ID

34377

Descrizione

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

versioni (1)
  1. 17/01/19 17/01/19 -
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GlaxoSmithKline

Caricato su

17 gennaio 2019

DOI

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Licenza

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)

Inglese

Serious Adverse Event (SAE)

1 moduli  
Administrative data
Descrizione

Administrative data

Alias
UMLS CUI-1
C1320722
Subject number
Descrizione

Subject number

Tipo di dati

text

Alias
UMLS CUI [1]
C2348585
Experience of any serious adverse events during the study
Descrizione

Experience of any serious adverse events during the study

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C2347804
Did the subject experience any serious adverse events during the study?
Descrizione

If YES, indicate below.

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2347804
Demography
Descrizione

Demography

Alias
UMLS CUI-1
C0011298
Date of birth
Descrizione

Date of birth

Tipo di dati

date

Unità di misura
  • dd.mm.yyyy
Alias
UMLS CUI [1]
C0421451
dd.mm.yyyy
Sex
Descrizione

Gender

Tipo di dati

integer

Alias
UMLS CUI [1]
C0079399
Race
Descrizione

Race

Tipo di dati

integer

Alias
UMLS CUI [1]
C0034510
Weight
Descrizione

Weight

Tipo di dati

float

Unità di misura
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Height
Descrizione

Height

Tipo di dati

integer

Unità di misura
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Serious adverse events
Descrizione

Serious adverse events

Alias
UMLS CUI-1
C1519255
Diagnosis or serious signs/symptoms
Descrizione

Diagnosis or serious signs/symptoms of SAE

Tipo di dati

text

Alias
UMLS CUI [1,1]
C0011900
UMLS CUI [1,2]
C0037088
UMLS CUI [1,3]
C1519255
Date of onset
Descrizione

Date of onset SAE

Tipo di dati

date

Unità di misura
  • dd.mm.yyyy
Alias
UMLS CUI [1,1]
C0574845
UMLS CUI [1,2]
C1519255
dd.mm.yyyy
Time of onset
Descrizione

Time of onset SAE

Tipo di dati

time

Unità di misura
  • hh:mm
Alias
UMLS CUI [1,1]
C0449244
UMLS CUI [1,2]
C1519255
hh:mm
Maximum Intensity
Descrizione

Maximum Intensity SAE

Tipo di dati

integer

Alias
UMLS CUI [1,1]
C0518690
UMLS CUI [1,2]
C1519255
Outcome
Descrizione

Outcome SAE

Tipo di dati

integer

Alias
UMLS CUI [1]
C1705586
Date of resolution or death
Descrizione

Date of resolution or death

Tipo di dati

date

Unità di misura
  • dd.mm.yyyy
Alias
UMLS CUI [1]
C2985918
UMLS CUI [2]
C1148348
dd.mm.yyyy
Time of resolution or death
Descrizione

Time of resolution or death

Tipo di dati

time

Unità di misura
  • hh:mm
Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C2699488
UMLS CUI [1,3]
C1519255
UMLS CUI [2]
C1301931
hh:mm
Action taken with investigational product(s) as a result of the SAE
Descrizione

Investigational drug, change of dose

Tipo di dati

integer

Alias
UMLS CUI [1,1]
C0013230
UMLS CUI [1,2]
C1608430
Did the subject withdraw from study as a result of this SAE?
Descrizione

Withdrawal

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C1710677
UMLS CUI [1,2]
C1519255
Is there a reasonable possibility the SAE may have been caused by the investigational product(s)?
Descrizione

Relationship to investigational product

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0085978
UMLS CUI [1,3]
C0013230
Does the AE meet the definition of serious?
Descrizione

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 di dati

boolean

Alias
UMLS CUI [1,1]
C1704788
UMLS CUI [1,2]
C1710056
Possible Causes of SAE other than lnvestigational Product(s)
Descrizione

Possible Causes of SAE other than lnvestigational Product(s)

Alias
UMLS CUI-1
C0205394
UMLS CUI-2
C1519255
UMLS CUI-3
C0085978
Disease under study
Descrizione

Disease under study

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0347984
UMLS CUI [1,3]
C0008976
Treatment failure
Descrizione

Treatment failure

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0162643
Withdrawal of investigational product(s)
Descrizione

Withdrawal of investigational product(s)

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C0013227
Concomitant disorder
Descrizione

Concomitant disorder

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0009488
If 'concomitant disorder' was choosen, specify:
Descrizione

Specify concomitant disorder

Tipo di dati

text

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C1521902
Concomitant medication
Descrizione

Concomitant medication

Tipo di dati

boolean

Alias
UMLS CUI [1]
C2347852
If 'concomitant medication' was choosen, specify:
Descrizione

Specify concomitant medication

Tipo di dati

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C1521902
Activity related to study participation (e.g., procedures)
Descrizione

Activity related to study participation (e.g., procedures)

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0199171
If answer 'Activity related to study participation' was choosen, specify:
Descrizione

Specify 'Activity related to study participation'

Tipo di dati

text

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0199171
Seriousness of SAE
Descrizione

Seriousness of SAE

Alias
UMLS CUI-1
C1710056
Death
Descrizione

Death

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0011065
Life threatening
Descrizione

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 di dati

boolean

Alias
UMLS CUI [1]
C1517874
Hospitallization required or prolonged
Descrizione

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 di dati

boolean

Alias
UMLS CUI [1,1]
C2348993
UMLS CUI [1,2]
C1519255
Disabling or incapacitating
Descrizione

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 di dati

boolean

Alias
UMLS CUI [1,1]
C3830477
UMLS CUI [1,2]
C1519255
Congenital anomaly
Descrizione

Congenital anomaly

Tipo di dati

boolean

Alias
UMLS CUI [1]
C2826727
Other (see definition)
Descrizione

Specify below.

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C3845569
UMLS CUI [1,2]
C1519255
Specify, if the answer was 'other'
Descrizione

Specify, if the answer was 'other'

Tipo di dati

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C1521902
lf fatal, was an autopsy done/to be performed?
Descrizione

Send autopsy report if available.

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C1705232
UMLS CUI [1,2]
C0004398
Relevant Medical Conditions
Descrizione

Relevant Medical Conditions

Alias
UMLS CUI-1
C0243087
Specify any relevant past or current medical disorders, allergies, surgeries, etc. that can help explain the SAE.
Descrizione

Relevant Medical Conditions

Tipo di dati

text

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0262926
UMLS CUI [1,3]
C1519255
Date of onset
Descrizione

Date of onset of medical condition

Tipo di dati

date

Unità di misura
  • dd.mm.yyyy
Alias
UMLS CUI [1,1]
C0574845
UMLS CUI [1,2]
C0012634
dd.mm.yyyy
Condition present at time of the SAE
Descrizione

Condition present at time of the SAE

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0150312
UMLS CUI [1,3]
C1519255
If 'No', date of last occurrence:
Descrizione

Date of last occurrence

Tipo di dati

date

Unità di misura
  • dd.mm.yyyy
Alias
UMLS CUI [1,1]
C2745955
UMLS CUI [1,2]
C0012634
UMLS CUI [1,3]
C0011008
UMLS CUI [2]
C1519255
dd.mm.yyyy
Other relevant risk factors
Descrizione

Other relevant risk factors

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0035648
UMLS CUI-3
C0205394
Specify any family history or any social history (e.g., smoking, alcohol, diet, drug abuse, occupational hazard) relevant to the SAE.
Descrizione

Specify other relevant risk factors

Tipo di dati

text

Alias
UMLS CUI [1,1]
C0035648
UMLS CUI [1,2]
C1519255
UMLS CUI [2]
C0241889
UMLS CUI [3]
C0424945
Details of lnvestigational Product(s)
Descrizione

