ID

42906

Description

A Phase IIa prospective, open-label, multicenter study to determine the pharmacokinetics (PK) and safety and tolerability of aztreonam-avibactam (ATM-AVI) for the treatment of complicated Intra-Abdominal Infections (cIAIs) in hospitalized adults. NCT02655419 Sponsors and Collaborators: Pfizer Innovative Medicines Initiative (IMI) COMBACTE-CARE Investigators: Study Director:Pfizer CT.gov Call Center;Pfizer Principal Investigator:Oliver Cornely;Clinical Trials Centre Cologne

Keywords

Versions (2)
  1. 3/7/18 3/7/18 -
  2. 9/17/21 9/17/21 -
Copyright Holder

Pfizer

Uploaded on

September 17, 2021

DOI

To request one please log in.

License

Creative Commons BY-NC 3.0
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REJUVENATE NCT02655419

English

Test of Cure-Visit 17

8 forms  
Test of Cure Visit
Description

Test of Cure Visit

Alias
UMLS CUI-1
C0679252
UMLS CUI-2
C0220825
Visit Date
Description

Visit Date

Data type

date

Alias
UMLS CUI [1]
C1320303
Expected Visit Date
Description

Expected Visit Date

Data type

date

Alias
UMLS CUI [1,1]
C1320303
UMLS CUI [1,2]
C1517001
Earliest Expected Visit Date
Description

Earliest Expected Visit Date

Data type

date

Alias
UMLS CUI [1,1]
C1320303
UMLS CUI [1,2]
C1517001
UMLS CUI [1,3]
C1279919
Latest Expected Visit Date
Description

Latest Expected Visit Date

Data type

date

Alias
UMLS CUI [1,1]
C1320303
UMLS CUI [1,2]
C1517001
UMLS CUI [1,3]
C0205087
Administrative Information
Description

Administrative Information

Alias
UMLS CUI-1
C1320722
Patient Caption
Description

Patient Caption

Data type

text

Alias
UMLS CUI [1,1]
C2825231
UMLS CUI [1,2]
C0030705
Visit Number
Description

Visit Number

Data type

integer

Alias
UMLS CUI [1]
C1549755
Trial name
Description

Trial name

Data type

text

Alias
UMLS CUI [1]
C1629065
Visit Name
Description

Visit Name

Data type

text

Alias
UMLS CUI [1]
C2826704
Visit date
Description

Visit date

Data type

date

Alias
UMLS CUI [1]
C1320303
Site Name
Description

Study site

Data type

text

Alias
UMLS CUI [1]
C2825164
Physical Examination
Description

Physical Examination

Alias
UMLS CUI-1
C0031809
Examination performed
Description

Examination performed

Data type

boolean

Alias
UMLS CUI [1]
C0031809
if 'no', provide reason
Description

Not done reason

Data type

text

Alias
UMLS CUI [1]
C2826287
Weight
Description

Patient Weight

Data type

float

Measurement units
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Physical examination
Description

Physical examination

Alias
UMLS CUI-1
C0031809
Body system
Description

Body system

Data type

integer

Alias
UMLS CUI [1,1]
C0460002
UMLS CUI [1,2]
C0031809
Result
Description

Result

Data type

integer

Alias
UMLS CUI [1]
C1274040
if 'abnormal', brief description
Description

Description of finding

Data type

text

Alias
UMLS CUI [1,1]
C0747585
UMLS CUI [1,2]
C0678257
if 'abnormal', assessment of clinical significance
Description

clinical significance

Data type

boolean

Alias
UMLS CUI [1]
C2826293
Kind of other examination
Description

other examination

Data type

text

Alias
UMLS CUI [1]
C0260879
Infection-related Examination
Description

Infection-related Examination

Alias
UMLS CUI-1
C3714514
UMLS CUI-2
C0031809
Examination performed
Description

Examination performed

Data type

boolean

Alias
UMLS CUI [1]
C0031809
if 'no', provide reason
Description

Not done reason

Data type

text

Alias
UMLS CUI [1]
C2826287
CRF Comment
Description

Comment

Data type

text

Alias
UMLS CUI [1]
C0947611
Infection related Signs and Symptoms
Description

Infection related Signs and Symptoms

Alias
UMLS CUI-1
C0037088
UMLS CUI-2
C3714514
Signs and Symptoms
Description

Signs and Symptoms

Data type

integer

Alias
UMLS CUI [1]
C0037088
Please specify Other Sign or Symptom
Description

Other Sign or Symptom

Data type

text

Alias
UMLS CUI [1,1]
C0037088
UMLS CUI [1,2]
C0205394
Clinical Event Intensity
Description

