ID

41666

Description

Study ID: 110106 Clinical Study ID: 110106 Study Title: A single centre, randomized, double-blind, dose ascending, placebo-controlled study, in two parts, to evaluate the safety, tolerability and pharmacokinetics of escalating single and repeat inhaled doses of GSK573719 and placebo formulated with the excipient magnesium stearate, in healthy subjects and in a healthy population of Cytochrome P450 Isoenzyme 2D6 poor metabolisers. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00803673 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK573719, Placebo Study Indication: Pulmonary Disease, Chronic Obstructive

Keywords

Versions (1)
  1. 12/7/20 12/7/20 -
Copyright Holder

GlaxoSmithKline

Uploaded on

December 7, 2020

DOI

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License

Creative Commons BY 4.0
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Safety, tolerability and pharmacokinetics of GSK573719 and placebo formulated with the excipient magnesium stearate NCT00803673

English

Logs and Repeats - Adverse Event/ Concomitant Medication/ Repeat Assessment Check Question; Non-Serious Adverse Events; Serious Adverse Events

1 forms  
Date of Visit/ Assessment
Description

Date of Visit/ Assessment

Alias
UMLS CUI-1
C1320303
UMLS CUI-2
C2985720
Date of Visit/ Assessment
Description

Date of Visit/ Assessment

Data type

date

Alias
UMLS CUI [1,1]
C1320303
UMLS CUI [1,2]
C2985720
Adverse Event/ Concomitant Medication/ Repeat Assessment Check Questions
Description

Adverse Event/ Concomitant Medication/ Repeat Assessment Check Questions

Alias
UMLS CUI-1
C0877248
UMLS CUI-2
C2347852
UMLS CUI-3
C0205341
UMLS CUI-4
C0220825
Were any concomitant medications taken by the subject during the study?
Description

Were any concomitant medications taken by the subject during the study?

Data type

boolean

Alias
UMLS CUI [1]
C2347852
UMLS CUI [2,1]
C0008976
UMLS CUI [2,2]
C0347984
Did the subject experience any non-serious adverse events during the study?
Description

Did the subject experience any non-serious adverse events during the study?

Data type

boolean

Alias
UMLS CUI [1]
C1518404
UMLS CUI [2,1]
C0008976
UMLS CUI [2,2]
C0347984
Did the subject experience any serious adverse event during the study?
Description

Did the subject experience any serious adverse event during the study?

Data type

boolean

Alias
UMLS CUI [1]
C1519255
UMLS CUI [2,1]
C0008976
UMLS CUI [2,2]
C0347984
Were any abnormal, clinically significant ECG measurements recorded for this subject during the study?
Description

Were any abnormal, clinically significant ECG measurements recorded for this subject during the study?

Data type

boolean

Alias
UMLS CUI [1]
C0522055
Were any repeat haematology or clinical chemistry samples taken?
Description

Were any repeat haematology or clinical chemistry samples taken?

Data type

boolean

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0200345
UMLS CUI [2,1]
C0018941
UMLS CUI [2,2]
C0200345
Were any repeat ECGs performed?
Description

Were any repeat ECGs performed?

Data type

boolean

Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C0205341
Were any repeat vital signs recorded?
Description

Were any repeat vital signs recorded?

Data type

boolean

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0205341
Were any repeat PK blood samples taken?
Description

Were any repeat PK blood samples taken?

Data type

boolean

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C0205341
Were any repeat Pulmonary Function Tests performed?
Description

Were any repeat Pulmonary Function Tests performed?

Data type

boolean

Alias
UMLS CUI [1,1]
C0024119
UMLS CUI [1,2]
C0205341
Was any repeat Holter monitoring performed?
Description

Was any repeat Holter monitoring performed?

Data type

boolean

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C0205341
Non-Serious Adverse Event
Description

Non-Serious Adverse Event

Alias
UMLS CUI-1
C1518404
Non-Serious Adverse Event Sequence Number
Description

Non-Serious Adverse Event Sequence Number

Data type

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2348184
Non-Serious Adverse Event
Description

Diagnosis Only (if known) Otherwise Sign/Symptom

Data type

text

Alias
UMLS CUI [1]
C1518404
Non-Serious Adverse Event - Modified term
Description

Non-Serious Adverse Event - Modified term

Data type

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C2826798
Non-Serious Adverse Event MedDRA synonym
Description

Non-Serious Adverse Event MedDRA synonym

Data type

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C1140263
Non-Serious Adverse Event MedDRA lower level term code
Description

Non-Serious Adverse Event MedDRA lower level term code

Data type

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C3898442
Non-Serious Adverse Event - Failed coding
Description

Non-Serious Adverse Event - Failed coding

Data type

text

Alias
UMLS CUI [1]
C1518404
UMLS CUI [2,1]
C0805701
UMLS CUI [2,2]
C0231175
Non-Serious Adverse Event - Start Date
Description

Non-Serious Adverse Event - Start Date

Data type

date

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0808070
Non-Serious Adverse Event - Start Time
Description

Non-Serious Adverse Event - Start Time

Data type

time

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C1301880
Non-Serious Adverse Event Outcome
Description

Non-Serious Adverse Event Outcome

Data type

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C1705586
Non-Serious Adverse Event End Date
Description

Non-Serious Adverse Event End Date

Data type

date

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0806020
Non-Serious Adverse Event - End Time
Description

Non-Serious Adverse Event - End Time

Data type

time

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C1522314
Non-Serious Adverse Event Frequency
Description

Non-Serious Adverse Event Frequency

Data type

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0439603
Non-Serious Adverse Event - Maximum Intensity
Description

Non-Serious Adverse Event - Maximum Intensity

Data type

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0518690
UMLS CUI [1,3]
C0806909
Non-Serious Adverse Event - Maximum Grade
Description

Non-Serious Adverse Event - Maximum Grade

Data type

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0441800
UMLS CUI [1,3]
C0806909
Non-Serious Adverse Event - Maximum Grade or Intensity
Description

Non-Serious Adverse Event - Maximum Grade or Intensity

Data type

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0441800
UMLS CUI [1,3]
C0518690
UMLS CUI [1,4]
C0806909
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]
C1518404
Did the subject withdraw from study as a result of this AE?
Description

Did the subject withdraw from study as a result of this AE?

Data type

boolean

Alias
UMLS CUI [1,1]
C1710677
UMLS CUI [1,2]
C1518404
Is there a reasonable possibility that the AE may have been caused by the investigational product?
Description

Is there a reasonable possibility that the AE may have been caused by the investigational product?

Data type

boolean

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0013230
UMLS CUI [1,3]
C0439849
Duration of AE if < 24 hours
Description

Duration of AE if < 24 hours

Data type

integer

Measurement units
  • h
Alias
UMLS CUI [1,1]
C0449238
UMLS CUI [1,2]
C1518404
h
Duration of AE if < 24 hours
Description

Duration of AE if < 24 hours

Data type

integer

Measurement units
  • min
Alias
UMLS CUI [1,1]
C0449238
UMLS CUI [1,2]
C1518404
min
Serious Adverse Event - Type of Report
Description

Serious Adverse Event - Type of Report

Alias
UMLS CUI-1
C3897642
UMLS CUI-2
C0332307
Initial Report
Description

Initial Report

Data type

integer

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

Follow-Up Report

Data type

integer

Alias
UMLS CUI [1]
C1704685
Serious Adverse Event - Randomisation
Description

Serious Adverse Event - Randomisation

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

Did SAE occur after initiation of study medication?

Data type

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0304229
Serious Adverse Event
Description

Serious Adverse Event

Alias
UMLS CUI-1
C1519255
SAE Sequence Number
Description

SAE Sequence Number

Data type

integer

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

Diagnosis Only (if known) Otherwise Sign/Symptom

Data type

text

Alias
UMLS CUI [1]
C1519255
Serious Adverse Event - Modified Term
Description

Serious Adverse Event - Modified Term

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2826798
Serious Adverse Event - MedDRA synonym
Description

Serious Adverse Event - MedDRA synonym

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1140263
Serious Adverse Event - MedDRA lower level term code
Description

Serious Adverse Event - MedDRA lower level term code

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C3898442
Serious Adverse Event - Failed coding
Description

Serious Adverse Event - Failed coding

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0805701
UMLS CUI [1,3]
C0231175
Serious Adverse Event - Start Date
Description

Serious Adverse Event - Start Date

Data type

date

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0808070
Serious Adverse Event - Start Time
Description

Serious Adverse Event - Start Time

Data type

time

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1301880
Serious Adverse Event - Outcome
Description

Serious Adverse Event - Outcome

Data type

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1705586
Serious Adverse Event - End Date
Description

Serious Adverse Event - End Date

Data type

date

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0806020
Serious Adverse Event - End Time
Description

Serious Adverse Event - End Time

Data type

time

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1522314
Serious Adverse Event - Maximum Intensity
Description

Serious Adverse Event - Maximum Intensity

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0518690
UMLS CUI [1,3]
C0806909
Serious Adverse Event - Maximum Grade
Description

Serious Adverse Event - Maximum Grade

Data type

integer

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

Serious Adverse Event - Maximum Grade or Intensity

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0441800
UMLS CUI [1,3]
C0518690
UMLS CUI [1,4]
C0806909
Action Taken with Investigational Product(s) as a Result of the SAE
Description

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

Data type

text

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

Serious Adverse Event - Did the subject withdraw from study as a result of this AE?

