ID

38906

Description

Study ID: 110951 Clinical Study ID: 110951 Study Title: A two-part, randomised, placebo-controlled study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of single doses of intravenously infused GSK1995057 in healthy subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01476046 See https://clinicaltrials.gov/ct2/show/NCT01476046 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: N/A, Placebo Trade Name: N/A Study Indication: Respiratory Disorders This phase I trial primarily studies the safety and tolerability of ascending single intravenous doses of the selective TNFR1 antagonist GSK1995057 in healthy volunteers, and secondly explores the drug's pharmacodynamics, pharmacokinetics, concentration in lung epithelial lining fluid as well as its effect on immune system markers. The drug is hypothesized to be useful for Acute Lung Injury. The single-centre study consists of two parts A and B with seven cohorts/ten subcohorts in total. Part A includes ascending doses of the investigational product given to subjects negative or positive for pre-existing human anti-heavy chain variable domain (HAVH) antibodies (Cohorts 1 to 3 with Subcohorts 1a, 2a and 3a negative for HAVH and 1b, 2b, 3b positive for HAVH). Part B includes only subjects negative for HAVH, with ascending doses given to Cohorts 4 to 6. Cohort 7 receives the same dose as Cohort 6, but whereas the other Cohorts are single-blinded, Cohort 7 is open-label and additionally receives a bronchoalveolar lavage (BAL). The study consists of a Screening Visit (up to 56 days before Day 1, the day of the drug administration), Visits on Day -1, 1, 2, 3, 5, 7, 14, 28 and Follow-Up Visits on Day 57 and 85. This form should be filled in in case of a serious adverse event.

Link

https://clinicaltrials.gov/ct2/show/NCT01476046

Keywords

Versions (3)
  1. 10/22/19 10/22/19 -
  2. 10/22/19 10/22/19 -
  3. 11/12/19 11/12/19 - Sarah Riepenhausen
Copyright Holder

GlaxoSmithKline

Uploaded on

November 12, 2019

DOI

To request one please log in.

License

Creative Commons BY-NC 3.0
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Phase I Trial of Intravenous TNFR1 Antagonist GSK1995057 in Healthy Subjects - NCT01476046

English

Serious Adverse Event

1 forms  
  1. StudyEvent: ODM
    1. Serious Adverse Event
Administrative data
Description

Administrative data

Alias
UMLS CUI-1
C1320722
Date/Time of Assessment
Description

Date/Time of Assessment

Data type

datetime

Alias
UMLS CUI [1,1]
C1516048
UMLS CUI [1,2]
C1264639
Subject Number
Description

Subject Number

Data type

integer

Alias
UMLS CUI [1]
C2348585
Type of Report
Description

Type of Report

Alias
UMLS CUI-1
C0585733
Initial Report
Description

Initial Report

Data type

boolean

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

Follow-Up Report

Data type

boolean

Alias
UMLS CUI [1]
C1704685
Randomisation
Description

Randomisation

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

SAE after initiation of study medication

Data type

text

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
Description

Serious adverse event Entry

Alias
UMLS CUI-1
C1519255
Sequence Number
Description

Hidden

Data type

text

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

SAE Diagnosis or Sign/Symptom

Data type

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
Description

Hidden

Data type

text

Alias
UMLS CUI [1]
C2826798
MedDRA synonym
Description

Hidden

Data type

text

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

Hidden

Data type

text

Alias
UMLS CUI [1]
C3898442
Failed coding
Description

Hidden

Data type

boolean

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

Adverse Event Start Date/Time

Data type

partialDatetime

Alias
UMLS CUI [1]
C2826806
Adverse Event Outcome
Description

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

Data type

integer

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

if applicable

Data type

partialDatetime

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

Serious Adverse Event Frequency

Data type

integer

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

[hidden]

Data type

text

Alias
UMLS CUI [1]
C1710066
SAE Maximum Grade
Description

SAE Maximum Grade

Data type

integer

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

[hidden]

Data type

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
Description

Action regarding Investigational Product

Data type

text

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

Subject withdrawal because of AE

Data type

text

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)?
Description

AE possibly caused by investigational product

Data type

text

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
Description

[hidden]

Data type

time

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

[hidden]

Data type

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)?
Description

SAE caused by activities related to study participation

Data type

text

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?
Description

[hidden]

Data type

text

Alias
UMLS CUI [1]
C1547644
Seriousness
Description

Seriousness

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

Adverse Event Results in death

Data type

boolean

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

Adverse event is life-threatening

Data type

boolean

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

adverse event requires hospitalisation or prolongation of hospitalisation

Data type

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
Description

Serious adverse event results in disability/incapacity

Data type

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
Description

Serious adverse event: Congenital anomaly/birth defect

Data type

boolean

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

specify within general narrative comment

Data type

boolean

Alias
UMLS CUI [1,1]
C3840932
UMLS CUI [1,2]
C1519255
Is associated with liver injury and impaired liver function defined as: ALT >= 3xULN, and either total bilirubin >= 2xULN or INR > 1.5
Description

Liver injury and impaired liver function by ALT, Total bilirubin, INR

Data type

boolean

Alias
UMLS CUI [1]
C0160390
UMLS CUI [2]
C0086565
UMLS CUI [3]
C0036828
UMLS CUI [4]
C0201913
UMLS CUI [5]
C0525032
Relevant concomitant/treatment medications Entry
Description

Relevant concomitant/treatment medications Entry

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

[hidden]

Data type

text

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

(Trade Name preferred)

