ID

39144

Description

Study ID: 108062 Clinical Study ID: 108062 Study Title: A three part, staggered cohort, open-label and double blind, randomized, placebo controlled study to investigate the efficacy, safety, tolerability and pharmacokinetics of eltrombopag, a thrombopoietin receptor agonist, in previously treated pediatric patients with chronic idiopathic thrombocytopenic purpura (ITP). Eltrombopag PETIT: Eltrombopag in PEdiatric patients with Thrombocytopenia from ITP Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00908037 https://clinicaltrials.gov/ct2/show/NCT00908037 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: eltrombopag, Placebo Trade Name: N/A Study Indication: Purpura, Thrombocytopaenic, Idiopathic The study consists of a screening, Day 1 and three parts. All subjects were supposed to receive 24 weeks (6 months) of eltrombopag treatment during Part 2/3. Screening period: Up to 28 days prior to Day 1 of treatment. Day 1 Part 1 (Dose Finding Phase): A 24-week (6 months) open label treatment period for 5 subjects in each age cohort. (short: P1W1-P1W7, P1W8-23, P1W24/EW). A safety, PK and platelet count review took place after 12 weeks (3 months) of treatment. Subjects in the Dose Finding Phase did not participate in the Randomized Period. Part 2 (Randomized Period): A 7-week randomized, double-blind, placebo-controlled period involving 18 subjects per cohort (short: P2W1-P2W7). Part 3: An open-label treatment period where subjects randomized to eltrombopag in Part 2 received an additional 17 weeks of eltrombopag in Part 3 and subjects randomized to placebo in Part 2 received 24 weeks of eltrombopag in Part 3 (short: P3W8-P3W23, P3W24/EW, P3W8-30, P3W31/EW). Follow-up: 4 weeks following the last dose of eltrombopag (short: FUW1- FUW4). Additional ocular examinations were performed at 12 and 24 weeks (3 and 6 months) after the last dose of eltrombopag (short: FUM3, FUM6). The subjects were enrolled in 3 cohorts: Cohort 1: Subjects between 12 and 17 years old (<18 years of age at Day 1). Cohort 2: Subjects between 6 and 11 years old (<12 years of age at Day 1). Cohort 3: Subjects between 1 and 5 years old (<6 years of age at Day 1). The enrollment was started with the oldest cohort (Cohort 1). The younger cohorts were not enrolled until safety, PK and platelet counts had been reviewed in the older cohort(s). This document contains the SAE form. It has to be filled in if a SAE occurs during the study.

Link

https://clinicaltrials.gov/ct2/show/NCT00908037

Keywords

Versions (2)
  1. 10/22/19 10/22/19 -
  2. 12/5/19 12/5/19 - Sarah Riepenhausen
Copyright Holder

GlaxoSmithKline

Uploaded on

December 5, 2019

DOI

To request one please log in.

License

Creative Commons BY-NC 3.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Effects of eltrombopag in children with chronic idiopathic thrombocytopenic purpura, NCT00908037

English

Serious Adverse Event

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

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Number
Description

Subject Number

Data type

integer

Alias
UMLS CUI [1]
C2348585
Type of report, SAE
Description

Type of report, SAE

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0585733
Initial report
Description

Initial report

Data type

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0684224
UMLS CUI [1,3]
C0205265
Folllow-up report
Description

Folllow-up report

Data type

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1704685
Randomisation
Description

Randomisation

Alias
UMLS CUI-1
C0034656
UMLS CUI-2
C1519255
Did SAE occur after initiation of study medication?
Description

SAE occurrence after initiation of study medication

Data type

text

Alias
UMLS CUI [1,1]
C2745955
UMLS CUI [1,2]
C1519255
UMLS CUI [1,3]
C0304229
Serious adverse events
Description

Serious adverse events

Alias
UMLS CUI-1
C1519255
SAE Sequence Number
Description

In the original form this item is hidden.

Data type

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2348184
Modified term of SAE
Description

In the original form this item is hidden.

Data type

text

Alias
UMLS CUI [1,1]
C2826302
UMLS CUI [1,2]
C1519255
MedDRA synonym of SAE
Description

In the original form this item is hidden.

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1140263
MedDRA lower level term code of SAE
Description

In the original form this item is hidden.

Data type

text

Alias
UMLS CUI [1,1]
C3898442
UMLS CUI [1,2]
C1140263
Failed coding
Description

In the original form this item is hidden.

Data type

text

Alias
UMLS CUI [1,1]
C0805701
UMLS CUI [1,2]
C0231175
UMLS CUI [1,3]
C1140263
Serious Adverse Event
Description

Diagnosis Only (if known) Otherwise Sign/Symptom

Data type

text

Alias
UMLS CUI [1]
C1519255
Start Date of SAE
Description

day month year

Data type

date

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C1519255
Outcome of SAE
Description

If you tick "Recovered/Resolved"or "Recovered/Resolved with sequelae", provide End Date and Time in the following items. If you tick "Fatal", record Date of Death in the following item.

Data type

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1705586
End Date of SAE/Date of Death
Description

day month year

Data type

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C1519255
UMLS CUI [2]
C1148348
End Time of SAE
Description

00:00-23:59

Data type

time

Alias
UMLS CUI [1,1]
C1522314
UMLS CUI [1,2]
C1519255
Maximum Intensity
Description

This item may be hidden if either the "Maximum Grade" or "Maximum Grade or Intensity" item has been used.

Data type

text

Alias
UMLS CUI [1,1]
C0518690
UMLS CUI [1,2]
C1519255
Maximum Grade
Description

This item may be hidden if either the "Maximum Intensity" or "Maximum Grade or Intensity" item has been used Grade 5 is optional.

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0441800
UMLS CUI [1,3]
C0806909
Maximum Grade or Intensity
Description

This item may be hidden if either the "Maximum Intensity" or "Maximum Grade" item has been used Grade 5 is optional.

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0441800
UMLS CUI [1,3]
C0806909
UMLS CUI [2,1]
C0518690
UMLS CUI [2,2]
C0806909
UMLS CUI [2,3]
C1519255
Action Taken with Investigational Product(s) as a Result of the AE
Description

Action Taken with Investigational Product(s) as a Result of the AE

Data type

text

Alias
UMLS CUI [1,1]
C1704758
UMLS CUI [1,2]
C1519255
Did the subject withdraw from study as a result of this AE?
Description

Withdrawal as result of SAE

Data type

text

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C1519255
Is there a reasonable possibility that the AE may have been caused by the investigational product?
Description

Relationship between SAE and investigational product

Data type

text

Alias
UMLS CUI [1,1]
C0439849
UMLS CUI [1,2]
C0304229
UMLS CUI [1,3]
C1519255
Duration of AE if < 24 hours
Description

In the original form this item is hidden.

Data type

integer

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

In the original form this item is hidden.

Data type

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0332162
UMLS CUI [1,3]
C0040223
UMLS CUI [1,4]
C3174092
UMLS CUI [1,5]
C1517741
Was SAE caused by activities related to study participation (e.g. procedures)?
Description

Relationship between SAE to study participation

Data type

text

Alias
UMLS CUI [1,1]
C0439849
UMLS CUI [1,2]
C1519255
UMLS CUI [1,3]
C2348568
Was the event serious?
Description

In the original form this item is hidden.

Data type

text

Alias
UMLS CUI [1,1]
C1705586
UMLS CUI [1,2]
C1519255
Seriousness
Description

Seriousness

Alias
UMLS CUI-1
C1710056
Specify the reason for considering this an SAE. Check all that apply. Results in death
Description

Results in death

Data type

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0011065
Specify the reason for considering this an SAE. Check all that apply. Life-threatening
Description

Life-threatening

Data type

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1517874
Specify the reason for considering this an SAE. Check all that apply. Requires hospitalisation or prolongation of existing hospitalisation
Description

Requires hospitalisation or prolongation of existing hospitalisation

Data type

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0019993
UMLS CUI [2,1]
C1519255
UMLS CUI [2,2]
C0745041
Specify the reason for considering this an SAE. Check all that apply. Results in disability/incapacity
Description

Results in disability/incapacity

Data type

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0231170
Specify the reason for considering this an SAE. Check all that apply. Congenital anomaly/birth defect
Description

Congenital anomaly/birth defect

Data type

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0000768
Specify the reason for considering this an SAE. Check all that apply. Other
Description

Other reason

Data type

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C3840932
If other reason, please specify within general narrative comment
Description