Details of lnvestigational Product(s)

Alias
UMLS CUI-1
C0013230
Day
Descrizione

Day

Tipo di dati

integer

Alias
UMLS CUI [1,1]
C3161471
UMLS CUI [1,2]
C0439228
Date of dose
Descrizione

Date of dose of investigational product

Tipo di dati

date

Unità di misura
  • dd.mm.yyyy
Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0011008
dd.mm.yyyy
Time of inhalation
Descrizione

Time of inhalation

Tipo di dati

time

Unità di misura
  • hh:mm
Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0001559
hh:mm
Relevant Concomitant Medications
Descrizione

Relevant Concomitant Medications

Alias
UMLS CUI-1
C1704627
Drug (Trade name preferred)
Descrizione

Drug Name

Tipo di dati

text

Alias
UMLS CUI [1]
C2347852
Dose
Descrizione

Dose of concomitant medication

Tipo di dati

float

Alias
UMLS CUI [1]
C2826638
Unit
Descrizione

Unit of concomitant medication

Tipo di dati

text

Alias
UMLS CUI [1]
C2826646
Frequency
Descrizione

Frequency of concomitant medication

Tipo di dati

text

Alias
UMLS CUI [1]
C2826654
Route
Descrizione

Route of concomitant medication

Tipo di dati

text

Alias
UMLS CUI [1]
C2826730
Date started
Descrizione

Start Date of concomitant medication

Tipo di dati

date

Unità di misura
  • dd.mm.yyyy
Alias
UMLS CUI [1]
C2826734
dd.mm.yyyy
Started pre-study
Descrizione

Concomitant medication started pre-study

Tipo di dati

boolean

Alias
UMLS CUI [1]
C2981448
Date stopped
Descrizione

Stop Date of concomitant medication

Tipo di dati

date

Unità di misura
  • dd.mm.yyyy
Alias
UMLS CUI [1]
C2826744
dd.mm.yyyy
Medication continued post-SAE
Descrizione

Concomitant Medication continued post-SAE

Tipo di dati

boolean

Alias
UMLS CUI [1]
C2826666
Conditions treated/indication
Descrizione

Reason for Concomitant Medication

Tipo di dati

text

Alias
UMLS CUI [1]
C2826696
Description of SAE
Descrizione

Description of SAE

Alias
UMLS CUI-1
C0678257
UMLS CUI-2
C1519255
Provide a textual description of the serious adverse event (including treatment of the event).
Descrizione

Provide a textual description of the serious adverse event (including treatment of the event).

Tipo di dati

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0678257
UMLS CUI [2,1]
C1519255
UMLS CUI [2,2]
C0087111
Details of relevant Assessments
Descrizione

Details of relevant Assessments

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0431080
Provide details of other assessments (e.g., laboratory data with normal ranges) or supplemental examinations
Descrizione

Provide details of other assessments (e.g., laboratory data with normal ranges) or supplemental examinations

Tipo di dati

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
Reporting lnvestigator: To the best of my knowledge, all information entered on these Serious Adverse Event pages for this subject is correct.
Descrizione

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
Reporting lnvestigator: Name
Descrizione

Reporting lnvestigator

Tipo di dati

text

Alias
UMLS CUI [1]
C2826892
Reporting lnvestigator: Address
Descrizione

Reporting lnvestigator: Address

Tipo di dati

text

Alias
UMLS CUI [1,1]
C2986286
UMLS CUI [1,2]
C1442065
Reporting lnvestigator: Signature
Descrizione

Reporting lnvestigator: Signature

Tipo di dati

text

Alias
UMLS CUI [1,1]
C2986286
UMLS CUI [1,2]
C1519316
Date
Descrizione

Date of report

Tipo di dati

date

Unità di misura
  • dd.mm.yyyy
Alias
UMLS CUI [1]
C1302584
dd.mm.yyyy
Additional or follow-up information
Descrizione

