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])
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])
CL Item
Single Episode (1)
Item
Maximum Intensity
text
C1518404 (UMLS CUI [1,1])
C1710066 (UMLS CUI [1,2])
Code List
Maximum Intensity
Item
Action Taken with Investigational Product(s) as a Result of the AE
text
C1518404 (UMLS CUI [1,1])
C1704758 (UMLS CUI [1,2])
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Investigational product(s) withdrawn (1)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])
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])
CL Item
Recovered/Resolved (1)
CL Item
Recovering/Resolving (2)
CL Item
Not recovered/Not resolved (3)
CL Item
Recovered/Resolved with sequelae (4)
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])
Code List
Maximum Intensity
Item
Action Taken with Investigational Product(s) as a Result of the AE
text
C1519255 (UMLS CUI [1,1])
C1704758 (UMLS CUI [1,2])
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])
Code List
Intensity of event segment
Item
Grade of event segment
text
C1519255 (UMLS CUI [1,1])
C2985911 (UMLS CUI [1,2])
Code List
Grade of event segment
Item
Grade or Intensity of event segment
text
C1519255 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C2985911 (UMLS CUI [1,3])
Code List
Grade or Intensity of event segment
CL Item
Moderate or Grade 2 (2)
CL Item
Severe or Grade 3 (3)
Item
Seriousness?
text
C1519255 (UMLS CUI [1,1])
C1710056 (UMLS CUI [1,2])
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])
Code List
Relevant Medical Conditions/Risk Factors - Continuing?
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])
Code List
Rechallenge - If investigational product(s) were stopped temporarily, did the reported event(s) recur after investigational products were restarted?
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])
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, 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 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])
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])
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])
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])
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])
Code List
Was an infiltrate present?
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])
Code List
Infiltrate unilateral or bilateral
Item
Characterization of infiltrate
text
C0039985 (UMLS CUI [1,1])
C0235896 (UMLS CUI [1,2])
C1880022 (UMLS CUI [1,3])
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])
Code List
Right upper lobe involved with infiltrate
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])
Code List
Right middle lobe involved with infiltrate
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])
Code List
Right lower lobe involved with infiltrate
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])
Code List
Left upper lobe involved with infiltrate
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])
Code List
Lingula involved with infiltrate
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])
Code List
Left lower lobe involved with infiltrate
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])
Code List
Was a pleural effusion identified?
Item
Present, specify Location
text
C0039985 (UMLS CUI [1,1])
C0032227 (UMLS CUI [1,2])
C0450429 (UMLS CUI [1,3])
Code List
Present, specify Location
Item
Lung findings atelectasis
text
C0039985 (UMLS CUI [1,1])
C0004144 (UMLS CUI [1,2])
Code List
Lung findings atelectasis
Item
Lung findings mass?
text
C0039985 (UMLS CUI [1,1])
C0149726 (UMLS CUI [1,2])
Code List
Lung findings mass?
Item
Lung findings cardiomegaly?
text
C0039985 (UMLS CUI [1,1])
C0018800 (UMLS CUI [1,2])
Code List
Lung findings cardiomegaly?
Item
Was pulmonary edema identified?
text
C0039985 (UMLS CUI [1,1])
C0034063 (UMLS CUI [1,2])
Code List
Was pulmonary edema identified?
Plain chest X-ray, Comment
Item
Comment
text
C0039985 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
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])
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])
Code List
Increased sputum purulence
Item
Was the chest auscultation normal?
text
C0032285 (UMLS CUI [1,1])
C0577960 (UMLS CUI [1,2])
Code List
Was the chest auscultation normal?
Item
Dyspnea
text
C0032285 (UMLS CUI [1,1])
C0013404 (UMLS CUI [1,2])
Item
Culture/swab taken?
text
C0032285 (UMLS CUI [1,1])
C0200949 (UMLS CUI [1,2])
Code List
Culture/swab taken?
Item
Yes, pathogen from pneumonia culture
text
C0032285 (UMLS CUI [1,1])
C0200949 (UMLS CUI [1,2])
C0450254 (UMLS CUI [1,3])
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)
Item
Pleural effusion location code
text
C0032285 (UMLS CUI [1,1])
C0032227 (UMLS CUI [1,2])
C0450429 (UMLS CUI [1,3])
Code List
Pleural effusion location code
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])
Code List
Does subject have elevated WBC?
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])
Code List
Was this subject in a health care setting (inpatient) when the pneumonia developed?
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])
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])
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])
Code List
Are images technically adequate?
CL Item
Readable, but not optimal (2)
CL Item
Other, specify (4)
Item
Indicate the liver size
text
C2711860 (UMLS CUI [1,1])
C0426688 (UMLS CUI [1,2])
Code List
Indicate the liver size
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])
Code List
Indicate the liver texture
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])
Code List
Grade the diffuse and/or geographic fatty infiltrate of the liver
CL Item
Not applicable - no fatty infiltration (1)
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])
Code List
Ascites present
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])
Code List
Are Focal Hepatic Lesions characterisable?
CL Item
Not applicable - no hepatic lesions (1)
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])
Code List
Gallstones or gallbladder lesions?
CL Item
Gallbladder polyp(s) (3)
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])
Code List
Biliary ductal lesions?
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
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])
Code List
Portal/Hepatic vein abnormalities?
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)
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])
Code List
Final Diagnosis
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
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
Other, specify (31)
Item
Liver Architecture
text
C0193388 (UMLS CUI [1,1])
C0935919 (UMLS CUI [1,2])
Code List
Liver Architecture
CL Item
Bridging fibrosis (2)
CL Item
Diffuse fibrosis (3)
CL Item
Nodular regenerative hyperplasia (4)
CL Item
Congenital hepatic fibrosis (5)
CL Item
Centrilobular congestion (7)
CL Item
Endophlebitis (8)
CL Item
Veno-occlusive disease (9)
CL Item
Canalicular cholestasis (10)
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
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])
Code List
Description of Liver Cells or Hepatocytes
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])
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])
Code List
Hepatocyte or Liver Cell Nuclear Abnormalities
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])
Code List
Liver or Lobular Infiltrates
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])
Code List
Portal Tract Inflammation
CL Item
Lymphoid aggregates and/or follicles (3)
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])
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])
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])
Code List
Liver Infections
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])
Code List
Parasites or Ova
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])
Code List
Histologic Staining or Additional Studies Obtained
CL Item
Haematoxylin and eosin (or H & E) (1)
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
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)