Date of Visit/Assessment
Item
Date of Visit/Assessment
date
C1320303 (UMLS CUI [1])
C2985720 (UMLS CUI [2])
Study site
Item
Site
text
C2825164 (UMLS CUI [1])
Patient
Item
Patient
text
C1299487 (UMLS CUI [1])
Subject No.
Item
Patient No.
text
C2348585 (UMLS CUI [1])
Initial Report
Item
Initial Report
boolean
C0684224 (UMLS CUI [1,1])
C0205265 (UMLS CUI [1,2])
Follow-Up Report
Item
Follow-Up Report
boolean
C1704685 (UMLS CUI [1])
Item
Did SAE occur after initiation of study medication?
text
C1519255 (UMLS CUI [1,1])
C0332282 (UMLS CUI [1,2])
C1704686 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,4])
Code List
Did SAE occur after initiation of study medication?
SAE Sequence Number
Item
Sequence Number
text
C1519255 (UMLS CUI [1,1])
C2348184 (UMLS CUI [1,2])
SAE Diagnosis or Sign/Symptom
Item
Serious Adverse Event Diagnosis Only (if known) Otherwise Sign/Symptom
text
C1519255 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2,1])
C3540840 (UMLS CUI [2,2])
Adverse Event Modified Reported Term
Item
Adverse Event Modified Reported Term
text
C2826798 (UMLS CUI [1])
MedDRA synonym
Item
MedDRA synonym
text
C1140263 (UMLS CUI [1])
MedDRA lower level term code
Item
MedDRA lower level term code
text
C3898442 (UMLS CUI [1])
Failed coding
Item
Failed coding
text
C0805701 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
Adverse Event Start Date/Time
Item
Start Date and Time
datetime
C2826806 (UMLS CUI [1])
Item
Outcome
text
C1705586 (UMLS CUI [1])
CL Item
Recovered/Resolved, provide End Date and Time (Recovered/Resolved, provide End Date and Time)
CL Item
Recovering/Resolving (Recovering/Resolving)
CL Item
Not recovered/Not resolved (Not recovered/Not resolved)
CL Item
Recovered/Resolved with sequelae, provide End Date and Time (Recovered/Resolved with sequelae, provide End Date and Time)
CL Item
Fatal, record Date and Time of Death (Fatal, record Date and Time of Death)
Adverse Event End Date/Time
Item
End Date and Time
datetime
C2826793 (UMLS CUI [1])
Item
Maximum Intensity
text
C1710066 (UMLS CUI [1])
Code List
Maximum Intensity
CL Item
Moderate (Moderate)
CL Item
Not applicable (Not applicable)
Item
Maximum Grade
text
C0441799 (UMLS CUI [1,1])
C1710066 (UMLS CUI [1,2])
CL Item
Grade 1 (Grade 1)
CL Item
Grade 2 (Grade 2)
CL Item
Grade 3 (Grade 3)
CL Item
Grade 4 (Grade 4)
CL Item
Grade 5 (Grade 5)
CL Item
Not applicable (Not applicable)
Item
Maximum Grade or Intensity
text
C0441799 (UMLS CUI [1,1])
C1710066 (UMLS CUI [1,2])
C0518690 (UMLS CUI [2,1])
C1519255 (UMLS CUI [2,2])
Code List
Maximum Grade or Intensity
CL Item
Mild or Grade 1 (Mild or Grade 1)
CL Item
Moderate or Grade 2 (Moderate or Grade 2)
CL Item
Severe or Grade 3 (Severe or Grade 3)
CL Item
Grade 4 (Grade 4)
CL Item
Grade 5 (Grade 5)
CL Item
Not applicable (Not applicable)
Item
Action Taken with Investigational Product(s) as a Result of the AE
text
C1704758 (UMLS CUI [1])
Code List
Action Taken with Investigational Product(s) as a Result of the AE
CL Item
Investigational product(s) withdrawn (Investigational product(s) withdrawn)
CL Item
Dose reduced (Dose reduced)
CL Item
Dose increased (Dose increased)
CL Item
Dose not changed (Dose not changed)
CL Item
Dose interrupted (Dose interrupted)
CL Item
Not applicable (Not applicable)
Item
Did the subject withdraw from study as a result of this AE?
text
C0422727 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,3])
Code List
Did the subject withdraw from study as a result of this AE?
Item
Is there a reasonable possibility that the AE may have been caused by the investigational product(s)?
text
C0304229 (UMLS CUI [1,1])
C0332149 (UMLS CUI [1,2])
C0085978 (UMLS CUI [1,3])
C0877248 (UMLS CUI [1,4])
Code List
Is there a reasonable possibility that the AE may have been caused by the investigational product(s)?
Duration of AE
Item
Duration of AE if < 24 hours
time
C0449238 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Interval between Last Dose and AE Onset
Item
Time to Onset Since Last Dose
time
C1272706 (UMLS CUI [1,1])
C1517741 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
C0439659 (UMLS CUI [1,4])
C1519255 (UMLS CUI [1,5])
Item
Was SAE caused by activities related to study participation (e.g. procedures)?
text
C1519255 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C0441655 (UMLS CUI [1,3])
C2348568 (UMLS CUI [1,4])
Code List
Was SAE caused by activities related to study participation (e.g. procedures)?
