ID

36654

Description

Study ID: 102970 Clinical Study ID: 102970 Study Title: A 52-week Efficacy and Safety Study to Compare the Effect of Three Dosage Strengths of Fluticasone Furoate/GW642444 Inhalation Powder With GW642444 on the Annual Rate of Exacerbations in Subjects With Chronic Obstructive Pulmonary Disease (COPD) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01017952 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: GW642444 Inhalation Powder; FF/GW642444 Inhalation Powder Trade Name: Fluticasone Furoate;Fluticasone Propionate;Fluticasone Propionate/Salmeterol;Salmeterol;Vilanterol Study Indication: Pulmonary Disease, Chronic Obstructive

Keywords

Versions (3)
  1. 2/25/19 2/25/19 -
  2. 5/28/19 5/28/19 -
  3. 4/30/20 4/30/20 - Sarah Riepenhausen
Copyright Holder

GlaxoSmithKline

Uploaded on

May 28, 2019

DOI

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License

Creative Commons BY-NC 3.0
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Effect of Fluticasone Furoate/GW642444 Inhalation Powder With GW642444 on Annual Rate of Exacerbations in Subjects with COPD 102970

English

Common CRF

1 forms  
  1. StudyEvent: ODM
    1. Common CRF
Administrative Data
Description

Administrative Data

Site
Description

Study Site

Data type

text

Alias
UMLS CUI [1]
C2825164
Subject
Description

Clinical trial participant

Data type

text

Alias
UMLS CUI [1]
C1997894
Subject No.
Description

Clinical Trial Subject Unique Identifier

Data type

integer

Alias
UMLS CUI [1]
C2348585
Non-Serious Adverse Event
Description

Non-Serious Adverse Event

Alias
UMLS CUI-1
C1518404
Event (Diagnosis Only (if known) Otherwise Sign/Symptom)
Description

Non-serious Adverse Event

Data type

text

Alias
UMLS CUI [1]
C1518404
Start Date
Description

Non-serious Adverse Event, Start Date

Data type

date

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0808070
Outcome
Description

Non-serious Adverse Event, Adverse Event Outcome

Data type

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C1705586
Recovered/Resolved, provide End Date
Description

Non-serious Adverse Event, End Date

Data type

date

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0806020
Recovered/Resolved with sequelae, provide End Date
Description

Non-serious Adverse Event, End Date

Data type

date

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0806020
Frequency
Description

Non-serious Adverse Event, Frequencies

Data type

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0439603
Maximum Intensity
Description

Non-serious Adverse Event, Severity of Adverse Event

Data type

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C1710066
Action Taken with Investigational Product(s) as a Result of the AE
Description

Non-serious Adverse Event, Action Taken with Study Treatment

Data type

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C1704758
Did the subject withdraw from study as a result of this AE?
Description

Non-serious Adverse Event, Withdrawal by Subject

Data type

boolean

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

Non-serious Adverse Event, Investigational New Drugs, Relationships

Data type

boolean

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0013230
UMLS CUI [1,3]
C0439849
Serious Adverse Events
Description

Serious Adverse Events

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

Serious Adverse Event, Experimental drug, Initiation

Data type

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0304229
UMLS CUI [1,3]
C1704686
Serious Adverse Event (Diagnosis Only (if known) Otherwise Sign/Symptom)
Description

Serious Adverse Event

Data type

text

Alias
UMLS CUI [1]
C1519255
Start Date
Description

Serious Adverse Event, Start Date

Data type

date

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

Serious Adverse Event, Adverse Event Outcome

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1705586
Recovered/Resolved, provide End Date
Description

Serious Adverse Event, End Date

Data type

date

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0806020
Recovered/Resolved with sequelae, provide End Date
Description

Serious Adverse Event, End Date

Data type

date

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0806020
Fatal, provide End Date
Description

Serious Adverse Event, End Date

Data type

date

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0806020
Maximum Intensity
Description

Serious Adverse Event, Severity of Adverse Event

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1710066
Action Taken with Investigational Product(s) as a Result of the AE
Description

Serious Adverse Event, Action Taken with Study Treatment

Data type

text

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

Serious Adverse Event, Withdrawal by Subject

Data type

boolean

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

Serious Adverse Event, Investigational New Drugs, Relationships

Data type

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0013230
UMLS CUI [1,3]
C0439849
Was the SAE caused by activities related to study participation other than investigational product (e.g. procedures, blood draws, washout, etc)?
Description

Serious Adverse Event, Subject Study Participation Status, Relationships

Data type

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C0439849
Start Date and Time of event segment
Description

Serious Adverse Event, Start Date, Start time

Data type

datetime

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0808070
UMLS CUI [1,3]
C1301880
Intensity of event segment
Description

Serious Adverse Event, Symptom intensity

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0518690
Grade of event segment
Description

Serious Adverse Event, Adverse Event Grade Code

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2985911
Grade or Intensity of event segment
Description

Serious Adverse Event, Symptom intensity, Adverse Event Grade Code

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0518690
UMLS CUI [1,3]
C2985911
Seriousness?
Description

Serious Adverse Event, Seriousness of Adverse Event

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1710056
Drug name
Description

Serious Adverse Event, Concomitant Agent, Medication name

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C2360065
Dose
Description

Serious Adverse Event, Concomitant Agent, Dosage

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C0178602
Units
Description

Serious Adverse Event, Concomitant Agent, Unit

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C0439148
Frequency
Description

Serious Adverse Event, Concomitant Agent, Frequencies

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C0439603
Route
Description

Serious Adverse Event, Concomitant Agent, Drug Administration Routes

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C0013153
Start Date
Description

Serious Adverse Event, Concomitant Medication Start Date

Data type

date

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2826734
Ongoing?
Description

Serious Adverse Event, Concomitant Medication Ongoing

Data type

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2826666
No, specify End Date
Description

Serious Adverse Event, Concomitant Medication End Date

Data type

date

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2826744
Primary Indication
Description

Serious Adverse Event, Concomitant Agent, Indication

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C0392360
Drug Type
Description

Serious Adverse Event, Concomitant Agent, Type

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C0332307
Relevant Medical Conditions/Risk Factors - Specific Condition Name (Enter a medical diagnosis not description)
Description

Serious Adverse Event, Disease

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0012634
Relevant Medical Conditions/Risk Factors - Date of onset
Description

Serious Adverse Event, Disease, Start Date

Data type

date

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0012634
UMLS CUI [1,3]
C0808070
Relevant Medical Conditions/Risk Factors - Continuing?
Description

Serious Adverse Event, Disease, Continuous

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0012634
UMLS CUI [1,3]
C0549178
Relevant Medical Conditions/Risk Factors - If No, No, specify date of last occurrence
Description

Serious Adverse Event, Disease, End Date

Data type

date

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0012634
UMLS CUI [1,3]
C0806020
Relevant Diagnostic Details - Test Name
Description

Serious Adverse Event, Diagnostic procedure, Test Name

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0430022
UMLS CUI [1,3]
C2826273
Relevant Diagnostic Details - Test Date
Description

Serious Adverse Event, Diagnostic procedure, Date in time

Data type

date

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0430022
UMLS CUI [1,3]
C0011008
Relevant Diagnostic Details - Test Result
Description

Serious Adverse Event, Diagnostic procedure, Result

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0430022
UMLS CUI [1,3]
C1274040
Relevant Diagnostic Details - Test Units
Description

Serious Adverse Event, Diagnostic procedure, Unit of Measure

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0430022
UMLS CUI [1,3]
C1519795
Relevant Diagnostic Details - Normal Low Range
Description

Serious Adverse Event, Diagnostic procedure, Normal Range, Low

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0430022
UMLS CUI [1,3]
C0086715
UMLS CUI [1,4]
C0205251
Relevant Diagnostic Details - Normal High Range
Description

Serious Adverse Event, Diagnostic procedure, Normal Range, High

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0430022
UMLS CUI [1,3]
C0086715
UMLS CUI [1,4]
C0205250
Relevant Diagnostic Details - Relevant diagnostic results not noted above
Description

Serious Adverse Event, Diagnostic procedure, Result, Relevance

Data type

text

Relevant Diagnostic Details - Relevant diagnostic results not noted above
Description

Serious Adverse Event, Diagnostic procedure, Result, Relevance

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0430022
UMLS CUI [1,3]
C1274040
UMLS CUI [1,4]
C2347946
Rechallenge - If investigational product(s) were stopped temporarily, did the reported event(s) recur after investigational products were restarted?
Description

Serious Adverse Event, Experimental drug, Causations

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0304229
UMLS CUI [1,3]
C0085978
Investigational Product - Study Drug
Description

Serious Adverse Event, Experimental drug

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0304229
Investigational Product - Start Date
Description

Serious Adverse Event, Experimental drug, Start Date

Data type

date

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0304229
UMLS CUI [1,3]
C0808070
Investigational Product - Stop Date
Description

Serious Adverse Event, Experimental drug, End Date

Data type

date

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0304229
UMLS CUI [1,3]
C0806020
Investigational Product - Regimen
Description

Serious Adverse Event, Experimental drug

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0304229
Investigational Product - Dose
Description

Serious Adverse Event, Experimental drug, Medication dose

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0304229
UMLS CUI [1,3]
C3174092
Investigational Product - Cumulative Dose
Description

Serious Adverse Event, Experimental drug, Cumulative Dose

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0304229
UMLS CUI [1,3]
C2986497
General narrative comments
Description

Serious Adverse Event, Comment

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0947611
COPD Exacerbations
Description

COPD Exacerbations

Alias
UMLS CUI-1
C0740304
Date of Onset
Description

COPD exacerbation, Start Date

Data type

date

Alias
UMLS CUI [1,1]
C0740304
UMLS CUI [1,2]
C0808070
Outcome
Description

COPD exacerbation, Patient Outcome

Data type

text

Alias
UMLS CUI [1,1]
C0740304
UMLS CUI [1,2]
C1547647
Resolved, provide End Date
Description

COPD exacerbation, Recovered or Resolved, End Date

Data type

date

Alias
UMLS CUI [1,1]
C0740304
UMLS CUI [1,2]
C1709863
UMLS CUI [1,3]
C0806020
Fatal, provide End Date
Description

COPD exacerbation, Fatal, End Date

Data type

date

Alias
UMLS CUI [1,1]
C0740304
UMLS CUI [1,2]
C1302234
UMLS CUI [1,3]
C0806020
Severity
Description

COPD exaverbation, Severities

Data type

text

Alias
UMLS CUI [1,1]
C0740304
UMLS CUI [1,2]
C0439793
Was the subject withdrawn due to this exacerbation?
Description

COPD exacerbation, Withdraw

Data type

boolean

Alias
UMLS CUI [1,1]
C0740304
UMLS CUI [1,2]
C2349954
Primary cause of exacerbation?
Description

COPD exacerbation, Causations

Data type

text

Alias
UMLS CUI [1,1]
C0740304
UMLS CUI [1,2]
C0085978
Were systemic/oral corticosteroids taken for the exacerbation?
Description

COPD exacerbation, Adrenal Cortex Hormones

Data type

boolean

Alias
UMLS CUI [1,1]
C0740304
UMLS CUI [1,2]
C0001617
Were antibiotics taken for the exacerbation?
Description

COPD exacerbation, Antibiotics

Data type

boolean

Alias
UMLS CUI [1,1]
C0740304
UMLS CUI [1,2]
C0003232
Was the subject hospitalised due to this exacerbation?
Description

COPD exacerbation, Hospitalization

Data type

boolean

Alias
UMLS CUI [1,1]
C0740304
UMLS CUI [1,2]
C0019993
Was rescue medication use increased due to the exacerbation?
Description

COPD exacerbation, Rescue remedy, Changed status

Data type

boolean

Alias
UMLS CUI [1,1]
C0740304
UMLS CUI [1,2]
C0884980
UMLS CUI [1,3]
C0443172
Was an x-ray performed?
Description

COPD exacerbation, Plain chest X-ray

Data type

boolean

Alias
UMLS CUI [1,1]
C0740304
UMLS CUI [1,2]
C0039985
Number of home visits
Description

COPD exacerbation, Home care of patient, Count of entities

Data type

integer

Alias
UMLS CUI [1,1]
C0740304
UMLS CUI [1,2]
C0204977
UMLS CUI [1,3]
C0449788
Number of physician office/practice visits
Description

COPD exacerbation, Physicisn, Visit, Count of entities

Data type

integer

Alias
UMLS CUI [1,1]
C0740304
UMLS CUI [1,2]
C0031831
UMLS CUI [1,3]
C0545082
UMLS CUI [1,4]
C0449788
Number of urgent care/outpatient clinic visits
Description

COPD exacerbation, Clinic Visit, Outpatient, Count of entities

Data type

integer

Alias
UMLS CUI [1,1]
C0740304
UMLS CUI [1,2]
C0008952
UMLS CUI [1,3]
C0545084
UMLS CUI [1,4]
C0449788
Number of emergency room visits
Description

COPD exacerbation, Emergency Room admission, Count of entities

Data type

integer

Alias
UMLS CUI [1,1]
C0740304
UMLS CUI [1,2]
C0583237
UMLS CUI [1,3]
C0449788
Number of inpatient hospitalisation days
Description

COPD exacerbation, Hospitalization length of stay

Data type

integer

Alias
UMLS CUI [1,1]
C0740304
UMLS CUI [1,2]
C3694481
Exacerbation Medication - Drug Name
Description

COPD exacerbation, Pharmaceutical Preparations, Medication name

Data type

text

Alias
UMLS CUI [1,1]
C0740304
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C2360065
Exacerbation Medication - Unit Dose
Description

COPD exacerbation, Pharmaceutical Preparations, Dosage

Data type

text

Alias
UMLS CUI [1,1]
C0740304
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C0178602
Exacerbation Medication - Units
Description

COPD exacerbation, Pharmaceutical Preparations, Unit

Data type

text

Alias
UMLS CUI [1,1]
C0740304
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C0439148
Exacerbation Medication - Frequency
Description

COPD exacerbation, Pharmaceutical Preparations, Frequencies

Data type

text

Alias
UMLS CUI [1,1]
C0740304
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C0439603
Exacerbation Medication - Route
Description

COPD exacerbation, Pharmaceutical Preparations, Drug Administration Routes

Data type

text

Alias
UMLS CUI [1,1]
C0740304
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C0013153
Exacerbation Medication - Start Date
Description

COPD exacerbation, Pharmaceutical Preparations, Start Date

Data type

date

Alias
UMLS CUI [1,1]
C0740304
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C0808070
Exacerbation Medication - Taken Prior to Study?
Description

COPD exacerbation, Pharmaceutical Preparations, Previous

Data type

boolean

Alias
UMLS CUI [1,1]
C0740304
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C0205156
Exacerbation Medication - Ongoing
Description

COPD exacerbation, Pharmaceutical Preparations, Continuous

Data type

boolean

Alias
UMLS CUI [1,1]
C0740304
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C0549178
Exacerbation Medication - End Date
Description

COPD exacerbation, Pharmaceutical Preparations, End Date

Data type

date

Alias
UMLS CUI [1,1]
C0740304
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C0806020
Concomitant Medications
Description

Concomitant Medications

Alias
UMLS CUI-1
C2347852
Drug Name
Description

Concomitant Agent, Medication name

Data type

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C2360065
Unit Dose
Description

Concomitant Agent, Dosage

Data type

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0178602
Units
Description

Concomitant Agent, Unit

Data type

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0439148
Frequency
Description

Concomitant Agent, Frequencies

Data type

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0439603
Route
Description

Concomitant Agent, Drug Administration Routes

Data type

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0013153
Reason for Medication
Description

Concomitant Agent, Indication

Data type

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C3146298
Start Date
Description

Concomitant Medication Start Date

Data type

date

Alias
UMLS CUI [1]
C2826734
Taken Prior to Study?
Description

Concomitant Medication Previous Occurrence

Data type

boolean

Alias
UMLS CUI [1]
C2826667
Ongoing?
Description

Concomitant Medication Ongoing

Data type

boolean

Alias
UMLS CUI [1]
C2826666
No, specify End Date
Description

Concomitant Medication End Date

Data type

date

Alias
UMLS CUI [1]
C2826744
Was drug administered as a rescue medication?
Description

Concomitant Agent, Rescue remedy

Data type

boolean

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0884980
Medication Type
Description

Concomitant Agent, Type

Data type

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0332307
Fracture
Description

Fracture

Alias
UMLS CUI-1
C0016658
Date of Fracture
Description

Fracture, Date in time

Data type

date

Alias
UMLS CUI [1,1]
C0016658
UMLS CUI [1,2]
C0011008
Fracture site/location code
Description

Fracture, Anatomic Site, Code

Data type

text

Alias
UMLS CUI [1,1]
C0016658
UMLS CUI [1,2]
C1515974
UMLS CUI [1,3]
C0805701
Type of fracture code
Description

Fracture, Type

Data type

text

Alias
UMLS CUI [1,1]
C0016658
UMLS CUI [1,2]
C0332307
Double Blind Investigational Product Compliance
Description

Double Blind Investigational Product Compliance

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C1321605
Investigational product container number
Description

Experimental drug; Containers; Identifier

Data type

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0180098
UMLS CUI [1,3]
C0600091
Visit Investigational Product Dispensed
Description

Experimental drug, Dispensed, Visit

Data type

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C1880359
UMLS CUI [1,3]
C0545082
Date Investigational Product Dispensed
Description

Experimental drug, Dispensed, Date in time

Data type

date

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C1880359
UMLS CUI [1,3]
C0011008
Dose Counter Start
Description

Dosage, Count, Start

Data type

text

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C0750480
UMLS CUI [1,3]
C0452588
Visit Investigational Product Returned
Description

Experimental drug, Return, Visit

Data type

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0332156
UMLS CUI [1,3]
C0545082
Date Investigational Product Returned
Description

Experimental drug, Return, Date in time

Data type

date

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0332156
UMLS CUI [1,3]
C0011008
Dose Counter Stop
Description

Drug Dose, Stop

Data type

text

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C2746065
Open Label Diskus Taken During Run-in
Description

Open Label Diskus Taken During Run-in

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C1321605
Investigational product container number
Description

Experimental drug; Containers; Identifier

Data type

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0180098
UMLS CUI [1,3]
C0600091
Visit Investigational Product Dispensed
Description

Experimental drug, Dispensed, Visit

Data type

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C1880359
UMLS CUI [1,3]
C0545082
Date Investigational Product Dispensed
Description

Experimental drug, Dispensed, Date in time

Data type

date

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C1880359
UMLS CUI [1,3]
C0011008
Dose Counter Start
Description

Dosage, Count, Start

Data type

text

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C0750480
UMLS CUI [1,3]
C0452588
Visit Investigational Product Returned
Description

Experimental drug, Return, Visit

Data type

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0332156
UMLS CUI [1,3]
C0545082
Date Investigational Product Returned
Description

Experimental drug, Return, Date in time

Data type

date

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0332156
UMLS CUI [1,3]
C0011008
Dose Counter Stop
Description

Drug Dose, Stop

Data type

text

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C2746065
IP Device Malfunction
Description

IP Device Malfunction

Alias
UMLS CUI-1
C3898691
UMLS CUI-2
C0086138
Investigational product container number
Description

Investigational Medicinal Product Documentation, Identifier

Data type

integer

Alias
UMLS CUI [1,1]
C3898691
UMLS CUI [1,2]
C0600091
Mark all applicable reasons for device malfunction
Description

Medical Device Failure or Malfunction; Indication of (contextual qualifier)

Data type

text

Alias
UMLS CUI [1,1]
C1881681
UMLS CUI [1,2]
C0392360
Chest X-Ray
Description

Chest X-Ray

Alias
UMLS CUI-1
C0039985
Date of x-ray
Description

Plain chest X-ray, Date in time

Data type

date

Alias
UMLS CUI [1,1]
C0039985
UMLS CUI [1,2]
C0011008
Was an infiltrate present?
Description

x-ray of chest: pulmonary infiltrate

Data type

text

Alias
UMLS CUI [1]
C2073654
Infiltrate unilateral or bilateral
Description

Plain chest X-ray, Pulmonary infiltrate, Bilateral, Unilateral

Data type

text

Alias
UMLS CUI [1,1]
C0039985
UMLS CUI [1,2]
C0235896
UMLS CUI [1,3]
C0238767
UMLS CUI [1,4]
C0205092
Characterization of infiltrate
Description

Plain chest X-ray, Pulmonary infiltrate, Characterization

Data type

text

Alias
UMLS CUI [1,1]
C0039985
UMLS CUI [1,2]
C0235896
UMLS CUI [1,3]
C1880022
Right upper lobe involved with infiltrate
Description

Plain chest X-ray, Pulmonary infiltrate, Structure of right upper lobe of lung

Data type

text

Alias
UMLS CUI [1,1]
C0039985
UMLS CUI [1,2]
C0235896
UMLS CUI [1,3]
C1261074
Right middle lobe involved with infiltrate
Description

Plain chest X-ray, Pulmonary infiltrate, Structure of middle lobe of lung

Data type

text

Alias
UMLS CUI [1,1]
C0039985
UMLS CUI [1,2]
C0235896
UMLS CUI [1,3]
C0225757
Right lower lobe involved with infiltrate
Description

Plain chest X-ray, Pulmonary infiltrate, Structure of right lower lobe of lung

Data type

text

Alias
UMLS CUI [1,1]
C0039985
UMLS CUI [1,2]
C0235896
UMLS CUI [1,3]
C1261075
Left upper lobe involved with infiltrate
Description

Plain chest X-ray, Pulmonary infiltrate, Structure of left upper lobe of lung

Data type

text

Alias
UMLS CUI [1,1]
C0039985
UMLS CUI [1,2]
C0235896
UMLS CUI [1,3]
C1261076
Lingula involved with infiltrate
Description

Plain chest X-ray, Pulmonary infiltrate, Lingula of left lung

Data type

text

Alias
UMLS CUI [1,1]
C0039985
UMLS CUI [1,2]
C0235896
UMLS CUI [1,3]
C0225740
Left lower lobe involved with infiltrate
Description

Plain chest X-ray, Pulmonary infiltrate, Structure of left lower lobe of lung

Data type

text

Alias
UMLS CUI [1,1]
C0039985
UMLS CUI [1,2]
C0235896
UMLS CUI [1,3]
C1261077
Was a pleural effusion identified?
Description

Plain chest X-ray, Pleural effusion disorder

Data type

text

Alias
UMLS CUI [1,1]
C0039985
UMLS CUI [1,2]
C0032227
UMLS CUI [1,3]
C0450429
Present, specify Location
Description

Plain chest X-ray, Pleural effusion disorder, Location

Data type

text

Alias
UMLS CUI [1,1]
C0039985
UMLS CUI [1,2]
C0032227
UMLS CUI [1,3]
C0450429
Lung findings atelectasis
Description

Plain chest X-ray, Atelectasis

Data type

text

Alias
UMLS CUI [1,1]
C0039985
UMLS CUI [1,2]
C0004144
Lung findings mass?
Description

Plain chest X-ray, Lung mass

Data type

text

Alias
UMLS CUI [1,1]
C0039985
UMLS CUI [1,2]
C0149726
Lung findings cardiomegaly?
Description

Plain chest X-ray, Cardiomegaly

Data type

text

Alias
UMLS CUI [1,1]
C0039985
UMLS CUI [1,2]
C0018800
Was pulmonary edema identified?
Description

Plain chest X-ray, Pulmonary Edema

Data type

text

Alias
UMLS CUI [1,1]
C0039985
UMLS CUI [1,2]
C0034063
Comment
Description

Plain chest X-ray, Comment

Data type

text

Alias
UMLS CUI [1,1]
C0039985
UMLS CUI [1,2]
C0947611
Pneumonia Assessment
Description

Pneumonia Assessment

Alias
UMLS CUI-1
C0032285
UMLS CUI-2
C0220825
Onset Date
Description

Pneumonia, Start Date

Data type

date

Alias
UMLS CUI [1,1]
C0032285
UMLS CUI [1,2]
C0808070
Level of cough code
Description

Pneumonia, Coughing, Level

Data type

text

Alias
UMLS CUI [1,1]
C0032285
UMLS CUI [1,2]
C0010200
UMLS CUI [1,3]
C2946261
Increased sputum purulence
Description

Pneumonia, Purulent sputum

Data type

text

Alias
UMLS CUI [1,1]
C0032285
UMLS CUI [1,2]
C0241235
Was the chest auscultation normal?
Description

Pneumonia, Chest auscultation finding

Data type

text

Alias
UMLS CUI [1,1]
C0032285
UMLS CUI [1,2]
C0577960
Dyspnea
Description

Pneumonia, Dyspnea

Data type

text

Alias
UMLS CUI [1,1]
C0032285
UMLS CUI [1,2]
C0013404
Culture/swab taken?
Description

Pneumonia, Blood culture

Data type

text

Alias
UMLS CUI [1,1]
C0032285
UMLS CUI [1,2]
C0200949
Yes, pathogen from pneumonia culture
Description

Pneumonia, Blood culture, Pathogenic organism

Data type

text

Alias
UMLS CUI [1,1]
C0032285
UMLS CUI [1,2]
C0200949
UMLS CUI [1,3]
C0450254
Pleural effusion location code
Description

Pneumonia, Pleural effusion disorder, Location

Data type

text

Alias
UMLS CUI [1,1]
C0032285
UMLS CUI [1,2]
C0032227
UMLS CUI [1,3]
C0450429
Temperature
Description

Body Temperature

Data type

float

Measurement units
  • °C
Alias
UMLS CUI [1]
C0005903
°C
Respiration rate
Description

Respiratory rate

Data type

integer

Measurement units
  • breaths/min
Alias
UMLS CUI [1]
C0231832
breaths/min
Heart rate
Description

Heart rate

Data type

integer

Measurement units
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
Blood pressure (systolic)
Description

Systolic Pressure

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0522019
mmHg
Blood pressure (diastolic)
Description

Diastolic blood pressure

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Does subject have hypoxemia?
Description

Pneumonia, Hypoxemia

Data type

text

Alias
UMLS CUI [1,1]
C0032285
UMLS CUI [1,2]
C0700292
Does subject have elevated WBC?
Description

Pneumonia, White blood cell count procedure

Data type

text

Alias
UMLS CUI [1,1]
C0032285
UMLS CUI [1,2]
C0023508
Was this subject in a health care setting (inpatient) when the pneumonia developed?
Description

Pneumonia, Inpatient

Data type

text

Alias
UMLS CUI [1,1]
C0032285
UMLS CUI [1,2]
C0021562
Was an x-ray performed?
Description

Pneumonia, X-Ray confirmed

Data type

boolean

Alias
UMLS CUI [1]
C3843750
Was subject hospitalised due to this diagnosis of pneumonia?
Description

Pneumonia, Hospitalization

Data type

boolean

Alias
UMLS CUI [1,1]
C0032285
UMLS CUI [1,2]
C0019993
Did subject die as a result of the pneumonia?
Description

Pneumonia, Cessation of life

Data type

boolean

Alias
UMLS CUI [1,1]
C0032285
UMLS CUI [1,2]
C0011065
Liver Imaging
Description

Liver Imaging

Alias
UMLS CUI-1
C2711860
Date of hepatic or liver imaging test
Description

Imaging of liver, Date in time

Data type

date

Alias
UMLS CUI [1,1]
C2711860
UMLS CUI [1,2]
C0011008
What method was used for this imaging test?
Description

Imaging of liver, Imaging modality

Data type

text

Alias
UMLS CUI [1,1]
C2711860
UMLS CUI [1,2]
C1275506
Are images technically adequate?
Description

Imaging of liver, Adequate

Data type

text

Alias
UMLS CUI [1,1]
C2711860
UMLS CUI [1,2]
C0332306
Indicate the liver size
Description

Imaging of liver, Liver size

Data type

text

Alias
UMLS CUI [1,1]
C2711860
UMLS CUI [1,2]
C0426688
Indicate the liver texture
Description

Imaging of liver, Texture Perceiption

Data type

text

Alias
UMLS CUI [1,1]
C2711860
UMLS CUI [1,2]
C0679033
Grade the diffuse and/or geographic fatty infiltrate of the liver
Description

Imaging of liver, Fatty Liver

Data type

text

Alias
UMLS CUI [1,1]
C2711860
UMLS CUI [1,2]
C0015695
Ascites present
Description

Imaging of liver, Ascites

Data type

text

Alias
UMLS CUI [1,1]
C2711860
UMLS CUI [1,2]
C0003962
Are Focal Hepatic Lesions characterisable?
Description

Imaging of liver, Lesion of liver, Focal

Data type

text

Alias
UMLS CUI [1,1]
C2711860
UMLS CUI [1,2]
C0577053
UMLS CUI [1,3]
C0205234
Gallstones or gallbladder lesions?
Description

Imaging of liver, Gallstones/Gallbladder problems, Lesions

Data type

text

Alias
UMLS CUI [1,1]
C2711860
UMLS CUI [1,2]
C3842395
UMLS CUI [1,3]
C0221198
Biliary ductal lesions?
Description

Imaging of liver, Biliary duct structure, lesions

Data type

text

Alias
UMLS CUI [1,1]
C2711860
UMLS CUI [1,2]
C0005423
UMLS CUI [1,3]
C0221198
Portal/Hepatic vein abnormalities?
Description

Imaging of liver, Portal vein structure, Structure of hepatic vein, Abnormality

Data type

text

Alias
UMLS CUI [1,1]
C2711860
UMLS CUI [1,2]
C0032718
UMLS CUI [1,3]
C0019155
UMLS CUI [1,4]
C1704258
Liver Biopsy
Description

Liver Biopsy

Alias
UMLS CUI-1
C0193388
Date of liver biopsy
Description

Biopsy of liver, Date in time

Data type

date

Alias
UMLS CUI [1,1]
C0193388
UMLS CUI [1,2]
C0011008
Approximate size of liver biopsy
Description

Biopsy of liver, Specimen size

Data type

integer

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C0193388
UMLS CUI [1,2]
C1299482
mm
Final Diagnosis
Description

Biopsy of liver, Diagnosis

Data type

text

Alias
UMLS CUI [1,1]
C0193388
UMLS CUI [1,2]
C0011900
Liver Architecture
Description

Biopsy of liver, Cellular structure aspects

Data type

text

Alias
UMLS CUI [1,1]
C0193388
UMLS CUI [1,2]
C0935919
Description of Liver Cells or Hepatocytes
Description

Biopsy of liver, Hepatocyte

Data type

text

Alias
UMLS CUI [1,1]
C0193388
UMLS CUI [1,2]
C0227525
UMLS CUI [1,3]
C1849376
Liver Cell or Hepatocyte Inclusions or Vacuoles
Description

