ID

23006

Beschrijving

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

Trefwoorden

Versies (2)
  1. 18-06-17 18-06-17 -
  2. 19-06-17 19-06-17 -
Geüploaded op

19 juni 2017

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY-NC 3.0
Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Terug naar het model Commentaren
Itemgroep Commentaren voor :

Item Commentaren voor :

U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

Serious Adverse Event (SAE) - GSK Milveterol COPD 100527

Engels

Serious Adverse Event (SAE) - GSK Milveterol COPD 100527

1 Formulieren  
Demography
Beschrijving

Demography

Alias
UMLS CUI-1
C0011298
Date of birth
Beschrijving

Date of birth

Datatype

date

Maateenheden
  • dd.mm.yyyy
Alias
UMLS CUI [1]
C0421451
dd.mm.yyyy
Sex
Beschrijving

Gender

Datatype

integer

Alias
UMLS CUI [1]
C0079399
Race
Beschrijving

Race

Datatype

integer

Alias
UMLS CUI [1]
C0034510
Weight
Beschrijving

Weight

Datatype

float

Maateenheden
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Height
Beschrijving

Height

Datatype

integer

Maateenheden
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Serious adverse events
Beschrijving

Serious adverse events

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

serious adverse events

Datatype

boolean

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

Diagnosis or serious signs/symptoms of SAE

Datatype

text

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

Date of onset SAE

Datatype

date

Maateenheden
  • dd.mm.yyyy
Alias
UMLS CUI [1,1]
C0574845
UMLS CUI [1,2]
C1519255
dd.mm.yyyy
Time of onset
Beschrijving

Time of onset SAE

Datatype

time

Maateenheden
  • hh:mm
Alias
UMLS CUI [1,1]
C0449244
UMLS CUI [1,2]
C1519255
hh:mm
Maximum Intensity
Beschrijving

Maximum Intensity SAE

Datatype

integer

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

Outcome SAE

Datatype

integer

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

Date of resolution or death

Datatype

date

Maateenheden
  • dd.mm.yyyy
Alias
UMLS CUI [1]
C2985918
UMLS CUI [2]
C1148348
dd.mm.yyyy
Time of resolution or death
Beschrijving

Time of resolution or death

Datatype

time

Maateenheden
  • 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
Beschrijving

Investigational drug, change of dose

Datatype

integer

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

Withdrawal

Datatype

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)?
Beschrijving

Relationship to investigational product

Datatype

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?
Beschrijving

Definition of Seriousness

Datatype

boolean

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

possible causes of SAE

Datatype

integer

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

Seriousness

Datatype

integer

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

SAE fatal, autopsy

Datatype

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).
Beschrijving

Narrative / Comments

Datatype

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.
Beschrijving

Details of Relevant Assessments

Datatype

text

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

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.
Beschrijving

Relevant Medical Conditions

Datatype

text

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

Date of onset

Datatype

date

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

Condition present at time of the SAE

Datatype

boolean

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

Date of last occurrence

Datatype

date

Maateenheden
  • 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.
Beschrijving

Other relevant risk factors

Datatype

text

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

Details of lnvestigational Product(s)

Alias
UMLS CUI-1
C0013230
Treatment period
Beschrijving

Treatment period

Datatype

integer

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

Date of dose

Datatype

date

Maateenheden
  • 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
Beschrijving

Start time of dose

Datatype

time

Maateenheden
  • 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?
Beschrijving

event during washout period

Datatype

boolean

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

event during screening

Datatype

boolean

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

event during follow-up

Datatype

boolean

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

Relevant Concomitant Medications

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

Drug Name

Datatype

text

Alias
UMLS CUI [1]
C2347852
Dose
Beschrijving

Dose

Datatype

float

Alias
UMLS CUI [1]
C2826638
Unit
Beschrijving

Unit

Datatype

text

Alias
UMLS CUI [1]
C2826646
Frequency
Beschrijving

Frequency

Datatype

text

Alias
UMLS CUI [1]
C2826654
Route
Beschrijving

Route

Datatype

text

Alias
UMLS CUI [1]
C2826730
Date started
Beschrijving

Start Date

Datatype

date

Maateenheden
  • dd.mm.yyyy
Alias
UMLS CUI [1]
C2826734
dd.mm.yyyy
Started pre-study
Beschrijving

Started pre-study

Datatype

boolean

Alias
UMLS CUI [1]
C2981448
Date stopped
Beschrijving

Stop Date

Datatype

date

Maateenheden
  • dd.mm.yyyy
Alias
UMLS CUI [1]
C2826744
dd.mm.yyyy
Medication continued post-SAE
Beschrijving

Ongoing Medication

Datatype

boolean

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

Reason for Medication

Datatype

text

Alias
UMLS CUI [1]
C2826696
Reporting lnvestigator
Beschrijving

Reporting lnvestigator

Alias
UMLS CUI-1
C2826892
Reporting lnvestigator: Name
Beschrijving

Reporting lnvestigator

Datatype

text

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

Reporting lnvestigator: Address

Datatype

text

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

Reporting lnvestigator: Signature

Datatype

text

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

Date of report

Datatype

date

Maateenheden
  • dd.mm.yyyy
Alias
UMLS CUI [1]
C1302584
dd.mm.yyyy
Additional or follow-up information
Beschrijving

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.
Beschrijving

Additional or follow-up information

Datatype

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
Terug naar het begin van de pagina

Similar models

Serious Adverse Event (SAE) - GSK Milveterol COPD 100527

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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])
Terug naar het begin van de pagina 

Contact

Gebruik dit formulier voor feedback, vragen en verbeteringsvoorstellen.

Velden gemarkeerd met een * zijn verplicht.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial