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.
Mots-clés
Versions (1)
- 17/01/2019 17/01/2019 -
Détendeur de droits
GlaxoSmithKline
Téléchargé le
17 janvier 2019
DOI
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Licence
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
Type de données
date
Unités de mesure
- dd.mm.yyyy
Alias
- UMLS CUI [1]
- C0421451
Description
Gender
Type de données
integer
Alias
- UMLS CUI [1]
- C0079399
Description
Race
Type de données
integer
Alias
- UMLS CUI [1]
- C0034510
Description
Weight
Type de données
float
Unités de mesure
- kg
Alias
- UMLS CUI [1]
- C0005910
Description
Height
Type de données
integer
Unités de mesure
- cm
Alias
- UMLS CUI [1]
- C0005890
Description
Serious adverse events
Alias
- UMLS CUI-1
- C1519255
Description
Diagnosis or serious signs/symptoms of SAE
Type de données
text
Alias
- UMLS CUI [1,1]
- C0011900
- UMLS CUI [1,2]
- C0037088
- UMLS CUI [1,3]
- C1519255
Description
Date of onset SAE
Type de données
date
Unités de mesure
- dd.mm.yyyy
Alias
- UMLS CUI [1,1]
- C0574845
- UMLS CUI [1,2]
- C1519255
Description
Time of onset SAE
Type de données
time
Unités de mesure
- hh:mm
Alias
- UMLS CUI [1,1]
- C0449244
- UMLS CUI [1,2]
- C1519255
Description
Maximum Intensity SAE
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C1519255
Description
Outcome SAE
Type de données
integer
Alias
- UMLS CUI [1]
- C1705586
Description
Date of resolution or death
Type de données
date
Unités de mesure
- dd.mm.yyyy
Alias
- UMLS CUI [1]
- C2985918
- UMLS CUI [2]
- C1148348
Description
Time of resolution or death
Type de données
time
Unités de mesure
- 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
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0013230
- UMLS CUI [1,2]
- C1608430
Description
Withdrawal
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C1710677
- UMLS CUI [1,2]
- C1519255
Description
Relationship to investigational product
Type de données
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.
Type de données
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
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0347984
- UMLS CUI [1,3]
- C0008976
Description
Treatment failure
Type de données
boolean
Alias
- UMLS CUI [1]
- C0162643
Description
Withdrawal of investigational product(s)
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C2349954
- UMLS CUI [1,2]
- C0013227
Description
Concomitant disorder
Type de données
boolean
Alias
- UMLS CUI [1]
- C0009488
Description
Specify concomitant disorder
Type de données
text
Alias
- UMLS CUI [1,1]
- C0009488
- UMLS CUI [1,2]
- C1521902
Description
Concomitant medication
Type de données
boolean
Alias
- UMLS CUI [1]
- C2347852
Description
Specify concomitant medication
Type de données
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C1521902
Description
Activity related to study participation (e.g., procedures)
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C2348568
- UMLS CUI [1,2]
- C0199171
Description
Specify 'Activity related to study participation'
Type de données
text
Alias
- UMLS CUI [1,1]
- C2348568
- UMLS CUI [1,2]
- C0199171
Description
Seriousness of SAE
Alias
- UMLS CUI-1
- C1710056
Description
Death
Type de données
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.
Type de données
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.
Type de données
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.
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C3830477
- UMLS CUI [1,2]
- C1519255
Description
Congenital anomaly
Type de données
boolean
Alias
- UMLS CUI [1]
- C2826727
Description
Specify below.
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C3845569
- UMLS CUI [1,2]
- C1519255
Description
Specify, if the answer was 'other'
Type de données
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C1521902
Description
Send autopsy report if available.
Type de données
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
Type de données
text
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0262926
- UMLS CUI [1,3]
- C1519255
Description
Date of onset of medical condition
Type de données
date
Unités de mesure
- dd.mm.yyyy
Alias
- UMLS CUI [1,1]
- C0574845
- UMLS CUI [1,2]
- C0012634
Description
Condition present at time of the SAE
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0150312
- UMLS CUI [1,3]
- C1519255
Description
Date of last occurrence
Type de données
date
Unités de mesure
- 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
Specify other relevant risk factors
Type de données
text
Alias
- UMLS CUI [1,1]
- C0035648
- UMLS CUI [1,2]
- C1519255
- UMLS CUI [2]
- C0241889
- UMLS CUI [3]
- C0424945
Description
Details of lnvestigational Product(s)
Alias
- UMLS CUI-1
- C0013230
Description
Day
Type de données
integer
Alias
- UMLS CUI [1,1]
- C3161471
- UMLS CUI [1,2]
- C0439228
Description
Date of dose of investigational product
Type de données
date
Unités de mesure
- dd.mm.yyyy
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0178602
- UMLS CUI [1,3]
- C0011008
Description
Time of inhalation
Type de données
time
Unités de mesure
- 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
Type de données
text
Alias
- UMLS CUI [1]
- C2347852
Description
Dose of concomitant medication
Type de données
float
Alias
- UMLS CUI [1]
- C2826638
Description
Unit of concomitant medication
Type de données
text
Alias
- UMLS CUI [1]
- C2826646
Description
Frequency of concomitant medication
Type de données
text
Alias
- UMLS CUI [1]
- C2826654
Description
Route of concomitant medication
Type de données
text
Alias
- UMLS CUI [1]
- C2826730
Description
Start Date of concomitant medication
Type de données
date
Unités de mesure
- dd.mm.yyyy
Alias
- UMLS CUI [1]
- C2826734
Description
Concomitant medication started pre-study
Type de données
boolean
Alias
- UMLS CUI [1]
- C2981448
Description
Stop Date of concomitant medication
Type de données
date
Unités de mesure
- dd.mm.yyyy
Alias
- UMLS CUI [1]
- C2826744
Description
Concomitant Medication continued post-SAE
Type de données
boolean
Alias
- UMLS CUI [1]
- C2826666
Description
Reason for Concomitant Medication
Type de données
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).
Type de données
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
Type de données
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
Type de données
text
Alias
- UMLS CUI [1]
- C2826892
Description
Reporting lnvestigator: Address
Type de données
text
Alias
- UMLS CUI [1,1]
- C2986286
- UMLS CUI [1,2]
- C1442065
Description
Reporting lnvestigator: Signature
Type de données
text
Alias
- UMLS CUI [1,1]
- C2986286
- UMLS CUI [1,2]
- C1519316
Description
Date of report
Type de données
date
Unités de mesure
- 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
Type de données
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
Type de données
text
Alias
- UMLS CUI [1]
- C2826892
Description
Reporting lnvestigator: Address
Type de données
text
Alias
- UMLS CUI [1,1]
- C2986286
- UMLS CUI [1,2]
- C1442065
Description
Reporting lnvestigator: Signature
Type de données
text
Alias
- UMLS CUI [1,1]
- C2986286
- UMLS CUI [1,2]
- C1519316
Description
Date of report
Type de données
date
Unités de mesure
- 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])