Non-Serious Adverse Event Sequence Number
Item
Non-Serious Adverse Event Sequence Number
integer
C1518404 (UMLS CUI [1,1])
C2348184 (UMLS CUI [1,2])
Event
Item
Event
text
C1518404 (UMLS CUI [1])
Non-Serious Adverse Event Modified term
Item
Non-Serious Adverse Event Modified term
text
C1518404 (UMLS CUI [1,1])
C2826302 (UMLS CUI [1,2])
Non-serious Adverse Event MedDRA synonym
Item
Non-serious Adverse Event MedDRA synonym
text
C1518404 (UMLS CUI [1,1])
C1140263 (UMLS CUI [1,2])
Non-Seroius Adverse Event MedDRA lower level term code
Item
Non-Seroius Adverse Event MedDRA lower level term code
text
C1518404 (UMLS CUI [1,1])
C3898442 (UMLS CUI [1,2])
Non-Serious Adverse Event Failed Coding
Item
Non-Serious Adverse Event Failed Coding
text
C1518404 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,3])
Non-Serious Adverse Event Start Date
Item
Non-Serious Adverse Event Start Date
date
C1518404 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Item
Non-Serious Adverse Event Outcome
integer
C1518404 (UMLS CUI [1,1])
C1705586 (UMLS CUI [1,2])
Code List
Non-Serious Adverse Event Outcome
CL Item
Recovered/Resolved, provide End Date (1)
CL Item
Recovering/Resolving (2)
CL Item
Not recovered/ Not resolved (3)
CL Item
Recovered/ Resolved with sequelae, provide End Date (4)
Non-Serious Adverse Event - Provide End Date if Recovered/ Resolved
Item
Non-Serious Adverse Event - Provide End Date if Recovered/ Resolved
date
C1518404 (UMLS CUI [1])
C1709863 (UMLS CUI [2,1])
C0806020 (UMLS CUI [2,2])
Non-Serious Adverse Event - Provide End Date, if Recovered/ Resolved with sequelae
Item
Non-Serious Adverse Event - Provide End Date, if Recovered/ Resolved with sequelae
date
C1518404 (UMLS CUI [1])
C1709862 (UMLS CUI [2,1])
C0806020 (UMLS CUI [2,2])
Item
Non-Serious Adverse Event Maximum Intensity
integer
C1518404 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
Code List
Non-Serious Adverse Event Maximum Intensity
CL Item
Not applicable (4)
Item
Non-Serious Adverse Event Maximum Grade
integer
C1518404 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
Code List
Non-Serious Adverse Event Maximum Grade
Item
Action Taken with Investigational Product(s) as a Result of the AE
integer
C1704758 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Code List
Action Taken with Investigational Product(s) as a Result of the AE
CL Item
Investigational product(s) withdrawn (1)
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 study including all follow up as a result of this AE?
Item
Did the subject withdraw from study including all follow up as a result of this AE?
boolean
C1710677 (UMLS CUI [1,1])
C1522577 (UMLS CUI [1,2])
C1518404 (UMLS CUI [2,1])
C1274040 (UMLS CUI [2,2])
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
C1518404 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
SAE Sequence Number
Item
SAE Sequence Number
integer
C1519255 (UMLS CUI [1,1])
C2348184 (UMLS CUI [1,2])
Serious Adverse Event
Item
Serious Adverse Event
text
C1519255 (UMLS CUI [1])
SAE Modified term
Item
SAE Modified term
text
C1519255 (UMLS CUI [1,1])
C2826302 (UMLS CUI [1,2])
SAE MedDRA synonym
Item
SAE MedDRA synonym
text
C1519255 (UMLS CUI [1,1])
C1140263 (UMLS CUI [1,2])
SAE MedDRA lower level term code
Item
SAE MedDRA lower level term code
text
C1519255 (UMLS CUI [1,1])
C3898442 (UMLS CUI [1,2])
SAE Failed coding
Item
SAE Failed coding
text
C1519255 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,3])
SAE Start Date
Item
SAE Start Date
date
C0808070 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item
SAE Outcome
integer
C1519255 (UMLS CUI [1,1])
C1705586 (UMLS CUI [1,2])
CL Item
Recovered/Resolved, provide End Date (1)
CL Item
Recovering/ Resolving (2)
CL Item
Not recovered/Not resolved (3)
CL Item