Other reason, specification

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C3840932
UMLS CUI [1,3]
C2348235
Specify the reason for considering this an SAE. Check all that apply. Grade 4 laboratory abnormalities (except thrombocytopenia); ocular events of concern
Description

Laboratory abnormalities (except thrombocytopenia), ocular event

Data type

boolean

Alias
UMLS CUI [1,1]
C1853129
UMLS CUI [1,2]
C0332300
UMLS CUI [1,3]
C0040034
UMLS CUI [2,1]
C1299003
UMLS CUI [2,2]
C0877248
Relevant Concomitant/treatment medications
Description

Relevant Concomitant/treatment medications

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C2347852
UMLS CUI-3
C0304229
CM Sequence Number
Description

In the original form this item is hidden.

Data type

integer

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 of medication
Description

Dose of medication

Data type

float

Alias
UMLS CUI [1]
C3174092
Unit of dosage
Description

Unit of dosage

Data type

text

Alias
UMLS CUI [1]
C2348328
Frequency of medication
Description

Frequency of medication

Data type

text

Alias
UMLS CUI [1]
C3476109
Route of medication
Description

Route of medication

Data type

text

Alias
UMLS CUI [1]
C0013153
Start Date of medication
Description

day month year

Data type

partialDate

Alias
UMLS CUI [1]
C2826734
Is the medication ongoing?
Description

If you tick No, please specify the End Date in the following item.

Data type

text

Alias
UMLS CUI [1]
C2826666
End Date of medication
Description

day month year

Data type

partialDate

Alias
UMLS CUI [1]
C2826744
Primary Indication for medication
Description

Primary Indication

Data type

text

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C1519255
Modified reported term, Primary Indication
Description

In the original form this item is hidden.

Data type

text

Alias
UMLS CUI [1,1]
C2826302
UMLS CUI [1,2]
C3146298
UMLS CUI [1,3]
C2347852
UMLS CUI [1,4]
C1519255
Drug Type
Description

Drug Type

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C0332307
Relevant medical conditions/Risk factors
Description

Relevant medical conditions/Risk factors

Alias
UMLS CUI-1
C0262926
UMLS CUI-2
C0035648
UMLS CUI-3
C1519255
MHx Sequence Number
Description

In the original form this item is hidden.

Data type

integer

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

Specify past or current medical disorders, allergies, surgeries, family or social history that may help explain the SAE.

Data type

text

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C2348235
Modified reported term
Description

In the original form this item is hidden.

Data type

text

Alias
UMLS CUI [1,1]
C2826302
UMLS CUI [1,2]
C0262926
Date of onset
Description

day month year

Data type

partialDate

Alias
UMLS CUI [1,1]
C0574845
UMLS CUI [1,2]
C0012634
Continuing?
Description

If you tick No, please specify the date of last occurrence in the following item.

Data type

text

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0549178
Date of last occurrence
Description

day month year

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 Medical History / Risk Factors not noted above

Data type

text

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C0262926
UMLS CUI [2,1]
C0205394
UMLS CUI [2,2]
C0035648
Relevant diagnostic results
Description

Relevant diagnostic results

Alias
UMLS CUI-1
C0430022
UMLS CUI-2
C0456984
UMLS CUI-3
C1519255
Lab Sequence Number
Description

In the original form this item is hidden.

Data type

integer

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

Test Name

Data type

text

Alias
UMLS CUI [1]
C0022885
Test Date
Description

day month year

Data type

partialDate

Alias
UMLS CUI [1]
C2826247
Test Result
Description

Test Result

Data type

text

Alias
UMLS CUI [1]
C0587081
Test Units
Description

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

float

Alias
UMLS CUI [1]
C1272773
Normal High Range
Description

Normal High Range

Data type

float

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

Relevant diagnostic results not noted above

Data type

text

Alias
UMLS CUI [1,1]
C0430022
UMLS CUI [1,2]
C0456984
UMLS CUI [1,3]
C0205394
Investigational Products
Description

Investigational Products

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

Recurrence of event after investigational product administration

Data type

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0034897
UMLS CUI [1,3]
C0304229
UMLS CUI [1,4]
C1533734
General Narrative Comments
Description

General Narrative Comments

Alias
UMLS CUI-1
C0947611
UMLS CUI-2
C1519255
General narrative comments
Description

Provide a brief narrative description of SAE, possible other causes of the event (e.g. lack of efficacy, withdrawal of investigational product, the disease under study or other medical conditions) and details of the treatment.