Item
Was the event serious?
text
C1547644 (UMLS CUI [1])
Code List
Was the event serious?
Adverse Event Results in death
Item
Results in death
boolean
C1320832 (UMLS CUI [1])
Adverse event is life-threatening
Item
Is life-threatening
boolean
C1517874 (UMLS CUI [1])
adverse event requires hospitalisation or prolongation of hospitalisation
Item
Requires hospitalisation or prolongation of existing hospitalisation
boolean
C2826664 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C0745041 (UMLS CUI [2,1])
C1519255 (UMLS CUI [2,2])
Serious adverse event results in disability/incapacity
Item
Results in disability/incapacity
boolean
C3176592 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C0231170 (UMLS CUI [2,1])
C1519255 (UMLS CUI [2,2])
Serious adverse event: Congenital anomaly/birth defect
Item
Congenital anomaly/birth defect
boolean
C0000768 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Other reason for event seriousness
Item
Other, specify within general narrative comment
boolean
C3840932 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Concomitant Medication Sequence Number
Item
CM Sequence Number
text
C2348184 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Drug name
Item
Drug name
text
C2360065 (UMLS CUI [1])
Concomitant medication dose
Item
Dose
float
C2826811 (UMLS CUI [1])
Concomitant medication unit
Item
Unit
text
C2826646 (UMLS CUI [1])
Concomitant medication frequency
Item
Frequency
text
C2826654 (UMLS CUI [1])
Concomitant medication route
Item
Route
text
C2826730 (UMLS CUI [1])
Concomitant Medication Start Date
Item
Start Date
date
C2826734 (UMLS CUI [1])
Item
Ongoing?
text
C2826666 (UMLS CUI [1])
Concomitant medication end date
Item
Medication not ongoing, specify end date
date
C2826744 (UMLS CUI [1])
Concomitant Medication Primary Indication
Item
Primary Indication
text
C2826696 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
Drug Type
Item
Drug Type
text
C0457591 (UMLS CUI [1])
MHx Sequence Number
Item
MHx Sequence Number
text
C2348184 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
Specific Condition
Item
Specific Condition Name
text
C0012634 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Date of onset
Item
Date of onset
date
C0574845 (UMLS CUI [1])
Item
Continuing?
text
C0012634 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
CL Item
Unknown (Unknown)
Date of last disease occurence
Item
If no, specify date of last occurrence
date
C0012634 (UMLS CUI [1,1])
C1517741 (UMLS CUI [1,2])
C2745955 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
Relevant Other Medical History / Risk Factors
Item
Relevant Medical History / Risk Factors not noted above
text
C2347946 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0262926 (UMLS CUI [1,3])
C2347946 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C0035648 (UMLS CUI [2,3])
Lab Sequence Number
Item
Lab Sequence Number
text
C0022885 (UMLS CUI [1,1])
C2348184 (UMLS CUI [1,2])
Lab Test Name
Item
Test Name
text
C0022885 (UMLS CUI [1])
Test Date
Item
Test Date
date
C2826247 (UMLS CUI [1])
Laboratory Test Result
Item
Laboratory Test Result
text
C0587081 (UMLS CUI [1])
Laboratory Test Units
Item
Laboratory Test Units
text
C1519795 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
Normal Low Range
Item
Normal Low Range
text
C1272773 (UMLS CUI [1])
Normal High Range
Item
Normal High Range
text
C1299400 (UMLS CUI [1])
Relevant other diagnostic laboratory results
Item
Relevant diagnostic results not noted above
text
C2347946 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
Item
If Investigational product(s) stopped, did the reported event(s) recur after further investigational product(s) were administered?
text
C0034897 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1517331 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,4])
Code List
If Investigational product(s) stopped, did the reported event(s) recur after further investigational product(s) were administered?
CL Item
Unknown at this time (Unknown at this time)
CL Item
Not applicable (Not applicable)
General comment
Item
General narrative comment
text
C0947611 (UMLS CUI [1])
send incomplete SAE data to sponsoring company
Item
Send incomplete SAE data to GSK Safety
boolean
C1519246 (UMLS CUI [1,1])
C0205257 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C1511726 (UMLS CUI [1,4])
C2347796 (UMLS CUI [1,5])
Receipt date by sponsoring company
Item
Receipt by GSK date
datetime
C2985846 (UMLS CUI [1,1])
C2347796 (UMLS CUI [1,2])
Item
Was the event serious?
text
C1519255 (UMLS CUI [1])
Code List
Was the event serious?
SAE Sequence Number
Item
SAE Sequence Number
text
C1519255 (UMLS CUI [1,1])
C2348184 (UMLS CUI [1,2])
Version Number
Item
Version Number
text
C2985700 (UMLS CUI [1])
Case ID
Item
Case ID
text
C1698493 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Randomisation Number
Item
Randomisation Number
text
C0034656 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
OCEANS Code
Item
OCEANS Code
text
C0805701 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
Email
Item
Email Flag
text
C0013849 (UMLS CUI [1])