ID

32844

Description

Study ID: 106827 Clinical Study ID: HZA106827 Study Title: HZA106827:A randomised, double-blind, placebo-controlled (with rescue medication), parallel group multicentre study of Fluticasone Furoate/GW642444 Inhalation Powder and Fluticasone Furoate Inhalation Powder alone in the treatment of persistent asthma in adults and adolescents Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01165138 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: fluticasone furoate/vilanterol Trade Name: Allermist,Veramyst,Avamys; Relvar Study Indication: Asthma

Keywords

Versions (2)
  1. 11/10/18 11/10/18 -
  2. 11/16/18 11/16/18 -
Copyright Holder

GlaxoSmithKline

Uploaded on

November 16, 2018

DOI

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License

Creative Commons BY-NC 3.0
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Fluticasone Furoate GW642444 Inhalation Powder and Fluticasone Furoate Inhalation Powder alone in the treatment of persistent asthma NCT01165138

English

SAE Status, Log Status, Subject Withdrawal Status, Serious Adverse Events, Non- Serious Adverse Event - Subjects Logs

1 forms  
SAE Log Status
Description

SAE Log Status

Alias
UMLS CUI-1
C1708728
UMLS CUI-2
C0449438
Did the subject experience a serious adverse event during the study?
Description

Serious adverse event during the study

Data type

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0008976
UMLS CUI [1,3]
C0347984
Log Status
Description

Log Status

Alias
UMLS CUI-1
C1708728
UMLS CUI-2
C0449438
Did the subject experience any non-serious adverse events during the study?
Description

Non-serious adverse events during the study

Data type

boolean

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0008976
UMLS CUI [1,3]
C0347984
Were any concomitant medications taken by the subject during the study?
Description

Concomitant medications

Data type

boolean

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0008976
UMLS CUI [1,3]
C0347984
Did the subject experience any protocol defined serious exacerbations during the study?
Description

Protocol defined serious exacerbations

Data type

boolean

Alias
UMLS CUI [1,1]
C4086268
UMLS CUI [1,2]
C0205404
Was a chest x-ray performed? (to confirm diagnosis of pneumonia)
Description

Chest x-ray

Data type

boolean

Alias
UMLS CUI [1]
C0039985
UMLS CUI [2]
C0032285
Did any device(s) supplied to die subject malfunction during the course of the study?
Description

Dvice(s) supplied to die subject malfunction

Data type

boolean

Alias
UMLS CUI [1]
C0699733
UMLS CUI [2,1]
C0231174
UMLS CUI [2,2]
C0681850
Did the subject have any unscheduled asthma related healthcare contacts (eg deteriorating asthma)?
Description

Unscheduled asthma related healthcare contacts

Data type

boolean

Alias
UMLS CUI [1,1]
C0086388
UMLS CUI [1,2]
C0004096
UMLS CUI [1,3]
C3854240
UMLS CUI [1,4]
C0332158
Subject Withdrawal Status
Description

Subject Withdrawal Status

Alias
UMLS CUI-1
C0422727
UMLS CUI-2
C0449438
Did the subject withdraw between visits?
Description

Subject withdraw between visits

Data type

boolean

Alias
UMLS CUI [1]
C0422727
UMLS CUI [2]
C0545082
Serious Adverse Event - Type of Report
Description

Serious Adverse Event - Type of Report

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0585733
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]
C1519255
UMLS CUI [2]
C0304229
Serious Adverse Event
Description

Serious Adverse Event

Alias
UMLS CUI-1
C1519255
SAE Sequence Number
Description

SAE Sequence Number

Data type

text

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

Serious Adverse Event Diagnosis / Sign/ Symptom

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0011900
UMLS CUI [2,1]
C1519255
UMLS CUI [2,2]
C0037088
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 Outcome
Description

Serious Adverse Event Outcome

Data type

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1547647
If Serious Adverse Event Outcome is "Recovered/ Resolved", provide End Date
Description

Serious Adverse Event Outcome is Recovered/ Resolved End Date

Data type

date

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1547647
UMLS CUI [1,3]
C1709863
UMLS CUI [1,4]
C0806020
If Serious Adverse Event Outcome is "Recovered/ Resolved with sequelae", provide End Date.
Description

Serious Adverse Event Outcome is Recovered/ Resolved End Date

Data type

date

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1547647
UMLS CUI [1,3]
C1709862
UMLS CUI [1,4]
C0806020
If Serious Adverse Event Outcome is fatal, record Date of Death.
Description

Serious Adverse Event Outcome is fatal, Date of Death

Data type

date

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1547647
UMLS CUI [1,3]
C1302234
UMLS CUI [1,4]
C1148348
Maximum Intensity of Serious Adverse Event
Description

Maximum Intensity of Serious Adverse Event

Data type

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0518690
UMLS CUI [1,3]
C0806909
Intensity at onset of event
Description

Intensity at onset of event

Data type

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0332162
UMLS CUI [1,3]
C0518690
Maximum Grade of Serious Adverse Event
Description

