Inglese

Serious Adverse Event

1 moduli  
  1. StudyEvent: ODM
    1. Serious Adverse Event
Administrative data
Descrizione

Administrative data

Alias
UMLS CUI-1
C1320722
Cohort
Descrizione

Cohort

Tipo di dati

integer

Alias
UMLS CUI [1]
C0599755
Date/Time of Assessment
Descrizione

Date/Time of Assessment

Tipo di dati

datetime

Alias
UMLS CUI [1,1]
C1516048
UMLS CUI [1,2]
C1264639
Subject ID
Descrizione

Subject ID

Tipo di dati

integer

Alias
UMLS CUI [1]
C2348585
Type of Report
Descrizione

Type of Report

Alias
UMLS CUI-1
C0585733
Initial Report
Descrizione

Initial Report

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0684224
UMLS CUI [1,2]
C0205265
Follow-Up Report
Descrizione

Follow-Up Report

Tipo di dati

boolean

Alias
UMLS CUI [1]
C1704685
Randomisation
Descrizione

Randomisation

Alias
UMLS CUI-1
C0034656
Did SAE occur after initiation of study medication?
Descrizione

SAE after initiation of study medication

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0332282
UMLS CUI [1,3]
C1704686
UMLS CUI [1,4]
C0304229
Serious adverse event Entry
Descrizione

Serious adverse event Entry

Alias
UMLS CUI-1
C1519255
Sequence Number
Descrizione

Hidden

Tipo di dati

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2348184
Serious Adverse Event Diagnosis Only (if known) Otherwise Sign/Symptom
Descrizione

SAE Diagnosis or Sign/Symptom

Tipo di dati

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0011900
UMLS CUI [2,1]
C1519255
UMLS CUI [2,2]
C3540840
Adverse Event Modified Reported Term
Descrizione

Hidden

Tipo di dati

text

Alias
UMLS CUI [1]
C2826798
MedDRA synonym
Descrizione

Hidden

Tipo di dati

text

Alias
UMLS CUI [1]
C1140263
MedDRA lower level term code
Descrizione

Hidden

Tipo di dati

text

Alias
UMLS CUI [1]
C3898442
Failed coding
Descrizione

Hidden

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0805701
UMLS CUI [1,2]
C0231175
Adverse Event Start Date and Time
Descrizione

Adverse Event Start Date/Time

Tipo di dati

datetime

Alias
UMLS CUI [1]
C2826806
Adverse Event Outcome
Descrizione

if Recovered/Resolved (with or without sequelae) provide End Date and Time if Fatal, record Date and Time of Death

Tipo di dati

integer

Alias
UMLS CUI [1]
C1705586
Adverse Event End Date and Time
Descrizione

if applicable

Tipo di dati

datetime

Alias
UMLS CUI [1]
C2826793
Serious Adverse Event Frequency
Descrizione

Serious Adverse Event Frequency

Tipo di dati

integer

Alias
UMLS CUI [1,1]
C0439603
UMLS CUI [1,2]
C1519255
SAE Maximum Intensity
Descrizione

SAE Maximum Intensity

Tipo di dati

text

Alias
UMLS CUI [1]
C1710066
SAE Maximum Grade
Descrizione

[hidden]

Tipo di dati

text

Alias
UMLS CUI [1,1]
C0441799
UMLS CUI [1,2]
C1710066
SAE Maximum Grade or Intensity
Descrizione

[hidden]

Tipo di dati

text

Alias
UMLS CUI [1,1]
C0441799
UMLS CUI [1,2]
C1710066
UMLS CUI [2,1]
C0518690
UMLS CUI [2,2]
C1519255
Action Taken with Investigational Product(s) as a Result of the AE
Descrizione

Action regarding Investigational Product

Tipo di dati

text

Alias
UMLS CUI [1]
C1704758
Did the subject withdraw from study as a result of this AE?
Descrizione

subject withdrawal because of AE

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0566251
UMLS CUI [1,3]
C0877248
Is there a reasonable possibility that the AE may have been caused by the investigational product(s)?
Descrizione