Biopsy of liver, Hepatocyte, Inclusion, Vacuoles

Data type

text

Alias
UMLS CUI [1,1]
C0227525
UMLS CUI [1,2]
C0042219
UMLS CUI [1,3]
C1512693
Hepatocyte or Liver Cell Nuclear Abnormalities
Description

Biopsy of Liver, Hepatocyte, Abnormal nuclear morphology

Data type

text

Alias
UMLS CUI [1,1]
C0193388
UMLS CUI [1,2]
C0227525
UMLS CUI [1,3]
C1849376
Liver or Lobular Infiltrates
Description

Biopsy of liver, Infiltrates

Data type

text

Alias
UMLS CUI [1,1]
C0193388
UMLS CUI [1,2]
C1400896
Portal Tract Inflammation
Description

Biopsy of liver, Portal Tract Inflammation

Data type

text

Alias
UMLS CUI [1,1]
C0193388
UMLS CUI [1,2]
C3854488
Bile Ducts
Description

Biopsy of liver, Bile Duct structure

Data type

text

Alias
UMLS CUI [1,1]
C0193388
UMLS CUI [1,2]
C0005400
Portal Veins
Description

Biopsy of liver, Portal Vein structure

Data type

text

Alias
UMLS CUI [1,1]
C0193388
UMLS CUI [1,2]
C0032718
Liver Infections
Description

Biopsy of liver, Hepatic Infection

Data type

text

Alias
UMLS CUI [1,1]
C0193388
UMLS CUI [1,2]
C1112211
Parasites or Ova
Description

Biopsy of liver, Parasite, Ovum of parasite

Data type

text

Alias
UMLS CUI [1,1]
C0193388
UMLS CUI [1,2]
C0030498
UMLS CUI [1,3]
C1267673
Histologic Staining or Additional Studies Obtained
Description

Biopsy of liver, Staining method

Data type

text

Alias
UMLS CUI [1,1]
C0193388
UMLS CUI [1,2]
C0487602
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Similar models

Common CRF

1 forms
  1. StudyEvent: ODM
    1. Common CRF
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
Study Site
Item
Site
text
C2825164 (UMLS CUI [1])
Clinical trial participant
Item
Subject
text
C1997894 (UMLS CUI [1])
Clinical Trial Subject Unique Identifier
Item
Subject No.
integer
C2348585 (UMLS CUI [1])
Item Group
Non-Serious Adverse Event
C1518404 (UMLS CUI-1)
Non-serious Adverse Event
Item
Event (Diagnosis Only (if known) Otherwise Sign/Symptom)
text
C1518404 (UMLS CUI [1])
Non-serious Adverse Event, Start Date
Item
Start Date
date
C1518404 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Item
Outcome
text
C1518404 (UMLS CUI [1,1])
C1705586 (UMLS CUI [1,2])
Non-serious Adverse Event, Adverse Event Outcome
Code List
Outcome
CL Item
Recovered/Resolved (1)
CL Item
Recovering/Resolving (2)
CL Item
Not recovered/Not resolved (3)
CL Item
Recovered/Resolved with sequelae (4)
Non-serious Adverse Event, End Date
Item
Recovered/Resolved, provide End Date
date
C1518404 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Non-serious Adverse Event, End Date
Item
Recovered/Resolved with sequelae, provide End Date
date
C1518404 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Item
Frequency
text
C1518404 (UMLS CUI [1,1])
C0439603 (UMLS CUI [1,2])
Non-serious Adverse Event, Frequencies
Code List
Frequency
CL Item
Single Episode  (1)
CL Item
Intermittent (2)
Item
Maximum Intensity
text
C1518404 (UMLS CUI [1,1])
C1710066 (UMLS CUI [1,2])
Non-serious Adverse Event, Severity of Adverse Event
Code List
Maximum Intensity
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Action Taken with Investigational Product(s) as a Result of the AE
text
C1518404 (UMLS CUI [1,1])
C1704758 (UMLS CUI [1,2])
Non-serious Adverse Event, Action Taken with Study Treatment
Code List
Action Taken with Investigational Product(s) as a Result of the AE
CL Item
Investigational product(s) withdrawn  (1)
CL Item
Dose not changed (2)
CL Item
Dose interrupted (3)
CL Item
Not applicable (4)
Non-serious Adverse Event, Withdrawal by Subject
Item
Did the subject withdraw from study as a result of this AE?
boolean
C1518404 (UMLS CUI [1,1])
C1710677 (UMLS CUI [1,2])
Non-serious Adverse Event, Investigational New Drugs, Relationships
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])
Item Group
Serious Adverse Events
C1519255 (UMLS CUI-1)
Serious Adverse Event, Experimental drug, Initiation
Item
Did SAE occur after initiation of study medication?
boolean
C1519255 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C1704686 (UMLS CUI [1,3])
Serious Adverse Event
Item
Serious Adverse Event (Diagnosis Only (if known) Otherwise Sign/Symptom)
text
C1519255 (UMLS CUI [1])
Serious Adverse Event, Start Date
Item
Start Date
date
C1519255 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Item
Outcome
text
C1519255 (UMLS CUI [1,1])
C1705586 (UMLS CUI [1,2])
Serious Adverse Event, Adverse Event Outcome
Code List
Outcome
CL Item
Recovered/Resolved (1)
CL Item
Recovering/Resolving (2)
CL Item
Not recovered/Not resolved (3)
CL Item
Recovered/Resolved with sequelae (4)
CL Item
Fatal (5)
Serious Adverse Event, End Date
Item
Recovered/Resolved, provide End Date
date
C1519255 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Serious Adverse Event, End Date
Item
Recovered/Resolved with sequelae, provide End Date
date
C1519255 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Serious Adverse Event, End Date
Item
Fatal, provide End Date
date
C1519255 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Item
Maximum Intensity
text
C1519255 (UMLS CUI [1,1])
C1710066 (UMLS CUI [1,2])
Serious Adverse Event, Severity of Adverse Event
Code List
Maximum Intensity
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Action Taken with Investigational Product(s) as a Result of the AE
text
C1519255 (UMLS CUI [1,1])
C1704758 (UMLS CUI [1,2])
Serious Adverse Event, Action Taken with Study Treatment
Code List
Action Taken with Investigational Product(s) as a Result of the AE
CL Item
Investigational product(s) withdrawn  (1)
CL Item
Dose not changed (2)
CL Item
Dose interrupted (3)
CL Item
Not applicable (4)
Serious Adverse Event, Withdrawal by Subject
Item
Did the subject withdraw from study as a result of this AE?
boolean
C1519255 (UMLS CUI [1,1])
C1710677 (UMLS CUI [1,2])
Serious Adverse Event, Investigational New Drugs, Relationships
Item
Is there a reasonable possibility that the AE may have been caused by the investigational product?
boolean
C1519255 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
Serious Adverse Event, Subject Study Participation Status, Relationships
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])
C2348568 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
Serious Adverse Event, Start Date, Start time
Item
Start Date and Time of event segment
datetime
C1519255 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,3])
Item
Intensity of event segment
text
C1519255 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
Serious Adverse Event, Symptom intensity
Code List
Intensity of event segment
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Grade of event segment
text
C1519255 (UMLS CUI [1,1])
C2985911 (UMLS CUI [1,2])
Serious Adverse Event, Symptom intensity
Code List
Grade of event segment
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
Grade 6 (6)
Item
Grade or Intensity of event segment
text
C1519255 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C2985911 (UMLS CUI [1,3])
Serious Adverse Event, Symptom intensity
Code List
Grade or Intensity of event segment
CL Item
Mild 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)
Item
Seriousness?
text
C1519255 (UMLS CUI [1,1])
C1710056 (UMLS CUI [1,2])
Serious Adverse Event, Symptom intensity
Code List
Seriousness?
CL Item
Results in death (1)
CL Item
Is life-threatening (2)
CL Item
Requires hospitalisation or prolongation of existing hospitalisation  (3)
CL Item
Results in disability/incapacity (4)
CL Item
Congenital anomaly/birth defect (5)
CL Item
Other, specify within general narrative comment (6)
Serious Adverse Event, Concomitant Agent, Medication name
Item
Drug name
text
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C2360065 (UMLS CUI [1,3])
Serious Adverse Event, Concomitant Agent, Dosage
Item
Dose
text
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
Serious Adverse Event, Concomitant Agent, Unit
Item
Units
text
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C0439148 (UMLS CUI [1,3])
Serious Adverse Event, Concomitant Agent, Frequencies
Item
Frequency
text
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C0439603 (UMLS CUI [1,3])
Serious Adverse Event, Concomitant Agent, Drug Administration Routes
Item
Route
text
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C0013153 (UMLS CUI [1,3])
Serious Adverse Event, Concomitant Medication Start Date
Item
Start Date
date
C1519255 (UMLS CUI [1,1])
C2826734 (UMLS CUI [1,2])
Serious Adverse Event, Concomitant Medication Ongoing
Item
Ongoing?
boolean
C1519255 (UMLS CUI [1,1])
C2826666 (UMLS CUI [1,2])
Serious Adverse Event, Concomitant Medication End Date
Item
No, specify End Date
date
C1519255 (UMLS CUI [1,1])
C2826744 (UMLS CUI [1,2])
Serious Adverse Event, Concomitant Agent, Indication
Item
Primary Indication
text
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
Serious Adverse Event, Concomitant Agent, Type
Item
Drug Type
text
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,3])
Serious Adverse Event, Disease
Item
Relevant Medical Conditions/Risk Factors - Specific Condition Name (Enter a medical diagnosis not description)
text
C1519255 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
Serious Adverse Event, Disease, Start Date
Item
Relevant Medical Conditions/Risk Factors - Date of onset
date
C1519255 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
Item
Relevant Medical Conditions/Risk Factors - Continuing?
text
C1519255 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,3])
Serious Adverse Event, Disease, Continuous
Code List
Relevant Medical Conditions/Risk Factors - Continuing?
CL Item
Yes (1)
CL Item
No (2)
CL Item
Unknown (3)
Serious Adverse Event, Disease, End Date
Item
Relevant Medical Conditions/Risk Factors - If No, No, specify date of last occurrence
date
C1519255 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,3])
Serious Adverse Event, Diagnostic procedure, Test Name
Item
Relevant Diagnostic Details - Test Name
text
C1519255 (UMLS CUI [1,1])
C0430022 (UMLS CUI [1,2])
C2826273 (UMLS CUI [1,3])
Serious Adverse Event, Diagnostic procedure, Date in time
Item
Relevant Diagnostic Details - Test Date
date
C1519255 (UMLS CUI [1,1])
C0430022 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Serious Adverse Event, Diagnostic procedure, Result
Item
Relevant Diagnostic Details - Test Result
text
C1519255 (UMLS CUI [1,1])
C0430022 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
Serious Adverse Event, Diagnostic procedure, Unit of Measure
Item
Relevant Diagnostic Details - Test Units
text
C1519255 (UMLS CUI [1,1])
C0430022 (UMLS CUI [1,2])
C1519795 (UMLS CUI [1,3])
Serious Adverse Event, Diagnostic procedure, Normal Range, Low
Item
Relevant Diagnostic Details - Normal Low Range
text
C1519255 (UMLS CUI [1,1])
C0430022 (UMLS CUI [1,2])
C0086715 (UMLS CUI [1,3])
C0205251 (UMLS CUI [1,4])
Serious Adverse Event, Diagnostic procedure, Normal Range, High
Item
Relevant Diagnostic Details - Normal High Range
text
C1519255 (UMLS CUI [1,1])
C0430022 (UMLS CUI [1,2])
C0086715 (UMLS CUI [1,3])
C0205250 (UMLS CUI [1,4])
Serious Adverse Event, Diagnostic procedure, Result, Relevance
Item
Relevant Diagnostic Details - Relevant diagnostic results not noted above
text
Serious Adverse Event, Diagnostic procedure, Result, Relevance
Item
Relevant Diagnostic Details - Relevant diagnostic results not noted above
text
C1519255 (UMLS CUI [1,1])
C0430022 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
C2347946 (UMLS CUI [1,4])
Item
Rechallenge - If investigational product(s) were stopped temporarily, did the reported event(s) recur after investigational products were restarted?
text
C1519255 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0085978 (UMLS CUI [1,3])
Serious Adverse Event, Experimental drug, Causations
Code List
Rechallenge - If investigational product(s) were stopped temporarily, did the reported event(s) recur after investigational products were restarted?
CL Item
No (1)
CL Item
Yes (2)
CL Item
Unknown at this time  (3)
CL Item
Not applicable (4)
Serious Adverse Event, Experimental drug
Item
Investigational Product - Study Drug
text
C1519255 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Serious Adverse Event, Experimental drug, Start Date
Item
Investigational Product - Start Date
date
C1519255 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
Serious Adverse Event, Experimental drug, End Date
Item
Investigational Product - Stop Date
date
C1519255 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,3])
Serious Adverse Event, Experimental drug
Item
Investigational Product - Regimen
text
C1519255 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Serious Adverse Event, Experimental drug, Medication dose
Item
Investigational Product - Dose
text
C1519255 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C3174092 (UMLS CUI [1,3])
Serious Adverse Event, Experimental drug, Cumulative Dose
Item
Investigational Product - Cumulative Dose
text
C1519255 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C2986497 (UMLS CUI [1,3])
Serious Adverse Event, Comment
Item
General narrative comments
text
C1519255 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
Item Group
COPD Exacerbations
C0740304 (UMLS CUI-1)
COPD exacerbation, Start Date
Item
Date of Onset
date
C0740304 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Item
Outcome
text
C0740304 (UMLS CUI [1,1])
C1547647 (UMLS CUI [1,2])
COPD exacerbation, Patient Outcome
Code List
Outcome
CL Item
Resolved (1)
CL Item
Fatal (2)
CL Item
Not resolved (3)
COPD exacerbation, Recovered or Resolved, End Date
Item
Resolved, provide End Date
date
C0740304 (UMLS CUI [1,1])
C1709863 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,3])
COPD exacerbation, Fatal, End Date
Item
Fatal, provide End Date
date
C0740304 (UMLS CUI [1,1])
C1302234 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,3])
Item
Severity
text
C0740304 (UMLS CUI [1,1])
C0439793 (UMLS CUI [1,2])
COPD exaverbation, Severities
Code List
Severity
CL Item
Mild  (1)
CL Item
Moderate  (2)
CL Item
Severe (3)
COPD exacerbation, Withdraw
Item
Was the subject withdrawn due to this exacerbation?
boolean
C0740304 (UMLS CUI [1,1])
C2349954 (UMLS CUI [1,2])
COPD exacerbation, Causations
Item
Primary cause of exacerbation?
text
C0740304 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
COPD exacerbation, Adrenal Cortex Hormones
Item
Were systemic/oral corticosteroids taken for the exacerbation?
boolean
C0740304 (UMLS CUI [1,1])
C0001617 (UMLS CUI [1,2])
COPD exacerbation, Antibiotics
Item
Were antibiotics taken for the exacerbation?
boolean
C0740304 (UMLS CUI [1,1])
C0003232 (UMLS CUI [1,2])
COPD exacerbation, Hospitalization
Item
Was the subject hospitalised due to this exacerbation?
boolean
C0740304 (UMLS CUI [1,1])
C0019993 (UMLS CUI [1,2])
COPD exacerbation, Rescue remedy, Changed status
Item
Was rescue medication use increased due to the exacerbation?
boolean
C0740304 (UMLS CUI [1,1])
C0884980 (UMLS CUI [1,2])
C0443172 (UMLS CUI [1,3])
COPD exacerbation, Plain chest X-ray
Item
Was an x-ray performed?
boolean
C0740304 (UMLS CUI [1,1])
C0039985 (UMLS CUI [1,2])
COPD exacerbation, Home care of patient, Count of entities
Item
Number of home visits
integer
C0740304 (UMLS CUI [1,1])
C0204977 (UMLS CUI [1,2])
C0449788 (UMLS CUI [1,3])
COPD exacerbation, Physicisn, Visit, Count of entities
Item
Number of physician office/practice visits
integer
C0740304 (UMLS CUI [1,1])
C0031831 (UMLS CUI [1,2])
C0545082 (UMLS CUI [1,3])
C0449788 (UMLS CUI [1,4])
COPD exacerbation, Clinic Visit, Outpatient, Count of entities
Item
Number of urgent care/outpatient clinic visits
integer
C0740304 (UMLS CUI [1,1])
C0008952 (UMLS CUI [1,2])
C0545084 (UMLS CUI [1,3])
C0449788 (UMLS CUI [1,4])
COPD exacerbation, Emergency Room admission, Count of entities
Item
Number of emergency room visits
integer
C0740304 (UMLS CUI [1,1])
C0583237 (UMLS CUI [1,2])
C0449788 (UMLS CUI [1,3])
COPD exacerbation, Hospitalization length of stay
Item
Number of inpatient hospitalisation days
integer
C0740304 (UMLS CUI [1,1])
C3694481 (UMLS CUI [1,2])
COPD exacerbation, Pharmaceutical Preparations, Medication name
Item
Exacerbation Medication - Drug Name
text
C0740304 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C2360065 (UMLS CUI [1,3])
COPD exacerbation, Pharmaceutical Preparations, Dosage
Item
Exacerbation Medication - Unit Dose
text
C0740304 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
COPD exacerbation, Pharmaceutical Preparations, Unit
Item
Exacerbation Medication - Units
text
C0740304 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0439148 (UMLS CUI [1,3])
COPD exacerbation, Pharmaceutical Preparations, Frequencies
Item
Exacerbation Medication - Frequency
text
C0740304 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0439603 (UMLS CUI [1,3])
COPD exacerbation, Pharmaceutical Preparations, Drug Administration Routes
Item
Exacerbation Medication - Route
text
C0740304 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0013153 (UMLS CUI [1,3])
COPD exacerbation, Pharmaceutical Preparations, Start Date
Item
Exacerbation Medication - Start Date
date
C0740304 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
COPD exacerbation, Pharmaceutical Preparations, Previous
Item
Exacerbation Medication - Taken Prior to Study?
boolean
C0740304 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0205156 (UMLS CUI [1,3])
COPD exacerbation, Pharmaceutical Preparations, Continuous
Item
Exacerbation Medication - Ongoing
boolean
C0740304 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,3])
COPD exacerbation, Pharmaceutical Preparations, End Date
Item
Exacerbation Medication - End Date
date
C0740304 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,3])
Item Group
Concomitant Medications
C2347852 (UMLS CUI-1)
Concomitant Agent, Medication name
Item
Drug Name
text
C2347852 (UMLS CUI [1,1])
C2360065 (UMLS CUI [1,2])
Concomitant Agent, Dosage
Item
Unit Dose
text
C2347852 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
Concomitant Agent, Unit
Item
Units
text
C2347852 (UMLS CUI [1,1])
C0439148 (UMLS CUI [1,2])
Concomitant Agent, Frequencies
Item
Frequency
text
C2347852 (UMLS CUI [1,1])
C0439603 (UMLS CUI [1,2])
Concomitant Agent, Drug Administration Routes
Item
Route
text
C2347852 (UMLS CUI [1,1])
C0013153 (UMLS CUI [1,2])
Concomitant Agent, Indication
Item
Reason for Medication
text
C2347852 (UMLS CUI [1,1])
C3146298 (UMLS CUI [1,2])
Concomitant Medication Start Date
Item
Start Date
date
C2826734 (UMLS CUI [1])
Concomitant Medication Previous Occurrence
Item
Taken Prior to Study?
boolean
C2826667 (UMLS CUI [1])
Concomitant Medication Ongoing
Item
Ongoing?
boolean
C2826666 (UMLS CUI [1])
Concomitant Medication End Date
Item
No, specify End Date
date
C2826744 (UMLS CUI [1])
Concomitant Agent, Rescue remedy
Item
Was drug administered as a rescue medication?
boolean
C2347852 (UMLS CUI [1,1])
C0884980 (UMLS CUI [1,2])
Concomitant Agent, Type
Item
Medication Type
text
C2347852 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Item Group
Fracture
C0016658 (UMLS CUI-1)
Fracture, Date in time
Item
Date of Fracture
date
C0016658 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Fracture, Anatomic Site, Code
Item
Fracture site/location code
text
C0016658 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,3])
Item
Type of fracture code
text
C0016658 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Fracture, Type
Code List
Type of fracture code
CL Item
Non-Traumatic  (1)
CL Item
Traumatic (2)
Item Group
Double Blind Investigational Product Compliance
C0304229 (UMLS CUI-1)
C1321605 (UMLS CUI-2)
Experimental drug; Containers; Identifier
Item
Investigational product container number
text
C0304229 (UMLS CUI [1,1])
C0180098 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,3])
Experimental drug, Dispensed, Visit
Item
Visit Investigational Product Dispensed
text
C0304229 (UMLS CUI [1,1])
C1880359 (UMLS CUI [1,2])
C0545082 (UMLS CUI [1,3])
Experimental drug, Dispensed, Date in time
Item
Date Investigational Product Dispensed
date
C0304229 (UMLS CUI [1,1])
C1880359 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Dosage, Count, Start
Item
Dose Counter Start
text
C0178602 (UMLS CUI [1,1])
C0750480 (UMLS CUI [1,2])
C0452588 (UMLS CUI [1,3])
Experimental drug, Return, Visit
Item
Visit Investigational Product Returned
text
C0304229 (UMLS CUI [1,1])
C0332156 (UMLS CUI [1,2])
C0545082 (UMLS CUI [1,3])
Experimental drug, Return, Date in time
Item
Date Investigational Product Returned
date
C0304229 (UMLS CUI [1,1])
C0332156 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Drug Dose, Stop
Item
Dose Counter Stop
text
C0178602 (UMLS CUI [1,1])
C2746065 (UMLS CUI [1,2])
Item Group
Open Label Diskus Taken During Run-in
C0304229 (UMLS CUI-1)
C1321605 (UMLS CUI-2)
Experimental drug; Containers; Identifier
Item
Investigational product container number
text
C0304229 (UMLS CUI [1,1])
C0180098 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,3])
Experimental drug, Dispensed, Visit
Item
Visit Investigational Product Dispensed
text
C0304229 (UMLS CUI [1,1])
C1880359 (UMLS CUI [1,2])
C0545082 (UMLS CUI [1,3])
Experimental drug, Dispensed, Date in time
Item
Date Investigational Product Dispensed
date
C0304229 (UMLS CUI [1,1])
C1880359 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Dosage, Count, Start
Item
Dose Counter Start
text
C0178602 (UMLS CUI [1,1])
C0750480 (UMLS CUI [1,2])
C0452588 (UMLS CUI [1,3])
Experimental drug, Return, Visit
Item
Visit Investigational Product Returned
text
C0304229 (UMLS CUI [1,1])
C0332156 (UMLS CUI [1,2])
C0545082 (UMLS CUI [1,3])
Experimental drug, Return, Date in time
Item
Date Investigational Product Returned
date
C0304229 (UMLS CUI [1,1])
C0332156 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Drug Dose, Stop
Item
Dose Counter Stop
text
C0178602 (UMLS CUI [1,1])
C2746065 (UMLS CUI [1,2])
Item Group
IP Device Malfunction
C3898691 (UMLS CUI-1)
C0086138 (UMLS CUI-2)
Investigational Medicinal Product Documentation, Identifier
Item
Investigational product container number
integer
C3898691 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Item
Mark all applicable reasons for device malfunction
text
C1881681 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Medical Device Failure or Malfunction; Indication of (contextual qualifier)
Code List
Mark all applicable reasons for device malfunction
CL Item
Mouthpiece Cover does not stay at the fully actuated position  (1)
CL Item
Mouthpiece cover came apart from the mechanism (2)
CL Item
Inhaler is cracked or broken apart (3)
CL Item
Difficult to open mouthpiece cover/force to actuate was too high  (4)
CL Item
Difficult to close mouthpiece cover (5)
CL Item
Powder fell out prior to use (6)
CL Item
No powder came out (7)
CL Item
Device squeaks in operation (8)
CL Item
Device rattles in operation (9)
CL Item
Dose counter did not count (10)
CL Item
Dose counter is ambiguous (11)
CL Item
Dose counter overcounted (12)
CL Item
Dose counter undercounted (13)
CL Item
Difficult to pull air through the device as described in the leaflet  (14)
CL Item
Device smelt/bad odour when pack opened (15)
CL Item
16Other, specify (16Other, specify)
Item Group
Chest X-Ray
C0039985 (UMLS CUI-1)
Plain chest X-ray, Date in time
Item
Date of x-ray
date
C0039985 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Was an infiltrate present?
text
C2073654 (UMLS CUI [1])
x-ray of chest: pulmonary infiltrate
Code List
Was an infiltrate present?
CL Item
No (1)
CL Item
Unknown (2)
CL Item
Yes (3)
Item
Infiltrate unilateral or bilateral
text
C0039985 (UMLS CUI [1,1])
C0235896 (UMLS CUI [1,2])
C0238767 (UMLS CUI [1,3])
C0205092 (UMLS CUI [1,4])
Plain chest X-ray, Pulmonary infiltrate, Bilateral, Unilateral
Code List
Infiltrate unilateral or bilateral
CL Item
Unilateral (1)
CL Item
Bilateral (2)
Item
Characterization of infiltrate
text
C0039985 (UMLS CUI [1,1])
C0235896 (UMLS CUI [1,2])
C1880022 (UMLS CUI [1,3])
Plain chest X-ray, Pulmonary infiltrate, Characterization
Code List
Characterization of infiltrate
CL Item
Reticular (patchy)  (1)
CL Item
Reticulonodular (2)
CL Item
Acinar (consolidated) (3)
CL Item
Acinar with Air Bronchograms  (4)
CL Item
Not applicable (5)
Item
Right upper lobe involved with infiltrate
text
C0039985 (UMLS CUI [1,1])
C0235896 (UMLS CUI [1,2])
C1261074 (UMLS CUI [1,3])
Plain chest X-ray, Pulmonary infiltrate, Structure of right upper lobe of lung
Code List
Right upper lobe involved with infiltrate
CL Item
Yes (1)
CL Item
No (2)
CL Item
Not applicable (3)
Item
Right middle lobe involved with infiltrate
text
C0039985 (UMLS CUI [1,1])
C0235896 (UMLS CUI [1,2])
C0225757 (UMLS CUI [1,3])
Plain chest X-ray, Pulmonary infiltrate, Structure of middle lobe of lung
Code List
Right middle lobe involved with infiltrate
CL Item
Yes (1)
CL Item
No (2)
CL Item
Not applicable (3)
Item
Right lower lobe involved with infiltrate
text
C0039985 (UMLS CUI [1,1])
C0235896 (UMLS CUI [1,2])
C1261075 (UMLS CUI [1,3])
Plain chest X-ray, Pulmonary infiltrate, Structure of right lower lobe of lung
Code List
Right lower lobe involved with infiltrate
CL Item
Yes (1)
CL Item
No (2)
CL Item
Not applicable (3)
Item
Left upper lobe involved with infiltrate
text
C0039985 (UMLS CUI [1,1])
C0235896 (UMLS CUI [1,2])
C1261076 (UMLS CUI [1,3])
Plain chest X-ray, Pulmonary infiltrate, Structure of left upper lobe of lung
Code List
Left upper lobe involved with infiltrate
CL Item
Yes (1)
CL Item
No (2)
CL Item
Not applicable (3)
Item
Lingula involved with infiltrate
text
C0039985 (UMLS CUI [1,1])
C0235896 (UMLS CUI [1,2])
C0225740 (UMLS CUI [1,3])
Plain chest X-ray, Pulmonary infiltrate, Lingula of left lung
Code List
Lingula involved with infiltrate
CL Item
Yes (1)
CL Item
No (2)
CL Item
Not applicable (3)
Item
Left lower lobe involved with infiltrate
text
C0039985 (UMLS CUI [1,1])
C0235896 (UMLS CUI [1,2])
C1261077 (UMLS CUI [1,3])
Plain chest X-ray, Pulmonary infiltrate, Structure of left lower lobe of lung
Code List
Left lower lobe involved with infiltrate
CL Item
Yes (1)
CL Item
No (2)
CL Item
Not applicable (3)
Item
Was a pleural effusion identified?
text
C0039985 (UMLS CUI [1,1])
C0032227 (UMLS CUI [1,2])
C0450429 (UMLS CUI [1,3])
Plain chest X-ray, Pleural effusion disorder
Code List
Was a pleural effusion identified?
CL Item
Absent  (1)
CL Item
Unknown (2)
CL Item
Present (3)
Item
Present, specify Location
text
C0039985 (UMLS CUI [1,1])
C0032227 (UMLS CUI [1,2])
C0450429 (UMLS CUI [1,3])
Plain chest X-ray, Pleural effusion disorder, Location
Code List
Present, specify Location
CL Item
Right chest (1)
CL Item
Left chest  (2)
CL Item
Bilateral (3)
Item
Lung findings atelectasis
text
C0039985 (UMLS CUI [1,1])
C0004144 (UMLS CUI [1,2])
Plain chest X-ray, Atelectasis
Code List
Lung findings atelectasis
CL Item
Yes (1)
CL Item
No (2)
CL Item
Unknown (3)
Item
Lung findings mass?
text
C0039985 (UMLS CUI [1,1])
C0149726 (UMLS CUI [1,2])
Plain chest X-ray, Lung mass
Code List
Lung findings mass?
CL Item
Yes (1)
CL Item
No (2)
CL Item
Unknown (3)
Item
Lung findings cardiomegaly?
text
C0039985 (UMLS CUI [1,1])
C0018800 (UMLS CUI [1,2])
Plain chest X-ray, Cardiomegaly
Code List
Lung findings cardiomegaly?
CL Item
Yes (1)
CL Item
No (2)
CL Item
Unknown (3)
Item
Was pulmonary edema identified?
text
C0039985 (UMLS CUI [1,1])
C0034063 (UMLS CUI [1,2])
Plain chest X-ray, Pulmonary Edema
Code List
Was pulmonary edema identified?
CL Item
Yes (1)
CL Item
No (2)
CL Item
Unknown (3)
Plain chest X-ray, Comment
Item
Comment
text
C0039985 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
Item Group
Pneumonia Assessment
C0032285 (UMLS CUI-1)
C0220825 (UMLS CUI-2)
Pneumonia, Start Date
Item
Onset Date
date
C0032285 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Item
Level of cough code
text
C0032285 (UMLS CUI [1,1])
C0010200 (UMLS CUI [1,2])
C2946261 (UMLS CUI [1,3])
Pneumonia, Coughing, Level
Code List
Level of cough code
CL Item
Usual level of cough  (1)
CL Item
Increased cough (2)
Item
Increased sputum purulence
text
C0032285 (UMLS CUI [1,1])
C0241235 (UMLS CUI [1,2])
Pneumonia, Purulent sputum
Code List
Increased sputum purulence
CL Item
Yes (1)
CL Item
No (2)
CL Item
Unknown (3)
Item
Was the chest auscultation normal?
text
C0032285 (UMLS CUI [1,1])
C0577960 (UMLS CUI [1,2])
Pneumonia, Chest auscultation finding
Code List
Was the chest auscultation normal?
CL Item
Yes (1)
CL Item
No (2)
CL Item
Unknown (3)
Item
Dyspnea
text
C0032285 (UMLS CUI [1,1])
C0013404 (UMLS CUI [1,2])
Pneumonia, Dyspnea
Code List
Dyspnea
CL Item
Yes (1)
CL Item
No (2)
CL Item
Unknown (3)
Item
Culture/swab taken?
text
C0032285 (UMLS CUI [1,1])
C0200949 (UMLS CUI [1,2])
Pneumonia, Blood culture
Code List
Culture/swab taken?
CL Item
No (1)
CL Item
Unknown (2)
CL Item
Yes (3)
Item
Yes, pathogen from pneumonia culture
text
C0032285 (UMLS CUI [1,1])
C0200949 (UMLS CUI [1,2])
C0450254 (UMLS CUI [1,3])
Pneumonia, Blood culture, Pathogenic organism
Code List
Yes, pathogen from pneumonia culture
CL Item
Streptococcus pneumoniae  (1)
CL Item
Haemophilus influenza  (2)
CL Item
Staphlococcus aureus (3)
CL Item
Streptococcus pyogenes  (4)
CL Item
Klebsiella pneumoniae  (5)
CL Item
Pseudomonas aeruginosa (6)
CL Item
Moraxella catarrhalis (7)
CL Item
Other (8)
Item
Pleural effusion location code
text
C0032285 (UMLS CUI [1,1])
C0032227 (UMLS CUI [1,2])
C0450429 (UMLS CUI [1,3])
Pneumonia, Pleural effusion disorder, Location
Code List
Pleural effusion location code
CL Item
Right chest  (1)
CL Item
Left chest  (2)
CL Item
Bilateral (3)
Body Temperature
Item
Temperature
float
C0005903 (UMLS CUI [1])
Respiratory rate
Item
Respiration rate
integer
C0231832 (UMLS CUI [1])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Systolic Pressure
Item
Blood pressure (systolic)
integer
C0871470 (UMLS CUI [1,1])
C0522019 (UMLS CUI [1,2])
Diastolic blood pressure
Item
Blood pressure (diastolic)
integer
C0428883 (UMLS CUI [1])
Pneumonia, Hypoxemia
Item
Does subject have hypoxemia?
text
C0032285 (UMLS CUI [1,1])
C0700292 (UMLS CUI [1,2])
Item
Does subject have elevated WBC?
text
C0032285 (UMLS CUI [1,1])
C0023508 (UMLS CUI [1,2])
Pneumonia, White blood cell count procedure
Code List
Does subject have elevated WBC?
CL Item
Yes (1)
CL Item
No (2)
CL Item
Unknown (3)
Item
Was this subject in a health care setting (inpatient) when the pneumonia developed?
text
C0032285 (UMLS CUI [1,1])
C0021562 (UMLS CUI [1,2])
Pneumonia, Inpatient
Code List
Was this subject in a health care setting (inpatient) when the pneumonia developed?
CL Item
Yes (1)
CL Item
No (2)
CL Item
Unknown (3)
Pneumonia, X-Ray confirmed
Item
Was an x-ray performed?
boolean
C3843750 (UMLS CUI [1])
Pneumonia, Hospitalization
Item
Was subject hospitalised due to this diagnosis of pneumonia?
boolean
C0032285 (UMLS CUI [1,1])
C0019993 (UMLS CUI [1,2])
Pneumonia, Cessation of life
Item
Did subject die as a result of the pneumonia?
boolean
C0032285 (UMLS CUI [1,1])
C0011065 (UMLS CUI [1,2])
Item Group
Liver Imaging
C2711860 (UMLS CUI-1)
Imaging of liver, Date in time
Item
Date of hepatic or liver imaging test
date
C2711860 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
What method was used for this imaging test?
text
C2711860 (UMLS CUI [1,1])
C1275506 (UMLS CUI [1,2])
Imaging of liver, Imaging modality
Code List
What method was used for this imaging test?
CL Item
Ultrasound - transabdominal (1)
CL Item
Ultrasound - endoscopic (2)
CL Item
Magnetic Resonance Imaging (MRI) (3)
CL Item
Computerised Tomography (CT) (4)
CL Item
Endoscopic Retrograde Cholangiopancreatography (ERCP)  (5)
CL Item
Positron Emission Tomography (PET) (6)
CL Item
Positron Emission Tomography/Computerised Tomography (PET/CT) (7)
CL Item
Other, specify: (8)
Item
Are images technically adequate?
text
C2711860 (UMLS CUI [1,1])
C0332306 (UMLS CUI [1,2])
Imaging of liver, Adequate
Code List
Are images technically adequate?
CL Item
Optimal (1)
CL Item
Readable, but not optimal  (2)
CL Item
Not readable (3)
CL Item
Other, specify (4)
Item
Indicate the liver size
text
C2711860 (UMLS CUI [1,1])
C0426688 (UMLS CUI [1,2])
Imaging of liver, Liver size
Code List
Indicate the liver size
CL Item
Normal size (1)
CL Item
Hypertrophy (or enlarged)  (2)
CL Item
Atrophy (or smaller than normal)  (3)
CL Item
Segmental hypertrophy (4)
CL Item
Other, specify (5)
Item
Indicate the liver texture
text
C2711860 (UMLS CUI [1,1])
C0679033 (UMLS CUI [1,2])
Imaging of liver, Texture Perceiption
Code List
Indicate the liver texture
CL Item
Normal (1)
CL Item
Heterogenous (2)
CL Item
Suggestive of fibrosis (3)
CL Item
Nodular or suggestive of cirrhosis (4)
CL Item
Other, specify (5)
Item
Grade the diffuse and/or geographic fatty infiltrate of the liver
text
C2711860 (UMLS CUI [1,1])
C0015695 (UMLS CUI [1,2])
Imaging of liver, Fatty Liver
Code List
Grade the diffuse and/or geographic fatty infiltrate of the liver
CL Item
Not applicable - no fatty infiltration  (1)
CL Item
Mild (<=25%) (2)
CL Item
Moderate (>25% to <75%) (3)
CL Item
Severe (>=75%) (4)
CL Item
Other, specify (5)
Item
Ascites present
text
C2711860 (UMLS CUI [1,1])
C0003962 (UMLS CUI [1,2])
Imaging of liver, Ascites
Code List
Ascites present
CL Item
None present (1)
CL Item
Yes - small amount (2)
CL Item
Yes - moderate or severe amount (3)
CL Item
Other, specify (4)
Item
Are Focal Hepatic Lesions characterisable?
text
C2711860 (UMLS CUI [1,1])
C0577053 (UMLS CUI [1,2])
C0205234 (UMLS CUI [1,3])
Imaging of liver, Lesion of liver, Focal
Code List
Are Focal Hepatic Lesions characterisable?
CL Item
Not applicable - no hepatic lesions  (1)
CL Item
Solid (2)
CL Item
Cystic (3)
CL Item
Hemangioma (4)
CL Item
Focal Nodular Hyperplasia (5)
CL Item
Other, specify: (6)
Item
Gallstones or gallbladder lesions?
text
C2711860 (UMLS CUI [1,1])
C3842395 (UMLS CUI [1,2])
C0221198 (UMLS CUI [1,3])
Imaging of liver, Gallstones/Gallbladder problems, Lesions
Code List
Gallstones or gallbladder lesions?
CL Item
None (1)
CL Item
Gallstones (2)
CL Item
Gallbladder polyp(s) (3)
CL Item
Sludge (4)
CL Item
Gallbladder wall thickening/oedema  (5)
CL Item
Gallbladder wall gas (6)
CL Item
Cholecystitis (7)
CL Item
Gallbladder wall calcification  (8)
CL Item
Gallbladder mass (9)
CL Item
Other, specify: (10)
Item
Biliary ductal lesions?
text
C2711860 (UMLS CUI [1,1])
C0005423 (UMLS CUI [1,2])
C0221198 (UMLS CUI [1,3])
Imaging of liver, Biliary duct structure, lesions
Code List
Biliary ductal lesions?
CL Item
None (1)
CL Item
Intrahepatic ductal dilation (focal involving the right hepatic lobe) (2)
CL Item
Intrahepatic ductal dilation (focal involving the left hepatic lobe) (3)
CL Item
Intrahepatic ductal dilation (involving both right and left hepatic lobes) (4)
CL Item
Extrahepatic ductal dilation (5)
CL Item
Diffuse ductal dilation (involving both intrahepatic and extrahepatic ducts) (6)
CL Item
Acute Cholangitis (7)
CL Item
Primary sclerosing cholangitis  (8)
CL Item
Choledocholithiasis (gallstone in duct)  (9)
CL Item
Ductal filling defect(s), other than gallstone  (10)
CL Item
Ductal wall thickening or oedema  (11)
CL Item
Choledochal cyst (12)
CL Item
Ductal mass (13)
CL Item
Extrinsic mass compressing bile duct(s) (14)
CL Item
Other, specify (15)
Item
Portal/Hepatic vein abnormalities?
text
C2711860 (UMLS CUI [1,1])
C0032718 (UMLS CUI [1,2])
C0019155 (UMLS CUI [1,3])
C1704258 (UMLS CUI [1,4])
Imaging of liver, Portal vein structure, Structure of hepatic vein, Abnormality
Code List
Portal/Hepatic vein abnormalities?
CL Item
None (1)
CL Item
Portal vein enlargement (2)
CL Item
Hepatic vein enlargement (3)
CL Item
Nonocclusive portal vein thrombosis  (4)
CL Item
Occlusive portal vein thrombosis - bland  (5)
CL Item
Hepatic vein thrombosis - bland (6)
CL Item
Occlusive portal vein thrombosis - malignant  (7)
CL Item
Hepatic vein thrombosis - malignant  (8)
CL Item
Involvement of the main portal vein  (9)
CL Item
Involvement of the right portal vein (10)
CL Item
Involvement of the left portal vein  (11)
CL Item
Budd-Chiari syndrome (12)
CL Item
Other, specify (13)
Item Group
Liver Biopsy
C0193388 (UMLS CUI-1)
Biopsy of liver, Date in time
Item
Date of liver biopsy
date
C0193388 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Biopsy of liver, Specimen size
Item
Approximate size of liver biopsy
integer
C0193388 (UMLS CUI [1,1])
C1299482 (UMLS CUI [1,2])
Item
Final Diagnosis
text
C0193388 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Biopsy of liver, Diagnosis
Code List
Final Diagnosis
CL Item
Normal (1)
CL Item
Acute hepatitis (2)
CL Item
Chronic hepatitis  (3)
CL Item
Cholestatic hepatitis  (4)
CL Item
Drug-induced cholestasis  (5)
CL Item
Acute viral hepatitis  (6)
CL Item
Chronic viral hepatitis  (7)
CL Item
Drug-induced hepatitis  (8)
CL Item
Autoimmune hepatitis  (9)
CL Item
Bridging necrosis  (10)
CL Item
Submassive hepatic necrosis  (11)
CL Item
Massive hepatic necrosis  (12)
CL Item
Steatosis - microvesicular  (13)
CL Item
Steatosis - macrovesicular (14)
CL Item
Steatosis - mixed (15)
CL Item
Non-alcoholic steatohepatitis  (16)
CL Item
Alcoholic hepatitis (17)
CL Item
Hepatic granulomas  (18)
CL Item
Sarcoidosis  (19)
CL Item
Fibrosis (20)
CL Item
Cirrhosis (21)
CL Item
Primary biliary cirrhosis  (22)
CL Item
Primary sclerosing cholangitis  (23)
CL Item
Autoimmune overlap syndrome  (24)
CL Item
Hemochromatosis  (25)
CL Item
Alpha-1-antitrypsin deficiency  (26)
CL Item
Wilson's disease  (27)
CL Item
Veno-occlusive disease  (28)
CL Item
Budd-Chiari syndrome  (29)
CL Item
Neoplasia (30)
CL Item
Other, specify (31)
Item
Liver Architecture
text
C0193388 (UMLS CUI [1,1])
C0935919 (UMLS CUI [1,2])
Biopsy of liver, Cellular structure aspects
Code List
Liver Architecture
CL Item
Normal (1)
CL Item
Bridging fibrosis (2)
CL Item
Diffuse fibrosis (3)
CL Item
Nodular regenerative hyperplasia (4)
CL Item
Congenital hepatic fibrosis (5)
CL Item
Cirrhosis (6)
CL Item
Centrilobular congestion (7)
CL Item
Endophlebitis (8)
CL Item
Veno-occlusive disease (9)
CL Item
Canalicular cholestasis (10)
CL Item
Apoptosis (11)
CL Item
Focal (or spotty or mild) hepatocellular necrosis  (12)
CL Item
Interface hepatitis (periportal hepatitis or piecemeal necrosis) (13)
CL Item
Ischaemic necrosis (14)
CL Item
Centrolobular (Zone 3) necrosis (15)
CL Item
Focal coagulative necrosis (16)
CL Item
Centrolobular (Zone 3) coagulative necrosis  (17)
CL Item
Bridging hepatocellular necrosis (18)
CL Item
Massive or panlobular hepatocellular necrosis  (19)
CL Item
Dysplasia (20)
CL Item
Neoplasia (21)
CL Item
Other, specify (22)
Item
Description of Liver Cells or Hepatocytes
text
C0193388 (UMLS CUI [1,1])
C0227525 (UMLS CUI [1,2])
C1849376 (UMLS CUI [1,3])
Biopsy of liver, Hepatocyte
Code List
Description of Liver Cells or Hepatocytes
CL Item
Normal (1)
CL Item
Ballooning (2)
CL Item
Acidophilic  (3)
CL Item
Pseudoxanthomatous  (4)
CL Item
Multinucleated giant hepatocytes (5)
CL Item
Other, specify (6)
Item
Liver Cell or Hepatocyte Inclusions or Vacuoles
text
C0227525 (UMLS CUI [1,1])
C0042219 (UMLS CUI [1,2])
C1512693 (UMLS CUI [1,3])
Biopsy of liver, Hepatocyte, Inclusion, Vacuoles
Code List
Liver Cell or Hepatocyte Inclusions or Vacuoles
CL Item
No inclusions (1)
CL Item
Macrovesicular steatosis (2)
CL Item
Microvesicular steatosis (3)
CL Item
Bile accumulation (4)
CL Item
Diastase-resistant, PAS-positive cytoplasmic inclusions (5)
CL Item
Alpha-1-antitrypsin inclusions (6)
CL Item
Megamitochondria (7)
CL Item
Mallory bodies (8)
CL Item
"Ground Glass" inclusions (9)
CL Item
Lipofuscin pigment (10)
CL Item
Hemosiderin granules (11)
CL Item
Orcein-positive cytoplasmin granules  (12)
CL Item
Protoporphyrin crystals (birefringent under polarised light) (13)
CL Item
Uroporphyrin crystals (red fluorescence under ultraviolet light) (14)
CL Item
Other, specify (15)
Item
Hepatocyte or Liver Cell Nuclear Abnormalities
text
C0193388 (UMLS CUI [1,1])
C0227525 (UMLS CUI [1,2])
C1849376 (UMLS CUI [1,3])
Biopsy of Liver, Hepatocyte, Abnormal nuclear morphology
Code List
Hepatocyte or Liver Cell Nuclear Abnormalities
CL Item
None (1)
CL Item
Hepatocellular mitosis (2)
CL Item
Binucleated or multinucleated hepatocytes  (3)
CL Item
CMV inclusion bodies (4)
CL Item
HSV inclusions (5)
CL Item
Varicella inclusions (6)
CL Item
Other, specify (7)
Item
Liver or Lobular Infiltrates
text
C0193388 (UMLS CUI [1,1])
C1400896 (UMLS CUI [1,2])
Biopsy of liver, Infiltrates
Code List
Liver or Lobular Infiltrates
CL Item
None (1)
CL Item
Eosinophils (2)
CL Item
Lymphocytes (3)
CL Item
Plasma cells (4)
CL Item
Neutrophils (5)
CL Item
Macrophages and proliferating Kupffer cells Granulomas (6)
CL Item
Other, specify (7)
Item
Portal Tract Inflammation
text
C0193388 (UMLS CUI [1,1])
C3854488 (UMLS CUI [1,2])
Biopsy of liver, Portal Tract Inflammation
Code List
Portal Tract Inflammation
CL Item
None (1)
CL Item
Eosinophils (2)
CL Item
Lymphoid aggregates and/or follicles  (3)
CL Item
Plasma cells (4)
CL Item
Neutrophils (5)
CL Item
Histocytes and macrophages (6)
CL Item
Other, specify (7)
Item
Bile Ducts
text
C0193388 (UMLS CUI [1,1])
C0005400 (UMLS CUI [1,2])
Biopsy of liver, Bile Duct structure
Code List
Bile Ducts
CL Item
Normal (1)
CL Item
Proliferation of bile ducts (bile ductular reaction)  (2)
CL Item
Dilation, degeneration or disruption of portal bile ducts (3)
CL Item
Paucity of bile ducts (4)
CL Item
Periductal fibrosis (5)
CL Item
Other, specify (6)
Item
Portal Veins
text
C0193388 (UMLS CUI [1,1])
C0032718 (UMLS CUI [1,2])
Biopsy of liver, Portal Vein structure
Code List
Portal Veins
CL Item
Normal (1)
CL Item
Pyelophlebitis (2)
CL Item
Thrombosis, sclerosis or occlusion of portal vein  (3)
CL Item
Neoplastic invasion of portal vein  (4)
CL Item
Granulomatous compression of portal vein (5)
CL Item
Other, specify (6)
Item
Liver Infections
text
C0193388 (UMLS CUI [1,1])
C1112211 (UMLS CUI [1,2])
Biopsy of liver, Hepatic Infection
Code List
Liver Infections
CL Item
Normal (1)
CL Item
Leishmaniasis donovani  (2)
CL Item
Plasmodium falciparum  (3)
CL Item
Toxoplasmosis  (4)
CL Item
Cryptococcus neoformans  (5)
CL Item
Histoplasma capsulatum  (6)
CL Item
Mycobacterium tuberculois  (7)
CL Item
Other mycobacterial species (8)
CL Item
Other, specify (9)
Item
Parasites or Ova
text
C0193388 (UMLS CUI [1,1])
C0030498 (UMLS CUI [1,2])
C1267673 (UMLS CUI [1,3])
Biopsy of liver, Parasite, Ovum of parasite
Code List
Parasites or Ova
CL Item
None (1)
CL Item
Schistosome and/or ova (2)
CL Item
Ascaris and/or ova (3)
CL Item
Toxocara and/or ova (4)
CL Item
Echinococcus cysts (5)
CL Item
Hepatic capillariasis worms and/or ova (6)
CL Item
Other, specify (7)
Item
Histologic Staining or Additional Studies Obtained
text
C0193388 (UMLS CUI [1,1])
C0487602 (UMLS CUI [1,2])
Biopsy of liver, Staining method
Code List
Histologic Staining or Additional Studies Obtained
CL Item
Haematoxylin and eosin (or H & E)  (1)
CL Item
Masson (2)
CL Item
Toluidine blue or Giemsa (3)
CL Item
Prussian blue (4)
CL Item
Periodic Acidic Schiff (PAS), with or without diastase  (5)
CL Item
Oil red O (6)
CL Item
Congo red (7)
CL Item
Hall's stain (8)
CL Item
Gridley's stain (9)
CL Item
Rhodanine (copper) (10)
CL Item
Rubeanic acid (copper) (11)
CL Item
Orcein, aldehyde fuchsin or Victoria blue  (12)
CL Item
Electron microscopy (13)
CL Item
Hepatitis A immunostains positive (14)
CL Item
Hepatitis B core antigen or hepatitis B surface antibody immunostains positive (15)
CL Item
Hepatitis D immunostains (16)
CL Item
Other immunostains (17)
CL Item
Other, specify (18)
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