Maximum Grade of Serious Adverse Event

Data type

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0806909
UMLS CUI [1,3]
C0441800
Grade at onset of event
Description

Grade at onset of event

Data type

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0332162
UMLS CUI [1,3]
C0441800
Maximum Grade or Intensity of Serious Adverse Event
Description

Maximum Grade or Intensity of Serious Adverse Event

Data type

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0441800
UMLS CUI [1,3]
C0806909
UMLS CUI [2,1]
C1519255
UMLS CUI [2,2]
C0518690
UMLS CUI [2,3]
C0806909
Grade or Intensity at onset of event
Description

Grade or Intensity at onset of event

Data type

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0441800
UMLS CUI [1,3]
C0332162
UMLS CUI [2,1]
C1519255
UMLS CUI [2,2]
C0518690
UMLS CUI [2,3]
C0332162
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

integer

Alias
UMLS CUI [1,1]
C1704758
UMLS CUI [1,2]
C0877248
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]
C0422727
UMLS CUI [1,2]
C0877248
Is there a reasonable possibility that the AE may have been caused by the investigational product?
Description

AE may have been caused by the investigational product

Data type

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0085978
UMLS CUI [1,3]
C0304229
Duration of AE if < 24 hours [Hr(s):Min(s)]
Description

Duration of AE if < 24 hours

Data type

text

Measurement units
  • Hr(s):Min(s)
Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0449238
Hr(s):Min(s)
Time to Onset Since Last Dose [Hr(s):Min(s)]
Description

Time to Onset Since Last Dose

Data type

text

Alias
UMLS CUI [1,1]
C0332162
UMLS CUI [1,2]
C0040223
UMLS CUI [1,3]
C3174092
UMLS CUI [1,4]
C1517741
Was the SAE caused by activities related to study participation other than investigational product (e.g. procedures, blood draws, washout, etc)?
Description

SAE caused by activities related to study participation other than investigational product

Data type

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0085978
UMLS CUI [2,1]
C0441655
UMLS CUI [2,2]
C2348568
UMLS CUI [3]
C0304229
UMLS CUI [4]
C2700391
UMLS CUI [5]
C0005834
UMLS CUI [6]
C1710661
Was the event serious?
Description

Was the event serious?

Data type

boolean

Alias
UMLS CUI [1]
C1519255
Related investigational Product
Description

Related investigational Product

Data type

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0439849
Serious Adverse Event - Seriousness
Description

Serious Adverse Event - Seriousness

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C1710056
Seriousness of Adverse Event
Description

Seriousness of Adverse Event

Data type

text

Alias
UMLS CUI [1]
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-4
C1519255
UMLS CUI-5
C0013227
Drug Name
Description

Enter drug name, not description (Generic name preferred. If combination product, enter Trade name).

Data type

text

Alias
UMLS CUI [1]
C2360065
Drug dose
Description

Drug dose

Data type

text

Alias
UMLS CUI [1]
C0678766
Drug dose unit
Description

Drug dose unit

Data type

integer

Alias
UMLS CUI [1]
C2826646
Drug Frequency
Description

Drug Frequency

Data type

integer

Alias
UMLS CUI [1]
C3476109
Medication Route
Description

Medication Route

Data type

integer

Alias
UMLS CUI [1]
C0013153
Medication start date
Description

Medication start date

Data type

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0808070
Concomitant/ Treatment Medication ongoing?
Description

Concomitant/ Treatment Medication ongoing?

Data type

boolean

Alias
UMLS CUI [1]
C2826666
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0549178
If Concomitent/ Treatment Medication is not ongoing, specify End Date
Description

End Date of Concomitent/ Treatment Medication

Data type

date

Alias
UMLS CUI [1,1]
C2826666
UMLS CUI [1,2]
C0806020
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0549178
UMLS CUI [2,3]
C0806020
Primary Indication for Concomitant/ Treatment Medication
Description

Primary Indication for Concomitant/ Treatment Medication

Data type

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C3146298
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C3146298
Drug type
Description

Drug type

Data type

integer

Alias
UMLS CUI [1]
C0457591
Serious Adverse Event - Relevant Conditions/ Risk Factors
Description

Serious Adverse Event - Relevant Conditions/ Risk Factors

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0035648
UMLS CUI-3
C1519255
UMLS CUI-4
C0012634
Specific Condition Name
Description

Specific Condition Name

Data type

text

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C2348235
UMLS CUI [1,3]
C0027365
Date of onset
Description

Date of onset

Data type

date

Alias
UMLS CUI [1]
C0574845
Continuing medical condition/ risk factor?
Description

Continuing medical condition/ risk factor?

