ID

23006

Description

Study ID: 100527 Clinical Study ID: B2E100527 Study Title: A randomised, double blind, placebo controlled, parellel group study to examine the efficacy, safety, tolerability and systemic pharmacokinetic profile of repeated inhaled doses of GSK159797 Sponsor: GlaxoSmithKline Phase: phase 2 Study Recruitment Status: Completed Generic Name: milveterol Trade Name: Milveterol Study Indication: Pulmonary Disease, Chronic Obstructive

Keywords

Versions (2)
  1. 6/18/17 6/18/17 -
  2. 6/19/17 6/19/17 -
Uploaded on

June 19, 2017

DOI

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Creative Commons BY-NC 3.0
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Serious Adverse Event (SAE) - GSK Milveterol COPD 100527

English

Serious Adverse Event (SAE) - GSK Milveterol COPD 100527

1 forms  
Demography
Description

Demography

Alias
UMLS CUI-1
C0011298
Date of birth
Description

Date of birth

Data type

date

Measurement units
  • dd.mm.yyyy
Alias
UMLS CUI [1]
C0421451
dd.mm.yyyy
Sex
Description

Gender

Data type

integer

Alias
UMLS CUI [1]
C0079399
Race
Description

Race

Data type

integer

Alias
UMLS CUI [1]
C0034510
Weight
Description

Weight

Data type

float

Measurement units
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Height
Description

Height

Data type

integer

Measurement units
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Serious adverse events
Description

Serious adverse events

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

serious adverse events

Data type

boolean

Alias
UMLS CUI [1]
C1519255
Diagnosis or serious signs/symptoms
Description

Diagnosis or serious signs/symptoms of SAE

Data type

text

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

Date of onset SAE

Data type

date

Measurement units
  • dd.mm.yyyy
Alias
UMLS CUI [1,1]
C0574845
UMLS CUI [1,2]
C1519255
dd.mm.yyyy
Time of onset
Description

Time of onset SAE

Data type

time

Measurement units
  • hh:mm
Alias
UMLS CUI [1,1]
C0449244
UMLS CUI [1,2]
C1519255
hh:mm
Maximum Intensity
Description

Maximum Intensity SAE

Data type

integer

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

Outcome SAE

Data type

integer

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

Date of resolution or death

Data type

date

Measurement units
  • dd.mm.yyyy
Alias
UMLS CUI [1]
C2985918
UMLS CUI [2]
C1148348
dd.mm.yyyy
Time of resolution or death
Description

Time of resolution or death

Data type

time

Measurement units
  • 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
Description

Investigational drug, change of dose

Data type

integer

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

Withdrawal

Data type

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)?
Description

Relationship to investigational product

Data type

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?
Description

Definition of Seriousness

Data type

boolean

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

possible causes of SAE

Data type

integer

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C1519255
UMLS CUI [1,3]
C0085978
Seriousness of SAE
Description

Seriousness

Data type

integer

Alias
UMLS CUI [1]
C1710056
lf fatal, was an autopsy done/to be performed?
Description

SAE fatal, autopsy

Data type

boolean

Alias
UMLS CUI [1,1]
C1705232
UMLS CUI [1,2]
C0004398
Narrative / Comments: Provide a textual description of the serious adverse event (including treatment of the event).
Description

Narrative / Comments

Data type

text

Alias
UMLS CUI [1,1]
C0947611
UMLS CUI [1,2]
C1519255
Details of Relevant Assessments: Provide details of other assessments (e.g., laboratory data with normal ranges) or supplemental examinations.
Description

Details of Relevant Assessments

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0431080
Relevant Medical Conditions
Description

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.
Description

Relevant Medical Conditions

Data type

text

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

Date of onset

Data type

date

Measurement units
  • dd.mm.yyyy
Alias
UMLS CUI [1,1]
C0574845
UMLS CUI [1,2]
C0012634
dd.mm.yyyy
Condition present at time of the SAE
Description

Condition present at time of the SAE

Data type

boolean

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

Date of last occurrence

Data type

date

Measurement units
  • 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: Specify any family history or any social history (e.g., smoking, alcohol, diet, drug abuse, occupational hazard) relevant to the SAE.
Description

Other relevant risk factors

Data type

text

Alias
UMLS CUI [1,1]
C0035648
UMLS CUI [1,2]
C1519255
Details of lnvestigational Product(s)
Description

Details of lnvestigational Product(s)

Alias
UMLS CUI-1
C0013230
Treatment period
Description

Treatment period

Data type

integer

Alias
UMLS CUI [1,1]
C3161471
UMLS CUI [1,2]
C1948053
Date of dose
Description

Date of dose

Data type

date

Measurement units
  • dd.mm.yyyy
Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0011008
dd.mm.yyyy
Start time of dose
Description

Start time of dose

Data type

time

Measurement units
  • hh:mm
Alias
UMLS CUI [1,1]
C1301880
UMLS CUI [1,2]
C0304229
UMLS CUI [1,3]
C0178602
hh:mm
Did the event occur during the washout period?
Description

event during washout period

Data type

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2348792
UMLS CUI [1,3]
C1710661
Did the event occur during screening?
Description

event during screening

Data type

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2348792
UMLS CUI [1,3]
C1710477
Did the event occur during follow-up?
Description

event during follow-up

Data type

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2348792
UMLS CUI [1,3]
C1522577
Relevant Concomitant Medications
Description