Clinical Event Intensity

Data type

integer

Alias
UMLS CUI [1]
C0518690
Post-Operative Wound Examination
Description

Post-Operative Wound Examination

Alias
UMLS CUI-1
C2112579
UMLS CUI-2
C0886052
Examination performed
Description

Examination performed

Data type

boolean

Alias
UMLS CUI [1]
C0031809
If no, provide reason
Description

Not done reason

Data type

text

Alias
UMLS CUI [1]
C2826287
Does the Patient have a Superficial Infection?
Description

Superficial Infection

Data type

boolean

Alias
UMLS CUI [1,1]
C0043241
UMLS CUI [1,2]
C0205124
Does the Patient have a Deep Wound Infection?
Description

Deep Wound Infection

Data type

boolean

Alias
UMLS CUI [1]
C0406103
Type of Wound
Description

Type of Wound

Data type

integer

Alias
UMLS CUI [1]
C1276783
Kind of other Wound Type
Description

other Wound Type

Data type

text

Alias
UMLS CUI [1,1]
C1276783
UMLS CUI [1,2]
C0205394
Negative Pressure Wound Device present
Description

Negative Pressure Wound Device

Data type

boolean

Alias
UMLS CUI [1]
C1956078
Specimen for Culture obtained
Description

Specimen collection for culture

Data type

boolean

Alias
UMLS CUI [1,1]
C0200345
UMLS CUI [1,2]
C0430400
CRF Comment
Description

Comment

Data type

text

Alias
UMLS CUI [1]
C0947611
Signs and Symptoms of Wound Infection
Description

Signs and Symptoms of Wound Infection

Alias
UMLS CUI-1
C0043241
UMLS CUI-2
C0037088
Signs and Symptoms
Description

Signs and Symptoms

Data type

integer

Alias
UMLS CUI [1]
C0037088
Clinical Event Intensity
Description

Event Intensity

Data type

integer

Alias
UMLS CUI [1]
C0518690
If not assessed, please provide a comment
Description

not assessed,comment

Data type

text

Alias
UMLS CUI [1,1]
C3846720
UMLS CUI [1,2]
C0947611
Please specify Other Sign or Symptom
Description

Other Sign or Symptom,specify

Data type

text

Alias
UMLS CUI [1,1]
C0037088
UMLS CUI [1,2]
C3845569
Vital Signs examination
Description

Vital Signs examination

Alias
UMLS CUI-1
C0518766
UMLS CUI-2
C0031809
Examination performed
Description

Examination performed

Data type

boolean

Alias
UMLS CUI [1]
C0031809
if 'no', provide reason
Description

Not done reason

Data type

text

Alias
UMLS CUI [1]
C2826287
Supine Blood Pressure Systolic
Description

Supine Blood Pressure Systolic

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0038846
mmHg
Clinically relevant?
Description

Relevance

Data type

boolean

Alias
UMLS CUI [1]
C2347946
Supine Blood Pressure Diastolic
Description

Supine Blood Pressure Diastolic

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0038846
mmHg
Clinically relevant?
Description

Relevance

Data type

boolean

Alias
UMLS CUI [1]
C2347946
Heart rate
Description

Heart rate

Data type

integer

Measurement units
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
Clinically relevant?
Description

Relevance

Data type

boolean

Alias
UMLS CUI [1]
C2347946
Respiratory Rate
Description

Respiratory Rate

Data type

integer

Measurement units
  • breaths/min
Alias
UMLS CUI [1]
C0231832
breaths/min
Clinically relevant?
Description

Relevance

Data type

boolean

Alias
UMLS CUI [1]
C2347946
CRF Comment
Description

Comment

Data type

text

Alias
UMLS CUI [1]
C0947611
Temperature
Description

Temperature

Alias
UMLS CUI-1
C0005903
Temperature
Description

Temperature

Data type

float

Measurement units
  • °C
Alias
UMLS CUI [1]
C0039476
°C
Time of measurement
Description

HH:MM

Data type

time

Alias
UMLS CUI [1,1]
C0242485
UMLS CUI [1,2]
C0040223
Method of Measurement
Description

Method of Measurement

Data type

integer

Alias
UMLS CUI [1,1]
C1299991
UMLS CUI [1,2]
C0039476
Kind of Other Method
Description

Other Method

Data type

text

Alias
UMLS CUI [1,1]
C1299991
UMLS CUI [1,2]
C0205394
Clinically relevant?
Description

Relevance

Data type

boolean

Alias
UMLS CUI [1]
C2347946
Laboratory Tests
Description

Laboratory Tests

Alias
UMLS CUI-1
C1880016
UMLS CUI-2
C0022885
Clinical Chemistry sample collected
Description

Clinical Chemistry sample collected

Data type

boolean

Alias
UMLS CUI [1,1]
C0200345
UMLS CUI [1,2]
C0008000
If 'no', please provide reason
Description

Not done reason

Data type

integer

Alias
UMLS CUI [1]
C2826287
Other, please specify
Description

Other, please specify

Data type

text

Alias
UMLS CUI [1]
C3845569
Collection Date
Description

Collection Date

Data type

date

Alias
UMLS CUI [1]
C1302413
Collection time
Description

Collection time

Data type

time

Alias
UMLS CUI [1]
C4064021
Central Lab ID
Description

Central Laboratory ID

Data type

text

Alias
UMLS CUI [1,1]
C1880016
UMLS CUI [1,2]
C2986056
Sample sent to central lab
Description

Sample sent to central lab

Data type

boolean

Alias
UMLS CUI [1,1]
C0370003
UMLS CUI [1,2]
C1515023
UMLS CUI [1,3]
C1880016
If 'no', please provide reason
Description

Not done reason

Data type

text

Alias
UMLS CUI [1]
C2826287
Hematology sample collected
Description

Hematology sample collected

Data type

boolean

Alias
UMLS CUI [1,1]
C0200345
UMLS CUI [1,2]
C0018941
If 'no', please provide reason
Description

Not done reason

Data type

integer

Alias
UMLS CUI [1]
C2826287
Other, please specify
Description

Other, please specify

Data type

text

Alias
UMLS CUI [1]
C3845569
Collection Date
Description

Collection Date

Data type

date

Alias
UMLS CUI [1]
C1302413
Collection time
Description

Collection time

Data type

time

Alias
UMLS CUI [1]
C4064021
Central Lab ID
Description

Central Laboratory ID

Data type

text

Alias
UMLS CUI [1,1]
C1880016
UMLS CUI [1,2]
C2986056
Sample sent to central lab
Description

Sample sent to central lab

Data type

boolean

Alias
UMLS CUI [1,1]
C0370003
UMLS CUI [1,2]
C1515023
UMLS CUI [1,3]
C1880016
If 'no', please provide reason
Description

Not done reason

Data type

text

Alias
UMLS CUI [1]
C2826287
Urinalysis sample collected
Description

Urinalysis sample collected

Data type

boolean

Alias
UMLS CUI [1,1]
C0200345
UMLS CUI [1,2]
C0042014
If 'no', please provide reason
Description

Not done reason

Data type

integer

Alias
UMLS CUI [1]
C2826287
Other, please specify
Description

Other, please specify

Data type

text

Alias
UMLS CUI [1]
C3845569
Collection Date
Description

Collection Date

Data type

date

Alias
UMLS CUI [1]
C1302413
Collection time
Description

Collection time

Data type

time

Alias
UMLS CUI [1]
C4064021
Central Lab ID
Description

Central Laboratory ID

Data type

text

Alias
UMLS CUI [1,1]
C1880016
UMLS CUI [1,2]
C2986056
Sample sent to central lab
Description