Data type

text

Alias
UMLS CUI [1,1]
C0947611
UMLS CUI [1,2]
C1519255
Non Clinical
Description

Non Clinical

Alias
UMLS CUI-1
C0205210
UMLS CUI-2
C1298908
Send incomplete SAE data to GSK Safety
Description

Incomplete SAE data to GSK

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

Receipt by GSK date

Data type

partialDate

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

Serious event

Data type

text

Alias
UMLS CUI [1,1]
C1705586
UMLS CUI [1,2]
C1519255
SAE Sequence Number
Description

SAE Sequence Number

Data type

integer

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

Version Number

Data type

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0333052
UMLS CUI [1,3]
C0237753
Case ID
Description

Case ID

Data type

text

Alias
UMLS CUI [1,1]
C0868928
UMLS CUI [1,2]
C0600091
UMLS CUI [1,3]
C1519255
Randomisation Number
Description

Randomisation Number

Data type

integer

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0237753
UMLS CUI [1,3]
C1519255
OCEANS Code
Description

OCEANS Code

Data type

text

Alias
UMLS CUI [1]
C0805701
Email Flag
Description

Email Flag

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0013849
Back to the top of the page

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)
Subject Number
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Item Group
Type of report, SAE
C1519255 (UMLS CUI-1)
C0585733 (UMLS CUI-2)
Initial report
Item
Initial report
boolean
C1519255 (UMLS CUI [1,1])
C0684224 (UMLS CUI [1,2])
C0205265 (UMLS CUI [1,3])
Folllow-up report
Item
Folllow-up report
boolean
C1519255 (UMLS CUI [1,1])
C1704685 (UMLS CUI [1,2])
Item Group
Randomisation
C0034656 (UMLS CUI-1)
C1519255 (UMLS CUI-2)
Item
Did SAE occur after initiation of study medication?
text
C2745955 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
SAE occurrence
Code List
Did SAE occur after initiation of study medication?
CL Item
Yes (Y)
CL Item
No (N)
Item Group
Serious adverse events
C1519255 (UMLS CUI-1)
SAE Sequence Number
Item
SAE Sequence Number
integer
C1519255 (UMLS CUI [1,1])
C2348184 (UMLS CUI [1,2])
Modified term of SAE
Item
Modified term of SAE
text
C2826302 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
MedDRA synonym of SAE
Item
MedDRA synonym of SAE
text
C1519255 (UMLS CUI [1,1])
C1140263 (UMLS CUI [1,2])
MedDRA lower level term code of SAE
Item
MedDRA lower level term code of SAE
text
C3898442 (UMLS CUI [1,1])
C1140263 (UMLS CUI [1,2])
Failed coding
Item
Failed coding
text
C0805701 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
C1140263 (UMLS CUI [1,3])
Serious Adverse Event
Item
Serious Adverse Event
text
C1519255 (UMLS CUI [1])
Start Date of SAE
Item
Start Date of SAE
date
C0808070 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item
Outcome of SAE
integer
C1519255 (UMLS CUI [1,1])
C1705586 (UMLS CUI [1,2])
Outcome of SAE
Code List
Outcome of SAE
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)
End Date of SAE/Date of Death
Item
End Date of SAE/Date of Death
date
C0806020 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C1148348 (UMLS CUI [2])
End Time of SAE
Item
End Time of SAE
time
C1522314 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item
Maximum Intensity
text
C0518690 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Maximum Intensity
Code List
Maximum Intensity
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Not applicable (X)
Item
Maximum Grade
text
C1519255 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
Maximum Intensity
Code List
Maximum Grade
CL Item
Grade 1 (1)
CL Item
Grade 2 (2)
CL Item
Grade 3 (3)
CL Item
Not applicable (X)
CL Item
Grade 4 (4)
CL Item
Grade 5 (5)
Item
Maximum Grade or Intensity
text
C1519255 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
C0518690 (UMLS CUI [2,1])
C0806909 (UMLS CUI [2,2])
C1519255 (UMLS CUI [2,3])
Maximum Intensity
Code List
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)
CL Item
Grade 4 (4)
CL Item
Grade 5 (5)
Item
Action Taken with Investigational Product(s) as a Result of the AE
text
C1704758 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Action Taken with Investigational Product(s) as a Result of the AE
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
C2349954 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Withdrawal as result of SAE