Recovered/ Resolved with sequelae, provide End date (4)
CL Item
Fatal, record Date of Death (5)
Serious Adverse Event - Provide End Date if Recovered/ Resolved
Item
Serious Adverse Event - Provide End Date if Recovered/ Resolved
date
C1519255 (UMLS CUI [1])
C1709863 (UMLS CUI [2,1])
C0806020 (UMLS CUI [2,2])
Serious Adverse Event - Provide End Date, if Recovered/ Resolved with sequelae
Item
Serious Adverse Event - Provide End Date, if Recovered/ Resolved with sequelae
date
C1519255 (UMLS CUI [1])
C1709862 (UMLS CUI [2,1])
C0806020 (UMLS CUI [2,2])
Serious Adverse Event - Provide Date of Death if fatal Outcome
Item
Serious Adverse Event - Provide Date of Death if fatal Outcome
date
C1519255 (UMLS CUI [1])
C1148348 (UMLS CUI [2])
C0206277 (UMLS CUI [3])
Item
SAE Maximum Intensity
integer
C1519255 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
Code List
SAE Maximum Intensity
CL Item
Not applicable (4)
Item
SAE Maximum Grade
integer
C1519255 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
Code List
SAE Maximum Grade
Item
SAE Maximum Grade or Intensity
integer
C1519255 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
C1519255 (UMLS CUI [2,1])
C0518690 (UMLS CUI [2,2])
C0806909 (UMLS CUI [2,3])
Code List
SAE Maximum Grade or Intensity
CL Item
Mild or Grade 1 (1)
CL Item
Moderate or Grade 2 (2)
CL Item
Severe or Grade 3 (3)
CL Item
Not applicable (6)
Item
Action Taken with Investigational Product(s) as a Result of the AE
integer
C1704758 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Code List
Action Taken with Investigational Product(s) as a Result of the AE
CL Item
Investigational product(s) withdrawn (1)
CL Item
Dose increased (3)
CL Item
Dose not changed (4)
CL Item
Dose interru pted (5)
CL Item
Not applicable (6)
Did the subject withdraw from study including all follow up as a result of this AE?
Item
Did the subject withdraw from study including all follow up as a result of this AE?
boolean
C1710677 (UMLS CUI [1,1])
C1522577 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2,1])
C1274040 (UMLS CUI [2,2])
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
C1519255 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
Duration of AE if < 24 hours
Item
Duration of AE if < 24 hours
durationDatetime
C0449238 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Time to Onset of SAE Since Last Dose
Item
Time to Onset of SAE Since Last Dose
durationDatetime
C1519255 (UMLS CUI [1,1])
C0946444 (UMLS CUI [1,2])
C0449244 (UMLS CUI [1,3])
Was the SAE caused by activities related to study participation other than investigational product?
Item
Was the SAE caused by activities related to study participation other than investigational product (e.g. procedures, blood draws, washout, etc)?
boolean
C3641099 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C2700391 (UMLS CUI [2])
C0005834 (UMLS CUI [3])
C1710661 (UMLS CUI [4])
Was the event serious?
Item
Was the event serious?
boolean
C1519255 (UMLS CUI [1])
Related Investigational Product
Item
Related Investigational Product
text
C0304229 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
Item
Serious Adverse Event Initial Report
integer
C1519255 (UMLS CUI [1,1])
C0684224 (UMLS CUI [1,2])
C0205265 (UMLS CUI [1,3])
Code List
Serious Adverse Event Initial Report
Item
Serious Adverse Event Follow-Up Report
integer
C1519255 (UMLS CUI [1,1])
C1704685 (UMLS CUI [1,2])
Code List
Serious Adverse Event Follow-Up Report
CL Item
Follow-Up Report (1)
Did SAE occur after initiation of study medication?
Item
Did SAE occur after initiation of study medication?
boolean
C1519255 (UMLS CUI [1])
C0304229 (UMLS CUI [2,1])
C1704686 (UMLS CUI [2,2])
Item
Seriousness of SAE?
integer
C1710056 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Code List
Seriousness of SAE?
