ID

36653

Beschreibung

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

Stichworte

Versionen (2)
  1. 25.02.19 25.02.19 -
  2. 28.05.19 28.05.19 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

28. Mai 2019

DOI

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Lizenz

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

Englisch

LOGS

1 Formulare  
  1. StudyEvent: ODM
    1. LOGS
Administrative Data
Beschreibung

Administrative Data

Site
Beschreibung

Study Site

Datentyp

text

Alias
UMLS CUI [1]
C2825164
Subject
Beschreibung

Clinical trial participant

Datentyp

text

Alias
UMLS CUI [1]
C1997894
Subject No.
Beschreibung

Clinical Trial Subject Unique Identifier

Datentyp

integer

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

Non-Serious Adverse Event

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

Non-serious Adverse Event

Datentyp

text

Alias
UMLS CUI [1]
C1518404
Start Date
Beschreibung

Non-serious Adverse Event, Start Date

Datentyp

date

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

Non-serious Adverse Event, Adverse Event Outcome

Datentyp

text

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

Non-serious Adverse Event, End Date

Datentyp

date

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

Non-serious Adverse Event, End Date

Datentyp

date

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

Non-serious Adverse Event, Frequencies

Datentyp

text

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

Non-serious Adverse Event, Severity of Adverse Event

Datentyp

text

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

Non-serious Adverse Event, Action Taken with Study Treatment

Datentyp

text

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

Non-serious Adverse Event, Withdrawal by Subject

Datentyp

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?
Beschreibung

Non-serious Adverse Event, Investigational New Drugs, Relationships

Datentyp

boolean

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

Serious Adverse Events

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

Serious Adverse Event, Experimental drug, Initiation

Datentyp

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)
Beschreibung

Serious Adverse Event

Datentyp

text

Alias
UMLS CUI [1]
C1519255
Start Date
Beschreibung

Serious Adverse Event, Start Date

Datentyp

date

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

Serious Adverse Event, Adverse Event Outcome

Datentyp

text

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

Serious Adverse Event, End Date

Datentyp

date

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

Serious Adverse Event, End Date

Datentyp

date

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

Serious Adverse Event, End Date

Datentyp

date

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

Serious Adverse Event, Severity of Adverse Event

Datentyp

text

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

Serious Adverse Event, Action Taken with Study Treatment

Datentyp

text

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

Serious Adverse Event, Withdrawal by Subject

Datentyp

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?
Beschreibung

Serious Adverse Event, Investigational New Drugs, Relationships

Datentyp

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)?
Beschreibung

Serious Adverse Event, Subject Study Participation Status, Relationships

Datentyp

boolean

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

Serious Adverse Event, Start Date, Start time

Datentyp

datetime

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

Serious Adverse Event, Symptom intensity

Datentyp

text

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

Serious Adverse Event, Adverse Event Grade Code

Datentyp

text

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

Serious Adverse Event, Symptom intensity, Adverse Event Grade Code

Datentyp

text

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

Serious Adverse Event, Seriousness of Adverse Event

Datentyp

text

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

Serious Adverse Event, Concomitant Agent, Medication name

Datentyp

text

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

Serious Adverse Event, Concomitant Agent, Dosage

Datentyp

text

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

Serious Adverse Event, Concomitant Agent, Unit

Datentyp

text

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

Serious Adverse Event, Concomitant Agent, Frequencies

Datentyp

text

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

Serious Adverse Event, Concomitant Agent, Drug Administration Routes

Datentyp

text

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

Serious Adverse Event, Concomitant Medication Start Date

Datentyp

date

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

Serious Adverse Event, Concomitant Medication Ongoing

Datentyp

boolean

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

Serious Adverse Event, Concomitant Medication End Date

Datentyp

date

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

Serious Adverse Event, Concomitant Agent, Indication

Datentyp

text

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

Serious Adverse Event, Concomitant Agent, Type

Datentyp

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)
Beschreibung

Serious Adverse Event, Disease

Datentyp

text

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

Serious Adverse Event, Disease, Start Date

Datentyp

date

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

Serious Adverse Event, Disease, Continuous

Datentyp

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
Beschreibung

Serious Adverse Event, Disease, End Date

Datentyp

date

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

Serious Adverse Event, Diagnostic procedure, Test Name

Datentyp

text

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

Serious Adverse Event, Diagnostic procedure, Date in time

Datentyp

date

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

Serious Adverse Event, Diagnostic procedure, Result

Datentyp

text

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

Serious Adverse Event, Diagnostic procedure, Unit of Measure

Datentyp

text

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

Serious Adverse Event, Diagnostic procedure, Normal Range, Low

Datentyp

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
Beschreibung

Serious Adverse Event, Diagnostic procedure, Normal Range, High

Datentyp

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
Beschreibung

Serious Adverse Event, Diagnostic procedure, Result, Relevance

Datentyp

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?
Beschreibung

Serious Adverse Event, Experimental drug, Causations

Datentyp

text

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

Serious Adverse Event, Experimental drug

Datentyp

text

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

Serious Adverse Event, Experimental drug, Start Date

Datentyp

date

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

Serious Adverse Event, Experimental drug, End Date

Datentyp

date

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

Serious Adverse Event, Experimental drug

Datentyp

text

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

Serious Adverse Event, Experimental drug, Medication dose

Datentyp

text

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

Serious Adverse Event, Experimental drug, Cumulative Dose

Datentyp

text

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

Serious Adverse Event, Comment

Datentyp

text

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

COPD Exacerbations

Alias
UMLS CUI-1
C0740304
Date of Onset
Beschreibung

COPD exacerbation, Start Date

Datentyp

date

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

COPD exacerbation, Patient Outcome

Datentyp

text

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

COPD exacerbation, Recovered or Resolved, End Date

Datentyp

date

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

COPD exacerbation, Fatal, End Date

Datentyp

date

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

COPD exaverbation, Severities

Datentyp

text

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

COPD exacerbation, Withdraw

Datentyp

boolean

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

COPD exacerbation, Causations

Datentyp

text

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

COPD exacerbation, Adrenal Cortex Hormones

Datentyp

boolean

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

COPD exacerbation, Antibiotics

Datentyp

boolean

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

COPD exacerbation, Hospitalization

Datentyp

boolean

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

COPD exacerbation, Rescue remedy, Changed status

Datentyp

boolean

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

COPD exacerbation, Plain chest X-ray

Datentyp

boolean

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

COPD exacerbation, Home care of patient, Count of entities

Datentyp

integer

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

COPD exacerbation, Physicisn, Visit, Count of entities

Datentyp

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
Beschreibung

COPD exacerbation, Clinic Visit, Outpatient, Count of entities

Datentyp

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
Beschreibung

COPD exacerbation, Emergency Room admission, Count of entities

Datentyp

integer

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

COPD exacerbation, Hospitalization length of stay

Datentyp

integer

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

COPD exacerbation, Pharmaceutical Preparations, Medication name

Datentyp

text

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

COPD exacerbation, Pharmaceutical Preparations, Dosage

Datentyp

text

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

COPD exacerbation, Pharmaceutical Preparations, Unit

Datentyp

text

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

COPD exacerbation, Pharmaceutical Preparations, Frequencies

Datentyp

text

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

COPD exacerbation, Pharmaceutical Preparations, Drug Administration Routes

Datentyp

text

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

COPD exacerbation, Pharmaceutical Preparations, Start Date

Datentyp

date

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

COPD exacerbation, Pharmaceutical Preparations, Previous

Datentyp

boolean

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

COPD exacerbation, Pharmaceutical Preparations, Continuous

Datentyp

boolean

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

COPD exacerbation, Pharmaceutical Preparations, End Date

Datentyp

date

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

Concomitant Medications

Alias
UMLS CUI-1
C2347852
Drug Name
Beschreibung

Concomitant Agent, Medication name

Datentyp

text

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

Concomitant Agent, Dosage

Datentyp

text

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

Concomitant Agent, Unit

Datentyp

text

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

Concomitant Agent, Frequencies

Datentyp

text

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

Concomitant Agent, Drug Administration Routes

Datentyp

text

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

Concomitant Agent, Indication

Datentyp

text

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

Concomitant Medication Start Date

Datentyp

date

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

Concomitant Medication Previous Occurrence

Datentyp

boolean

Alias
UMLS CUI [1]
C2826667
Ongoing?
Beschreibung

Concomitant Medication Ongoing

Datentyp

boolean

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

Concomitant Medication End Date

Datentyp

date

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

Concomitant Agent, Rescue remedy

Datentyp

boolean

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

Concomitant Agent, Type

Datentyp

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0332307
Date of Visit/Assessment
Beschreibung

Date of Visit/Assessment

Alias
UMLS CUI-1
C1320303
UMLS CUI-2
C2985720
Date of visit/assessment
Beschreibung

Date of visit, Assessment Date

Datentyp

date

Alias
UMLS CUI [1,1]
C1320303
UMLS CUI [1,2]
C2985720
Fracture
Beschreibung

Fracture

Alias
UMLS CUI-1
C0016658
Date of Fracture
Beschreibung

Fracture, Date in time

Datentyp

date

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

Fracture, Anatomic Site, Code

Datentyp

text

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

Fracture, Type

Datentyp

text

Alias
UMLS CUI [1,1]
C0016658
UMLS CUI [1,2]
C0332307
Pharmacogenetic (PGx) Research Consent / Sample Collection
Beschreibung

