ID

39791

Beschreibung

Study ID: 110399 Clinical Study ID: 110399 Study Title: A randomized, double blind, parallel group, placebo controlled 28 day study to investigate the safety, tolerability and pharmacodynamics of SB-656933 in subjects with cystic fibrosis. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00903201 https://clinicaltrials.gov/ct2/show/NCT00903201?term=NCT00903201 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: SB656933, Placebo Trade Name: N/A Study Indication: Cystic Fibrosis The study consists of a screening, five study visits and a follow-up (time relative to Baseline in days): Visit 1: Screening, Day -28 to -16 Visit 2a: Day -7 to -4 Visit 2b: Day 1 Visit 3: Day 14 Visit 4: Day 21 Visit 5: Day 28 Visit 6: Early Withdrawal/ Follow-up, Day 35 to 42. From day 1 to day 28 the patients will receive daily doses. This document contains the SAE form. It has to be filled in if the subject experience a SAE during the study trial.

Link

https://clinicaltrials.gov/ct2/show/NCT00903201?term=NCT00903201

Stichworte

Versionen (1)
  1. 19.02.20 19.02.20 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

19. Februar 2020

DOI

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Lizenz

Creative Commons BY-NC 3.0
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Safety, tolerability and pharmacodynamics of Elubrixin in cystic fibrosis patients, NCT00903201

Englisch

Serious Adverse Event (SAE)

1 Formulare  
Administrative data
Beschreibung

Administrative data

Alias
UMLS CUI-1
C1320722
Subject Number
Beschreibung

Subject Number

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Type of report
Beschreibung

Type of report

Alias
UMLS CUI-1
C3897642
UMLS CUI-2
C0332307
Type of report
Beschreibung

Type of report

Datentyp

integer

Alias
UMLS CUI [1,1]
C3897642
UMLS CUI [1,2]
C0332307
Randomisation
Beschreibung

Randomisation

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

SAE occurrence after initiation of study medication

Datentyp

text

Alias
UMLS CUI [1,1]
C2745955
UMLS CUI [1,2]
C1519255
UMLS CUI [1,3]
C0304229
Serious Adverse Event (SAE)
Beschreibung

Serious Adverse Event (SAE)

Alias
UMLS CUI-1
C1519255
SAE Sequence Number
Beschreibung

In the original form this item is hidden.

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2348184
Serious Adverse Event
Beschreibung

Diagnosis Only (if known) Otherwise Sign/Symptom. An SAE is any untoward medical occurrence that, at any dose: - Results in death - Is life-threatening - Requires hospitalization or prolongation of existing hospitalization. - Results in disability/incapacity, or - Is a congenital anomaly/birth defect - Medical or scientific judgment should be exercised in deciding whether reporting is appropriate in other situations, such as important medical events that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the subject or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition. These should also be considered serious. Examples of such events are invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that do not result in hospitalization, or development of drug dependency or drug abuse. - Is associated with liver injury and impaired liver function defined as: ALT ≥ 3xULN, and total bilirubin ≥ 2xULN or INR > 1.5.

Datentyp

text

Alias
UMLS CUI [1]
C1519255
Modified term
Beschreibung

In the original form this item is hidden.

Datentyp

text

Alias
UMLS CUI [1,1]
C2826302
UMLS CUI [1,2]
C1519255
MedDRA synonym
Beschreibung

In the original form this item is hidden.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1140263
UMLS CUI [1,2]
C1519255
MedDRA lower level term code
Beschreibung

In the original form this item is hidden.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3898442
UMLS CUI [1,2]
C1519255
Failed coding
Beschreibung

In the original form this item is hidden.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0805701
UMLS CUI [1,2]
C0231175
UMLS CUI [1,3]
C1519255
SAE Start Date
Beschreibung

day month year

Datentyp

partialDate

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C1519255
SAE Start Time
Beschreibung

00:00-23:9

Datentyp

time

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1301880
Outcome of SAE
Beschreibung

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

Datentyp

integer

Alias
UMLS CUI [1,1]
C1624730
UMLS CUI [1,2]
C1519255
SAE end Date
Beschreibung

day month year

Datentyp

partialDate

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C1519255
SAE end Time
Beschreibung

00:00-23:59

Datentyp

time

Alias
UMLS CUI [1,1]
C1522314
UMLS CUI [1,2]
C1519255
Date of death
Beschreibung

day month year

Datentyp

partialDate

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1148348
Time of death
Beschreibung

00:00-23:59

Datentyp

time

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1301931
SAE intensity (maximum)
Beschreibung

Mild: An event which is easily tolerated Moderate: An event which is sufficiently discomforting to interfere with daily activity Severe: An event which prevents normal everyday activities.