Data type

text

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0549178
UMLS CUI [2,1]
C0035648
UMLS CUI [2,2]
C0549178
If medical condition/ risk factor is not continuing, specify date of last occurence
Description

Medical condition/ risk factor date of last occurence

Data type

date

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C2745955
UMLS CUI [1,3]
C1517741
UMLS CUI [1,4]
C0011008
UMLS CUI [2,1]
C0035648
UMLS CUI [2,2]
C2745955
UMLS CUI [2,3]
C1517741
UMLS CUI [2,4]
C0011008
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

text

Alias
UMLS CUI [1,1]
C0022877
UMLS CUI [1,2]
C2348184
Test Name
Description

Test Name

Data type

integer

Alias
UMLS CUI [1]
C2826273
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]
C0456984
Test Units
Description

Test Units

Data type

text

Alias
UMLS CUI [1,1]
C0039593
UMLS CUI [1,2]
C1519795
Normal Low Range
Description

Normal Low Range

Data type

text

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

Normal High Range

Data type

text

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 [1,1]
C0430022
UMLS CUI [1,2]
C1274040
UMLS CUI [1,3]
C0205394
Serious Adverse Event - Rechallenge
Description

Serious Adverse Event - Rechallenge

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C2347900
If investigational product(s) were stopped temporarily, did the reported event(s) recur after investigational products were restarted?
Description

Recurrence of reported event(s) after investigational products were restarted

Data type

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0850893
UMLS CUI [1,3]
C0205374
UMLS CUI [2,1]
C1519255
UMLS CUI [2,2]
C0034897
UMLS CUI [3]
C0580673
Serious Adverse Event - Investigational Product
Description

Serious Adverse Event - Investigational Product

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0304229
Study Drug
Description

Study Drug

Data type

integer

Alias
UMLS CUI [1]
C0304229
Study Drug Regimen
Description

Study Drug Regimen

Data type

integer

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0237125
Study Drug Dose
Description

Study Drug Dose

Data type

integer

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0678766
Study Drug Frequency
Description

Study Drug Frequency

Data type

integer

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C3476109
Study Drug Course
Description

Study Drug Course

Data type

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0750729
Study Drug Start Date
Description

Study Drug Start Date

Data type

date

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0808070
Study Drug Stop Date
Description

Study Drug Stop Date

Data type

date

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0806020
Serious Adverse Event - General Narrative Comments
Description

Serious Adverse Event - General Narrative Comments

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0947611
UMLS CUI-3
C1135957
General Narrative Comments
Description

General Narrative Comments

Data type

text

Alias
UMLS CUI [1,1]
C0947611
UMLS CUI [1,2]
C1135957
Non- serious Adverse Event
Description

Non- serious Adverse Event

Alias
UMLS CUI-1
C1518404
Sequence Number
Description

Sequence Number

Data type

text

Alias
UMLS CUI [1]
C2348184
Event Diagnosis Only (if known) Otherwise Sign/ Symptom
Description

Event Diagnosis

Data type

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0011900
UMLS CUI [2,1]
C1518404
UMLS CUI [2,2]
C0037088
Start Date of Non- serious Adverse Event
Description

Start Date of Non- serious Adverse Event

Data type

date

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0808070
Non- serious Adverse Event Outcome
Description

Non- serious Adverse Event Outcome

Data type

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C1547647
If Non- Serious Adverse Event Outcome is "Recovered/ Resolved", provide End Date.
Description

Non- Serious Adverse Event Outcome Recovered/ Resolved End Date

Data type

date

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C1547647
UMLS CUI [1,3]
C1709863
UMLS CUI [1,4]
C0806020
If Non- Serious Adverse Event Outcome is Recovered/ Resolved with sequelae, provide End Date.
Description

Non- Serious Adverse Event Outcome is Recovered/ Resolved with sequelae End Date

Data type

date

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C1547647
UMLS CUI [1,3]
C1709862
UMLS CUI [1,4]
C0806020
Non- Serious Adverse Event Outcome is fatal, Date of Death If Serious Adverse Event Outcome is fatal, record Date of Death.
Description

Non- Serious Adverse Event Outcome is fatal, Date of Death

Data type

date

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C1547647
UMLS CUI [1,3]
C1302234
UMLS CUI [1,4]
C1148348
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
Maximum Intenity of Non- serious Adverse Event
Description

Maximum Intenity of Non- serious Adverse Event

Data type

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0518690
UMLS CUI [1,3]
C0806909
Intensity at onset of event
Description

Intensity at onset of event

Data type

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0332162
UMLS CUI [1,3]
C0518690
Maximum Grade of Non- Serious Adverse Event
Description

Maximum Grade of Non- Serious Adverse Event

Data type

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0806909
UMLS CUI [1,3]
C0441800
Grade at onset of event
Description

Grade at onset of event

Data type

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0332162
UMLS CUI [1,3]
C0441800
Maximum Grade or Intensity of Non- Serious Adverse Event
Description