Data type

boolean

Alias
UMLS CUI [1,1]
C1710677
UMLS CUI [1,2]
C1519255
Is there a reasonable possibility that the SAE may have been caused by the investigational product?
Description

Is there a reasonable possibility that the SAE may have been caused by the investigational product?

Data type

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0013230
UMLS CUI [1,3]
C0439849
Duration of SAE if < 24 hours
Description

Duration of SAE if < 24 hours

Data type

integer

Measurement units
  • h
Alias
UMLS CUI [1,1]
C0449238
UMLS CUI [1,2]
C1519255
h
Duration of SAE if < 24 hours
Description

Duration of SAE if < 24 hours

Data type

integer

Measurement units
  • min
Alias
UMLS CUI [1,1]
C0449238
UMLS CUI [1,2]
C1519255
min
Was SAE caused by activities related to study participation (e.g. procedures)?
Description

Was SAE caused by activities related to study participation (e.g. procedures)?

Data type

boolean

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

Was the event serious?

Data type

boolean

Alias
UMLS CUI [1]
C1519255
Serious Adverse Event - Seriousness
Description

Serious Adverse Event - Seriousness

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C1710056
Seriousness?
Description

Seriousness?

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1710056
Serious Adverse Event - Relevant Concomitant/ Treatment Medications
Description

Serious Adverse Event - Relevant Concomitant/ Treatment Medications

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C2347852
UMLS CUI-3
C2347946
UMLS CUI-4
C0304229
CM Sequence Number
Description

CM Sequence Number

Data type

integer

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

Concomitant medication - Drug name

Data type

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C2347852
Concomitant medication dose
Description

Concomitant medication dose

Data type

float

Alias
UMLS CUI [1,1]
C3174092
UMLS CUI [1,2]
C2347852
Concomitant medication unit
Description

Concomitant medication unit

Data type

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C1519795
Concomitant medication frequency
Description

Concomitant medication frequency

Data type

text

Alias
UMLS CUI [1,1]
C3476109
UMLS CUI [1,2]
C2347852
Concomitant medication route
Description

Medication Route

Data type

text

Alias
UMLS CUI [1,1]
C0013153
UMLS CUI [1,2]
C2347852
Concomitant medication start date
Description

Concomitant medication start date

Data type

date

Alias
UMLS CUI [1]
C2826734
Concomitant Medication continuing?
Description

Concomitant Medication continuing?

Data type

boolean

Alias
UMLS CUI [1]
C2826666
If concomitant medication is not ongoing, specify end date.
Description

If concomitant medication is not ongoing, specify end date.

Data type

date

Alias
UMLS CUI [1]
C2826744
Concomitant medication - Primary Indication
Description

Concomitant medication - Primary Indication

Data type

text

Alias
UMLS CUI [1]
C2826696
Concomitant medication - Drug type
Description

Concomitant medication - Drug type

Data type

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0457591
Serious Adverse Events - Relevant Medical Conditions/ Risk Factors
Description

Serious Adverse Events - Relevant Medical Conditions/ Risk Factors

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

MHx Sequence Number

Data type

integer

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

Specific Condition Name

Data type

text

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

Medical Condition - Date of onset

Data type

date

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

Medical Condition - Continuing?

Data type

text

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0549178
Medical Condition - Date of last occurence
Description

Medical Condition - Date of last occurence

Data type

date

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C2745955
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C1517741
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]
C0262926
UMLS CUI [1,2]
C0035648
Serious Adverse Event - Relevant Diagnostic Results
Description

Serious Adverse Event - Relevant Diagnostic Results

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

Lab Sequence Number

Data type

integer

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

Test Name

Data type

integer

Alias
UMLS CUI [1]
C0022885
Test Date
Description

Test Date

Data type

date

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

integer

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

Normal High Range

Data type

integer

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

Relevant diagnostic results not noted above

Data type

text

Alias
UMLS CUI [1]
C0587081
Serious Adverse Event - Investigational Product
Description

Serious Adverse Event - 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?
Description

If Investigational product(s) stopped, did the reported event(s) recur after further investigational product(s) were administered?

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0034897
UMLS CUI [1,3]
C0304229
UMLS CUI [1,4]
C0457454
General Narrative Comments
Description

General Narrative Comments

Alias
UMLS CUI-1
C0947611
General Narrative Comments
Description

General Narrative Comments

Data type

text

Alias
UMLS CUI [1]
C0947611
Serious Adverse Event - Non clinical
Description

Serious Adverse Event - Non clinical

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0205210
Send incomplete SAE data to GSK Safety
Description

Send incomplete SAE data to GSK Safety

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1511726
UMLS CUI [1,3]
C0205257
Receipt by GSK date
Description

Receipt by GSK date

Data type

datetime

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

Was the event serious?

Data type

boolean

Alias
UMLS CUI [1]
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

text

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

Case ID

Data type

text

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

Randomisation Number

Data type

text

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0237753
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]
C0013849
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Similar models

Logs and Repeats - Adverse Event/ Concomitant Medication/ Repeat Assessment Check Question; Non-Serious Adverse Events; Serious Adverse Events

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Date of Visit/ Assessment
C1320303 (UMLS CUI-1)
C2985720 (UMLS CUI-2)
Date of Visit/ Assessment
Item
Date of Visit/ Assessment
date
C1320303 (UMLS CUI [1,1])
C2985720 (UMLS CUI [1,2])
Item Group
Adverse Event/ Concomitant Medication/ Repeat Assessment Check Questions
C0877248 (UMLS CUI-1)
C2347852 (UMLS CUI-2)
C0205341 (UMLS CUI-3)
C0220825 (UMLS CUI-4)
Were any concomitant medications taken by the subject during the study?
Item
Were any concomitant medications taken by the subject during the study?
boolean
C2347852 (UMLS CUI [1])
C0008976 (UMLS CUI [2,1])
C0347984 (UMLS CUI [2,2])
Did the subject experience any non-serious adverse events during the study?
Item
Did the subject experience any non-serious adverse events during the study?
boolean
C1518404 (UMLS CUI [1])
C0008976 (UMLS CUI [2,1])
C0347984 (UMLS CUI [2,2])
Did the subject experience any serious adverse event during the study?
Item
Did the subject experience any serious adverse event during the study?
boolean
C1519255 (UMLS CUI [1])
C0008976 (UMLS CUI [2,1])
C0347984 (UMLS CUI [2,2])
Were any abnormal, clinically significant ECG measurements recorded for this subject during the study?
Item
Were any abnormal, clinically significant ECG measurements recorded for this subject during the study?
boolean
C0522055 (UMLS CUI [1])
Were any repeat haematology or clinical chemistry samples taken?
Item
Were any repeat haematology or clinical chemistry samples taken?
boolean
C0008000 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C0018941 (UMLS CUI [2,1])
C0200345 (UMLS CUI [2,2])
Were any repeat ECGs performed?
Item
Were any repeat ECGs performed?
boolean
C1623258 (UMLS CUI [1,1])
C0205341 (UMLS CUI [1,2])
Were any repeat vital signs recorded?
Item
Were any repeat vital signs recorded?
boolean
C0518766 (UMLS CUI [1,1])
C0205341 (UMLS CUI [1,2])
Were any repeat PK blood samples taken?
Item
Were any repeat PK blood samples taken?
boolean
C0031328 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0205341 (UMLS CUI [1,3])
Were any repeat Pulmonary Function Tests performed?
Item
Were any repeat Pulmonary Function Tests performed?
boolean
C0024119 (UMLS CUI [1,1])
C0205341 (UMLS CUI [1,2])
Was any repeat Holter monitoring performed?
Item
Was any repeat Holter monitoring performed?
boolean
C0013801 (UMLS CUI [1,1])
C0205341 (UMLS CUI [1,2])
Item Group
Non-Serious Adverse Event
C1518404 (UMLS CUI-1)
Non-Serious Adverse Event Sequence Number
Item
Non-Serious Adverse Event Sequence Number
integer
C1519255 (UMLS CUI [1,1])
C2348184 (UMLS CUI [1,2])
Non-Serious Adverse Event
Item
Non-Serious Adverse Event
text
C1518404 (UMLS CUI [1])
Non-Serious Adverse Event - Modified term
Item
Non-Serious Adverse Event - Modified term
text