Additional or follow-up information

Alias
UMLS CUI-1
C1533716
UMLS CUI-2
C1519255
Provide any additional details on the serious adverse event not already captured in the previous pages.
Descrizione

Additional or follow-up information

Tipo di dati

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
Reporting lnvestigator: To the best of my knowledge, all information entered on these Serious Adverse Event pages for this subject is correct.
Descrizione

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
Reporting lnvestigator: Name
Descrizione

Reporting lnvestigator

Tipo di dati

text

Alias
UMLS CUI [1]
C2826892
Reporting lnvestigator: Address
Descrizione

Reporting lnvestigator: Address

Tipo di dati

text

Alias
UMLS CUI [1,1]
C2986286
UMLS CUI [1,2]
C1442065
Reporting lnvestigator: Signature
Descrizione

Reporting lnvestigator: Signature

Tipo di dati

text

Alias
UMLS CUI [1,1]
C2986286
UMLS CUI [1,2]
C1519316
Date
Descrizione

Date of report

Tipo di dati

date

Unità di misura
  • dd.mm.yyyy
Alias
UMLS CUI [1]
C1302584
dd.mm.yyyy
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Similar models

Serious Adverse Event (SAE)

1 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Subject number
Item
Subject number
text
C2348585 (UMLS CUI [1])
Item Group
Experience of any serious adverse events during the study
C1519255 (UMLS CUI-1)
C2347804 (UMLS CUI-2)
Did the subject experience any serious adverse events during the study?
Item
Did the subject experience any serious adverse events during the study?
boolean
C1519255 (UMLS CUI [1,1])
C2347804 (UMLS CUI [1,2])
Item Group
Demography
C0011298 (UMLS CUI-1)
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Item
Sex
integer
C0079399 (UMLS CUI [1])
Gender
Code List
Sex
CL Item
Male (1)
CL Item
Female (2)
Item
Race
integer
C0034510 (UMLS CUI [1])
Race
Code List
Race
CL Item
White (1)
CL Item
Black (2)
CL Item
Asian (3)
CL Item
Other (4)
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Height
Item
Height
integer
C0005890 (UMLS CUI [1])
Item Group
Serious adverse events
C1519255 (UMLS CUI-1)
Diagnosis or serious signs/symptoms of SAE
Item
Diagnosis or serious signs/symptoms
text
C0011900 (UMLS CUI [1,1])
C0037088 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
Date of onset SAE
Item
Date of onset
date
C0574845 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Time of onset SAE
Item
Time of onset
time
C0449244 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item
Maximum Intensity
integer
C0518690 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Maximum Intensity SAE
Code List
Maximum Intensity
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Not applicable (4)
Item
Outcome
integer
C1705586 (UMLS CUI [1])
Outcome
Code List
Outcome
CL Item
Resolved (1)
CL Item
Resolved with Sequelae (2)
CL Item
Fatal (3)
CL Item
Not Resolved (4)
Date of resolution or death
Item
Date of resolution or death
date
C2985918 (UMLS CUI [1])
C1148348 (UMLS CUI [2])
Time of resolution or death
Item
Time of resolution or death
time
C0040223 (UMLS CUI [1,1])
C2699488 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C1301931 (UMLS CUI [2])
Item
Action taken with investigational product(s) as a result of the SAE
integer
C0013230 (UMLS CUI [1,1])
C1608430 (UMLS CUI [1,2])
Investigational drug, change of dose
Code List
Action taken with investigational product(s) as a result of the SAE
CL Item
None (1)
CL Item
Dose adjusted (2)
CL Item
Temporarily interrupted (3)
CL Item
Permanently discontinued (4)
CL Item
Not applicable (5)
Withdrawal
Item
Did the subject withdraw from study as a result of this SAE?
boolean
C1710677 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Relationship to investigational product
Item
