Date of Visit/ Assessment
Item
Date of Visit/ Assessment
date
C1320303 (UMLS CUI [1,1])
C2985720 (UMLS CUI [1,2])
Were any concomitant medications taken by the subject during the study?
Item
Were any concomitant medications taken by the subject during the study?
boolean
C2347852 (UMLS CUI [1])
C0008976 (UMLS CUI [2,1])
C0347984 (UMLS CUI [2,2])
Did the subject experience any non-serious adverse events during the study?
Item
Did the subject experience any non-serious adverse events during the study?
boolean
C1518404 (UMLS CUI [1])
C0008976 (UMLS CUI [2,1])
C0347984 (UMLS CUI [2,2])
Did the subject experience any serious adverse event during the study?
Item
Did the subject experience any serious adverse event during the study?
boolean
C1519255 (UMLS CUI [1])
C0008976 (UMLS CUI [2,1])
C0347984 (UMLS CUI [2,2])
Were any abnormal, clinically significant ECG measurements recorded for this subject during the study?
Item
Were any abnormal, clinically significant ECG measurements recorded for this subject during the study?
boolean
C0522055 (UMLS CUI [1])
Were any repeat haematology or clinical chemistry samples taken?
Item
Were any repeat haematology or clinical chemistry samples taken?
boolean
C0008000 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C0018941 (UMLS CUI [2,1])
C0200345 (UMLS CUI [2,2])
Were any repeat ECGs performed?
Item
Were any repeat ECGs performed?
boolean
C1623258 (UMLS CUI [1,1])
C0205341 (UMLS CUI [1,2])
Were any repeat vital signs recorded?
Item
Were any repeat vital signs recorded?
boolean
C0518766 (UMLS CUI [1,1])
C0205341 (UMLS CUI [1,2])
Were any repeat PK blood samples taken?
Item
Were any repeat PK blood samples taken?
boolean
C0031328 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0205341 (UMLS CUI [1,3])
Were any repeat Pulmonary Function Tests performed?
Item
Were any repeat Pulmonary Function Tests performed?
boolean
C0024119 (UMLS CUI [1,1])
C0205341 (UMLS CUI [1,2])
Was any repeat Holter monitoring performed?
Item
Was any repeat Holter monitoring performed?
boolean
C0013801 (UMLS CUI [1,1])
C0205341 (UMLS CUI [1,2])
Non-Serious Adverse Event Sequence Number
Item
Non-Serious Adverse Event Sequence Number
integer
C1519255 (UMLS CUI [1,1])
C2348184 (UMLS CUI [1,2])
Non-Serious Adverse Event
Item
Non-Serious Adverse 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])
C2826798 (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-Serious Adverse Event MedDRA lower level term code
Item
Non-Serious 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])
C0805701 (UMLS CUI [2,1])
C0231175 (UMLS CUI [2,2])
Non-Serious Adverse Event - Start Date
Item
Non-Serious Adverse Event - Start Date
date
C1518404 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Non-Serious Adverse Event - Start Time
Item
Non-Serious Adverse Event - Start Time
time
C1518404 (UMLS CUI [1,1])
C1301880 (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 End Date
Item
Non-Serious Adverse Event End Date
date
C1518404 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Non-Serious Adverse Event - End Time
Item
Non-Serious Adverse Event - End Time
time
C1518404 (UMLS CUI [1,1])
C1522314 (UMLS CUI [1,2])
Item
Non-Serious Adverse Event Frequency
integer
C1518404 (UMLS CUI [1,1])
C0439603 (UMLS CUI [1,2])
Code List
Non-Serious Adverse Event Frequency
CL Item
Single Episode (1)
Item
Non-Serious Adverse Event - Maximum Intensity
text
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 (X)
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
Non-Serious Adverse Event - Maximum Grade or Intensity
text
C1518404 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,3])
C0806909 (UMLS CUI [1,4])
Code List
Non-Serious Adverse Event - 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 (X)
Item
Action Taken with Investigational Product(s) as a Result of the AE
text
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 (X)
Did the subject withdraw from study as a result of this AE?