Maximum Grade or Intensity of Non- Serious Adverse Event

Data type

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0441800
UMLS CUI [1,3]
C0806909
UMLS CUI [2,1]
C1518404
UMLS CUI [2,2]
C0518690
UMLS CUI [2,3]
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

integer

Alias
UMLS CUI [1,1]
C1704758
UMLS CUI [1,2]
C0877248
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]
C0422727
UMLS CUI [1,2]
C0877248
Is there a reasonable possibility that the AE may have been caused by the investigational product?
Description

AE may have been caused by the investigational product

Data type

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0085978
UMLS CUI [1,3]
C0304229
Duration of AE if < 24 hours [Hr(s):Min(s)]
Description

Duration of AE if < 24 hours

Data type

text

Measurement units
  • Hr(s):Min(s)
Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0449238
Hr(s):Min(s)
Time to Onset Since Last Dose [Hr(s):Min(s)]
Description

Time to Onset Since Last Dose

Data type

text

Measurement units
  • Hr(s):Min(s)
Alias
UMLS CUI [1,1]
C0332162
UMLS CUI [1,2]
C0040223
UMLS CUI [1,3]
C3174092
UMLS CUI [1,4]
C1517741
Hr(s):Min(s)
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SAE Status, Log Status, Subject Withdrawal Status, Serious Adverse Events, Non- Serious Adverse Event - Subjects Logs

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Type
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Data type
Alias
Item Group
SAE Log Status
C1708728 (UMLS CUI-1)
C0449438 (UMLS CUI-2)
Serious adverse event during the study
Item
Did the subject experience a serious adverse event during the study?
boolean
C1519255 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C0347984 (UMLS CUI [1,3])
Item Group
Log Status
C1708728 (UMLS CUI-1)
C0449438 (UMLS CUI-2)
Non-serious adverse events during the study
Item
Did the subject experience any non-serious adverse events during the study?
boolean
C1518404 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C0347984 (UMLS CUI [1,3])
Concomitant medications
Item
Were any concomitant medications taken by the subject during the study?
boolean
C2347852 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C0347984 (UMLS CUI [1,3])
Protocol defined serious exacerbations
Item
Did the subject experience any protocol defined serious exacerbations during the study?
boolean
C4086268 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
Chest x-ray
Item
Was a chest x-ray performed? (to confirm diagnosis of pneumonia)
boolean
C0039985 (UMLS CUI [1])
C0032285 (UMLS CUI [2])
Dvice(s) supplied to die subject malfunction
Item
Did any device(s) supplied to die subject malfunction during the course of the study?
boolean
C0699733 (UMLS CUI [1])
C0231174 (UMLS CUI [2,1])
C0681850 (UMLS CUI [2,2])
Unscheduled asthma related healthcare contacts
Item
Did the subject have any unscheduled asthma related healthcare contacts (eg deteriorating asthma)?
boolean
C0086388 (UMLS CUI [1,1])
C0004096 (UMLS CUI [1,2])
C3854240 (UMLS CUI [1,3])
C0332158 (UMLS CUI [1,4])
Item Group
Subject Withdrawal Status
C0422727 (UMLS CUI-1)
C0449438 (UMLS CUI-2)
Subject withdraw between visits
Item
Did the subject withdraw between visits?
boolean
C0422727 (UMLS CUI [1])
C0545082 (UMLS CUI [2])
Item Group
Serious Adverse Event - Type of Report
C1519255 (UMLS CUI-1)
C0585733 (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])
C0304229 (UMLS CUI [2])
Item Group
Serious Adverse Event
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 Diagnosis / Sign/ Symptom
Item
Serious Adverse Event Diagnosis Only (if known) Otherwise Sign/ Symptom
text
C1519255 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2,1])
C0037088 (UMLS CUI [2,2])
Serious Adverse Event Start Date
Item
Serious Adverse Event Start Date
date
C1519255 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Item
Serious Adverse Event Outcome
integer
C1519255 (UMLS CUI [1,1])
C1547647 (UMLS CUI [1,2])
Serious Adverse Event Outcome
Code List
Serious Adverse Event Outcome
CL Item
Recovered/Rsolved, provide End Date (1)
CL Item
Recovering/Resolving (2)
CL Item
Not recovered/Not resolved (3)
CL Item
Recovered/Rsolved with sequela, provide End Date (4)
CL Item
Fatal, record Date of Death (5)
Serious Adverse Event Outcome is Recovered/ Resolved End Date
Item
If Serious Adverse Event Outcome is "Recovered/ Resolved", provide End Date
date
C1519255 (UMLS CUI [1,1])
C1547647 (UMLS CUI [1,2])
C1709863 (UMLS CUI [1,3])
C0806020 (UMLS CUI [1,4])
Serious Adverse Event Outcome is Recovered/ Resolved End Date
Item
If Serious Adverse Event Outcome is "Recovered/ Resolved with sequelae", provide End Date.
date
C1519255 (UMLS CUI [1,1])
C1547647 (UMLS CUI [1,2])
C1709862 (UMLS CUI [1,3])
C0806020 (UMLS CUI [1,4])
Serious Adverse Event Outcome is fatal, Date of Death
Item
If Serious Adverse Event Outcome is fatal, record Date of Death.
date
C1519255 (UMLS CUI [1,1])
C1547647 (UMLS CUI [1,2])
C1302234 (UMLS CUI [1,3])
C1148348 (UMLS CUI [1,4])
Item
Maximum Intensity of Serious Adverse Event
integer
C1519255 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
Maximum Intensity of Serious Adverse Event
Code List
Maximum Intensity of Serious Adverse Event
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Not applicable (4)
Item
Intensity at onset of event
integer
C1519255 (UMLS CUI [1,1])
C0332162 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,3])
Intensity at onset of event
Code List
Intensity at onset of event
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Not applicable (4)
Item
Maximum Grade of Serious Adverse Event
integer
C1519255 (UMLS CUI [1,1])
C0806909 (UMLS CUI [1,2])
C0441800 (UMLS CUI [1,3])
Maximum Grade of Serious Adverse Event
Code List
Maximum Grade of Serious Adverse Event
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)
Item
Grade at onset of event
integer
C1519255 (UMLS CUI [1,1])
C0332162 (UMLS CUI [1,2])
C0441800 (UMLS CUI [1,3])
Grade at onset of event
Code List
Grade at onset of event
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)
Item
Maximum Grade or Intensity of Serious Adverse Event
integer
C1519255 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
C1519255 (UMLS CUI [2,1])
C0518690 (UMLS CUI [2,2])
C0806909 (UMLS CUI [2,3])
undefined item
Code List
Maximum Grade or Intensity of Serious Adverse Event
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
Not applicable (5)
Item
Grade or Intensity at onset of event
integer
C1519255 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
C0332162 (UMLS CUI [1,3])
C1519255 (UMLS CUI [2,1])
C0518690 (UMLS CUI [2,2])
C0332162 (UMLS CUI [2,3])
Grade or Intensity at onset of event
Code List
Grade or Intensity at onset of event
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
Not applicable (5)
Item
Action Taken with Investigational Product(s) as a Result of the AE
integer
C1704758 (UMLS CUI [1,1])
C0877248 (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 (6)
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
C0422727 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
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
C0877248 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
Duration of AE if < 24 hours
Item
Duration of AE if < 24 hours [Hr(s):Min(s)]
text
C0877248 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Time to Onset Since Last Dose
Item
Time to Onset Since Last Dose [Hr(s):Min(s)]
text
C0332162 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C3174092 (UMLS CUI [1,3])
C1517741 (UMLS CUI [1,4])
SAE caused by activities related to study participation other than investigational product
Item
Was the SAE caused by activities related to study participation other than investigational product (e.g. procedures, blood draws, washout, etc)?
boolean
C1519255 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C0441655 (UMLS CUI [2,1])
C2348568 (UMLS CUI [2,2])
C0304229 (UMLS CUI [3])
C2700391 (UMLS CUI [4])
C0005834 (UMLS CUI [5])
C1710661 (UMLS CUI [6])
Was the event serious?
Item
Was the event serious?
boolean
C1519255 (UMLS CUI [1])
Related investigational Product
Item
Related investigational Product
text
C0304229 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
Item Group
Serious Adverse Event - Seriousness
C1519255 (UMLS CUI-1)
C1710056 (UMLS CUI-2)
Item
Seriousness of Adverse Event
text
C1710056 (UMLS CUI [1])
Seriousness of Adverse Event
Code List
Seriousness of Adverse Event
CL Item
Result 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)
CL Item
Possible drug- induced liver injury (see definition in SAE section of protocol). (G)
Item Group
Serious Adverse Event - Relevant Concomitant/ Treatment Medications
C1519255 (UMLS CUI-1)
C2347852 (UMLS CUI-2)
C1519255 (UMLS CUI-4)
C0013227 (UMLS CUI-5)
Drug Name
Item
Drug Name
text
C2360065 (UMLS CUI [1])
Drug dose
Item
Drug dose
text
C0678766 (UMLS CUI [1])
Item
Drug dose unit
integer
C2826646 (UMLS CUI [1])
Drug dose unit
Code List
Drug dose unit
CL Item
Actuation (1)
CL Item
Ampoule (2)
CL Item
Application (3)
CL Item
Bottle (4)
CL Item
Capsule (5)
CL Item
Cubic centimeter (6)
CL Item
Drops (7)
CL Item
Gram (8)
CL Item
International units (9)
CL Item
International units per kilogram (10)
CL Item
International units per millilitre (11)
CL Item
Litre (12)
CL Item
Litre per minute (13)
CL Item
Lozenge (14)
CL Item
Megaunits (million units) (15)
CL Item
Microgram (MCG) (16)
CL Item
Microgram (UG) (17)
CL Item
Microgram/kilogram (18)
CL Item
Microgram/kilogram per minute (19)
CL Item
Micrograms per minute (20)
CL Item
Microlitre (21)
CL Item
Milliequivalent (22)
CL Item
Milliequivalent per 24 hours (23)
CL Item
Milligram (24)
CL Item
Milligrams percent (25)
CL Item
Milligram per hour (26)
CL Item
Milligram/kilogram (27)
CL Item
Milligram/kilogram per hour (28)
CL Item
Milligram/kilogram per minute (29)
CL Item
Milligram/metre squared (30)
CL Item
Milligram/millilitre (31)
CL Item
Millilitre (32)
CL Item
Millilitre per hour (33)
CL Item
Millilitre per minune (34)
CL Item
Millimole (35)
CL Item
Million international units (36)
CL Item
Minimum alveolar concentration (37)
CL Item
Nebule (38)
CL Item
Patch (39)
CL Item
Percent (40)
CL Item
Puff (41)
CL Item
Sachet (42)
CL Item
Spray (43)
CL Item
Suppository (44)
CL Item
Tablespoon (45)
CL Item
Tablet (46)
CL Item
Teaspoon (47)
CL Item
Units (48)
CL Item
Unknown (49)
CL Item
Vial (50)
Item
Drug Frequency
integer
C3476109 (UMLS CUI [1])
Drug Frequency
Code List
Drug Frequency
CL Item
2 times per week (1)
CL Item
3 times per week (2)
CL Item
4 times per week (3)
CL Item
5 times per day (4)
CL Item
5 times per week (5)
CL Item
AC (6)
CL Item
BID (7)
CL Item
Continuous infusion (8)
CL Item
Every 2 weeks (9)
CL Item
Every 3 weeks (10)
CL Item
Every 3 months (11)
CL Item
Every other day (12)
CL Item
At Bedtime (13)
CL Item
Once a month (14)
CL Item
Once a week (15)
CL Item
Once daily (16)
CL Item
Once only (17)
CL Item
PC (18)
CL Item
PRN (19)
CL Item
Q2H (20)
CL Item
Q3D (21)
CL Item
Q4D (22)
CL Item
Q4H (23)
CL Item
Q6H (24)
CL Item
Q8H (25)
CL Item
Q12H (26)
CL Item
QAM (27)
CL Item
QH (28)
CL Item
QID (29)
CL Item
QPM (30)
CL Item
TID (31)
CL Item
Unknown (32)
Item
Medication Route
integer
C0013153 (UMLS CUI [1])
Medication Route
Code List
Medication Route
CL Item
Both eyes (1)
CL Item
Epidural (2)
CL Item
Gastrostomy tube (3)
CL Item
Inhalation (4)
CL Item
Injection (5)
CL Item
Intra-arterial (6)
CL Item
Intra-bursal (7)
CL Item
Intralesional (8)
CL Item
Intramuscular (9)
CL Item
Intranasal (10)
CL Item
Intraocular (11)
CL Item
lntraosteal (12)
CL Item
Intraperitoneal (13)
CL Item
Intrathekal (14)
CL Item
Intrauterine (15)
CL Item
Intravenous (16)
CL Item
Nasal (17)
CL Item
Oral (18)
CL Item
Rectal (19)
CL Item
Subcutaneous (20)
CL Item
Sublingual (21)
CL Item
Topical (22)
CL Item
Transdermal (23)
CL Item
Unknown (24)
CL Item
Vaginal (25)
Medication start date
Item
Medication start date
date
C0013227 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Concomitant/ Treatment Medication ongoing?
Item
Concomitant/ Treatment Medication ongoing?
boolean
C2826666 (UMLS CUI [1])
C0013227 (UMLS CUI [2,1])
C0549178 (UMLS CUI [2,2])
End Date of Concomitent/ Treatment Medication
Item
If Concomitent/ Treatment Medication is not ongoing, specify End Date
date
C2826666 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C0013227 (UMLS CUI [2,1])
C0549178 (UMLS CUI [2,2])
C0806020 (UMLS CUI [2,3])
Primary Indication for Concomitant/ Treatment Medication
Item
Primary Indication for Concomitant/ Treatment Medication
text
C2347852 (UMLS CUI [1,1])
C3146298 (UMLS CUI [1,2])
C0013227 (UMLS CUI [2,1])
C3146298 (UMLS CUI [2,2])
Item
Drug type
integer
C0457591 (UMLS CUI [1])
Drug type
Code List
Drug type
CL Item
Concomitant (1)
CL Item
Treatment (2)
CL Item
Cause of SAE (3)
Item Group
Serious Adverse Event - Relevant Conditions/ Risk Factors
C1519255 (UMLS CUI-1)
C0035648 (UMLS CUI-2)
C1519255 (UMLS CUI-3)
C0012634 (UMLS CUI-4)
Specific Condition Name
Item
Specific Condition Name
text
C0012634 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
C0027365 (UMLS CUI [1,3])
Date of onset
Item
Date of onset
date
C0574845 (UMLS CUI [1])
Item
Continuing medical condition/ risk factor?
text
C0012634 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
C0035648 (UMLS CUI [2,1])
C0549178 (UMLS CUI [2,2])
Continuing medical condition/ risk factor?
Code List
Continuing medical condition/ risk factor?
CL Item
Yes (Y)
CL Item
No, specify date of last occurence (N)
CL Item
Unknown (U)
Medical condition/ risk factor date of last occurence
Item
If medical condition/ risk factor is not continuing, specify date of last occurence
date
C0012634 (UMLS CUI [1,1])
C2745955 (UMLS CUI [1,2])
C1517741 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
C0035648 (UMLS CUI [2,1])
C2745955 (UMLS CUI [2,2])
C1517741 (UMLS CUI [2,3])
C0011008 (UMLS CUI [2,4])
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
text
C0022877 (UMLS CUI [1,1])
C2348184 (UMLS CUI [1,2])
Item
Test Name
integer
C2826273 (UMLS CUI [1])
Test Name
Code List
Test Name
CL Item
Activated partial thromboplastin (1)
CL Item
Alanine Amino Transferase (2)
CL Item
Albumin (3)
CL Item
Alkaline phosphatase (4)
CL Item
Amylase (5)
CL Item
Aspartate Amino Transferase (6)
CL Item
Basophils (7)
CL Item
Bicarbonate (8)
CL Item
Bilirubin (9)
CL Item
Bilirubin direct (10)
CL Item
Bilirubin total (11)
CL Item
Blood myoglobin (12)
CL Item
Blood pH (13)
CL Item
Blood pressure (14)
CL Item
Blood urea nitrogen (15)
CL Item
Body temperature (16)
CL Item
Calcium (17)
CL Item
CD4 lymphoctes (18)
CL Item
CD8 lymphoctes (19)
CL Item
Chloride (20)
CL Item
Cholesterol total (21)
CL Item
C-reactive protein (22)
CL Item
Creatine (23)
CL Item
Creatine phosphokinase (24)
CL Item
Creatine phosphokinase MB (25)
CL Item
Creatinine (26)
CL Item
Creatinine clearance (27)
CL Item
Diastolic blood pressure (28)
CL Item
Eosinophils (29)
CL Item
Erythrocyte sedimentation rate (30)
CL Item
Fasting blood glucose (31)
CL Item
FEV1 (32)
CL Item
Gamma-glutamyltransferase (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
Lymphoctes (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
Reticilocyte 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 l (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
C0456984 (UMLS CUI [1])
Test Units
Item
Test Units
text
C0039593 (UMLS CUI [1,1])
C1519795 (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])
Relevant diagnostic results not noted above
Item
Relevant diagnostic results not noted above
text
C0430022 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
Item Group
Serious Adverse Event - Rechallenge
C1519255 (UMLS CUI-1)
C2347900 (UMLS CUI-2)
Item
If investigational product(s) were stopped temporarily, did the reported event(s) recur after investigational products were restarted?
text
C0304229 (UMLS CUI [1,1])
C0850893 (UMLS CUI [1,2])
C0205374 (UMLS CUI [1,3])
C1519255 (UMLS CUI [2,1])
C0034897 (UMLS CUI [2,2])
C0580673 (UMLS CUI [3])
undefined item
Code List
If investigational product(s) were stopped temporarily, did the reported event(s) recur after investigational products were restarted?
CL Item
No (N)
CL Item
Yes (Y)
CL Item
Unknown at this time (U)
CL Item
Not applicable (X)
Item Group
Serious Adverse Event - Investigational Product
C1519255 (UMLS CUI-1)
C0304229 (UMLS CUI-2)
Item
Study Drug
integer
C0304229 (UMLS CUI [1])
Study Drug
Code List
Study Drug
CL Item
Diskus (1)
CL Item
Novel dry powder inhaler (2)
Item
Study Drug Regimen
integer
C0304229 (UMLS CUI [1,1])
C0237125 (UMLS CUI [1,2])
Study Drug Regimen
Code List
Study Drug Regimen
CL Item
Regimen 1 (1)
CL Item
Regimen 2 (2)
CL Item
Regimen 3 (3)
Item
Study Drug Dose
integer
C0304229 (UMLS CUI [1,1])
C0678766 (UMLS CUI [1,2])
Study Drug Dose
Code List
Study Drug Dose
CL Item
Dose Level 1 (1)
CL Item
Dose Level 2 (2)
CL Item
Dose Level 3 (3)
Item
Study Drug Frequency
integer
C0304229 (UMLS CUI [1,1])
C3476109 (UMLS CUI [1,2])
Study Drug Frequency
Code List
Study Drug Frequency
CL Item
Frequency 1 (1)
CL Item
Frequency 2 (2)
CL Item
Frequency 3 (3)
Study Drug Course
Item
Study Drug Course
text
C0304229 (UMLS CUI [1,1])
C0750729 (UMLS CUI [1,2])
Study Drug Start Date
Item
Study Drug Start Date
date
C0304229 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Study Drug Stop Date
Item
Study Drug Stop Date
date
C0304229 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Item Group
Serious Adverse Event - General Narrative Comments
C1519255 (UMLS CUI-1)
C0947611 (UMLS CUI-2)
C1135957 (UMLS CUI-3)
General Narrative Comments
Item
General Narrative Comments
text
C0947611 (UMLS CUI [1,1])
C1135957 (UMLS CUI [1,2])
Item Group
Non- serious Adverse Event
C1518404 (UMLS CUI-1)
Sequence Number
Item
Sequence Number
text
C2348184 (UMLS CUI [1])
Event Diagnosis
Item
Event Diagnosis Only (if known) Otherwise Sign/ Symptom
text
C1518404 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C1518404 (UMLS CUI [2,1])
C0037088 (UMLS CUI [2,2])
Start Date of Non- serious Adverse Event
Item
Start Date of Non- serious Adverse Event
date
C1518404 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Item
Non- serious Adverse Event Outcome
integer
C1518404 (UMLS CUI [1,1])
C1547647 (UMLS CUI [1,2])
Non- serious Adverse Event Outcome
Code List
Non- serious Adverse Event Outcome
CL Item
Recovered/Rsolved, provide End Date (1)
CL Item
Recovering/Resolving (2)
CL Item
Not recovered/Not resolved (3)
CL Item
Recovered/Rsolved with sequela, provide End Date (4)
CL Item
Fatal, record Date of Death (5)
Non- Serious Adverse Event Outcome Recovered/ Resolved End Date
Item
If Non- Serious Adverse Event Outcome is "Recovered/ Resolved", provide End Date.
date
C1518404 (UMLS CUI [1,1])
C1547647 (UMLS CUI [1,2])
C1709863 (UMLS CUI [1,3])
C0806020 (UMLS CUI [1,4])
Non- Serious Adverse Event Outcome is Recovered/ Resolved with sequelae End Date
Item
If Non- Serious Adverse Event Outcome is Recovered/ Resolved with sequelae, provide End Date.
date
C1518404 (UMLS CUI [1,1])
C1547647 (UMLS CUI [1,2])
C1709862 (UMLS CUI [1,3])
C0806020 (UMLS CUI [1,4])
Non- Serious Adverse Event Outcome is fatal, Date of Death
Item
Non- Serious Adverse Event Outcome is fatal, Date of Death If Serious Adverse Event Outcome is fatal, record Date of Death.
date
C1518404 (UMLS CUI [1,1])
C1547647 (UMLS CUI [1,2])
C1302234 (UMLS CUI [1,3])
C1148348 (UMLS CUI [1,4])
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
Maximum Intenity of Non- serious Adverse Event
integer
C1518404 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
Maximum Intenity of Non- serious Adverse Event
Code List
Maximum Intenity of Non- serious Adverse Event
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Not applicable (4)
Item
Intensity at onset of event
integer
C1518404 (UMLS CUI [1,1])
C0332162 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,3])
Intensity at onset of event
Code List
Intensity at onset of event
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Not applicable (4)
Item
Maximum Grade of Non- Serious Adverse Event
integer
C1518404 (UMLS CUI [1,1])
C0806909 (UMLS CUI [1,2])
C0441800 (UMLS CUI [1,3])
Maximum Grade of Non- Serious Adverse Event
Code List
Maximum Grade of Non- Serious Adverse Event
CL Item
Garde 1 (1)
CL Item
Grade 2 (2)
CL Item
Grade 3 (3)
CL Item
Grade 4 (4)
Item
Grade at onset of event
integer
C1518404 (UMLS CUI [1,1])
C0332162 (UMLS CUI [1,2])
C0441800 (UMLS CUI [1,3])
Grade at onset of event
Code List
Grade at onset of event
CL Item
Garde 1 (1)
CL Item
Grade 2 (2)
CL Item
Grade 3 (3)
CL Item
Grade 4 (4)
CL Item
Grade 5 (5)
Item
Maximum Grade or Intensity of Non- Serious Adverse Event
integer
C1518404 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
C1518404 (UMLS CUI [2,1])
C0518690 (UMLS CUI [2,2])
C0806909 (UMLS CUI [2,3])
Maximum Grade or Intensity of Non- Serious Adverse Event
Code List
Maximum Grade or Intensity of Non- Serious Adverse Event
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
Not applicable (5)
Item
Action Taken with Investigational Product(s) as a Result of the AE
integer
C1704758 (UMLS CUI [1,1])
C0877248 (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 (6)
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
C0422727 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
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
C0877248 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
Duration of AE if < 24 hours
Item
Duration of AE if < 24 hours [Hr(s):Min(s)]
text
C0877248 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Time to Onset Since Last Dose
Item
Time to Onset Since Last Dose [Hr(s):Min(s)]
text
C0332162 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C3174092 (UMLS CUI [1,3])
C1517741 (UMLS CUI [1,4])
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