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?
text
C0439849 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
Relationship between SAE and investigational product
Code List
Is there a reasonable possibility that the AE may have been caused by the investigational product?
CL Item
Yes (Y)
CL Item
No (N)
Duration of AE if < 24 hours
Item
Duration of AE if < 24 hours
integer
C1519255 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Time to Onset Since Last Dose
Item
Time to Onset Since Last Dose
integer
C1519255 (UMLS CUI [1,1])
C0332162 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C3174092 (UMLS CUI [1,4])
C1517741 (UMLS CUI [1,5])
Item
Was SAE caused by activities related to study participation (e.g. procedures)?
text
C0439849 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
Relation of SAE to study participation
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
C1705586 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Relation of SAE to study participation
Code List
Was the event serious?
CL Item
Yes (Y)
CL Item
No (N)
Item Group
Seriousness
C1710056 (UMLS CUI-1)
Results in death
Item
Specify the reason for considering this an SAE. Check all that apply. Results in death
boolean
C1519255 (UMLS CUI [1,1])
C0011065 (UMLS CUI [1,2])
Life-threatening
Item
Specify the reason for considering this an SAE. Check all that apply. Life-threatening
boolean
C1519255 (UMLS CUI [1,1])
C1517874 (UMLS CUI [1,2])
Requires hospitalisation or prolongation of existing hospitalisation
Item
Specify the reason for considering this an SAE. Check all that apply. Requires hospitalisation or prolongation of existing hospitalisation
boolean
C1519255 (UMLS CUI [1,1])
C0019993 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2,1])
C0745041 (UMLS CUI [2,2])
Results in disability/incapacity
Item
Specify the reason for considering this an SAE. Check all that apply. Results in disability/incapacity
boolean
C1519255 (UMLS CUI [1,1])
C0231170 (UMLS CUI [1,2])
Congenital anomaly/birth defect
Item
Specify the reason for considering this an SAE. Check all that apply. Congenital anomaly/birth defect
boolean
C1519255 (UMLS CUI [1,1])
C0000768 (UMLS CUI [1,2])
Other reason
Item
Specify the reason for considering this an SAE. Check all that apply. Other
boolean
C1519255 (UMLS CUI [1,1])
C3840932 (UMLS CUI [1,2])
Other reason, specification
Item
If other reason, please specify within general narrative comment
text
C1519255 (UMLS CUI [1,1])
C3840932 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Laboratory abnormalities (except thrombocytopenia), ocular event
Item
Specify the reason for considering this an SAE. Check all that apply. Grade 4 laboratory abnormalities (except thrombocytopenia); ocular events of concern
boolean
C1853129 (UMLS CUI [1,1])
C0332300 (UMLS CUI [1,2])
C0040034 (UMLS CUI [1,3])
C1299003 (UMLS CUI [2,1])
C0877248 (UMLS CUI [2,2])
Item Group
Relevant Concomitant/treatment medications
C1519255 (UMLS CUI-1)
C2347852 (UMLS CUI-2)
C0304229 (UMLS CUI-3)
CM Sequence Number
Item
CM Sequence Number
integer
C2348184 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Drug Name
Item
Drug Name
text
C2360065 (UMLS CUI [1])
Dose of medication
Item
Dose of medication
float
C3174092 (UMLS CUI [1])
Item
Unit of dosage
text
C2348328 (UMLS CUI [1])
Unit of dosage
Code List
Unit of dosage
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 (MCG)  (004 (MCG))
CL Item
Microgram (UG)  (004 (UG))
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 of medication
text
C3476109 (UMLS CUI [1])
Frequency of medication
Code List
Frequency of medication
CL Item
AC (AC)
CL Item
PC (PC)
CL Item
PRN (PRN)
CL Item
Q3D (Q3D)
CL Item
Q4D (Q4D)
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
BID  (2D)
CL Item
Continuous infusion  (CO)
CL Item
Every 2 weeks  (FO)
CL Item
Every 3 weeks  (Q3WK)
CL Item
Every 3 months  (Q3M)
CL Item
Every other day  (AD)
CL Item
At Bedtime  (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
Q2H  (12D)
CL Item
Q4H  (6D)
CL Item
Q6H  (4D)
CL Item
Q8H  (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 of medication
text
C0013153 (UMLS CUI [1])
Route of medication
Code List
Route of medication
CL Item
Both eyes  (047)
CL Item
Epidural  (008)
CL Item
Gastrostomy tube  (GT)
CL Item
Inhalation  (055)
CL Item
Injection  (INJ)
CL Item
