SAE
Data type
date
Measurement units
- dd.mm.yyyy
Alias
- UMLS CUI [1,1]
- C0574845
- UMLS CUI [1,2]
- C1519255
Description
Time of onset SAE
Data type
time
Measurement units
- hh:mm
Alias
- UMLS CUI [1,1]
- C0449244
- UMLS CUI [1,2]
- C1519255
Description
Maximum Intensity SAE
Data type
integer
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C1519255
Description
Outcome SAE
Data type
integer
Alias
- UMLS CUI [1]
- C1705586
Description
Date of resolution or death
Data type
date
Measurement units
- dd.mm.yyyy
Alias
- UMLS CUI [1]
- C2985918
- UMLS CUI [2]
- C1148348
Description
Time of resolution or death
Data type
time
Measurement units
- hh:mm
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C2699488
- UMLS CUI [1,3]
- C1519255
- UMLS CUI [2]
- C1301931
Description
Investigational drug, change of dose
Data type
integer
Alias
- UMLS CUI [1,1]
- C0013230
- UMLS CUI [1,2]
- C1608430
Description
Withdrawal
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1710677
- UMLS CUI [1,2]
- C1519255
Description
Relationship to investigational product
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0085978
- UMLS CUI [1,3]
- C0013230
Description
A serious adverse event is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalisation or prolongation of existing hospitalisation, results in disability/incapacity, or is a congenital anomaly/birth defect. Medical or scientific judgement should be exercised in deciding whether reporting is appropriate in other situations, such as important medical events that may not be immediately life-threatening or result in death or hospitalisation but may jeopardise the subject or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition. These should also be considered serious. Examples of such events are invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that do not result in hospitalisation, or development of drug dependency or drug abuse.
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1704788
- UMLS CUI [1,2]
- C1710056
Description
Possible Causes of SAE other than lnvestigational Product(s)
Alias
- UMLS CUI-1
- C0205394
- UMLS CUI-2
- C1519255
- UMLS CUI-3
- C0085978
Description
Disease under study
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0347984
- UMLS CUI [1,3]
- C0008976
Description
Treatment failure
Data type
boolean
Alias
- UMLS CUI [1]
- C0162643
Description
Withdrawal of investigational product(s)
Data type
boolean
Alias
- UMLS CUI [1,1]
- C2349954
- UMLS CUI [1,2]
- C0013227
Description
Concomitant disorder
Data type
boolean
Alias
- UMLS CUI [1]
- C0009488
Description
Specify concomitant disorder
Data type
text
Alias
- UMLS CUI [1,1]
- C0009488
- UMLS CUI [1,2]
- C1521902
Description
Concomitant medication
Data type
boolean
Alias
- UMLS CUI [1]
- C2347852
Description
Specify concomitant medication
Data type
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C1521902
Description
Activity related to study participation (e.g., procedures)
Data type
boolean
Alias
- UMLS CUI [1,1]
- C2348568
- UMLS CUI [1,2]
- C0199171
Description
Specify 'Activity related to study participation'
Data type
text
Alias
- UMLS CUI [1,1]
- C2348568
- UMLS CUI [1,2]
- C0199171
Description
Seriousness of SAE
Alias
- UMLS CUI-1
- C1710056
Description
Death
Data type
boolean
Alias
- UMLS CUI [1]
- C0011065
Description
NOTE: The term 'life-threatening' in the definition of 'serious' refers to an event in which the subject was at risk of death at the time of the event. It does not refer to an event, which hypothetically might have caused death, if it were more severe.
Data type
boolean
Alias
- UMLS CUI [1]
- C1517874
Description
NOTE: In general, hospitalisation signifies that the subject has been detained (usually involving at least an overnight stay) at the hospital or emergency ward for observation and/or treatment that would not have been appropriate in the physician’s office or out-patient setting. Complications that occur during hospitalisation are AEs. If a complication prolongs hospitalisation or fulfils any other serious criteria, the event is GM2004/00133/01 CONFIDENTIAL B2E101682 41 GM2005/00011/00 serious. When in doubt as to whether “hospitalisation” occurred or was necessary, the AE should be considered serious. Hospitalisation for elective treatment of a pre-existing condition that did not worsen from baseline is not considered an AE.
Data type
boolean
Alias
- UMLS CUI [1,1]
- C2348993
- UMLS CUI [1,2]
- C1519255
Description
NOTE: The term disability means a substantial disruption of a person’s ability to conduct normal life functions. This definition is not intended to include experiences of relatively minor medical significance such as uncomplicated headache, nausea, vomiting, diarrhoea, influenza, and accidental trauma (e.g. sprained ankle) which may interfere or prevent everyday life functions but do not constitute a substantial disruption.
Data type
boolean
Alias
- UMLS CUI [1,1]
- C3830477
- UMLS CUI [1,2]
- C1519255
Description
Congenital anomaly
Data type
boolean
Alias
- UMLS CUI [1]
- C2826727
Description
Specify below.
Data type
boolean
Alias
- UMLS CUI [1,1]
- C3845569
- UMLS CUI [1,2]
- C1519255
Description
Specify, if the answer was 'other'
Data type
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C1521902
Description
Send autopsy report if available.
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1705232
- UMLS CUI [1,2]
- C0004398
Description
Relevant Medical Conditions
Alias
- UMLS CUI-1
- C0243087
Description
Relevant Medical Conditions
Data type
text
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0262926
- UMLS CUI [1,3]
- C1519255
Description
Date of onset of medical condition
Data type
date
Measurement units
- dd.mm.yyyy
Alias
- UMLS CUI [1,1]
- C0574845
- UMLS CUI [1,2]
- C0012634
Description
Condition present at time of the SAE
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0150312
- UMLS CUI [1,3]
- C1519255
Description
Date of last occurrence
Data type
date
Measurement units
- dd.mm.yyyy
Alias
- UMLS CUI [1,1]
- C2745955
- UMLS CUI [1,2]
- C0012634
- UMLS CUI [1,3]
- C0011008
- UMLS CUI [2]
- C1519255
Description
Other relevant risk factors
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0035648
- UMLS CUI-3
- C0205394
Description
Details of lnvestigational Product(s)
Alias
- UMLS CUI-1
- C0013230
Description
Day
Data type
integer
Alias
- UMLS CUI [1,1]
- C3161471
- UMLS CUI [1,2]
- C0439228
Description
Date of dose of investigational product
Data type
date
Measurement units
- dd.mm.yyyy
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0178602
- UMLS CUI [1,3]
- C0011008
Description
Time of inhalation
Data type
time
Measurement units
- hh:mm
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0001559
Description
Relevant Concomitant Medications
Alias
- UMLS CUI-1
- C1704627
Description
Drug Name
Data type
text
Alias
- UMLS CUI [1]
- C2347852
Description
Dose of concomitant medication
Data type
float
Alias
- UMLS CUI [1]
- C2826638
Description
Unit of concomitant medication
Data type
text
Alias
- UMLS CUI [1]
- C2826646
Description
Frequency of concomitant medication
Data type
text
Alias
- UMLS CUI [1]
- C2826654
Description
Route of concomitant medication
Data type
text
Alias
- UMLS CUI [1]
- C2826730
Description
Start Date of concomitant medication
Data type
date
Measurement units
- dd.mm.yyyy
Alias
- UMLS CUI [1]
- C2826734
Description
Concomitant medication started pre-study
Data type
boolean
Alias
- UMLS CUI [1]
- C2981448
Description
Stop Date of concomitant medication
Data type
date
Measurement units
- dd.mm.yyyy
Alias
- UMLS CUI [1]
- C2826744
Description
Concomitant Medication continued post-SAE
Data type
boolean
Alias
- UMLS CUI [1]
- C2826666
Description
Reason for Concomitant Medication
Data type
text
Alias
- UMLS CUI [1]
- C2826696
Description
Description of SAE
Alias
- UMLS CUI-1
- C0678257
- UMLS CUI-2
- C1519255
Description
Provide a textual description of the serious adverse event (including treatment of the event).
Data type
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0678257
- UMLS CUI [2,1]
- C1519255
- UMLS CUI [2,2]
- C0087111
Description
Details of relevant Assessments
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0431080
Description
Provide details of other assessments (e.g., laboratory data with normal ranges) or supplemental examinations
Data type
text
Alias
- UMLS CUI [1,1]
- C0220825
- UMLS CUI [1,2]
- C1519255
- UMLS CUI [1,3]
- C1522508
- UMLS CUI [2]
- C0022885
- UMLS CUI [3,1]
- C0582103
- UMLS CUI [3,2]
- C0205394
Description
Reporting lnvestigator: To the best of my knowledge, all information entered on these Serious Adverse Event pages for this subject is correct.