Item
Did the subject withdraw from study as a result of this AE?
boolean
C1710677 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
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])
Duration of AE if < 24 hours
Item
Duration of AE if < 24 hours
integer
C0449238 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Duration of AE if < 24 hours
Item
Duration of AE if < 24 hours
integer
C0449238 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Item
Initial Report
integer
C0684224 (UMLS CUI [1,1])
C0205265 (UMLS CUI [1,2])
Item
Follow-Up Report
integer
C1704685 (UMLS CUI [1])
Code List
Follow-Up Report
Did SAE occur after initiation of study medication?
Item
Did SAE occur after initiation of study medication?
boolean
C1519255 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
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])
Serious Adverse Event - Modified Term
Item
Serious Adverse Event - Modified Term
text
C1519255 (UMLS CUI [1,1])
C2826798 (UMLS CUI [1,2])
Serious Adverse Event - MedDRA synonym
Item
Serious Adverse Event - MedDRA synonym
text
C1519255 (UMLS CUI [1,1])
C1140263 (UMLS CUI [1,2])
Serious Adverse Event - MedDRA lower level term code
Item
Serious Adverse Event - MedDRA lower level term code
text
C1519255 (UMLS CUI [1,1])
C3898442 (UMLS CUI [1,2])
Serious Adverse Event - Failed coding
Item
Serious Adverse Event - Failed coding
text
C1519255 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,3])
Serious Adverse Event - Start Date
Item
Serious Adverse Event - Start Date
date
C1519255 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Serious Adverse Event - Start Time
Item
Serious Adverse Event - Start Time
time
C1519255 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
Item
Serious Adverse Event - Outcome
integer
C1519255 (UMLS CUI [1,1])
C1705586 (UMLS CUI [1,2])
Code List
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)
CL Item
Fatal, record Date of Death (5)
Serious Adverse Event - End Date
Item
Serious Adverse Event - End Date
date
C1519255 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Serious Adverse Event - End Time
Item
Serious Adverse Event - End Time
time
C1519255 (UMLS CUI [1,1])
C1522314 (UMLS CUI [1,2])
Item
Serious Adverse Event - Maximum Intensity
text
C1519255 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
Code List
Serious Adverse Event - Maximum Intensity
CL Item
Not applicable (X)
Item
Serious Adverse Event - Maximum Grade
integer
C1519255 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
Code List
Serious Adverse Event - Maximum Grade
Item
Serious Adverse Event - Maximum Grade or Intensity
text
C1519255 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,3])
C0806909 (UMLS CUI [1,4])
Code List
Serious Adverse Event - 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 (X)
Item
Action Taken with Investigational Product(s) as a Result of the SAE
text
C1704758 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Code List
Action Taken with Investigational Product(s) as a Result of the SAE
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 (X)
Serious Adverse Event - Did the subject withdraw from study as a result of this AE?
Item
Serious Adverse Event - Did the subject withdraw from study as a result of this AE?
boolean
C1710677 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Is there a reasonable possibility that the SAE may have been caused by the investigational product?
Item
Is there a reasonable possibility that the SAE 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 SAE if < 24 hours
Item
Duration of SAE if < 24 hours
integer
C0449238 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Duration of SAE if < 24 hours
Item
Duration of SAE if < 24 hours
integer
C0449238 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Was SAE caused by activities related to study participation (e.g. procedures)?
Item
Was SAE caused by activities related to study participation (e.g. procedures)?
boolean
C1519255 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C0441655 (UMLS CUI [1,3])
C2348568 (UMLS CUI [1,4])
Was the event serious?