Intra-arterial  (013)
CL Item
Intra-bursa  (IBU)
CL Item
Intralesional  (026)
CL Item
Intramuscular  (030)
CL Item
Intranasal  (045)
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)
Start Date of medication
Item
Start Date of medication
partialDate
C2826734 (UMLS CUI [1])
Item
Is the medication ongoing?
text
C2826666 (UMLS CUI [1])
Medication ongoing
Code List
Is the medication ongoing?
CL Item
Yes (Y)
CL Item
No (N)
End Date of medication
Item
End Date of medication
partialDate
C2826744 (UMLS CUI [1])
Primary Indication
Item
Primary Indication for medication
text
C3146298 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
Modified reported term, Primary Indication
Item
Modified reported term, Primary Indication
text
C2826302 (UMLS CUI [1,1])
C3146298 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,3])
C1519255 (UMLS CUI [1,4])
Item
Drug Type
text
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,3])
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
C0262926 (UMLS CUI-1)
C0035648 (UMLS CUI-2)
C1519255 (UMLS CUI-3)
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])
Modified reported term
Item
Modified reported term
text
C2826302 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
Date of onset
Item
Date of onset
partialDate
C0574845 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
Item
Continuing?
text
C0012634 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Condition continuing
Code List
Continuing?
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Unknown (U)
Date of last occurrence
Item
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 Medical History / Risk Factors not noted above
Item
Relevant Medical History / Risk Factors not noted above
text
C0205394 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C0205394 (UMLS CUI [2,1])
C0035648 (UMLS CUI [2,2])
Item Group
Relevant diagnostic results
C0430022 (UMLS CUI-1)
C0456984 (UMLS CUI-2)
C1519255 (UMLS CUI-3)
Lab Sequence Number
Item
Lab Sequence Number
integer
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 partial thromboplastin time (Activated partial thromboplastin 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
Erythrocyte sedimentation rate (Erythrocyte 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 transferase (Glutamic-oxaloacetic transferase)
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
Platelet count (Platelet 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])
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
float
C1272773 (UMLS CUI [1])
Normal High Range
Item
Normal High Range
float
C1299400 (UMLS CUI [1])
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 Group
Investigational Products
C0304229 (UMLS CUI-1)
Item
If Investigational product(s) stopped, did the reported event(s) recur after further investigational product(s) were administered?
text
C0877248 (UMLS CUI [1,1])
C0034897 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
C1533734 (UMLS CUI [1,4])
Recurrence of event after investigational product administration
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)
C1519255 (UMLS CUI-2)
General narrative comments
Item
General narrative comments
text
C0947611 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item Group
Non Clinical
C0205210 (UMLS CUI-1)
C1298908 (UMLS CUI-2)
Incomplete SAE data to GSK
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 by GSK date
Item
Receipt by GSK date
partialDate
C2985846 (UMLS CUI [1,1])
C2347796 (UMLS CUI [1,2])
Item
Was the event serious?
text
C1705586 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Relationship between SAE and investigational product
Code List
Was the event serious?
CL Item
Yes (Y)
CL Item
No (N)
SAE Sequence Number
Item
SAE Sequence Number
integer
C1519255 (UMLS CUI [1,1])
C2348184 (UMLS CUI [1,2])
Version Number
Item
Version Number
integer
C1519255 (UMLS CUI [1,1])
C0333052 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
Case ID
Item
Case ID
text
C0868928 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
Randomisation Number
Item
Randomisation Number
integer
C0034656 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
OCEANS Code
Item
OCEANS Code
text
C0805701 (UMLS CUI [1])
Email Flag
Item
Email Flag
text
C1519255 (UMLS CUI [1,1])
C0013849 (UMLS CUI [1,2])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial