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ID
32475
Description
Study ID: 106837 Clinical Study ID: HZA106837 Study Title: A Long-Term, Randomized, Double-Blind, Parallel Group Study of Fluticasone Furoate/GW642444 Inhalation Powder Once-Daily and Fluticasone Furoate Inhalation Powder Once-Daily in Subjects with Asthma Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01086384 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: fluticasone furoate/vilanterol Trade Name: Relvar Study Indication: Asthma
Keywords
Versions (2)
- 11/2/18 11/2/18 -
- 11/30/18 11/30/18 -
Copyright Holder
GSK group of companies
Uploaded on
November 2, 2018
DOI
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License
Creative Commons BY-NC 3.0
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A Parallel Group Study of Fluticasone Furoate/Vilanterol in Subjects with Asthma - 106837
Initial Serious Adverse Event Form
- StudyEvent: ODM
Similar models
Initial Serious Adverse Event Form
- StudyEvent: ODM
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Did SAE occur after initiation of study medication?
Item
Did SAE occur after initiation of study medication?
boolean
SAE Sequence Number
Item
SAE Sequence Number
integer
Start Date
Item
Start Date
date
CL Item
Recovered/Resolved (1)
CL Item
Recovering/Resolving (2)
CL Item
Not recovered/not resolved (3)
CL Item
Recovered/Resolved with sequelae (4)
CL Item
Fatal (5)
End Date
Item
End Date
date
CL Item
[1] Mild (1)
CL Item
[2] Moderate (2)
CL Item
[3] Severe (3)
CL Item
[x] Not applicable (4)
CL Item
[1] Mild (1)
CL Item
[2] Moderate (2)
CL Item
[3] Severe (3)
CL Item
[x] Not applicable (4)
CL Item
Grade 1 (1)
CL Item
Grade 2 (2)
CL Item
Grade 3 (3)
CL Item
Grade 4 (4)
CL Item
Grade 5 (5)
CL Item
Grade 1 (1)
CL Item
Grade 2 (2)
CL Item
Grade 3 (3)
CL Item
Grade 4 (4)
CL Item
Grade 5 (5)
CL Item
Mild or Grade 1 (1)
CL Item
Moderate or Grade 2 (2)
CL Item
Severe or Grade 3 (3)
CL Item
Grade 4 (4)
CL Item
Grade 5 (5)
CL Item
Not applicable (6)
CL Item
Mild or Grade 1 (1)
CL Item
Moderate or Grade 2 (2)
CL Item
Severe or Grade 3 (3)
CL Item
Grade 4 (4)
CL Item
Grade 5 (5)
CL Item
Not applicable (6)
Item
Action taken with Investigational Product(s) as a result of AE?
text
Code List
Action taken with Investigational Product(s) as a result of AE?
CL Item
Investigational product(s) withdrawn (1)
CL Item
Dose reduced (2)
CL Item
Dose increased (3)
CL Item
Dose not changed (4)
CL Item
Dose interrupted (5)
CL Item
Not applicable (6)
Did the subject withdraw from the study as a result of AE?
Item
Did the subject withdraw from the study as a result of AE?
boolean
Is there a reasonable possibility that the AE may have been caused by the investigational product?
Item
Is there a reasonable possibility that the AE may have been caused by the investigational product?
boolean
Duration of AE if < 24 hours
Item
Duration of AE if < 24 hours
text
Time to Onset since last Dose
Item
Time to Onset since last Dose
time
Was the SAE caused by activities related to study participation other than investigational product (e.g., procedures, blood draws, washout, etc)?
Item
Was the SAE caused by activities related to study participation other than investigational product (e.g., procedures, blood draws, washout, etc)?
boolean
Was the event serious?
Item
Was the event serious?
boolean
Related Investigational Product
Item
Related Investigational Product
text
CL Item
results in death (1)
CL Item
is life threatening (2)
CL Item
requires hospitalisation or prolongation of existing hospitalisation (3)
CL Item
results in disability/incapacity (4)
CL Item
congenital anomaly/birth defect (5)
CL Item
other, specify within general narrative comment (6)
CM Sequence Number
Item
CM Sequence Number
text
Drug Name
Item
Drug Name
text
Modified reported term
Item
Modified reported term
text
Dose
Item
Dose
float
Unit
Item
Unit
text
Frequency
Item
Frequency
text
Route
Item
Route
text
Start Date
Item
Start Date
date
Ongoing?
Item
boolean
If NO, specify End Date
Item
If NO, specify End Date
date
Primary Indication
Item
Primary Indication
text
Modified reported term
Item
Modified reported term
text
Drug Type
Item
Drug Type
text
MHx Sequence Number
Item
MHx Sequence Number
text
Specific Condition Name
Item
Specific Condition Name
text
Modified reported term
Item
Modified reported term
text
Date of onset
Item
Date of onset
date
CL Item
Yes (1)
CL Item
No (2)
CL Item
Unknown (3)
If NO, specify date of last occurrence
Item
If NO, specify date of last occurrence
date
Lab Sequence Number
Item
Lab Sequence Number
text
Test Name
Item
Test Name
text
Test Date
Item
Test Date
date
Test Result
Item
Test Result
text
Test Units
Item
Test Units
text
Normal Low Range
Item
Normal Low Range
integer
Normal High Range
Item
Normal High Range
integer
Relevant diagnostic results not noted above
Item
text
Item
If the investigational product(s) were stopped temporarily, did the reported event(s) recur after investigational products were restarted?
text
Code List
If the investigational product(s) were stopped temporarily, did the reported event(s) recur after investigational products were restarted?
CL Item
No (1)
CL Item
Yes (2)
CL Item
Unknown at this time (3)
CL Item
Not applicable (4)
CL Item
Novel dry powder inhaler (1)
Start Date
Item
Start Date
date
Stop Date
Item
Stop Date
date
Regimen
Item
Regimen
text
A brief narrative description of SAE
Item
A brief narrative description of SAE
text
Send incomplete SAE data to GSK Safety
Item
Send incomplete SAE data to GSK Safety
text
Receipt by GSK date
Item
Receipt by GSK date
date
Was the event serious?
Item
Was the event serious?
boolean
SAE Sequence number
Item
SAE Sequence number
text
Version Number
Item
Version Number
text
Case ID
Item
Case ID
text
Randomisation Number
Item
Randomisation Number
text
OCEANS Code
Item
OCEANS Code
text