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