C1518404 (UMLS CUI [1,1])
C2826798 (UMLS CUI [1,2])
Non-Serious Adverse Event MedDRA synonym
Item
Non-Serious Adverse Event MedDRA synonym
text
C1518404 (UMLS CUI [1,1])
C1140263 (UMLS CUI [1,2])
Non-Serious Adverse Event MedDRA lower level term code
Item
Non-Serious Adverse Event MedDRA lower level term code
text
C1518404 (UMLS CUI [1,1])
C3898442 (UMLS CUI [1,2])
Non-Serious Adverse Event - Failed coding
Item
Non-Serious Adverse Event - Failed coding
text
C1518404 (UMLS CUI [1])
C0805701 (UMLS CUI [2,1])
C0231175 (UMLS CUI [2,2])
Non-Serious Adverse Event - Start Date
Item
Non-Serious Adverse Event - Start Date
date
C1518404 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Non-Serious Adverse Event - Start Time
Item
Non-Serious Adverse Event - Start Time
time
C1518404 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
Item
Non-Serious Adverse Event Outcome
integer
C1518404 (UMLS CUI [1,1])
C1705586 (UMLS CUI [1,2])
Non-Serious Adverse Event Outcome
Code List
Non-Serious Adverse Event Outcome
CL Item
Recovered/Resolved, provide End Date (1)
CL Item
Recovering/Resolving (2)
CL Item
Not recovered/Not resolved (3)
CL Item
Recovered/Resolved with sequelae, provide End Date (4)
Non-Serious Adverse Event End Date
Item
Non-Serious Adverse Event End Date
date
C1518404 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Non-Serious Adverse Event - End Time
Item
Non-Serious Adverse Event - End Time
time
C1518404 (UMLS CUI [1,1])
C1522314 (UMLS CUI [1,2])
Item
Non-Serious Adverse Event Frequency
integer
C1518404 (UMLS CUI [1,1])
C0439603 (UMLS CUI [1,2])
Non-Serious Adverse Event Frequency
Code List
Non-Serious Adverse Event Frequency
CL Item
Single Episode (1)
CL Item
Intermittent (2)
Item
Non-Serious Adverse Event - Maximum Intensity
text
C1518404 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
Non-Serious Adverse Event - Maximum Intensity
Code List
Non-Serious Adverse Event - Maximum Intensity
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Not applicable (X)
Item
Non-Serious Adverse Event - Maximum Grade
integer
C1518404 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
Non-Serious Adverse Event - Maximum Grade
Code List
Non-Serious Adverse Event - Maximum Grade
CL Item
Grade 1 (1)
CL Item
Grade 2 (2)
CL Item
Grade 3 (3)
CL Item
Grade 4 (4)
Item
Non-Serious Adverse Event - Maximum Grade or Intensity
text
C1518404 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,3])
C0806909 (UMLS CUI [1,4])
Non-Serious Adverse Event - Maximum Grade or Intensity
Code List
Non-Serious Adverse Event - 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 [1,1])
C1518404 (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)
Did the subject withdraw from study as a result of this AE?
Item
Did the subject withdraw from study as a result of this AE?
boolean
C1710677 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Is there a reasonable possibility that the AE may have been caused by the investigational product?
Item
Is there a reasonable possibility that the AE may have been caused by the investigational product?
boolean
C1518404 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
Duration of AE if < 24 hours
Item
Duration of AE if < 24 hours
integer
C0449238 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Duration of AE if < 24 hours
Item
Duration of AE if < 24 hours
integer
C0449238 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Item Group
Serious Adverse Event - Type of Report
C3897642 (UMLS CUI-1)
C0332307 (UMLS CUI-2)
Item
Initial Report
integer
C0684224 (UMLS CUI [1,1])
C0205265 (UMLS CUI [1,2])
Initial Report
Code List
Initial Report
CL Item
Initial (1)
Item
Follow-Up Report
integer
C1704685 (UMLS CUI [1])
Follow-Up Report
Code List
Follow-Up Report
CL Item
Follow-Up (2)
Item Group
Serious Adverse Event - Randomisation
C1519255 (UMLS CUI-1)
C0034656 (UMLS CUI-2)
Did SAE occur after initiation of study medication?
Item
Did SAE occur after initiation of study medication?
boolean
C1519255 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Item Group
Serious Adverse Event
C1519255 (UMLS CUI-1)
SAE Sequence Number
Item
SAE Sequence Number
integer
C1519255 (UMLS CUI [1,1])
C2348184 (UMLS CUI [1,2])
Serious Adverse Event
Item
Serious Adverse Event
text
C1519255 (UMLS CUI [1])
Serious Adverse Event - Modified Term
Item
Serious Adverse Event - Modified Term
text
C1519255 (UMLS CUI [1,1])
C2826798 (UMLS CUI [1,2])
Serious Adverse Event - MedDRA synonym
Item
Serious Adverse Event - MedDRA synonym
text
C1519255 (UMLS CUI [1,1])
C1140263 (UMLS CUI [1,2])
Serious Adverse Event - MedDRA lower level term code
Item
Serious Adverse Event - MedDRA lower level term code
text
C1519255 (UMLS CUI [1,1])
C3898442 (UMLS CUI [1,2])
Serious Adverse Event - Failed coding
Item
Serious Adverse Event - Failed coding
text
C1519255 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,3])
Serious Adverse Event - Start Date
Item
Serious Adverse Event - Start Date
date
C1519255 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Serious Adverse Event - Start Time
Item
Serious Adverse Event - Start Time
time
C1519255 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
Item
Serious Adverse Event - Outcome
integer
C1519255 (UMLS CUI [1,1])
C1705586 (UMLS CUI [1,2])
Serious Adverse Event - Outcome
Code List
Serious Adverse Event - Outcome
CL Item
Recovered/Resolved, provide End Date (1)
CL Item
Recovering/Resolving (2)
CL Item
Not recovered/Not resolved (3)
CL Item
Recovered/Resolved with sequelae, provide End Date (4)
CL Item
Fatal, record Date of Death (5)
Serious Adverse Event - End Date
Item
Serious Adverse Event - End Date
date
C1519255 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Serious Adverse Event - End Time
Item
Serious Adverse Event - End Time
time
C1519255 (UMLS CUI [1,1])
C1522314 (UMLS CUI [1,2])
Item
Serious Adverse Event - Maximum Intensity
text
C1519255 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
Serious Adverse Event - Maximum Intensity
Code List
Serious Adverse Event - Maximum Intensity
CL Item
Mild  (1)
CL Item
Moderate  (2)
CL Item
Severe  (3)
CL Item
Not applicable (X)
Item
Serious Adverse Event - Maximum Grade
integer
C1519255 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
Serious Adverse Event - Maximum Grade
Code List
Serious Adverse Event - Maximum Grade
CL Item
Grade 1  (1)
CL Item
Grade 2  (2)
CL Item
Grade 3  (3)
CL Item
Grade 4 (4)
Item
Serious Adverse Event - Maximum Grade or Intensity
text
C1519255 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,3])
C0806909 (UMLS CUI [1,4])
Serious Adverse Event - Maximum Grade or Intensity
Code List
Serious Adverse Event - 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 SAE
text
C1704758 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Action Taken with Investigational Product(s) as a Result of the SAE
Code List
Action Taken with Investigational Product(s) as a Result of the SAE
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)
Serious Adverse Event - Did the subject withdraw from study as a result of this AE?
Item
Serious Adverse Event - Did the subject withdraw from study as a result of this AE?
boolean
C1710677 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Is there a reasonable possibility that the SAE may have been caused by the investigational product?
Item
Is there a reasonable possibility that the SAE may have been caused by the investigational product?
boolean
C1519255 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
Duration of SAE if < 24 hours
Item
Duration of SAE if < 24 hours
integer
C0449238 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Duration of SAE if < 24 hours
Item
Duration of SAE if < 24 hours
integer
C0449238 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Was SAE caused by activities related to study participation (e.g. procedures)?
Item
Was SAE caused by activities related to study participation (e.g. procedures)?
boolean
C1519255 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C0441655 (UMLS CUI [1,3])
C2348568 (UMLS CUI [1,4])
Was the event serious?
Item
Was the event serious?
boolean
C1519255 (UMLS CUI [1])
Item Group
Serious Adverse Event - Seriousness
C1519255 (UMLS CUI-1)
C1710056 (UMLS CUI-2)
Item
Seriousness?
text
C1519255 (UMLS CUI [1,1])
C1710056 (UMLS CUI [1,2])
Seriousness?
Code List
Seriousness?
CL Item
Results in death (A)
CL Item