Item
Was the event serious?
boolean
C1519255 (UMLS CUI [1])
Item
Seriousness?
text
C1519255 (UMLS CUI [1,1])
C1710056 (UMLS CUI [1,2])
CL Item
Results in death (A)
CL Item
Is life-threatening (B)
CL Item
Requires hospitalisation or prolongation of existing hospitalisation (C)
CL Item
Results in disability/incapacity (D)
CL Item
Congenital anomaly/birth defect (E)
CL Item
Other, specify within general narrative comment (F)
CM Sequence Number
Item
CM Sequence Number
integer
C2348184 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Concomitant medication - Drug name
Item
Concomitant medication - Drug name
text
C0013227 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Concomitant medication dose
Item
Concomitant medication dose
float
C3174092 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Item
Concomitant medication unit
text
C2347852 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
Code List
Concomitant medication unit
CL Item
Cubic centimeter (CC)
CL Item
International units (025)
CL Item
International units per kilogram (028)
CL Item
International units per millilitre (IUML)
CL Item
Litre per minute (LM)
CL Item
Megaunits (million units) (MEGU)
CL Item
Microgram (UG) (004)
CL Item
Microgram (UG) (004)
CL Item
Microgram/kilogram (008)
CL Item
Microgram/kilogram per minute (MCG/KG/MIN)
CL Item
Micrograms per minute (MCG/MIN)
CL Item
Milliequivalent (029)
CL Item
Milliequivalent per 24 hours (MEQ24)
CL Item
Milligrams percent (MGPER)
CL Item
Milligram per hour (MGH)
CL Item
Milligram/kilogram (007)
CL Item
Milligram/kilogram per hour (MGKH)
CL Item
Milligram/kilogram per minute (MGKM)
CL Item
Milligram/metre squared (009)
CL Item
Milligram/millilitre (MGML)
CL Item
Millilitre per hour (MLH)
CL Item
Millilitre per minute (MLM)
CL Item
Million international units (027)
CL Item
Minimum alveolar concentration (MAC)
CL Item
Suppository (SUP)
Item
Concomitant medication frequency
text
C3476109 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Code List
Concomitant medication frequency
CL Item
2 times per week (2W)
CL Item
3 times per week (3W)
CL Item
4 times per week (4W)
CL Item
5 times per day (5D)
CL Item
5 times per week (5W)
CL Item
Continuous infusion (CO)
CL Item
Every 2 weeks (FO)
CL Item
Every 3 weeks (Q3W)
CL Item
Every 3 months (Q3M)
CL Item
Every other day (AD)
CL Item
Once a month (MO)
Item
Concomitant medication route
text
C0013153 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Code List
Concomitant medication route
CL Item
Gastrostomy tube (GT)
CL Item
Intra-arterial (013)
CL Item
Intra-bursa (IBU)
CL Item
Intralesional (026)
CL Item
Intramuscular (030)
CL Item
Intraocular (031)
CL Item
Intraosteal (IOS)
CL Item
Intraperitoneal (033)
CL Item
Intrathecal (037)
CL Item
Intrauterine (015)
CL Item
Intravenous (042)
CL Item
Subcutaneous (058)
CL Item
Transdermal (062)
Concomitant medication start date
Item
Concomitant medication start date
date
C2826734 (UMLS CUI [1])
Concomitant Medication continuing?
Item
Concomitant Medication continuing?
boolean
C2826666 (UMLS CUI [1])
If concomitant medication is not ongoing, specify end date.
Item
If concomitant medication is not ongoing, specify end date.
date
C2826744 (UMLS CUI [1])
Concomitant medication - Primary Indication
Item
Concomitant medication - Primary Indication
text
C2826696 (UMLS CUI [1])
Item
Concomitant medication - Drug type
text
C2347852 (UMLS CUI [1,1])
C0457591 (UMLS CUI [1,2])
Code List
Concomitant medication - Drug type
MHx Sequence Number
Item
MHx Sequence Number
integer
C2348184 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
Specific Condition Name
Item
Specific Condition Name
text
C0012634 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Medical Condition - Date of onset
Item
Medical Condition - Date of onset
date
C0012634 (UMLS CUI [1,1])
C0574845 (UMLS CUI [1,2])
Item
Medical Condition - Continuing?
text
C0012634 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Code List
Medical Condition - Continuing?