Is there a reasonable possibility the SAE may have been caused by the investigational product(s)?
boolean
C1519255 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C0013230 (UMLS CUI [1,3])
Definition of Seriousness
Item
Does the AE meet the definition of serious?
boolean
C1704788 (UMLS CUI [1,1])
C1710056 (UMLS CUI [1,2])
Item Group
Possible Causes of SAE other than lnvestigational Product(s)
C0205394 (UMLS CUI-1)
C1519255 (UMLS CUI-2)
C0085978 (UMLS CUI-3)
Disease under study
Item
Disease under study
boolean
C0012634 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Treatment failure
Item
Treatment failure
boolean
C0162643 (UMLS CUI [1])
Withdrawal of investigational product(s)
Item
Withdrawal of investigational product(s)
boolean
C2349954 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Concomitant disorder
Item
Concomitant disorder
boolean
C0009488 (UMLS CUI [1])
Specify concomitant disorder
Item
If 'concomitant disorder' was choosen, specify:
text
C0009488 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
Concomitant medication
Item
Concomitant medication
boolean
C2347852 (UMLS CUI [1])
Specify concomitant medication
Item
If 'concomitant medication' was choosen, specify:
text
C2347852 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
Activity related to study participation (e.g., procedures)
Item
Activity related to study participation (e.g., procedures)
boolean
C2348568 (UMLS CUI [1,1])
C0199171 (UMLS CUI [1,2])
Specify 'Activity related to study participation'
Item
If answer 'Activity related to study participation' was choosen, specify:
text
C2348568 (UMLS CUI [1,1])
C0199171 (UMLS CUI [1,2])
Item Group
Seriousness of SAE
C1710056 (UMLS CUI-1)
Death
Item
Death
boolean
C0011065 (UMLS CUI [1])
Life threatening
Item
Life threatening
boolean
C1517874 (UMLS CUI [1])
Hospitallization required or prolonged
Item
Hospitallization required or prolonged
boolean
C2348993 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Disabling or incapacitating
Item
Disabling or incapacitating
boolean
C3830477 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Congenital anomaly
Item
Congenital anomaly
boolean
C2826727 (UMLS CUI [1])
Other (see definition)
Item
Other (see definition)
boolean
C3845569 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Specify, if the answer was 'other'
Item
Specify, if the answer was 'other'
text
C1519255 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
SAE fatal, autopsy
Item
lf fatal, was an autopsy done/to be performed?
boolean
C1705232 (UMLS CUI [1,1])
C0004398 (UMLS CUI [1,2])
Item Group
Relevant Medical Conditions
C0243087 (UMLS CUI-1)
Relevant Medical Conditions
Item
Specify any relevant past or current medical disorders, allergies, surgeries, etc. that can help explain the SAE.
text
C0012634 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
Date of onset of medical condition
Item
Date of onset
date
C0574845 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
Condition present at time of the SAE
Item
Condition present at time of the SAE
boolean
C0012634 (UMLS CUI [1,1])
C0150312 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
Date of last occurrence
Item
If 'No', date of last occurrence:
date
C2745955 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C1519255 (UMLS CUI [2])
Item Group
Other relevant risk factors
C1519255 (UMLS CUI-1)
C0035648 (UMLS CUI-2)
C0205394 (UMLS CUI-3)
Specify other relevant risk factors
Item
Specify any family history or any social history (e.g., smoking, alcohol, diet, drug abuse, occupational hazard) relevant to the SAE.
text
C0035648 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C0241889 (UMLS CUI [2])
C0424945 (UMLS CUI [3])
Item Group
Details of lnvestigational Product(s)