Pharmacogenetic (PGx) Research Consent / Sample Collection

Alias
UMLS CUI-1
C0031325
UMLS CUI-2
C0021430
UMLS CUI-3
C0870078
Has informed consent been obtained for PGx research?
Beschreibung

Pharmacogenetics, Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0031325
UMLS CUI [1,2]
C0021430
Yes, record: Date informed consent obtained for PGx research
Beschreibung

Pharmacogenetics, Informed Consent, Date in time

Datentyp

date

Alias
UMLS CUI [1,1]
C0031325
UMLS CUI [1,2]
C0021430
UMLS CUI [1,3]
C0011008
Has sample been collected for PGx research?
Beschreibung

Pharmacogenetics, Sampling

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0031325
UMLS CUI [1,2]
C0870078
Yes, record date sample taken
Beschreibung

Pharmacogenetics, Sampling, Date in time

Datentyp

date

Alias
UMLS CUI [1,1]
C0031325
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C0011008
No, check reason
Beschreibung

Pharmacogenetics, Sampling, Reason

Datentyp

text

Alias
UMLS CUI [1,1]
C0031325
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C0566251
Double Blind Investigational Product Compliance
Beschreibung

Double Blind Investigational Product Compliance

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

Experimental drug; Containers; Identifier

Datentyp

text

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

Experimental drug, Dispensed, Visit

Datentyp

text

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

Experimental drug, Dispensed, Date in time

Datentyp

date

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

Dosage, Count, Start

Datentyp

text

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

Experimental drug, Return, Visit

Datentyp

text

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

Experimental drug, Return, Date in time

Datentyp

date

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

Drug Dose, Stop

Datentyp

text

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

Open Label Diskus Taken During Run-in

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

Experimental drug; Containers; Identifier

Datentyp

text

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

Experimental drug, Dispensed, Visit

Datentyp

text

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

Experimental drug, Dispensed, Date in time

Datentyp

date

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

Dosage, Count, Start

Datentyp

text

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

Experimental drug, Return, Visit

Datentyp

text

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

Experimental drug, Return, Date in time

Datentyp

date

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

Drug Dose, Stop

Datentyp

text

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

IP Device Malfunction

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

Investigational Medicinal Product Documentation, Identifier

Datentyp

integer

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

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

Datentyp

text

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

Chest X-Ray

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

Plain chest X-ray, Date in time

Datentyp

date

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

x-ray of chest: pulmonary infiltrate

Datentyp

text

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

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

Datentyp

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
Beschreibung

Plain chest X-ray, Pulmonary infiltrate, Characterization

Datentyp

text

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

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

Datentyp

text

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

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

Datentyp

text

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

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

Datentyp

text

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

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

Datentyp

text

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

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

Datentyp

text

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

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

Datentyp

text

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

Plain chest X-ray, Pleural effusion disorder

Datentyp

text

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

Plain chest X-ray, Pleural effusion disorder, Location

Datentyp

text

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

Plain chest X-ray, Atelectasis

Datentyp

text

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

Plain chest X-ray, Lung mass

Datentyp

text

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

Plain chest X-ray, Cardiomegaly

Datentyp

text

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

Plain chest X-ray, Pulmonary Edema

Datentyp

text

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

Plain chest X-ray, Comment

Datentyp

text

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

Pneumonia Assessment

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

Pneumonia, Start Date

Datentyp

date

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

Pneumonia, Coughing, Level

Datentyp

text

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

Pneumonia, Purulent sputum

Datentyp

text

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

Pneumonia, Chest auscultation finding

Datentyp

text

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

Pneumonia, Dyspnea

Datentyp

text

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

Pneumonia, Blood culture

Datentyp

text

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

Pneumonia, Blood culture, Pathogenic organism

Datentyp

text

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

Pneumonia, Pleural effusion disorder, Location

Datentyp

text

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

Body Temperature

Datentyp

float

Maßeinheiten
  • °C
Alias
UMLS CUI [1]
C0005903
°C
Respiration rate
Beschreibung

Respiratory rate

Datentyp

integer

Maßeinheiten
  • breaths/min
Alias
UMLS CUI [1]
C0231832
breaths/min
Heart rate
Beschreibung

Heart rate

Datentyp

integer

Maßeinheiten
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
Blood pressure (systolic)
Beschreibung

Systolic Pressure

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0522019
mmHg
Blood pressure (diastolic)
Beschreibung

Diastolic blood pressure

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Does subject have hypoxemia?
Beschreibung

Pneumonia, Hypoxemia

Datentyp

text

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

Pneumonia, White blood cell count procedure

Datentyp

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?
Beschreibung

Pneumonia, Inpatient

Datentyp

text

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

Pneumonia, X-Ray confirmed

Datentyp

boolean

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

Pneumonia, Hospitalization

Datentyp

boolean

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

Pneumonia, Cessation of life

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0032285
UMLS CUI [1,2]
C0011065
Log Status
Beschreibung

Log Status

Alias
UMLS CUI-1
C1708728
UMLS CUI-2
C0449438
Were any concomitant medications taken by the subject during the study?
Beschreibung

Concomitant Agent, During, Clinical Trials

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0347984
UMLS CUI [1,3]
C0008976
Did the subject experience any non-serious adverse events during the study?
Beschreibung

Non-serious Adverse Event

Datentyp

boolean

Alias
UMLS CUI [1]
C1518404
Did the subject experience any COPD exacerbations?
Beschreibung

COPD exacerbation

Datentyp

boolean

Alias
UMLS CUI [1]
C0740304
Has subject been diagnosed with pneumonia?
Beschreibung

Pneumonia

Datentyp

boolean

Alias
UMLS CUI [1]
C0032285
Did the subject have a fracture during the course of the study?
Beschreibung

Fracture

Datentyp

boolean

Alias
UMLS CUI [1]
C0016658
Did any Novel Dry Powder Inhaler device(s) supplied to the subject malfunction during the course of the study?
Beschreibung

Dry Powder Inhaler Device, Device Failure

Datentyp

text

Alias
UMLS CUI [1,1]
C1967611
UMLS CUI [1,2]
C0086138
SAE Status
Beschreibung

SAE Status

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0449438
Did the subject experience a serious adverse event during the study?
Beschreibung

Serious Adverse Event

Datentyp

boolean

Alias
UMLS CUI [1]
C1519255
Subject Status
Beschreibung

Subject Status

Alias
UMLS CUI-1
C2348568
Did the subject withdraw between visits?
Beschreibung

Withdrawal by Subject

Datentyp

boolean

Alias
UMLS CUI [1]
C1710677
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Ähnliche Modelle

LOGS

1 Formulare
  1. StudyEvent: ODM
    1. LOGS
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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
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
Date of Visit/Assessment
C1320303 (UMLS CUI-1)
C2985720 (UMLS CUI-2)
Date of visit, Assessment Date
Item
Date of visit/assessment
date
C1320303 (UMLS CUI [1,1])
C2985720 (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
Pharmacogenetic (PGx) Research Consent / Sample Collection
C0031325 (UMLS CUI-1)
C0021430 (UMLS CUI-2)
C0870078 (UMLS CUI-3)
Pharmacogenetics, Informed Consent
Item
Has informed consent been obtained for PGx research?
boolean
C0031325 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
Pharmacogenetics, Informed Consent, Date in time
Item
Yes, record: Date informed consent obtained for PGx research
date
C0031325 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Pharmacogenetics, Sampling
Item
Has sample been collected for PGx research?
boolean
C0031325 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
Pharmacogenetics, Sampling, Date in time
Item
Yes, record date sample taken
date
C0031325 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item
No, check reason
text
C0031325 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
Pharmacogenetics, Sampling, Reason
Code List
No, check reason
CL Item
Subject declined (1)
CL Item
Subject not asked by Investigator (2)
CL Item
Other, specify (3)
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
Log Status
C1708728 (UMLS CUI-1)
C0449438 (UMLS CUI-2)
Concomitant Agent, During, Clinical Trials
Item
Were any concomitant medications taken by the subject during the study?
boolean
C2347852 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Non-serious Adverse Event
Item
Did the subject experience any non-serious adverse events during the study?
boolean
C1518404 (UMLS CUI [1])
COPD exacerbation
Item
Did the subject experience any COPD exacerbations?
boolean
C0740304 (UMLS CUI [1])
Pneumonia
Item
Has subject been diagnosed with pneumonia?
boolean
C0032285 (UMLS CUI [1])
Fracture
Item
Did the subject have a fracture during the course of the study?
boolean
C0016658 (UMLS CUI [1])
Dry Powder Inhaler Device, Device Failure
Item
Did any Novel Dry Powder Inhaler device(s) supplied to the subject malfunction during the course of the study?
text
C1967611 (UMLS CUI [1,1])
C0086138 (UMLS CUI [1,2])
Item Group
SAE Status
C1519255 (UMLS CUI-1)
C0449438 (UMLS CUI-2)
Serious Adverse Event
Item
Did the subject experience a serious adverse event during the study?
boolean
C1519255 (UMLS CUI [1])
Item Group
Subject Status
C2348568 (UMLS CUI-1)
Withdrawal by Subject
Item
Did the subject withdraw between visits?
boolean
C1710677 (UMLS CUI [1])
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