Datentyp

text

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

SAE Maximum Grade

Datentyp

text

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

SAE Maximum Grade or Intensity

Datentyp

text

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

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

Datentyp

text

Alias
UMLS CUI [1]
C1547656
Did the subject withdraw from study as a result of this AE?
Beschreibung

Subject withdrawn

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0422727
Is there a reasonable possibility that the AE may have been caused by the investigational product?
Beschreibung

Relationship to Investigational Drug

Datentyp

text

Alias
UMLS CUI [1,1]
C0439849
UMLS CUI [1,2]
C3854006
Duration of AE if < 24 hours
Beschreibung

In the original form this item is hidden.

Datentyp

integer

Maßeinheiten
  • Hr(s)
Alias
UMLS CUI [1,1]
C0449238
UMLS CUI [1,2]
C1519255
Hr(s)
Duration of AE if < 1 hour
Beschreibung

In the original form this item is hidden.

Datentyp

integer

Maßeinheiten
  • Min(s)
Alias
UMLS CUI [1,1]
C0449238
UMLS CUI [1,2]
C1519255
Min(s)
Time of onset since last dose, hours
Beschreibung

In the original form this item is hidden.

Datentyp

integer

Maßeinheiten
  • Hr(s)
Alias
UMLS CUI [1,1]
C0449244
UMLS CUI [1,2]
C1762893
UMLS CUI [1,3]
C1519255
Hr(s)
Time of onset since last dose, mins
Beschreibung

In the original form this item is hidden.

Datentyp

integer

Maßeinheiten
  • Min(s)
Alias
UMLS CUI [1,1]
C0449244
UMLS CUI [1,2]
C1762893
UMLS CUI [1,3]
C1519255
Min(s)
Was SAE caused by activities related to study participation (e.g. procedure)?
Beschreibung

SAE caused by activities related to study participation

Datentyp

text

Alias
UMLS CUI [1,1]
C3641099
UMLS CUI [1,2]
C1519255
Was the event serious?
Beschreibung

In the original form this item is hidden.

Datentyp

text

Alias
UMLS CUI [1]
C1519255
Seriousness of SAE
Beschreibung

Seriousness of SAE

Alias
UMLS CUI-1
C1710056
Results in death
Beschreibung

Results in death

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0011065
UMLS CUI [1,2]
C1519255
Life threatening
Beschreibung

NOTE: The term 'life-threatening' in the definition of 'serious' refers to an event in which the subject was at risk of death at the time of the event. It does not refer to an event, which hypothetically might have caused death, if it were more severe.

Datentyp

boolean

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

NOTE: In general, hospitalisation signifies that the subject has been detained (usually involving at least an overnight stay) at the hospital or emergency ward for observation and/or treatment that would not have been appropriate in the physician's office or out-patient setting. Complications that occur during hospitalisation are AEs. If a complication prolongs hospitalisation or fulfils any other serious criteria, the event is serious. When in doubt as to whether ,,hospitalisation" occurred or was necessary, the AE should be considered serious. Hospitalisation for elective treatment ofa pre-existing condition that did not worsen from baseline is not considered anAE.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0019993
UMLS CUI [2,1]
C1519255
UMLS CUI [2,2]
C0745041
Results in disability/incapacity
Beschreibung

NOTE: The term disability means a substantial disruption ofa person's ability to conduct normal life functions. This definition is not intended to include experiences of relatively minor medical significance such as uncomplicated headache, nausea, vomiting, diarrhea, influenza, and accidental trauma (e.g. sprained ankle) which may interfere or prevent everyday life functions but do not consitute a substantial disruption.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0231170
Congenital anomaly/birth defect
Beschreibung

Congenital anomaly/birth defect

Datentyp

boolean

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

Medical or scientific judgement should be exercised in deciding whether reporting is appropriate in other situations, such as important medical events that may not be immediately life-threatening or result in death or hospitalisation but may jeopardize the subject or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition. These should also be considered serious. Examples of such events are invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that do not result in hospitalisation, or development of drug dependency or drug abuse.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3840932
UMLS CUI [1,2]
C1519255
If other reason, please specify
Beschreibung

Other reason, specification

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C3840932
UMLS CUI [1,3]
C1521902
Relevant concomitant/ treatment medications
Beschreibung

Relevant concomitant/ treatment medications

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C2347852
CM Sequence Number
Beschreibung

In the original form this item is hidden.

