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])
C1704686 (UMLS CUI [1,3])
SAE Sequence Number
Item
SAE Sequence Number
integer
C1519255 (UMLS CUI [1,1])
C2348184 (UMLS CUI [1,2])
Start Date
Item
Serious Adverse Event Start Date
date
C1519255 (UMLS CUI [1,1])
C2697888 (UMLS CUI [1,2])
Item
Serious Adverse Event Outcome
integer
C1705586 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Code List
Serious Adverse Event Outcome
CL Item
Recovered/Resolved (1)
CL Item
Recovering/Resolving (2)
CL Item
Not recovered/not resolved (3)
CL Item
Recovered/Resolved with sequelae (4)
End Date
Item
Serious Adverse Event End Date
date
C2697886 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item
Maximum Intensity of Serious Adverse Event
integer
C1519255 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
Code List
Maximum Intensity of Serious Adverse Event
CL Item
[x] Not applicable (4)
Item
Intensity at onset of event
text
C1519255 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0332162 (UMLS CUI [1,3])
Code List
Intensity at onset of event
CL Item
[x] Not applicable (4)
Item
Maximum Grade of Serious Adverse Event
integer
C1519255 (UMLS CUI [1,1])
C0806909 (UMLS CUI [1,2])
C0441800 (UMLS CUI [1,3])
Code List
Maximum Grade of Serious Adverse Event
Item
Grade at onset of event
integer
C0806909 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
C0332162 (UMLS CUI [1,3])
Code List
Grade at onset of event
Item
Maximum Grade of Intensity of Serious Adverse Event
text
C1519255 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0441800 (UMLS CUI [1,3])
C0806909 (UMLS CUI [1,4])
Code List
Maximum Grade of Intensity of Serious Adverse Event
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
Grade of Intensity at onset of event
text
C0518690 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
C0332162 (UMLS CUI [1,3])
Code List
Grade of Intensity at onset of event
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 AE?
integer
C2826626 (UMLS CUI [1])
Code List
Action taken with Investigational Product(s) as a result of 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Investigational product(s) withdrawn (1)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 the study as a result of AE?
Item
Did the subject withdraw from the study as a result of AE?
boolean
C0422727 (UMLS CUI [1])
C1519255 (UMLS CUI [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
C0304229 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
Duration of AE if < 24 hours
Item
Duration of AE if < 24 hours
text
C1519255 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Time to Onset since last Dose
Item
Time to Onset since last Dose
time
C0332162 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
C1517741 (UMLS CUI [1,4])
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
C1519255 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C2603343 (UMLS CUI [2,1])
C0679823 (UMLS CUI [2,2])
C0304229 (UMLS CUI [3])
C2700391 (UMLS CUI [4])
C0005834 (UMLS CUI [5])
C1710661 (UMLS CUI [6])
Was the event serious?
Item
Was the event serious?
boolean
C1710056 (UMLS CUI [1])
Related Investigational Product
Item
Related Investigational Product
text
C0304229 (UMLS CUI [1])
Item
Level of seriousness of the event
integer
C1710056 (UMLS CUI [1])
Code List
Level of seriousness of the event
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
C2360065 (UMLS CUI [1])
Modified reported term
Item
Modified reported term
text
C2826819 (UMLS CUI [1])
Dose
Item
Medication Dose
float
C3174092 (UMLS CUI [1])
Item
Medication Unit
text
C2826646 (UMLS CUI [1])
Code List
Medication Unit
CL Item
Cubic centimeter (6)
CL Item
International units (9)
CL Item
International units per kilogram (10)
CL Item
International units per mililire (11)
CL Item
Litre per minute (13)
CL Item
Megaunits (million units) (15)
CL Item
Microgram (MCG) (16)
CL Item
Microgram (UG) (17)
CL Item
Microgram/ kilogram (18)
CL Item
Microgram/ kilogram per minute (19)
CL Item
Micrograms per minute (20)
CL Item
Milliequivalent (22)
CL Item
Milliequivalent per 24 hours (23)
CL Item
Milligrams percent (25)
CL Item
Milligrams per hour (26)
CL Item
Milligram per hour (27)
CL Item
Milligram/ kilogram (28)
CL Item
Milligram/ kilogram per hour (29)
CL Item
Milligram/ kilogram per minute (30)
CL Item
Milligram per metre squared (31)
CL Item
Milligram/ millilitre (32)
CL Item
Millilitre per hour (34)
CL Item
Millilitre per minute (35)
CL Item
Million International Units (37)
CL Item
Minimum alveolar concentration (38)
Item
Medication Frequency
integer
C3476109 (UMLS CUI [1])
Code List
Medication Frequency
CL Item
2 times per week (1)
CL Item
3 times per week (2)
CL Item
4 times per week (3)
CL Item
5 times per day (4)
CL Item
5 times per week (5)
CL Item
Continuous infusion (8)
CL Item
Every 2 weeks (9)
CL Item
Every 3 weeks (10)
CL Item
Every 3 months (11)
CL Item
Every other day (12)
CL Item
Once a month (14)
Item
Medication Route
integer
C0013153 (UMLS CUI [1])
Code List
Medication Route
CL Item
Gastrostomy tube (3)
CL Item
Intra- arterial (6)
CL Item
Intralesional (8)
CL Item
Intramuscular (9)
CL Item
Intraperitoneal (13)
CL Item
Intrauterine (15)
CL Item
Subcutaneous (20)
Medication Start Date
Item
Medication Start Date
date
C2826734 (UMLS CUI [1])
Is medication ongoing?
Item
Is medication ongoing?
boolean
C2826666 (UMLS CUI [1])
If NO, specify End Date
Item
If NO, specify End Date
date
C2826744 (UMLS CUI [1])
Primary Indication
Item
Primary Indication for medication
text
C2826696 (UMLS CUI [1])
Modified reported term
Item
Modified reported term
text
C2826819 (UMLS CUI [1])
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 Name
Item
Specific Condition Name
text
C0012634 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Modified reported term
Item
Modified reported term
text
C2826923 (UMLS CUI [1])
Date of onset
Item
Date of onset
date
C0574845 (UMLS CUI [1])
Item
Is medical condition continuing?
integer
C0012634 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Code List
Is medical condition continuing?
If NO, specify date of last occurrence
Item
If NO, specify date of last occurrence
date
C2745955 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Lab Sequence Number
Item
Lab Sequence Number
text
C0022885 (UMLS CUI [1,1])
C2348184 (UMLS CUI [1,2])
Item
Test Name
integer
C0022885 (UMLS CUI [1,1])
C0027365 (UMLS CUI [1,2])
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 phoshokinase 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
C0205251 (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 [1,1])
C0205394 (UMLS CUI [1,2])
Item
If the 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 the 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)
Item
Study Drug
text
C0304229 (UMLS CUI [1])
CL Item
Novel dry powder inhaler (1)
Start Date
Item
Study Drug Start Date
date
C0304229 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Stop Date
Item
Study Drug Stop Date
date
C0304229 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Regimen
Item
Regimen
text
C1276413 (UMLS CUI [1])
A brief narrative description of SAE
Item
A brief narrative description of SAE
text
C1519255 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
Send incomplete SAE data to GSK Safety
Item
Send incomplete SAE data to GSK Safety
text
C1519255 (UMLS CUI [1,1])
C1511726 (UMLS CUI [1,2])
C0205257 (UMLS CUI [1,3])
Receipt by GSK date
Item
Receipt by GSK date
date
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
text
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])