Sample sent to central lab

Data type

boolean

Alias
UMLS CUI [1,1]
C0370003
UMLS CUI [1,2]
C1515023
UMLS CUI [1,3]
C1880016
If 'no', please provide reason
Description

Not done reason

Data type

text

Alias
UMLS CUI [1]
C2826287
CRF Comment
Description

Comment

Data type

text

Alias
UMLS CUI [1]
C0947611
Clinical Response Assessment
Description

Clinical Response Assessment

Alias
UMLS CUI-1
C0521982
UMLS CUI-2
C0220825
Clinical response
Description

In case of failure, please consider to fill in AE/SAE form, Completion/Withdrawal form or Antibiotic Co-Medication form

Data type

integer

Alias
UMLS CUI [1]
C0521982
Patient lost to follow up
Description

lost to follow up

Data type

boolean

Alias
UMLS CUI [1]
C1302313
Assessment not undertaken
Description

Not done

Data type

boolean

Alias
UMLS CUI [1]
C1272696
Other reason for indeterminate clinical response
Description

Other reason for indeterminate clinical response

Data type

boolean

Alias
UMLS CUI [1,1]
C3840932
UMLS CUI [1,2]
C0205258
UMLS CUI [1,3]
C4055223
CRF Comment
Description

Comment

Data type

text

Alias
UMLS CUI [1]
C0947611
Surgical Procedure
Description

Surgical Procedure

Alias
UMLS CUI-1
C0543467
Surgery performed
Description

Surgery performed

Data type

boolean

Alias
UMLS CUI [1]
C0543467
Kind of Surgical Procedure
Description

Surgery time

Data type

integer

Alias
UMLS CUI [1,1]
C0683312
UMLS CUI [1,2]
C0543467
Surgical Procedure
Description

Surgical Procedure

Data type

integer

Alias
UMLS CUI [1]
C0543467
Other procedure
Description

Other procedure

Data type

text

Alias
UMLS CUI [1]
C0543467
Start Date (incision)
Description

Start Date (incision)

Data type

date

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C0184898
Start Time (incision)
Description

Start Time (incision)

Data type

time

Alias
UMLS CUI [1,1]
C1301880
UMLS CUI [1,2]
C0184898
End Date (suture)
Description

End Date (suture)

Data type

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C0038969
End Time (suture)
Description

End Time (suture)

Data type

time

Alias
UMLS CUI [1,1]
C1522314
UMLS CUI [1,2]
C0038969
Reason for Procedure
Description

Reason for Procedure

Data type

integer

Alias
UMLS CUI [1]
C3258099
Other reason
Description

Other reason

Data type

text

Alias
UMLS CUI [1]
C3840932
CRF Comment
Description

Comment

Data type

text

Alias
UMLS CUI [1]
C0947611
Description of Findings
Description

Description of Findings

Alias
UMLS CUI-1
C0678257
UMLS CUI-2
C0243095
Description of Findings during Surgical Procedure
Description

If description is given, please use information form surgery report, if available

Data type

text

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C0678257
UMLS CUI [1,3]
C0243095
Microbiology
Description

Microbiology

Alias
UMLS CUI-1
C0085672
Was a specimen collected?
Description

Microbiology specimen collection

Data type

boolean

Alias
UMLS CUI [1,1]
C0200345
UMLS CUI [1,2]
C0025952
If no, please provide reason
Description

Not done reason

Data type

integer

Alias
UMLS CUI [1]
C2826287
Please specify inability
Description

inability

Data type

text

Alias
UMLS CUI [1,1]
C1299582
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C1521902
Please specify other reason
Description

inability

Data type

text

Alias
UMLS CUI [1,1]
C1299582
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C3845569
Date of collection
Description

Specimen collection date

Data type

date

Alias
UMLS CUI [1]
C1302413
Time of Collection
Description

Specimen collection time

Data type

time

Alias
UMLS CUI [1]
C4064021
Culture Processing Type
Description

Culture Processing Type

Data type

integer

Alias
UMLS CUI [1,1]
C0200949
UMLS CUI [1,2]
C0037793
UMLS CUI [1,3]
C0332307
Site of sample
Description

Specimen collection site

Data type

integer

Alias
UMLS CUI [1,1]
C0200345
UMLS CUI [1,2]
C1515974
Intra-Abdominal, please specify
Description