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
C2348184 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Drug name
Item
Drug name
text
C0013227 (UMLS CUI [1])
Concomitant Mediacation Modified reported term
Item
Concomitant Mediacation Modified reported term
text
C2826819 (UMLS CUI [1])
Concomitant Medication Dose
Item
Concomitant Medication Dose
text
C2347852 (UMLS CUI [1,1])
C3174092 (UMLS CUI [1,2])
Concomitant Medication Unit
Item
Concomitant Medication Unit
text
C2826646 (UMLS CUI [1])
Concomitant Medication Frequency
Item
Concomitant Medication Frequency
text
C2826654 (UMLS CUI [1])
Concomitant Medication Route
Item
Concomitant Medication Route
text
C2826730 (UMLS CUI [1])
Concomitant Medication Start Date
Item
Concomitant Medication Start Date
date
C2826734 (UMLS CUI [1])
Concomitant Medication Ongoing?
Item
Concomitant Medication Ongoing?
boolean
C2826666 (UMLS CUI [1])
If Concomitant Medication not Ongoing, specify End Date.
Item
If Concomitant Medication not Ongoing, specify End Date.
date
C2826666 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Primary Indication for Concomitant Medication
Item
Primary Indication for Concomitant Medication
text
C2826696 (UMLS CUI [1])
Concomitant Medication Modified reported term
Item
Concomitant Medication Modified reported term
text
C2826819 (UMLS CUI [1])
Drug Type
Item
Drug Type
text
C0457591 (UMLS CUI [1])
Relevant medical Conditions/ Risk Factors Sequence Number
Item
Relevant medical Conditions/ Risk Factors Sequence Number
integer
C0262926 (UMLS CUI [1,1])
C0035648 (UMLS CUI [1,2])
C2348184 (UMLS CUI [1,3])
Specific Condition Name
Item
Specific Condition Name
text
C0012634 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Relevant Medical Conditions/ Risk Factors Modified reported term
Item
Relevant Medical Conditions/ Risk Factors Modified reported term
text
C0262926 (UMLS CUI [1,1])
C0035648 (UMLS CUI [1,2])
C2826302 (UMLS CUI [1,3])
Relevant Medical Conditions/ Risk Factors Date of onset
Item
Relevant Medical Conditions/ Risk Factors Date of onset
date
C0262926 (UMLS CUI [1,1])
C0035648 (UMLS CUI [1,2])
C0574845 (UMLS CUI [1,3])
Item
Relevant Medical Conditions/ Risk Factors Continuing?
integer
C0262926 (UMLS CUI [1,1])
C0035648 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,3])
Code List
Relevant Medical Conditions/ Risk Factors Continuing?
If Relevant Medical Conditions/ Risk Factors not Continuing, specify date of last occurence.
Item
If Relevant Medical Conditions/ Risk Factors not Continuing, specify date of last occurence.
date
C0262926 (UMLS CUI [1,1])
C0035648 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,3])
C2745955 (UMLS CUI [1,4])
C1517741 (UMLS CUI [1,5])
C0011008 (UMLS CUI [1,6])
Relevant Medical History / Risk Factors not noted above
Item
Relevant Medical History / Risk Factors not noted above
text
C0262926 (UMLS CUI [1,1])
C0035648 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
Lab Sequence Number
Item
Lab Sequence Number
integer
C0022885 (UMLS CUI [1,1])
C2348184 (UMLS CUI [1,2])
Lab Test Name
Item
Lab Test Name
text
C0022885 (UMLS CUI [1])
Lab Test Date
Item
Lab Test Date
date
C0022885 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Lab Test Result
Item
Lab Test Result
text
C0022885 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Lab Test Units
Item
Lab Test Units
text
C0022885 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
Lab Normal Low Range
Item
Lab Normal Low Range
text
C0022885 (UMLS CUI [1,1])
C0086715 (UMLS CUI [1,2])
C0205251 (UMLS CUI [1,3])
Lab Normal High Range
Item
Lab Normal High Range
text
C0022885 (UMLS CUI [1,1])
C0086715 (UMLS CUI [1,2])
C0205250 (UMLS CUI [1,3])
Relevant diagnostic results not noted above
Item
Relevant diagnostic results not noted above
text
C0430022 (UMLS CUI [1,1])
C0456984 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
Item
If investigational product(s) were stopped temporarily, did the reported event(s) recur after investigational products were restarted?
integer
C0304229 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C0877248 (UMLS CUI [2,1])
C2745955 (UMLS CUI [2,2])
Code List
If investigational product(s) were stopped temporarily, did the reported event(s) recur after investigational products were restarted?
CL Item
Unknown at this time (3)
CL Item
Not applicable (4)
Study Drug
Item
Study Drug
text
C0304229 (UMLS CUI [1])
Investigational Product Start Date
Item
Investigational Product Start Date
date
C0304229 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Investigational Product Stop Date
Item
Investigational Product Stop Date
date
C0304229 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Study Drug
Item
Study Drug
text
C0304229 (UMLS CUI [1])
Investigational Product Start Date
Item
Investigational Product Start Date
date
C0304229 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Investigational Product Stop Date
Item
Investigational Product Stop Date
date
C0304229 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Study Drug
Item
Study Drug
text
C0304229 (UMLS CUI [1])
Investigational Product Start Date
Item
Investigational Product Start Date
date
C0304229 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Investigational Product Stop Date
Item
Investigational Product Stop Date
date
C0304229 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Investigational Product Dose
Item
Investigational Product Dose
text
C0304229 (UMLS CUI [1,1])
C3174092 (UMLS CUI [1,2])
Investigational Product Cumulative Dose
Item
Investigational Product Cumulative Dose
text
C2986497 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
General narrative comments
Item
General narrative comments
text
C1519255 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
Item
Send incomplete SAE data to GSK Safety
integer
C1519255 (UMLS CUI [1,1])
C1511726 (UMLS CUI [1,2])
C0205257 (UMLS CUI [1,3])
Code List
Send incomplete SAE data to GSK Safety
CL Item
Incomplete SAE (1)
Receipt by GSK date
Item
Receipt by GSK date
datetime
C2985846 (UMLS CUI [1])
Was the event serious?
Item
Was the event serious?
boolean
C1519255 (UMLS CUI [1])
SAE Sequence Number
Item
SAE Sequence Number
integer
C1519255 (UMLS CUI [1,1])
C2348184 (UMLS CUI [1,2])
Version Number
Item
Version Number
integer
C0333052 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Case ID
Item
Case ID
text
C1698493 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Randomisation Number
Item
Randomisation Number
integer
C0034656 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
OCEANS Code
Item
OCEANS Code
text
C0805701 (UMLS CUI [1])
Email Flag
Item
Email Flag
text
C0013849 (UMLS CUI [1])
Concomitant Medications Sequence Number
Item
Concomitant Medications Sequence Number
integer
C2347852 (UMLS CUI [1,1])
C2348184 (UMLS CUI [1,2])
Concomitant Medication Drug Name
Item
Concomitant Medication Drug Name
text
C2347852 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Concomitant Medication Modified reported term
Item
Concomitant Medication Modified reported term
text
C2826819 (UMLS CUI [1])
Concomitant Medication GSK Drug synonym
Item
Concomitant Medication GSK Drug synonym
text
C2347852 (UMLS CUI [1])
C0013227 (UMLS CUI [2,1])
C0871468 (UMLS CUI [2,2])
Concomitant Medication GSK Drug Collection code
Item
Concomitant Medication GSK Drug Collection code
text
C2347852 (UMLS CUI [1])
C1516698 (UMLS CUI [2,1])
C0805701 (UMLS CUI [2,2])
Concomitant Medication Failed coding
Item
Concomitant Medication Failed coding
text
C2347852 (UMLS CUI [1])
C0805701 (UMLS CUI [2,1])
C0231175 (UMLS CUI [2,2])
Concomitant Medication Units
Item
Concomitant Medication Units
text
C2347852 (UMLS CUI [1,1])
C0439148 (UMLS CUI [1,2])
Concomitant Medication Route
Item
Concomitant Medication Route
text
C2826730 (UMLS CUI [1])
Concomitant Medication Reason for Medication
Item
Concomitant Medication Reason for Medication
text
C2826696 (UMLS CUI [1])
Concomitant Medication start date
Item
Concomitant Medication start date
date
C2826734 (UMLS CUI [1])
Concomitant Medication Ongoing?
Item
Concomitant Medication Ongoing?
boolean
C2826666 (UMLS CUI [1])
If Concomitant Medication not Ongoing, specify End Date
Item
If Concomitant Medication not Ongoing, specify End Date
date
C2826666 (UMLS CUI [1])
C0806020 (UMLS CUI [2])
Concomitant Medication Total Daily Dose
Item
Concomitant Medication Total Daily Dose
text
C2826638 (UMLS CUI [1])
Concomitant Medication Type
Item
Concomitant Medication Type
text
C2347852 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])