Data type

text

Alias
UMLS CUI [1]
C2360065
Dose
Description

Concomitant medication dose

Data type

float

Alias
UMLS CUI [1]
C2826811
Unit
Description

Concomitant medication unit

Data type

text

Alias
UMLS CUI [1]
C2826646
Frequency
Description

Concomitant medication frequency

Data type

text

Alias
UMLS CUI [1]
C2826654
Route
Description

Concomitant medication route

Data type

text

Alias
UMLS CUI [1]
C2826730
Start Date
Description

Concomitant Medication Start Date

Data type

partialDate

Alias
UMLS CUI [1]
C2826734
Ongoing?
Description

if no, specify End Date

Data type

text

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

Concomitant medication end date

Data type

partialDate

Alias
UMLS CUI [1]
C2826744
Primary Indication
Description

Concomitant Medication Primary Indication

Data type

text

Alias
UMLS CUI [1,1]
C2826696
UMLS CUI [1,2]
C0205225
Drug Type
Description

Drug Type

Data type

text

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

Relevant Medical Conditions/Risk Factors

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

[hidden]

Data type

text

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

Specific Condition

Data type

text

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

Date of onset

Data type

partialDate

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

If no, specify date of last occurrence

Data type

text

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

Date of last disease occurence

Data type

partialDate

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
Description

Relevant Other Medical History / Risk Factors

Data type

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
Description

Relevant Diagnostic Results

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

[hidden]

Data type

text

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

Lab Test Name

Data type

text

Alias
UMLS CUI [1]
C0022885
Test Date
Description

Test Date

Data type

partialDate

Alias
UMLS CUI [1]
C2826247
Laboratory Test Result
Description

Laboratory Test Result

Data type

text

Alias
UMLS CUI [1]
C0587081
Laboratory Test Units
Description

Laboratory Test Units

Data type

text

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

Normal Low Range

Data type

text

Alias
UMLS CUI [1]
C1272773
Normal High Range
Description

Normal High Range

Data type

text

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

Relevant other diagnostic laboratory results

Data type

text

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

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?
Description

Event recurrence after investigational product administered again

Data type

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
Description

General narrative comments

Alias
UMLS CUI-1
C0947611
General narrative comment
Description

General comment

Data type

text

Alias
UMLS CUI [1]
C0947611
Non clinical
Description

Non clinical

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

[hidden]

Data type

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
Description

[hidden]

Data type

datetime

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

[hidden]

Data type

text

Alias
UMLS CUI [1]
C1519255
SAE Sequence Number
Description

[hidden]

Data type

text

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

[hidden]

Data type

text

Alias
UMLS CUI [1]
C2985700
Case ID
Description

[hidden]

Data type

text

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

[hidden]

Data type

text

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

[hidden]

Data type

text

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

[hidden]

Data type

text

Alias
UMLS CUI [1]
C0013849
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Similar models

Serious Adverse Event

1 forms
  1. StudyEvent: ODM
    1. Serious Adverse Event
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Date/Time of Assessment
Item
Date/Time of Assessment
datetime
C1516048 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
Subject Number
Item
Subject Number
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)
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])
SAE after initiation of study medication
Code List
Did SAE occur after initiation of study medication?
CL Item
No (N)
CL Item
Yes (Y)
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
partialDatetime
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
partialDatetime
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
integer
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)
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)
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])
Subject withdrawal because of AE
Code List
Did the subject withdraw from study as a result of this AE?
CL Item
Yes (Y)
CL Item
No (N)
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])
Subject withdrawal because of AE
Code List
Is there a reasonable possibility that the AE may have been caused by the investigational product(s)?
CL Item
Yes (Y)
CL Item
No (N)
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])
Subject withdrawal because of AE
Code List
Was SAE caused by activities related to study participation (e.g. procedures)?
CL Item
Yes (Y)
CL Item
No (N)
Item
Was the event serious?
text
C1547644 (UMLS CUI [1])
Subject withdrawal because of AE
Code List
Was the event serious?
CL Item
Yes (Y)
CL Item
No (N)
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 by ALT, Total bilirubin, INR
Item
Is associated with liver injury and impaired liver function defined as: ALT >= 3xULN, and either total bilirubin >= 2xULN or INR > 1.5
boolean
C0160390 (UMLS CUI [1])
C0086565 (UMLS CUI [2])
C0036828 (UMLS CUI [3])
C0201913 (UMLS CUI [4])
C0525032 (UMLS CUI [5])
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])
Concomitant medication dose
Item
Dose
float
C2826811 (UMLS CUI [1])
Item
Unit
text
C2826646 (UMLS CUI [1])
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
C2826654 (UMLS CUI [1])
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)
CL Item
3 times per week (3W)
Item
Route
text
C2826730 (UMLS CUI [1])
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
partialDate
C2826734 (UMLS CUI [1])
Item
Ongoing?
text
C2826666 (UMLS CUI [1])
Subject withdrawal because of AE
Code List
Ongoing?
CL Item
Yes (Y)
CL Item
No (N)
Concomitant medication end date
Item
If no ongoing medication, specify end date
partialDate
C2826744 (UMLS CUI [1])
Concomitant Medication Primary Indication
Item
Primary Indication
text
C2826696 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
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
partialDate
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
partialDate
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
Test Name
text
C0022885 (UMLS CUI [1])
Test Name
Code List
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
partialDate
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])
Item
Was the event serious?
text
C1519255 (UMLS CUI [1])
Subject withdrawal because of AE
Code List
Was the event serious?
CL Item
Yes (Y)
CL Item
No (N)
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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