Intra-Abdominal, please specify

Data type

integer

Alias
UMLS CUI [1,1]
C1512910
UMLS CUI [1,2]
C1521902
Other site, please specify
Description

Other site, please specify

Data type

text

Alias
UMLS CUI [1,1]
C1515974
UMLS CUI [1,2]
C3845569
Culture outcome
Description

Culture outcome

Data type

integer

Alias
UMLS CUI [1,1]
C2242979
UMLS CUI [1,2]
C0587081
Isolate name
Description

Isolate name

Data type

text

Alias
UMLS CUI [1]
C1764827
Pathogen Type
Description

Pathogen Type

Data type

integer

Alias
UMLS CUI [1]
C0450254
Isolate Classification
Description

Isolate Classification

Data type

integer

Alias
UMLS CUI [1,1]
C1764827
UMLS CUI [1,2]
C0008902
Disc Zone ATM-AVI
Description

(mm, Aerobic Pathogens only)

Data type

text

Alias
UMLS CUI [1,1]
C1283010
UMLS CUI [1,2]
C0004521
UMLS CUI [2,1]
C1283010
UMLS CUI [2,2]
C3489748
Sample sent to Central Lab?
Description

Sample sent to Central Lab

Data type

boolean

Alias
UMLS CUI [1,1]
C1880016
UMLS CUI [1,2]
C0370003
UMLS CUI [1,3]
C1515023
Central Lab Accession ID Number
Description

Central Laboratory Accession ID Number

Data type

text

Alias
UMLS CUI [1,1]
C2826726
UMLS CUI [1,2]
C1880016
If no, reason
Description

Not done reason

Data type

text

Alias
UMLS CUI [1]
C2826287
Backup Sample sent to Central Lab (if necessary)?
Description

Backup Sample sent to Central Laboratory

Data type

boolean

Alias
UMLS CUI [1,1]
C0370003
UMLS CUI [1,2]
C1515023
UMLS CUI [1,3]
C1880016
Central Lab Accession ID Number
Description

Central Laboratory Accession ID Number

Data type

text

Alias
UMLS CUI [1,1]
C2826726
UMLS CUI [1,2]
C1880016
CRF Comment
Description

Comment

Data type

text

Alias
UMLS CUI [1]
C0947611
Intensive Monitoring Lab Values
Description

Intensive Monitoring Lab Values

Alias
UMLS CUI-1
C2346633
Test Name
Description

Laboratory procedure

Data type

integer

Alias
UMLS CUI [1]
C0022885
Sample collected
Description

Specimen collection

Data type

boolean

Alias
UMLS CUI [1]
C0200345
If 'no', please provide reason
Description

Not done reason

Data type

integer

Alias
UMLS CUI [1]
C2826287
Other, please specify
Description

Specify other

Data type

text

Alias
UMLS CUI [1]
C3845569
Laboratory value
Description

Laboratory value

Data type

text

Alias
UMLS CUI [1]
C0587081
Lab Unit
Description

Lab Unit

Data type

integer

Alias
UMLS CUI [1]
C1519795
Other lab unit
Description

Other lab unit

Data type

text

Alias
UMLS CUI [1,1]
C1519795
UMLS CUI [1,2]
C0205394
Was this value clinically signifcant?
Description

Clinical significance

Data type

boolean

Alias
UMLS CUI [1]
C2826293
Upper limit of normal
Description

AST (GOT),ALT (GPT),Total Bilirubin

Data type

text

Alias
UMLS CUI [1]
C1519815
Increased LAB value (3xULN;2xULN)
Description

AST (GOT),ALT (GPT),Total Bilirubin

Data type

text

Alias
UMLS CUI [1,1]
C0587081
UMLS CUI [1,2]
C0205217
Potential Hy's Law
Description

Potential Hy's Law

Data type

boolean

Alias
UMLS CUI [1,1]
C0860207
UMLS CUI [1,2]
C0332149
Notification Lab Liver
Description

AST (GOT),ALT (GPT),Total Bilirubin

Data type

boolean

Alias
UMLS CUI [1,1]
C0422202
UMLS CUI [1,2]
C0023884
Laboratory procedures
Description

Laboratory procedures

Alias
UMLS CUI-1
C0022885
Examination performed
Description

Examination performed

Data type

boolean

Alias
UMLS CUI [1]
C0022885
if 'no', provide reason
Description

Not done reason

Data type

text

Alias
UMLS CUI [1]
C2826287
Collection Date
Description

Intensive monitoring is to be done every 24h if protocol criteria are fulfilled. Samples must be analysed at local lab and results must be entered IMMEDIATELY upon availability.