C0013230 (UMLS CUI-1)
Item
Day
integer
C3161471 (UMLS CUI [1,1])
C0439228 (UMLS CUI [1,2])
Treatment period
Code List
Day
Date of dose of investigational product
Item
Date of dose
date
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Time of inhalation
Item
Time of inhalation
time
C0040223 (UMLS CUI [1,1])
C0001559 (UMLS CUI [1,2])
Item Group
Relevant Concomitant Medications
C1704627 (UMLS CUI-1)
Drug Name
Item
Drug (Trade name preferred)
text
C2347852 (UMLS CUI [1])
Dose of concomitant medication
Item
Dose
float
C2826638 (UMLS CUI [1])
Unit of concomitant medication
Item
Unit
text
C2826646 (UMLS CUI [1])
Frequency of concomitant medication
Item
Frequency
text
C2826654 (UMLS CUI [1])
Route of concomitant medication
Item
Route
text
C2826730 (UMLS CUI [1])
Start Date of concomitant medication
Item
Date started
date
C2826734 (UMLS CUI [1])
Concomitant medication started pre-study
Item
Started pre-study
boolean
C2981448 (UMLS CUI [1])
Stop Date of concomitant medication
Item
Date stopped
date
C2826744 (UMLS CUI [1])
Concomitant Medication continued post-SAE
Item
Medication continued post-SAE
boolean
C2826666 (UMLS CUI [1])
Reason for Concomitant Medication
Item
Conditions treated/indication
text
C2826696 (UMLS CUI [1])
Item Group
Description of SAE
C0678257 (UMLS CUI-1)
C1519255 (UMLS CUI-2)
Provide a textual description of the serious adverse event (including treatment of the event).
Item
Provide a textual description of the serious adverse event (including treatment of the event).
text
C1519255 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2,1])
C0087111 (UMLS CUI [2,2])
Item Group
Details of relevant Assessments
C1519255 (UMLS CUI-1)
C0431080 (UMLS CUI-2)
Provide details of other assessments (e.g., laboratory data with normal ranges) or supplemental examinations
Item
Provide details of other assessments (e.g., laboratory data with normal ranges) or supplemental examinations
text
C0220825 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C1522508 (UMLS CUI [1,3])
C0022885 (UMLS CUI [2])
C0582103 (UMLS CUI [3,1])
C0205394 (UMLS CUI [3,2])
Item Group
Reporting lnvestigator: To the best of my knowledge, all information entered on these Serious Adverse Event pages for this subject is correct.
C2826892 (UMLS CUI-1)
C1519255 (UMLS CUI-2)
C1533716 (UMLS CUI-3)
C2349182 (UMLS CUI-4)
Reporting lnvestigator
Item
Reporting lnvestigator: Name
text
C2826892 (UMLS CUI [1])
Reporting lnvestigator: Address
Item
Reporting lnvestigator: Address
text
C2986286 (UMLS CUI [1,1])
C1442065 (UMLS CUI [1,2])
Reporting lnvestigator: Signature
Item
Reporting lnvestigator: Signature
text
C2986286 (UMLS CUI [1,1])
C1519316 (UMLS CUI [1,2])
Date of report
Item
Date
date
C1302584 (UMLS CUI [1])
Item Group
Additional or follow-up information
C1533716 (UMLS CUI-1)
C1519255 (UMLS CUI-2)
Additional or follow-up information
Item
Provide any additional details on the serious adverse event not already captured in the previous pages.
text
C1524062 (UMLS CUI [1,1])
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])
Item Group
Reporting lnvestigator: To the best of my knowledge, all information entered on these Serious Adverse Event pages for this subject is correct.
C2826892 (UMLS CUI-1)
C1519255 (UMLS CUI-2)
C1533716 (UMLS CUI-3)
C2349182 (UMLS CUI-4)
Reporting lnvestigator
Item
Reporting lnvestigator: Name
text
C2826892 (UMLS CUI [1])
Reporting lnvestigator: Address
Item
Reporting lnvestigator: Address
text
C2986286 (UMLS CUI [1,1])
C1442065 (UMLS CUI [1,2])
Reporting lnvestigator: Signature
Item
Reporting lnvestigator: Signature
text
C2986286 (UMLS CUI [1,1])
C1519316 (UMLS CUI [1,2])
Date of report
Item
Date
date
C1302584 (UMLS CUI [1])
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