Datentyp

integer

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

(Trade Name preferred)

Datentyp

text

Alias
UMLS CUI [1]
C0013227
Dose of drug
Beschreibung

Dose of drug

Datentyp

text

Alias
UMLS CUI [1]
C0678766
Unit
Beschreibung

Unit

Datentyp

text

Alias
UMLS CUI [1]
C1519795
Frequency of medication
Beschreibung

Frequency of medication

Datentyp

text

Alias
UMLS CUI [1]
C3476109
Route of medication
Beschreibung

Route of medication

Datentyp

text

Alias
UMLS CUI [1]
C0013153
Start date of medication
Beschreibung

day month year

Datentyp

partialDate

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0808070
Medication ongoing?
Beschreibung

Medication ongoing

Datentyp

text

Alias
UMLS CUI [1]
C2826666
If not ongoing, specify End Date
Beschreibung

day month year

Datentyp

partialDate

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0806020
Primary Indication of medication
Beschreibung

Primary Indication of medication

Datentyp

text

Alias
UMLS CUI [1]
C2826696
Drug type
Beschreibung

Drug type

Datentyp

text

Alias
UMLS CUI [1]
C0457591
Relevant medical conditions/ risk factors
Beschreibung

Relevant medical conditions/ risk factors

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

In the original form this item is hidden.

Datentyp

integer

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

Specific Condition Name

Datentyp

text

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

day month year

Datentyp

partialDate

Alias
UMLS CUI [1]
C0574845
Disease continuing?
Beschreibung

Disease continuing

Datentyp

text

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0549178
If disease not continuing, specify date of last occurrence
Beschreibung

day month year

Datentyp

partialDate

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

Other Relevant Medical History/ Risk Factors

Datentyp

text

Alias
UMLS CUI [1,1]
C2347946
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C0012634
UMLS CUI [2,1]
C2347946
UMLS CUI [2,2]
C0205394
UMLS CUI [2,3]
C0035648
Relevant diagnostic results
Beschreibung

Relevant diagnostic results

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

In the original form this item is hidden.

Datentyp

integer

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

Test Name

Datentyp

text

Alias
UMLS CUI [1]
C0022885
Test Date
Beschreibung

day month year

Datentyp

partialDate

Alias
UMLS CUI [1]
C2826247
Test Result
Beschreibung

Test Result

Datentyp

text

Alias
UMLS CUI [1]
C0587081
Test Units
Beschreibung

Test Units

Datentyp

text

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

Normal Low Range

Datentyp

text

Alias
UMLS CUI [1,1]
C0086715
UMLS CUI [1,2]
C0205251
Normal High Range
Beschreibung

Normal High Range

Datentyp

text

Alias
UMLS CUI [1,1]
C0086715
UMLS CUI [1,2]
C0205250
Relevant diagnostic results not noted above
Beschreibung

Other relevant diagnostic results

Datentyp

text

Alias
UMLS CUI [1,1]
C0430022
UMLS CUI [1,2]
C0456984
UMLS CUI [1,3]
C0205394
Investigational product
Beschreibung

Investigational product

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0304229
If Investigational product(s) stopped, did the reported event(s) recur after further investigational product(s) were administered?
Beschreibung

Recurrence of event after further investigational product(s) administration

Datentyp

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
Beschreibung

General narrative comments

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

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

Datentyp

text

Alias
UMLS CUI [1,1]
C0947611
UMLS CUI [1,2]
C1519255
Non clinical
Beschreibung

Non clinical

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C2698490
Incomplete SAE
Beschreibung

Send incomplete SAE data to GSK Safety. In the original form this item is hidden.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1710056
UMLS CUI [1,2]
C0205257
Receipt by GSK date
Beschreibung

In the original form this item is hidden.