Medical Condition - Date of last occurence
Item
Medical Condition - Date of last occurence
date
C0012634 (UMLS CUI [1,1])
C2745955 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C1517741 (UMLS CUI [1,4])
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])
Lab Sequence Number
Item
Lab Sequence Number
integer
C0022885 (UMLS CUI [1,1])
C2348184 (UMLS CUI [1,2])
Item
Test Name
integer
C0022885 (UMLS CUI [1])
CL Item
Activated partial thromboplastin time (1)
CL Item
Alkaline phosphatase (3)
CL Item
Bilirubin direct (8)
CL Item
Bilirubin total (9)
CL Item
Blood myoglobin (10)
CL Item
Blood pressure (12)
CL Item
Blood urea nitrogen (13)
CL Item
Body temperature (14)
CL Item
CD4 lymphocytes (16)
CL Item
CD8 lymphocytes (17)
CL Item
Cholesterol total (19)
CL Item
C-reactive protein (20)
CL Item
Creatine phosphokinase (22)
CL Item
Creatine phosphokinase MB (23)
CL Item
Creatinine clearance (25)
CL Item
Diastolic blood pressure (26)
CL Item
Erythrocyte sedimentation rate (28)
CL Item
Fasting blood glucose (29)
CL Item
Gamma-glutamyltransferase (31)
CL Item
Glutamic-oxaloacetic transferase (32)
CL Item
Glutamic-pyruvate transaminase (33)
CL Item
HBV-DNA decreased (35)
CL Item
HBV-DNA increased (36)
CL Item
High density lipoprotein (40)
CL Item
HIV viral load (41)
CL Item
Lactic dehydrogenase (43)
CL Item
Low density lipoprotein (45)
CL Item
Mean cell hemoglobin concentration (48)
CL Item
Mean corpuscular hemoglobin (49)
CL Item
Mean corpuscular volume (50)
CL Item
Oxygen saturation (53)
CL Item
Platelet count (57)
CL Item
Protein total (60)
CL Item
Prothrombin time (61)
CL Item
Red blood cell count (62)
CL Item
Respiratory rate (63)
CL Item
Reticulocyte count (64)
CL Item
Serum glucose (65)
CL Item
Serum uric acid (66)
CL Item
Systolic blood pressure (68)
CL Item
Thrombin time (69)
CL Item
Total lung capacity (70)
CL Item
Triglycerides (71)
CL Item
Urine myoglobin (75)
CL Item
Vital capacity (77)
CL Item
White blood cell count (78)
Test Date
Item
Test Date
date
C2826247 (UMLS CUI [1])
Test Result
Item
Test Result
text
C0587081 (UMLS CUI [1])
Test Units
Item
Test Units
text
C1519795 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
Normal Low Range
Item
Normal Low Range
integer
C0086715 (UMLS CUI [1,1])
C0205251 (UMLS CUI [1,2])
Normal High Range
Item
Normal High Range
integer
C0086715 (UMLS CUI [1,1])
C0205250 (UMLS CUI [1,2])
Relevant diagnostic results not noted above
Item
Relevant diagnostic results not noted above
text
C0587081 (UMLS CUI [1])
Item
If Investigational product(s) stopped, did the reported event(s) recur after further investigational product(s) were administered?
text
C1519255 (UMLS CUI [1,1])
C0034897 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
C0457454 (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 (U)
CL Item
Not applicable (X)
General Narrative Comments
Item
General Narrative Comments
text
C0947611 (UMLS CUI [1])
Item
Send incomplete SAE data to GSK Safety
text
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 (3)
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
text
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
text
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])