ID
34377
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 serious adverse events and should be completed only in case of occurrence of serious adverse events.
Stichworte
Versionen (1)
- 17.01.19 17.01.19 -
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
17. Januar 2019
DOI
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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
Beschreibung
Experience of any serious adverse events during the study
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C2347804
Beschreibung
Demography
Alias
- UMLS CUI-1
- C0011298
Beschreibung
Date of birth
Datentyp
date
Maßeinheiten
- dd.mm.yyyy
Alias
- UMLS CUI [1]
- C0421451
Beschreibung
Gender
Datentyp
integer
Alias
- UMLS CUI [1]
- C0079399
Beschreibung
Race
Datentyp
integer
Alias
- UMLS CUI [1]
- C0034510
Beschreibung
Weight
Datentyp
float
Maßeinheiten
- kg
Alias
- UMLS CUI [1]
- C0005910
Beschreibung
Height
Datentyp
integer
Maßeinheiten
- cm
Alias
- UMLS CUI [1]
- C0005890
Beschreibung
Serious adverse events
Alias
- UMLS CUI-1
- C1519255
Beschreibung
Diagnosis or serious signs/symptoms of SAE
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0011900
- UMLS CUI [1,2]
- C0037088
- UMLS CUI [1,3]
- C1519255
Beschreibung
Date of onset SAE
Datentyp
date
Maßeinheiten
- dd.mm.yyyy
Alias
- UMLS CUI [1,1]
- C0574845
- UMLS CUI [1,2]
- C1519255
Beschreibung
Time of onset SAE
Datentyp
time
Maßeinheiten
- hh:mm
Alias
- UMLS CUI [1,1]
- C0449244
- UMLS CUI [1,2]
- C1519255
Beschreibung
Maximum Intensity SAE
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C1519255
Beschreibung
Outcome SAE
Datentyp
integer
Alias
- UMLS CUI [1]
- C1705586
Beschreibung
Date of resolution or death
Datentyp
date
Maßeinheiten
- dd.mm.yyyy
Alias
- UMLS CUI [1]
- C2985918
- UMLS CUI [2]
- C1148348
Beschreibung
Time of resolution or death
Datentyp
time
Maßeinheiten
- hh:mm
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C2699488
- UMLS CUI [1,3]
- C1519255
- UMLS CUI [2]
- C1301931
Beschreibung
Investigational drug, change of dose
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0013230
- UMLS CUI [1,2]
- C1608430
Beschreibung
Withdrawal
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1710677
- UMLS CUI [1,2]
- C1519255
Beschreibung
Relationship to investigational product
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0085978
- UMLS CUI [1,3]
- C0013230
Beschreibung
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.
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1704788
- UMLS CUI [1,2]
- C1710056
Beschreibung
Possible Causes of SAE other than lnvestigational Product(s)
Alias
- UMLS CUI-1
- C0205394
- UMLS CUI-2
- C1519255
- UMLS CUI-3
- C0085978
Beschreibung
Disease under study
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0347984
- UMLS CUI [1,3]
- C0008976
Beschreibung
Treatment failure
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0162643
Beschreibung
Withdrawal of investigational product(s)
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C2349954
- UMLS CUI [1,2]
- C0013227
Beschreibung
Concomitant disorder
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0009488
Beschreibung
Specify concomitant disorder
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0009488
- UMLS CUI [1,2]
- C1521902
Beschreibung
Concomitant medication
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2347852
Beschreibung
Specify concomitant medication
Datentyp
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C1521902
Beschreibung
Activity related to study participation (e.g., procedures)
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C2348568
- UMLS CUI [1,2]
- C0199171
Beschreibung
Specify 'Activity related to study participation'
Datentyp
text
Alias
- UMLS CUI [1,1]
- C2348568
- UMLS CUI [1,2]
- C0199171
Beschreibung
Seriousness of SAE
Alias
- UMLS CUI-1
- C1710056
Beschreibung
Death
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0011065
Beschreibung
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.
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1517874
Beschreibung
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.
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C2348993
- UMLS CUI [1,2]
- C1519255
Beschreibung
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.
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C3830477
- UMLS CUI [1,2]
- C1519255
Beschreibung
Congenital anomaly
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2826727
Beschreibung
Specify below.
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C3845569
- UMLS CUI [1,2]
- C1519255
Beschreibung
Specify, if the answer was 'other'
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C1521902
Beschreibung
Send autopsy report if available.