Relevant Concomitant Medications

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

Drug Name

Data type

text

Alias
UMLS CUI [1]
C2347852
Dose
Description

Dose

Data type

float

Alias
UMLS CUI [1]
C2826638
Unit
Description

Unit

Data type

text

Alias
UMLS CUI [1]
C2826646
Frequency
Description

Frequency

Data type

text

Alias
UMLS CUI [1]
C2826654
Route
Description

Route

Data type

text

Alias
UMLS CUI [1]
C2826730
Date started
Description

Start Date

Data type

date

Measurement units
  • dd.mm.yyyy
Alias
UMLS CUI [1]
C2826734
dd.mm.yyyy
Started pre-study
Description

Started pre-study

Data type

boolean

Alias
UMLS CUI [1]
C2981448
Date stopped
Description

Stop Date

Data type

date

Measurement units
  • dd.mm.yyyy
Alias
UMLS CUI [1]
C2826744
dd.mm.yyyy
Medication continued post-SAE
Description

Ongoing Medication

Data type

boolean

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

Reason for Medication

Data type

text

Alias
UMLS CUI [1]
C2826696
Reporting lnvestigator
Description

Reporting lnvestigator

Alias
UMLS CUI-1
C2826892
Reporting lnvestigator: Name
Description

Reporting lnvestigator

Data type

text

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

Reporting lnvestigator: Address

Data type

text

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

Reporting lnvestigator: Signature

Data type

text

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

Date of report

Data type

date

Measurement units
  • dd.mm.yyyy
Alias
UMLS CUI [1]
C1302584
dd.mm.yyyy
Additional or follow-up information
Description

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 questions.
Description

Additional or follow-up information

Data type

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
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Similar models

Serious Adverse Event (SAE) - GSK Milveterol COPD 100527

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
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)
serious adverse events
Item
Did the subject experience any serious adverse events during the study?
boolean
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
Possible causes of SAE other than lnvestigational Product(s):
integer
C0205394 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C0085978 (UMLS CUI [1,3])
undefined item
Code List
Possible causes of SAE other than lnvestigational Product(s):
CL Item
Disease under study (1)
CL Item
Treatment failure  (2)
CL Item
Withdrawal of investigational product(s) (3)
CL Item
Concomitant disorder (4)
CL Item
Concomitant medication (5)
CL Item
Activity related to study participation (e.g. procedures) (6)
CL Item
Other (7)
Item
Seriousness of SAE
integer
C1710056 (UMLS CUI [1])
Seriousness
Code List
Seriousness of SAE
CL Item
Death (1)
CL Item
Life threatening (2)
CL Item
Hospitalization required or prolonged (3)
CL Item
Disabling or incapacitating (4)
CL Item
Congenital anomaly (5)
CL Item
Other (6)
SAE fatal, autopsy
Item
lf fatal, was an autopsy done/to be performed?
boolean
C1705232 (UMLS CUI [1,1])
C0004398 (UMLS CUI [1,2])
Narrative / Comments
Item
Narrative / Comments: Provide a textual description of the serious adverse event (including treatment of the event).
text
C0947611 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Details of Relevant Assessments
Item
Details of Relevant Assessments: Provide details of other assessments (e.g., laboratory data with normal ranges) or supplemental examinations.
text
C1519255 (UMLS CUI [1,1])
C0431080 (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
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])
Other relevant risk factors
Item
Other Relevant Risk Factors: 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])
Item Group
Details of lnvestigational Product(s)
C0013230 (UMLS CUI-1)
Item
Treatment period
integer
C3161471 (UMLS CUI [1,1])
C1948053 (UMLS CUI [1,2])
Treatment period
Code List
Treatment period
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
Date of dose
Item
Date of dose
date
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Start time of dose
Item
Start time of dose
time
C1301880 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
event during washout period
Item
Did the event occur during the washout period?
boolean
C1519255 (UMLS CUI [1,1])
C2348792 (UMLS CUI [1,2])
C1710661 (UMLS CUI [1,3])
event during screening
Item
Did the event occur during screening?
boolean
C1519255 (UMLS CUI [1,1])
C2348792 (UMLS CUI [1,2])
C1710477 (UMLS CUI [1,3])
event during follow-up
Item
Did the event occur during follow-up?
boolean
C1519255 (UMLS CUI [1,1])
C2348792 (UMLS CUI [1,2])
C1522577 (UMLS CUI [1,3])
Item Group
Relevant Concomitant Medications
C1704627 (UMLS CUI-1)
Drug Name
Item
Drug (Trade name preferred)
text
C2347852 (UMLS CUI [1])
Dose
Item
Dose
float
C2826638 (UMLS CUI [1])
Unit
Item
Unit
text
C2826646 (UMLS CUI [1])
Frequency
Item
Frequency
text
C2826654 (UMLS CUI [1])
Route
Item
Route
text
C2826730 (UMLS CUI [1])
Start Date
Item
Date started
date
C2826734 (UMLS CUI [1])
Started pre-study
Item
Started pre-study
boolean
C2981448 (UMLS CUI [1])
Stop Date
Item
Date stopped
date
C2826744 (UMLS CUI [1])
Ongoing Medication
Item
Medication continued post-SAE
boolean
C2826666 (UMLS CUI [1])
Reason for Medication
Item
Conditions treated/indication
text
C2826696 (UMLS CUI [1])
Item Group
Reporting lnvestigator
C2826892 (UMLS CUI-1)
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 questions.
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])
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