Is life-threatening (B)
CL Item
Requires hospitalisation or prolongation of existing hospitalisation (C)
CL Item
Results in disability/incapacity (D)
CL Item
Congenital anomaly/birth defect (E)
CL Item
Other, specify within general narrative comment (F)
Item Group
Serious Adverse Event - Relevant Concomitant/ Treatment Medications
C1519255 (UMLS CUI-1)
C2347852 (UMLS CUI-2)
C2347946 (UMLS CUI-3)
C0304229 (UMLS CUI-4)
CM Sequence Number
Item
CM Sequence Number
integer
C2348184 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Concomitant medication - Drug name
Item
Concomitant medication - Drug name
text
C0013227 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Concomitant medication dose
Item
Concomitant medication dose
float
C3174092 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Item
Concomitant medication unit
text
C2347852 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
Medication Unit
Code List
Concomitant medication 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
Concomitant medication frequency
text
C3476109 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Medication Frequency
Code List
Concomitant medication frequency
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
Q12H  (2D)
CL Item
Continuous infusion  (CO)
CL Item
Every 2 weeks  (FO)
CL Item
Every 3 weeks  (Q3W)
CL Item
Every 3 months  (Q3M)
CL Item
Every other day  (AD)
CL Item
QPM  (1N)
CL Item
Once a month  (MO)
CL Item
Once a week  (WE)
CL Item
Once daily  (1D)
CL Item
Once only  (1S)
CL Item
PC  (PC)
CL Item
PRN  (PRN)
CL Item
Q2H  (12D)
CL Item
Q3D  (Q3D)
CL Item
Q4D  (Q4D)
CL Item
Q4H  (6D)
CL Item
QID  (4D)
CL Item
TID  (3D)
CL Item
Q12H  (2D)
CL Item
QAM  (1M)
CL Item
QH  (24D)
CL Item
QID  (4D)
CL Item
QPM  (1N)
CL Item
TID  (3D)
CL Item
Unknown (U)
Item
Concomitant medication route
text
C0013153 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Medication Route
Code List
Concomitant medication route
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
Nasal  (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)
Concomitant medication start date
Item
Concomitant medication start date
date
C2826734 (UMLS CUI [1])
Concomitant Medication continuing?
Item
Concomitant Medication continuing?
boolean
C2826666 (UMLS CUI [1])
If concomitant medication is not ongoing, specify end date.
Item
If concomitant medication is not ongoing, specify end date.
date
C2826744 (UMLS CUI [1])
Concomitant medication - Primary Indication
Item
Concomitant medication - Primary Indication
text
C2826696 (UMLS CUI [1])
Item
Concomitant medication - Drug type
text
C2347852 (UMLS CUI [1,1])
C0457591 (UMLS CUI [1,2])
Concomitant medication - Drug type
Code List
Concomitant medication - Drug type
CL Item
Concomitant  (2)
CL Item
Treatment  (T)
CL Item
Cause of SAE (1)
Item Group
Serious Adverse Events - Relevant Medical Conditions/ Risk Factors
C1519255 (UMLS CUI-1)
C0262926 (UMLS CUI-2)
C0035648 (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])
Medical Condition - Date of onset
Item
Medical Condition - Date of onset
date
C0012634 (UMLS CUI [1,1])
C0574845 (UMLS CUI [1,2])
Item
Medical Condition - Continuing?
text
C0012634 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Medical Condition - Continuing?
Code List
Medical Condition - Continuing?
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Unknown (U)
Medical Condition - Date of last occurence
Item
Medical Condition - Date of last occurence
date
C0012634 (UMLS CUI [1,1])
C2745955 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C1517741 (UMLS CUI [1,4])
Relevant Medical History / Risk Factors not noted above
Item
Relevant Medical History / Risk Factors not noted above
text
C0262926 (UMLS CUI [1,1])
C0035648 (UMLS CUI [1,2])
Item Group
Serious Adverse Event - Relevant Diagnostic Results
C1519255 (UMLS CUI-1)
C0430022 (UMLS CUI-2)
C0456984 (UMLS CUI-3)
Lab Sequence Number
Item
Lab Sequence Number
integer
C0022885 (UMLS CUI [1,1])
C2348184 (UMLS CUI [1,2])
Item
Test Name
integer
C0022885 (UMLS CUI [1])
Test Name
Code List
Test Name
CL Item
Activated partial thromboplastin time (1)
CL Item
Albumin (2)
CL Item
Alkaline phosphatase (3)
CL Item
Amylase (4)
CL Item