Datentyp

date

Alias
UMLS CUI [1]
C2985846
Was the event serious?
Beschreibung

In the original form this item is hidden.

Datentyp

text

Alias
UMLS CUI [1]
C1519255
SAE Sequence Number
Beschreibung

In the original form this item is hidden.

Datentyp

integer

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

In the original form this item is hidden.

Datentyp

integer

Alias
UMLS CUI [1,1]
C0333052
UMLS CUI [1,2]
C0237753
Case ID
Beschreibung

In the original form this item is hidden.

Datentyp

integer

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

In the original form this item is hidden.

Datentyp

integer

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

In the original form this item is hidden.

Datentyp

text

Alias
UMLS CUI [1]
C0805701
Email flag
Beschreibung

In the original form this item is hidden.

Datentyp

text

Alias
UMLS CUI [1]
C0013849
Zum Seitenanfang zurückkehren

Ähnliche Modelle

Serious Adverse Event (SAE)

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Subject Number
Item
Subject Number
text
C2348585 (UMLS CUI [1])
Item Group
Type of report
C3897642 (UMLS CUI-1)
C0332307 (UMLS CUI-2)
Item
Type of report
integer
C3897642 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Type of report
Code List
Type of report
CL Item
Initial (1)
CL Item
Follow-up (2)
Item Group
Randomisation
C0034656 (UMLS CUI-1)
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])
Corrective Therapy
Code List
Did SAE occur after initiation of study medication?
CL Item
Yes (Y)
CL Item
No (N)
Item Group
Serious Adverse Event (SAE)
C1519255 (UMLS CUI-1)
SAE Sequence Number
Item
SAE Sequence Number
text
C1519255 (UMLS CUI [1,1])
C2348184 (UMLS CUI [1,2])
Serious Adverse Event
Item
Serious Adverse Event
text
C1519255 (UMLS CUI [1])
Modified term
Item
Modified term
text
C2826302 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
MedDRA synonym
Item
MedDRA synonym
boolean
C1140263 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
MedDRA lower level term code
Item
MedDRA lower level term code
boolean
C3898442 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Failed coding
Item
Failed coding
boolean
C0805701 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
SAE Start Date
Item
SAE Start Date
partialDate
C0808070 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
SAE Start Time
Item
SAE Start Time
time
C1519255 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
Item
Outcome of SAE
integer
C1624730 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Outcome
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)
SAE end Date
Item
SAE end Date
partialDate
C0806020 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
SAE end Time
Item
SAE end Time
time
C1522314 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Date of death
Item
Date of death
partialDate
C1519255 (UMLS CUI [1,1])
C1148348 (UMLS CUI [1,2])
Time of death
Item
Time of death
time
C1519255 (UMLS CUI [1,1])
C1301931 (UMLS CUI [1,2])
Item
SAE intensity (maximum)
text
C0518690 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Intensity (maximum)
Code List
SAE intensity (maximum)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Not applicable (X)
Item
SAE Maximum Grade
text
C1519255 (UMLS CUI [1,1])
C0806909 (UMLS CUI [1,2])
C0441800 (UMLS CUI [1,3])
SAE 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
C1519255 (UMLS CUI [1,1])
C0806909 (UMLS CUI [1,2])
C0441800 (UMLS CUI [1,3])
C1519255 (UMLS CUI [2,1])
C0806909 (UMLS CUI [2,2])
C0518690 (UMLS CUI [2,3])
SAE Maximum Grade or Intensity
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
C1547656 (UMLS CUI [1])
Action Taken
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
Drug interrupted (5)
CL Item
Not applicable (X)
Item
Did the subject withdraw from study as a result of this AE?
text
C1519255 (UMLS CUI [1,1])
C0422727 (UMLS CUI [1,2])
Subject withdrawn
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])
C3854006 (UMLS CUI [1,2])
SAE recur
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, hours
Item
Duration of AE if < 24 hours
integer
C0449238 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Duration of AE, mins
Item
Duration of AE if < 1 hour
integer
C0449238 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Time of onset since last dose, hours
Item
Time of onset since last dose, hours
integer
C0449244 (UMLS CUI [1,1])
C1762893 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
Time of onset since last dose, mins
Item
Time of onset since last dose, mins
integer
C0449244 (UMLS CUI [1,1])
C1762893 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
Item
Was SAE caused by activities related to study participation (e.g. procedure)?
text