Alias
- UMLS CUI-1
- C2826892
- UMLS CUI-2
- C1519255
- UMLS CUI-3
- C1533716
- UMLS CUI-4
- C2349182
Description
Reporting lnvestigator
Data type
text
Alias
- UMLS CUI [1]
- C2826892
Description
Reporting lnvestigator: Address
Data type
text
Alias
- UMLS CUI [1,1]
- C2986286
- UMLS CUI [1,2]
- C1442065
Description
Reporting lnvestigator: Signature
Data type
text
Alias
- UMLS CUI [1,1]
- C2986286
- UMLS CUI [1,2]
- C1519316
Description
Date of report
Data type
date
Measurement units
- dd.mm.yyyy
Alias
- UMLS CUI [1]
- C1302584
Description
Additional or follow-up information
Alias
- UMLS CUI-1
- C1533716
- UMLS CUI-2
- C1519255
Description
Additional or follow-up information
Data type
text
Alias
- UMLS CUI [1,1]
- C1524062
- UMLS CUI [1,2]
- C1533716
- UMLS CUI [1,3]
- C1519255
- UMLS CUI [2,1]
- C1522577
- UMLS CUI [2,2]
- C1533716
- UMLS CUI [2,3]
- C1519255
Description
Reporting lnvestigator: To the best of my knowledge, all information entered on these Serious Adverse Event pages for this subject is correct.
Alias
- UMLS CUI-1
- C2826892
- UMLS CUI-2
- C1519255
- UMLS CUI-3
- C1533716
- UMLS CUI-4
- C2349182
Description
Reporting lnvestigator
Data type
text
Alias
- UMLS CUI [1]
- C2826892
Description
Reporting lnvestigator: Address
Data type
text
Alias
- UMLS CUI [1,1]
- C2986286
- UMLS CUI [1,2]
- C1442065
Description
Reporting lnvestigator: Signature
Data type
text
Alias
- UMLS CUI [1,1]
- C2986286
- UMLS CUI [1,2]
- C1519316
Description
Date of report
Data type
date
Measurement units
- dd.mm.yyyy
Alias
- UMLS CUI [1]
- C1302584
Similar models
Serious Adverse Event (SAE)
- StudyEvent: ODM
C2347804 (UMLS CUI-2)
C2347804 (UMLS CUI [1,2])
C0037088 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C1148348 (UMLS CUI [2])
C2699488 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C1301931 (UMLS CUI [2])
C1608430 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C0085978 (UMLS CUI [1,2])
C0013230 (UMLS CUI [1,3])
C1710056 (UMLS CUI [1,2])
C1519255 (UMLS CUI-2)
C0085978 (UMLS CUI-3)
C0347984 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0013227 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,2])
C0199171 (UMLS CUI [1,2])
C0199171 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C0004398 (UMLS CUI [1,2])
C0262926 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C0012634 (UMLS CUI [1,2])
C0150312 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C0012634 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C1519255 (UMLS CUI [2])
C0035648 (UMLS CUI-2)
C0205394 (UMLS CUI-3)
C1519255 (UMLS CUI [1,2])
C0241889 (UMLS CUI [2])
C0424945 (UMLS CUI [3])
C0178602 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0001559 (UMLS CUI [1,2])
C0678257 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2,1])
C0087111 (UMLS CUI [2,2])
C0431080 (UMLS CUI-2)
C1519255 (UMLS CUI [1,2])
C1522508 (UMLS CUI [1,3])
C0022885 (UMLS CUI [2])
C0582103 (UMLS CUI [3,1])
C0205394 (UMLS CUI [3,2])
C1519255 (UMLS CUI-2)
C1533716 (UMLS CUI-3)
C2349182 (UMLS CUI-4)
C1442065 (UMLS CUI [1,2])
C1519316 (UMLS CUI [1,2])
C1519255 (UMLS CUI-2)
C1533716 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C1522577 (UMLS CUI [2,1])
C1533716 (UMLS CUI [2,2])
C1519255 (UMLS CUI [2,3])
C1519255 (UMLS CUI-2)
C1533716 (UMLS CUI-3)
C2349182 (UMLS CUI-4)
C1442065 (UMLS CUI [1,2])
C1519316 (UMLS CUI [1,2])