Basophils (5)
CL Item
Bicarbonate (6)
CL Item
Bilirubin (7)
CL Item
Bilirubin direct (8)
CL Item
Bilirubin total (9)
CL Item
Blood myoglobin (10)
CL Item
Blood pH (11)
CL Item
Blood pressure (12)
CL Item
Blood urea nitrogen (13)
CL Item
Body temperature (14)
CL Item
Calcium (15)
CL Item
CD4 lymphocytes (16)
CL Item
CD8 lymphocytes (17)
CL Item
Chloride (18)
CL Item
Cholesterol total (19)
CL Item
C-reactive protein (20)
CL Item
Creatine (21)
CL Item
Creatine phosphokinase (22)
CL Item
Creatine phosphokinase MB (23)
CL Item
Creatinine (24)
CL Item
Creatinine clearance (25)
CL Item
Diastolic blood pressure (26)
CL Item
Eosinophils (27)
CL Item
Erythrocyte sedimentation rate (28)
CL Item
Fasting blood glucose (29)
CL Item
FEV 1 (30)
CL Item
Gamma-glutamyltransferase (31)
CL Item
Glutamic-oxaloacetic transferase (32)
CL Item
Glutamic-pyruvate transaminase (33)
CL Item
HbA1c (34)
CL Item
HBV-DNA decreased (35)
CL Item
HBV-DNA increased (36)
CL Item
Heart rate (37)
CL Item
Hematocrit (38)
CL Item
Hemoglobin (39)
CL Item
High density lipoprotein (40)
CL Item
HIV viral load (41)
CL Item
INR (42)
CL Item
Lactic dehydrogenase (43)
CL Item
Lipase (44)
CL Item
Low density lipoprotein (45)
CL Item
Lymphocytes (46)
CL Item
Magnesium (47)
CL Item
Mean cell hemoglobin concentration (48)
CL Item
Mean corpuscular hemoglobin (49)
CL Item
Mean corpuscular volume (50)
CL Item
Monocytes (51)
CL Item
Neutrophils (52)
CL Item
Oxygen saturation (53)
CL Item
pCO2 (54)
CL Item
pH (55)
CL Item
Phosphate (56)
CL Item
Platelet count (57)
CL Item
pO2 (58)
CL Item
Potassium (59)
CL Item
Protein total (60)
CL Item
Prothrombin time (61)
CL Item
Red blood cell count (62)
CL Item
Respiratory rate (63)
CL Item
Reticulocyte count (64)
CL Item
Serum glucose (65)
CL Item
Serum uric acid (66)
CL Item
Sodium (67)
CL Item
Systolic blood pressure (68)
CL Item
Thrombin time (69)
CL Item
Total lung capacity (70)
CL Item
Triglycerides (71)
CL Item
Troponin (72)
CL Item
Troponin I (73)
CL Item
Troponin T (74)
CL Item
Urine myoglobin (75)
CL Item
Urine pH (76)
CL Item
Vital capacity (77)
CL Item
White blood cell count (78)
Test Date
Item
Test Date
date
C2826247 (UMLS CUI [1])
Test Result
Item
Test Result
text
C0587081 (UMLS CUI [1])
Test Units
Item
Test Units
text
C1519795 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
Normal Low Range
Item
Normal Low Range
integer
C0086715 (UMLS CUI [1,1])
C0205251 (UMLS CUI [1,2])
Normal High Range
Item
Normal High Range
integer
C0086715 (UMLS CUI [1,1])
C0205250 (UMLS CUI [1,2])
Relevant diagnostic results not noted above
Item
Relevant diagnostic results not noted above
text
C0587081 (UMLS CUI [1])
Item Group
Serious Adverse Event - 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
C1519255 (UMLS CUI [1,1])
C0034897 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
C0457454 (UMLS CUI [1,4])
If Investigational product(s) stopped, did the reported event(s) recur after further investigational product(s) were administered?
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 Narrative Comments
Item
General Narrative Comments
text
C0947611 (UMLS CUI [1])
Item Group
Serious Adverse Event - Non clinical
C1519255 (UMLS CUI-1)
C0205210 (UMLS CUI-2)
Item
Send incomplete SAE data to GSK Safety
text
C1519255 (UMLS CUI [1,1])
C1511726 (UMLS CUI [1,2])
C0205257 (UMLS CUI [1,3])
Send incomplete SAE data to GSK Safety
Code List
Send incomplete SAE data to GSK Safety
CL Item
Incomplete SAE (3)
Receipt by GSK date
Item
Receipt by GSK date
datetime
C2985846 (UMLS CUI [1])
Was the event serious?
Item
Was the event serious?
boolean
C1519255 (UMLS CUI [1])
SAE Sequence Number
Item
SAE Sequence Number
integer
C1519255 (UMLS CUI [1,1])
C2348184 (UMLS CUI [1,2])
Version Number
Item
Version Number
text
C0333052 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Case ID
Item
Case ID
text
C1698493 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Randomisation Number
Item
Randomisation Number
text
C0034656 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
OCEANS Code
Item
OCEANS Code
text
C0805701 (UMLS CUI [1])
Email Flag
Item
Email Flag
text
C0013849 (UMLS CUI [1])
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