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1705232
- UMLS CUI [1,2]
- C0004398
Beschreibung
Relevant Medical Conditions
Alias
- UMLS CUI-1
- C0243087
Beschreibung
Relevant Medical Conditions
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0262926
- UMLS CUI [1,3]
- C1519255
Beschreibung
Date of onset of medical condition
Datentyp
date
Maßeinheiten
- dd.mm.yyyy
Alias
- UMLS CUI [1,1]
- C0574845
- UMLS CUI [1,2]
- C0012634
Beschreibung
Condition present at time of the SAE
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0150312
- UMLS CUI [1,3]
- C1519255
Beschreibung
Date of last occurrence
Datentyp
date
Maßeinheiten
- dd.mm.yyyy
Alias
- UMLS CUI [1,1]
- C2745955
- UMLS CUI [1,2]
- C0012634
- UMLS CUI [1,3]
- C0011008
- UMLS CUI [2]
- C1519255
Beschreibung
Other relevant risk factors
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0035648
- UMLS CUI-3
- C0205394
Beschreibung
Details of lnvestigational Product(s)
Alias
- UMLS CUI-1
- C0013230
Beschreibung
Day
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C3161471
- UMLS CUI [1,2]
- C0439228
Beschreibung
Date of dose of investigational product
Datentyp
date
Maßeinheiten
- dd.mm.yyyy
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0178602
- UMLS CUI [1,3]
- C0011008
Beschreibung
Time of inhalation
Datentyp
time
Maßeinheiten
- hh:mm
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0001559
Beschreibung
Relevant Concomitant Medications
Alias
- UMLS CUI-1
- C1704627
Beschreibung
Drug Name
Datentyp
text
Alias
- UMLS CUI [1]
- C2347852
Beschreibung
Dose of concomitant medication
Datentyp
float
Alias
- UMLS CUI [1]
- C2826638
Beschreibung
Unit of concomitant medication
Datentyp
text
Alias
- UMLS CUI [1]
- C2826646
Beschreibung
Frequency of concomitant medication
Datentyp
text
Alias
- UMLS CUI [1]
- C2826654
Beschreibung
Route of concomitant medication
Datentyp
text
Alias
- UMLS CUI [1]
- C2826730
Beschreibung
Start Date of concomitant medication
Datentyp
date
Maßeinheiten
- dd.mm.yyyy
Alias
- UMLS CUI [1]
- C2826734
Beschreibung
Concomitant medication started pre-study
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2981448
Beschreibung
Stop Date of concomitant medication
Datentyp
date
Maßeinheiten
- dd.mm.yyyy
Alias
- UMLS CUI [1]
- C2826744
Beschreibung
Concomitant Medication continued post-SAE
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2826666
Beschreibung
Reason for Concomitant Medication
Datentyp
text
Alias
- UMLS CUI [1]
- C2826696
Beschreibung
Description of SAE
Alias
- UMLS CUI-1
- C0678257
- UMLS CUI-2
- C1519255
Beschreibung
Provide a textual description of the serious adverse event (including treatment of the event).
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0678257
- UMLS CUI [2,1]
- C1519255
- UMLS CUI [2,2]
- C0087111
Beschreibung
Details of relevant Assessments
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0431080
Beschreibung
Provide details of other assessments (e.g., laboratory data with normal ranges) or supplemental examinations
Datentyp
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
Beschreibung
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
Beschreibung
Reporting lnvestigator
Datentyp
text
Alias
- UMLS CUI [1]
- C2826892
Beschreibung
Reporting lnvestigator: Address
Datentyp
text
Alias
- UMLS CUI [1,1]
- C2986286
- UMLS CUI [1,2]
- C1442065
Beschreibung
Reporting lnvestigator: Signature
Datentyp
text
Alias
- UMLS CUI [1,1]
- C2986286
- UMLS CUI [1,2]
- C1519316
Beschreibung
Date of report
Datentyp
date
Maßeinheiten
- dd.mm.yyyy
Alias
- UMLS CUI [1]
- C1302584
Beschreibung
Additional or follow-up information
Alias
- UMLS CUI-1
- C1533716
- UMLS CUI-2
- C1519255
Beschreibung
Additional or follow-up information
Datentyp
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
Beschreibung
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
Beschreibung
Reporting lnvestigator
Datentyp
text
Alias
- UMLS CUI [1]
- C2826892
Beschreibung
Reporting lnvestigator: Address
Datentyp
text
Alias
- UMLS CUI [1,1]
- C2986286
- UMLS CUI [1,2]
- C1442065
Beschreibung
Reporting lnvestigator: Signature
Datentyp
text
Alias
- UMLS CUI [1,1]
- C2986286
- UMLS CUI [1,2]
- C1519316
Beschreibung
Date of report
Datentyp
date
Maßeinheiten
- dd.mm.yyyy
Alias
- UMLS CUI [1]
- C1302584
Ähnliche Modelle
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])