ID
34377
Beschrijving
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.
Trefwoorden
Versies (1)
- 17-01-19 17-01-19 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
17 januari 2019
DOI
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Licentie
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
Beschrijving
Experience of any serious adverse events during the study
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C2347804
Beschrijving
Demography
Alias
- UMLS CUI-1
- C0011298
Beschrijving
Date of birth
Datatype
date
Maateenheden
- dd.mm.yyyy
Alias
- UMLS CUI [1]
- C0421451
Beschrijving
Gender
Datatype
integer
Alias
- UMLS CUI [1]
- C0079399
Beschrijving
Race
Datatype
integer
Alias
- UMLS CUI [1]
- C0034510
Beschrijving
Weight
Datatype
float
Maateenheden
- kg
Alias
- UMLS CUI [1]
- C0005910
Beschrijving
Height
Datatype
integer
Maateenheden
- cm
Alias
- UMLS CUI [1]
- C0005890
Beschrijving
Serious adverse events
Alias
- UMLS CUI-1
- C1519255
Beschrijving
Diagnosis or serious signs/symptoms of SAE
Datatype
text
Alias
- UMLS CUI [1,1]
- C0011900
- UMLS CUI [1,2]
- C0037088
- UMLS CUI [1,3]
- C1519255
Beschrijving
Date of onset SAE
Datatype
date
Maateenheden
- dd.mm.yyyy
Alias
- UMLS CUI [1,1]
- C0574845
- UMLS CUI [1,2]
- C1519255
Beschrijving
Time of onset SAE
Datatype
time
Maateenheden
- hh:mm
Alias
- UMLS CUI [1,1]
- C0449244
- UMLS CUI [1,2]
- C1519255
Beschrijving
Maximum Intensity SAE
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C1519255
Beschrijving
Outcome SAE
Datatype
integer
Alias
- UMLS CUI [1]
- C1705586
Beschrijving
Date of resolution or death
Datatype
date
Maateenheden
- dd.mm.yyyy
Alias
- UMLS CUI [1]
- C2985918
- UMLS CUI [2]
- C1148348
Beschrijving
Time of resolution or death
Datatype
time
Maateenheden
- hh:mm
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C2699488
- UMLS CUI [1,3]
- C1519255
- UMLS CUI [2]
- C1301931
Beschrijving
Investigational drug, change of dose
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0013230
- UMLS CUI [1,2]
- C1608430
Beschrijving
Withdrawal
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1710677
- UMLS CUI [1,2]
- C1519255
Beschrijving
Relationship to investigational product
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0085978
- UMLS CUI [1,3]
- C0013230
Beschrijving
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.
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1704788
- UMLS CUI [1,2]
- C1710056
Beschrijving
Possible Causes of SAE other than lnvestigational Product(s)
Alias
- UMLS CUI-1
- C0205394
- UMLS CUI-2
- C1519255
- UMLS CUI-3
- C0085978
Beschrijving
Disease under study
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0347984
- UMLS CUI [1,3]
- C0008976
Beschrijving
Treatment failure
Datatype
boolean
Alias
- UMLS CUI [1]
- C0162643
Beschrijving
Withdrawal of investigational product(s)
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C2349954
- UMLS CUI [1,2]
- C0013227
Beschrijving
Concomitant disorder
Datatype
boolean
Alias
- UMLS CUI [1]
- C0009488
Beschrijving
Specify concomitant disorder
Datatype
text
Alias
- UMLS CUI [1,1]
- C0009488
- UMLS CUI [1,2]
- C1521902
Beschrijving
Concomitant medication
Datatype
boolean
Alias
- UMLS CUI [1]
- C2347852
Beschrijving
Specify concomitant medication
Datatype
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C1521902
Beschrijving
Activity related to study participation (e.g., procedures)
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C2348568
- UMLS CUI [1,2]
- C0199171
Beschrijving
Specify 'Activity related to study participation'
Datatype
text
Alias
- UMLS CUI [1,1]
- C2348568
- UMLS CUI [1,2]
- C0199171
Beschrijving
Seriousness of SAE
Alias
- UMLS CUI-1
- C1710056
Beschrijving
Death
Datatype
boolean
Alias
- UMLS CUI [1]
- C0011065
Beschrijving
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.
Datatype
boolean
Alias
- UMLS CUI [1]
- C1517874
Beschrijving
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.
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C2348993
- UMLS CUI [1,2]
- C1519255
Beschrijving
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.
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C3830477
- UMLS CUI [1,2]
- C1519255
Beschrijving
Congenital anomaly
Datatype
boolean
Alias
- UMLS CUI [1]
- C2826727
Beschrijving
Specify below.
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C3845569
- UMLS CUI [1,2]
- C1519255
Beschrijving
Specify, if the answer was 'other'
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C1521902
Beschrijving
Send autopsy report if available.