C3641099 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Randomization code broken
Code List
Was SAE caused by activities related to study participation (e.g. procedure)?
CL Item
Yes (Y)
CL Item
No (N)
Item
Was the event serious?
text
C1519255 (UMLS CUI [1])
Randomization code broken
Code List
Was the event serious?
CL Item
Yes (Y)
CL Item
No (N)
Item Group
Seriousness of SAE
C1710056 (UMLS CUI-1)
Results in death
Item
Results in death
boolean
C0011065 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Life threatening
Item
Life threatening
boolean
C1517874 (UMLS CUI [1])
Requires hospitalisation or prolongation of existing hospitalization
Item
Requires hospitalisation or prolongation of existing hospitalization
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
Results in disability/incapacity
boolean
C1519255 (UMLS CUI [1,1])
C0231170 (UMLS CUI [1,2])
Congenital anomaly/birth defect
Item
Congenital anomaly/birth defect
boolean
C0000768 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Other reason
Item
Other reason
boolean
C3840932 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Other reason, specification
Item
If other reason, please specify
text
C1519255 (UMLS CUI [1,1])
C3840932 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
Item Group
Relevant concomitant/ treatment medications
C1519255 (UMLS CUI-1)
C2347852 (UMLS CUI-2)
CM Sequence Number
Item
CM Sequence Number
integer
C2348184 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Drug name
Item
Drug name
text
C0013227 (UMLS CUI [1])
Dose of drug
Item
Dose of drug
text
C0678766 (UMLS CUI [1])
Item
Unit
text
C1519795 (UMLS CUI [1])
Unit
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 (MCG)  (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 of medication
text
C3476109 (UMLS CUI [1])
Frequency of medication
Code List
Frequency of medication
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
AC  (AC)
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
PC  (PC)
CL Item
PRN  (PRN)
CL Item
Q2H  (12D)
CL Item
Q3D  (Q3D)
CL Item
Q4D  (Q4D)
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
C0013227 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Item
Medication ongoing?
text
C2826666 (UMLS CUI [1])
Medication ongoing
Code List
Medication ongoing?
CL Item
Yes (Y)
CL Item
No (N)
End date of medication
Item
If not ongoing, specify End Date
partialDate
C0013227 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Primary Indication of medication
Item
Primary Indication of medication
text
C2826696 (UMLS CUI [1])
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
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])
Date of onset
Item
Date of onset
partialDate
C0574845 (UMLS CUI [1])
Item
Disease continuing?
text
C0012634 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Disease continuing
Code List
Disease continuing?
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Unknown (U)
Date of last occurrence
Item
If disease not continuing, specify date of last occurrence
partialDate
C1517741 (UMLS CUI [1,1])
C2745955 (UMLS CUI [1,2])
C0012634 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
Other Relevant Medical History/ Risk Factors
Item
Relevant Medical History/ Risk Factors not noted above
text
C2347946 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0012634 (UMLS CUI [1,3])
C2347946 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C0035648 (UMLS CUI [2,3])
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
text
C0086715 (UMLS CUI [1,1])
C0205251 (UMLS CUI [1,2])
Normal High Range
Item
Normal High Range
text
C0086715 (UMLS CUI [1,1])
C0205250 (UMLS CUI [1,2])
Other relevant diagnostic results
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 product
C1519255 (UMLS CUI-1)
C0304229 (UMLS CUI-2)
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 further investigational product(s) 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
C1519255 (UMLS CUI-1)
C0947611 (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
C1519255 (UMLS CUI-1)
C2698490 (UMLS CUI-2)
Incomplete SAE
Item
Incomplete SAE
boolean
C1710056 (UMLS CUI [1,1])
C0205257 (UMLS CUI [1,2])
Receipt by GSK date
Item
Receipt by GSK date
date
C2985846 (UMLS CUI [1])
Item
Was the event serious?
text
C1519255 (UMLS CUI [1])
Event serious
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
C0333052 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Case ID
Item
Case ID
integer
C1698493 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Randomisation Number
Item
Randomisation Number
integer
C0034656 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
OCEANS Code
Item
OCEANS Code
text
C0805701 (UMLS CUI [1])
Email flag
Item
Email flag
text
C0013849 (UMLS CUI [1])
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