AE possibly caused by investigational product

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0332149
UMLS CUI [1,3]
C0085978
UMLS CUI [1,4]
C0877248
Duration of AE if < 24 hours
Descrizione

[hidden]

Tipo di dati

time

Alias
UMLS CUI [1,1]
C0449238
UMLS CUI [1,2]
C1519255
Time to Onset Since Last Dose
Descrizione

[hidden]

Tipo di dati

time

Alias
UMLS CUI [1,1]
C1272706
UMLS CUI [1,2]
C1517741
UMLS CUI [1,3]
C0178602
UMLS CUI [1,4]
C0439659
UMLS CUI [1,5]
C1519255
Was SAE caused by activities related to study participation (e.g. procedures)?
Descrizione

SAE caused by activities related to study participation

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0085978
UMLS CUI [1,3]
C0441655
UMLS CUI [1,4]
C2348568
Was the event serious?
Descrizione

[hidden]

Tipo di dati

boolean

Alias
UMLS CUI [1]
C1547644
Seriousness
Descrizione

Seriousness

Alias
UMLS CUI-1
C0566251
UMLS CUI-2
C1547644
Results in death
Descrizione

Adverse Event Results in death

Tipo di dati

boolean

Alias
UMLS CUI [1]
C1320832
Adverse event is life-threatening
Descrizione

Adverse event is life-threatening

Tipo di dati

boolean

Alias
UMLS CUI [1]
C1517874
Requires hospitalisation or prolongation of existing hospitalisation
Descrizione

adverse event requires hospitalisation or prolongation of hospitalisation

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C2826664
UMLS CUI [1,2]
C1519255
UMLS CUI [2,1]
C0745041
UMLS CUI [2,2]
C1519255
Results in disability/incapacity
Descrizione

Serious adverse event results in disability/incapacity

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C3176592
UMLS CUI [1,2]
C1519255
UMLS CUI [2,1]
C0231170
UMLS CUI [2,2]
C1519255
Serious adverse event: Congenital anomaly/birth defect
Descrizione

Serious adverse event: Congenital anomaly/birth defect

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0000768
UMLS CUI [1,2]
C1519255
Other reason
Descrizione

specify within general narrative comment

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C3840932
UMLS CUI [1,2]
C1519255
Is associated with liver injury and impaired liver function that in the judgment of the investigator and medical monitor causes prolongation of hospitalisation out of what would be expected for normal clinical course
Descrizione

ALT >= 5xULN and bilirubin >= 2xULN (>35% direct).

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0160390
UMLS CUI [1,2]
C0678227
UMLS CUI [1,3]
C0745041
UMLS CUI [2,1]
C0086565
UMLS CUI [2,2]
C0678227
UMLS CUI [2,3]
C0745041
UMLS CUI [3,1]
C0008961
UMLS CUI [3,2]
C0022423
Relevant concomitant/treatment medications Entry
Descrizione

Relevant concomitant/treatment medications Entry

Alias
UMLS CUI-1
C2347852
UMLS CUI-2
C2347946
UMLS CUI-3
C0304229
CM Sequence Number
Descrizione

[hidden]

Tipo di dati

text

Alias
UMLS CUI [1,1]
C2348184
UMLS CUI [1,2]
C2347852
Drug name
Descrizione

(Trade Name preferred)

Tipo di dati

text

Alias
UMLS CUI [1]
C2360065
Dose
Descrizione

Dose

Tipo di dati

text

Alias
UMLS CUI [1]
C3174092
Unit
Descrizione

Unit of concomitant medication

Tipo di dati

text

Alias
UMLS CUI [1,1]
C1519795
UMLS CUI [1,2]
C2347852
Frequency
Descrizione

Concomitant medication Frequency

Tipo di dati

text

Alias
UMLS CUI [1,1]
C3476109
UMLS CUI [1,2]
C2347852
Route
Descrizione

Route of concomitant medication

Tipo di dati

text

Alias
UMLS CUI [1,1]
C0013153
UMLS CUI [1,2]
C2347852
Start Date
Descrizione

Concomitant Medication Start Date

Tipo di dati

date

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C2347852
Ongoing?
Descrizione

if no, specify End Date

Tipo di dati

boolean

Alias
UMLS CUI [1]
C2826666
If no ongoing medication, specify end date
Descrizione

Concomitant medication end date

Tipo di dati

date

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0806020
Primary Indication
Descrizione

Concomitant Medication Primary Indication

Tipo di dati

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C3146298
UMLS CUI [1,3]
C0205225
Drug Type
Descrizione

Drug Type

Tipo di dati

text

Alias
UMLS CUI [1]
C0457591
Relevant Medical Conditions/Risk Factors
Descrizione

Relevant Medical Conditions/Risk Factors

Alias
UMLS CUI-1
C2347946
UMLS CUI-2
C0012634
UMLS CUI-3
C0035648
MHx Sequence Number
Descrizione

[hidden]

Tipo di dati

text

Alias
UMLS CUI [1,1]
C2348184
UMLS CUI [1,2]
C0262926
Specific Condition Name
Descrizione

Specific Condition

Tipo di dati

text

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C2348235
Date of onset
Descrizione

Date of onset

Tipo di dati

date

Alias
UMLS CUI [1]
C0574845
Is medical condition continuing?
Descrizione

If no, specify date of last occurrence

Tipo di dati

text

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0549178
If no, specify date of last occurrence
Descrizione

Date of last disease occurence

Tipo di dati

date

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C1517741
UMLS CUI [1,3]
C2745955
UMLS CUI [1,4]
C0011008
Relevant Medical History / Risk Factors not noted above
Descrizione

Relevant Other Medical History / Risk Factors

Tipo di dati

text

Alias
UMLS CUI [1,1]
C2347946
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C0262926
UMLS CUI [2,1]
C2347946
UMLS CUI [2,2]
C0205394
UMLS CUI [2,3]
C0035648
Relevant Diagnostic Results
Descrizione

Relevant Diagnostic Results

Alias
UMLS CUI-1
C2347946
UMLS CUI-2
C0430022
UMLS CUI-3
C0456984
Lab Sequence Number
Descrizione

[hidden]

Tipo di dati

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C2348184
Lab Test Name
Descrizione

Lab Test Name

Tipo di dati

text

Alias
UMLS CUI [1]
C0022885
Test Date
Descrizione

Test Date

Tipo di dati

date

Alias
UMLS CUI [1]
C2826247
Laboratory Test Result
Descrizione

Laboratory Test Result

Tipo di dati

text

Alias
UMLS CUI [1]
C0587081
Laboratory Test Units
Descrizione

Laboratory Test Units

Tipo di dati

text

Alias
UMLS CUI [1,1]
C1519795
UMLS CUI [1,2]
C0587081
Normal Low Range
Descrizione

Normal Low Range

Tipo di dati

text

Alias
UMLS CUI [1]
C1272773
Normal High Range
Descrizione

Normal High Range

Tipo di dati

text

Alias
UMLS CUI [1]
C1299400
Relevant diagnostic results not noted above
Descrizione

Relevant other diagnostic laboratory results

Tipo di dati

text

Alias
UMLS CUI [1,1]
C2347946
UMLS CUI [1,2]
C0587081
UMLS CUI [1,3]
C0205394
Investigational Product
Descrizione

Investigational Product

Alias
UMLS CUI-1
C0304229
If Investigational product(s) stopped, did the reported event(s) recur after further investigational product(s) were administered?
Descrizione

event recurence after investigational product administered again

Tipo di dati

text

Alias
UMLS CUI [1,1]
C0034897
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C1517331
UMLS CUI [1,4]
C0304229
General narrative comments
Descrizione

General narrative comments

Alias
UMLS CUI-1
C0947611
General narrative comment
Descrizione

General comment

Tipo di dati

text

Alias
UMLS CUI [1]
C0947611
Non clinical
Descrizione

Non clinical

Alias
UMLS CUI-1
C1320722
Send incomplete SAE data to GSK Safety
Descrizione

[hidden]

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C1519246
UMLS CUI [1,2]
C0205257
UMLS CUI [1,3]
C1519255
UMLS CUI [1,4]
C1511726
UMLS CUI [1,5]
C2347796
Receipt by GSK date
Descrizione

[hidden]

Tipo di dati

datetime

Alias
UMLS CUI [1,1]
C2985846
UMLS CUI [1,2]
C2347796
Was the event serious?
Descrizione

[hidden]

Tipo di dati

boolean

Alias
UMLS CUI [1]
C1519255
SAE Sequence Number
Descrizione

[hidden]

Tipo di dati

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2348184
Version Number
Descrizione

[hidden]

Tipo di dati

text

Alias
UMLS CUI [1]
C2985700
Case ID
Descrizione

[hidden]

Tipo di dati

text

Alias
UMLS CUI [1,1]
C1698493
UMLS CUI [1,2]
C0600091
Randomisation Number
Descrizione

[hidden]

Tipo di dati

text

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0237753
OCEANS Code
Descrizione

[hidden]

Tipo di dati

text

Alias
UMLS CUI [1,1]
C0805701
UMLS CUI [1,2]
C1516728
Email Flag
Descrizione

[hidden]

Tipo di dati

text

Alias
UMLS CUI [1]
C0013849
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Similar models

Serious Adverse Event

1 moduli
  1. StudyEvent: ODM
    1. Serious Adverse Event
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Cohort
Item
Cohort
integer
C0599755 (UMLS CUI [1])
Date/Time of Assessment
Item
Date/Time of Assessment
datetime
C1516048 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
Subject ID
Item
Subject ID
integer
C2348585 (UMLS CUI [1])
Item Group
Type of Report
C0585733 (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 Group
Randomisation
C0034656 (UMLS CUI-1)
SAE after initiation of study medication
Item
Did SAE occur after initiation of study medication?
boolean
C1519255 (UMLS CUI [1,1])
C0332282 (UMLS CUI [1,2])
C1704686 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,4])
Item Group
Serious adverse event Entry
C1519255 (UMLS CUI-1)
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
boolean
C0805701 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
Adverse Event Start Date/Time
Item
Adverse Event Start Date and Time
datetime
C2826806 (UMLS CUI [1])
Item
Adverse Event Outcome
integer
C1705586 (UMLS CUI [1])
Outcome
Code List
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)
CL Item
Fatal (5)
Adverse Event End Date/Time
Item
Adverse Event End Date and Time
datetime
C2826793 (UMLS CUI [1])
Item
Serious Adverse Event Frequency
integer
C0439603 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Frequency
Code List
Serious Adverse Event Frequency
CL Item
Single Episode (1)
CL Item
Intermittent (2)
Item
SAE Maximum Intensity
text
C1710066 (UMLS CUI [1])
Maximum Intensity
Code List
SAE Maximum Intensity
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Not applicable (X)
Item
SAE Maximum Grade
text
C0441799 (UMLS CUI [1,1])
C1710066 (UMLS CUI [1,2])
Maximum Grade
Code List
SAE Maximum Grade
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
Not applicable (X)
Item
SAE 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])
Maximum Grade
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
Grade 4 (4)
CL Item
Grade 5 (5)
CL Item
Not applicable (X)
Item
Action Taken with Investigational Product(s) as a Result of the AE
text
C1704758 (UMLS CUI [1])
Action regarding Investigational Product
Code List
Action Taken with Investigational Product(s) as a Result of the 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 (X)
subject withdrawal because of AE
Item
Did the subject withdraw from study as a result of this AE?
boolean
C0422727 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,3])
AE possibly caused by investigational product
Item
Is there a reasonable possibility that the AE may have been caused by the investigational product(s)?
boolean
C0304229 (UMLS CUI [1,1])
C0332149 (UMLS CUI [1,2])
C0085978 (UMLS CUI [1,3])
C0877248 (UMLS CUI [1,4])
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])
SAE caused by activities related to study participation
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])
Event seriousness
Item
Was the event serious?
boolean
C1547644 (UMLS CUI [1])
Item Group
Seriousness
C0566251 (UMLS CUI-1)
C1547644 (UMLS CUI-2)
Adverse Event Results in death
Item
Results in death
boolean
C1320832 (UMLS CUI [1])
Adverse event is life-threatening
Item
Adverse event 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
Serious adverse event: Congenital anomaly/birth defect
boolean
C0000768 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Other reason for event seriousness
Item
Other reason
boolean
C3840932 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Liver injury and impaired liver function causing prolongation of hospitalisation, by investigator judgement
Item
Is associated with liver injury and impaired liver function that in the judgment of the investigator and medical monitor causes prolongation of hospitalisation out of what would be expected for normal clinical course
boolean
C0160390 (UMLS CUI [1,1])
C0678227 (UMLS CUI [1,2])
C0745041 (UMLS CUI [1,3])
C0086565 (UMLS CUI [2,1])
C0678227 (UMLS CUI [2,2])
C0745041 (UMLS CUI [2,3])
C0008961 (UMLS CUI [3,1])
C0022423 (UMLS CUI [3,2])
Item Group
Relevant concomitant/treatment medications Entry
C2347852 (UMLS CUI-1)
C2347946 (UMLS CUI-2)
C0304229 (UMLS CUI-3)
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])
Dose
Item
Dose
text
C3174092 (UMLS CUI [1])
Item
Unit
text
C1519795 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
units of medication
Code List
Unit
CL Item
Actuation (ACTU)
CL Item
Ampoule  (AMP)
CL Item
Application  (AP)
CL Item
Bottle  (BT)
CL Item
Capsule (CAP)
CL Item
Cubic centimeter (CC)
CL Item
Drops  (031)
CL Item
Gram (002)
CL Item
International units (025)
CL Item
International units per kilogram (028)
CL Item
International units per millilitre (IUML)
CL Item
Litre (011)
CL Item
Litre per minute (LM)
CL Item
Lozenge (LOZ)
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
Microlitre (013)
CL Item
Milliequivalent (029)
CL Item
Milliequivalent per 24 hours (MEQ24)
CL Item
Milligram (003)
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 (012)
CL Item
Millilitre per hour (MLH)
CL Item
Millilitre per minute (MLM)
CL Item
Millimole (023)
CL Item
Million international units (027)
CL Item
Minimum alveolar concentration (MAC)
CL Item
Nebule (NEB)
CL Item
Patch (PAT)
CL Item
Percent (030)
CL Item
Puff (PUFF)
CL Item
Sachet (SAC)
CL Item
Spray (SPR)
CL Item
Suppository (SUP)
CL Item
Tablespoon (TBS)
CL Item
Tablet (TAB)
CL Item
Teaspoon (TSP)
CL Item
Units (UNT)
CL Item
Unknown (U)
CL Item
Vial (VIA)
Item
Frequency
text
C3476109 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Frequency
Code List
Frequency
CL Item
3 times per week (2W)
CL Item
3 times per week (2W)
CL Item
4 times per week (4W)
CL Item
5 times per day (5D)
CL Item
5 times per week (5W)
CL Item
AC (AC)
CL Item
Q12H (2D)
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
QPM (1N)
CL Item
Once a month (MO)
CL Item
Once a week (WE)
CL Item
Once daily (1D)
CL Item
Once only (1S)
CL Item
PC (PC)
CL Item
PRN (PRN)
CL Item
Q2H (12D)
CL Item
Q3D (Q3D)
CL Item
Q4D (Q4D)
CL Item
Q4H (6D)
CL Item
QID (4D)
CL Item
TID (3D)
CL Item
Q12H (2D)
CL Item
QAM (1M)
CL Item
QH (24D)
CL Item
QID (4D)
CL Item
QPM (1N)
CL Item
TID (3D)
CL Item
Unknown (U)
Item
Route
text
C0013153 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Route of medication
Code List
Route
CL Item
Both eyes (047)
C0229118 (UMLS CUI-1)
(Comment:en)
CL Item
Epidural (008)
C0014537 (UMLS CUI-1)
(Comment:en)
CL Item
Gastrostomy tube (GT)
C0017196 (UMLS CUI-1)
C0041281 (UMLS CUI-2)
(Comment:en)
CL Item
Inhalation (055)
C0004048 (UMLS CUI-1)
(Comment:en)
CL Item
Injection (INJ)
C1272883 (UMLS CUI-1)
(Comment:en)
CL Item
Intra-arterial (013)
C0694634 (UMLS CUI-1)
(Comment:en)
CL Item
Intra-bursa (IBU)
C0230212 (UMLS CUI-1)
(Comment:en)
CL Item
Intralesional (026)
C1512954 (UMLS CUI-1)
(Comment:en)
CL Item
Intramuscular (030)
C0442117 (UMLS CUI-1)
(Comment:en)
CL Item
Nasal (045)
C0442118 (UMLS CUI-1)
(Comment:en)
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
Nasal (045)
CL Item
Oral (048)
CL Item
Rectal (054)
CL Item
Subcutaneous (058)
CL Item
Sublingual (060)
CL Item
Topical (061)
CL Item
Transdermal (062)
CL Item
Unknown (065)
CL Item
Vaginal (067)
Concomitant Medication Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Ongoing concomitant medication
Item
Ongoing?
boolean
C2826666 (UMLS CUI [1])
Concomitant medication end date
Item
If no ongoing medication, specify end date
date
C2347852 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Concomitant Medication Primary Indication
Item
Primary Indication
text
C2347852 (UMLS CUI [1,1])
C3146298 (UMLS CUI [1,2])
C0205225 (UMLS CUI [1,3])
Item
Drug Type
text
C0457591 (UMLS CUI [1])
Drug Type
Code List
Drug Type
CL Item
Concomitant (2)
CL Item
Treatment (T)
CL Item
Cause of SAE (1)
Item Group
Relevant Medical Conditions/Risk Factors
C2347946 (UMLS CUI-1)
C0012634 (UMLS CUI-2)
C0035648 (UMLS CUI-3)
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
Is medical condition continuing?
text
C0012634 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Continuing?
Code List
Is medical condition continuing?
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Unknown (U)
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])
Item Group
Relevant Diagnostic Results
C2347946 (UMLS CUI-1)
C0430022 (UMLS CUI-2)
C0456984 (UMLS CUI-3)
Lab Sequence Number
Item
Lab Sequence Number
text
C0022885 (UMLS CUI [1,1])
C2348184 (UMLS CUI [1,2])
Item
Lab Test Name
text
C0022885 (UMLS CUI [1])
Test Name
Code List
Lab Test Name
CL Item
Activated partical tromboplastin time (Activated partical tromboplastin time)
CL Item
Albumin (Albumin)
CL Item
Alkaline phosphatase (Alkaline phosphatase)
CL Item
Amylase (Amylase)
CL Item
Basophils (Basophils)
CL Item
Bicarbonate (Bicarbonate)
CL Item
Bilirubin (Bilirubin)
CL Item
Bilirubin direct (Bilirubin direct)
CL Item
Bilirubin total (Bilirubin total)
CL Item
Blood myoglobin (Blood myoglobin)
CL Item
Blood pH (Blood pH)
CL Item
Blood Pressure (Blood Pressure)
CL Item
Blood urea nitrogen (Blood urea nitrogen)
CL Item
Body temperature (Body temperature)
CL Item
Calcium (Calcium)
CL Item
CD4 Lymphocytes (CD4 Lymphocytes)
CL Item
CD8 lymphocytes (CD8 lymphocytes)
CL Item
Chloride (Chloride)
CL Item
Cholesterol total (Cholesterol total)
CL Item
C-reactive protein (C-reactive protein)
CL Item
Creatine (Creatine)
CL Item
Creatine phosphokinase (Creatine phosphokinase)
CL Item
Creatine phosphokinase MB (Creatine phosphokinase MB)
CL Item
Creatinine (Creatinine)
CL Item
Creatinine clearance (Creatinine clearance)
CL Item
Diastolic blood pressure (Diastolic blood pressure)
CL Item
Eosinophils (Eosinophils)
CL Item
Erithrocyte sedimentation rate (Erithrocyte sedimentation rate)
CL Item
Fasting blood glucose (Fasting blood glucose)
CL Item
FEV 1 (FEV 1)
CL Item
Gamma-glutamyltransferase (Gamma-glutamyltransferase)
CL Item
Glutamic-oxaloacetic transaminase (Glutamic-oxaloacetic transaminase)
CL Item
Glutamic-pyruvate transaminase (Glutamic-pyruvate transaminase)
CL Item
HbA1c (HbA1c)
CL Item
HBV-DNA decreased (HBV-DNA decreased)
CL Item
HBV-DNA increased (HBV-DNA increased)
CL Item
Heart rate (Heart rate)
CL Item
Hematocrit (Hematocrit)
CL Item
Hemoglobin (Hemoglobin)
CL Item
High density lipoprotein (High density lipoprotein)
CL Item
HIV viral load (HIV viral load)
CL Item
INR (INR)
CL Item
Lactic dehydrogenase (Lactic dehydrogenase)
CL Item
Lipase (Lipase)
CL Item
Low density lipoprotein (Low density lipoprotein)
CL Item
Lymphocytes (Lymphocytes)
CL Item
Magnesium (Magnesium)
CL Item
Mean cell hemoglobin concentration (Mean cell hemoglobin concentration)
CL Item
Mean corpuscular hemoglobin (Mean corpuscular hemoglobin)
CL Item
Mean corpuscular volume (Mean corpuscular volume)
CL Item
Monocytes (Monocytes)
CL Item
Neutrophils (Neutrophils)
CL Item
Oxygen saturation (Oxygen saturation)
CL Item
pCO2 (pCO2)
CL Item
pH (pH)
CL Item
Phosphate (Phosphate)
CL Item
Palatelet count (Palatelet count)
CL Item
pO2 (pO2)
CL Item
Potassium (Potassium)
CL Item
Protein total (Protein total)
CL Item
Prothrombin time (Prothrombin time)
CL Item
Red blood cell count (Red blood cell count)
CL Item
Respiratory rate (Respiratory rate)
CL Item
Reticulocyte count (Reticulocyte count)
CL Item
Serum glucose (Serum glucose)
CL Item
Serum uric acid (Serum uric acid)
CL Item
Sodium (Sodium)
CL Item
Systolic blood pressure (Systolic blood pressure)
CL Item
Thrombin time (Thrombin time)
CL Item
Total lung capacity (Total lung capacity)
CL Item
Triglycerides (Triglycerides)
CL Item
Troponin (Troponin)
CL Item
Troponin I (Troponin I)
CL Item
Troponin T (Troponin T)
CL Item
Urine myoglobin (Urine myoglobin)
CL Item
Urine pH (Urine pH)
CL Item
Vital capacity (Vital capacity)
CL Item
White blood cell count (White blood cell count)
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 Group
Investigational Product
C0304229 (UMLS CUI-1)
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])
event recurence after investigational product administered again
Code List
If Investigational product(s) stopped, did the reported event(s) recur after further investigational product(s) were administered?
CL Item
No (N)
CL Item
Yes (Y)
CL Item
Unknown at this time (U)
CL Item
Not applicable (X)
Item Group
General narrative comments
C0947611 (UMLS CUI-1)
General comment
Item
General narrative comment
text
C0947611 (UMLS CUI [1])
Item Group
Non clinical
C1320722 (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])
Serious Adverse Event
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
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])
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