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1705232
- UMLS CUI [1,2]
- C0004398
Beschrijving
Relevant Medical Conditions
Alias
- UMLS CUI-1
- C0243087
Beschrijving
Relevant Medical Conditions
Datatype
text
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0262926
- UMLS CUI [1,3]
- C1519255
Beschrijving
Date of onset of medical condition
Datatype
date
Maateenheden
- dd.mm.yyyy
Alias
- UMLS CUI [1,1]
- C0574845
- UMLS CUI [1,2]
- C0012634
Beschrijving
Condition present at time of the SAE
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0150312
- UMLS CUI [1,3]
- C1519255
Beschrijving
Date of last occurrence
Datatype
date
Maateenheden
- dd.mm.yyyy
Alias
- UMLS CUI [1,1]
- C2745955
- UMLS CUI [1,2]
- C0012634
- UMLS CUI [1,3]
- C0011008
- UMLS CUI [2]
- C1519255
Beschrijving
Other relevant risk factors
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0035648
- UMLS CUI-3
- C0205394
Beschrijving
Details of lnvestigational Product(s)
Alias
- UMLS CUI-1
- C0013230
Beschrijving
Day
Datatype
integer
Alias
- UMLS CUI [1,1]
- C3161471
- UMLS CUI [1,2]
- C0439228
Beschrijving
Date of dose of investigational product
Datatype
date
Maateenheden
- dd.mm.yyyy
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0178602
- UMLS CUI [1,3]
- C0011008
Beschrijving
Time of inhalation
Datatype
time
Maateenheden
- hh:mm
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0001559
Beschrijving
Relevant Concomitant Medications
Alias
- UMLS CUI-1
- C1704627
Beschrijving
Drug Name
Datatype
text
Alias
- UMLS CUI [1]
- C2347852
Beschrijving
Dose of concomitant medication
Datatype
float
Alias
- UMLS CUI [1]
- C2826638
Beschrijving
Unit of concomitant medication
Datatype
text
Alias
- UMLS CUI [1]
- C2826646
Beschrijving
Frequency of concomitant medication
Datatype
text
Alias
- UMLS CUI [1]
- C2826654
Beschrijving
Route of concomitant medication
Datatype
text
Alias
- UMLS CUI [1]
- C2826730
Beschrijving
Start Date of concomitant medication
Datatype
date
Maateenheden
- dd.mm.yyyy
Alias
- UMLS CUI [1]
- C2826734
Beschrijving
Concomitant medication started pre-study
Datatype
boolean
Alias
- UMLS CUI [1]
- C2981448
Beschrijving
Stop Date of concomitant medication
Datatype
date
Maateenheden
- dd.mm.yyyy
Alias
- UMLS CUI [1]
- C2826744
Beschrijving
Concomitant Medication continued post-SAE
Datatype
boolean
Alias
- UMLS CUI [1]
- C2826666
Beschrijving
Reason for Concomitant Medication
Datatype
text
Alias
- UMLS CUI [1]
- C2826696
Beschrijving
Description of SAE
Alias
- UMLS CUI-1
- C0678257
- UMLS CUI-2
- C1519255
Beschrijving
Provide a textual description of the serious adverse event (including treatment of the event).
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0678257
- UMLS CUI [2,1]
- C1519255
- UMLS CUI [2,2]
- C0087111
Beschrijving
Details of relevant Assessments
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0431080
Beschrijving
Provide details of other assessments (e.g., laboratory data with normal ranges) or supplemental examinations
Datatype
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
Beschrijving
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
Beschrijving
Reporting lnvestigator
Datatype
text
Alias
- UMLS CUI [1]
- C2826892
Beschrijving
Reporting lnvestigator: Address
Datatype
text
Alias
- UMLS CUI [1,1]
- C2986286
- UMLS CUI [1,2]
- C1442065
Beschrijving
Reporting lnvestigator: Signature
Datatype
text
Alias
- UMLS CUI [1,1]
- C2986286
- UMLS CUI [1,2]
- C1519316
Beschrijving
Date of report
Datatype
date
Maateenheden
- dd.mm.yyyy
Alias
- UMLS CUI [1]
- C1302584
Beschrijving
Additional or follow-up information
Alias
- UMLS CUI-1
- C1533716
- UMLS CUI-2
- C1519255
Beschrijving
Additional or follow-up information
Datatype
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
Beschrijving
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
Beschrijving
Reporting lnvestigator
Datatype
text
Alias
- UMLS CUI [1]
- C2826892
Beschrijving
Reporting lnvestigator: Address
Datatype
text
Alias
- UMLS CUI [1,1]
- C2986286
- UMLS CUI [1,2]
- C1442065
Beschrijving
Reporting lnvestigator: Signature
Datatype
text
Alias
- UMLS CUI [1,1]
- C2986286
- UMLS CUI [1,2]
- C1519316
Beschrijving
Date of report
Datatype
date
Maateenheden
- 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])