Data type

date

Alias
UMLS CUI [1]
C1302413
Collection time
Description

Intensive monitoring is to be done every 24h if protocol criteria are fulfilled. Samples must be analysed at local lab and results must be entered IMMEDIATELY upon availability.

Data type

time

Alias
UMLS CUI [1]
C4064021
Creatinine Clearance
Description

Creatinine Clearance

Data type

integer

Measurement units
  • mL/min
Alias
UMLS CUI [1]
C0373595
mL/min
Was this value clinically signifcant?
Description

Clinical significance

Data type

boolean

Alias
UMLS CUI [1]
C2826293
CRF Comment
Description

Comment

Data type

text

Alias
UMLS CUI [1]
C0947611
Liver Diagnostic Assessments
Description

Liver Diagnostic Assessments

Alias
UMLS CUI-1
C0232741
UMLS CUI-2
C0022885
Potential Hy's Law Examination performed
Description

Potential Hy's Law Examination

Data type

boolean

Alias
UMLS CUI [1,1]
C0860207
UMLS CUI [1,2]
C0332149
UMLS CUI [1,3]
C0220825
Potential Hy's Law Case Number
Description

Potential Hy's Law Case Number

Data type

integer

Alias
UMLS CUI [1,1]
C0860207
UMLS CUI [1,2]
C1698493
UMLS CUI [1,3]
C0600091
CRF comment
Description

Comment

Data type

text

Alias
UMLS CUI [1]
C0947611
Liver Diagnostic
Description

Liver Diagnostic

Alias
UMLS CUI-1
C0023884
UMLS CUI-2
C0430022
Liver Diagnostic Investigation
Description

Liver Diagnostic instrument

Data type

integer

Alias
UMLS CUI [1]
C0193374
Assessment performed
Description

Examination performed

Data type

boolean

Alias
UMLS CUI [1,1]
C2985643
UMLS CUI [1,2]
C0430022
Date of Assessment
Description

Date of Assessment

Data type

date

Alias
UMLS CUI [1]
C2985720
Liver Diagnostic Result
Description

Liver Diagnostic Result

Data type

text

Alias
UMLS CUI [1,1]
C0430022
UMLS CUI [1,2]
C1274040
Investigation Specification
Description

Tox Screening, Other; Serology for Hepatitis,CMV,EBV,autoimmune;other diagnostic investigation

Data type

text

Alias
UMLS CUI [1,1]
C2348235
UMLS CUI [1,2]
C1261322
Liver risk factors
Description

Liver risk factors

Alias
UMLS CUI-1
C0035648
UMLS CUI-2
C0023884
Potential Hy's Law Case Number
Description

Potential Hy's Law Case Number

Data type

integer

Alias
UMLS CUI [1,1]
C0860207
UMLS CUI [1,2]
C1698493
UMLS CUI [1,3]
C0600091
CRF comment
Description

comment

Data type

text

Alias
UMLS CUI [1]
C0947611
Liver risk factors
Description

Liver risk factors

Alias
UMLS CUI-1
C0035648
UMLS CUI-2
C0023884
Liver risk factor
Description

Risk factor

Data type

integer

Alias
UMLS CUI [1]
C0035648
Occurrence
Description

Occurrence

Data type

boolean

Alias
UMLS CUI [1]
C2745955
Risk Factor Details
Description

Risk Factor Details

Data type

text

Alias
UMLS CUI [1,1]
C0035648
UMLS CUI [1,2]
C1522508
Reference Period
Description

Reference Period

Data type

integer

Alias
UMLS CUI [1]
C1709877
Start Date
Description

Start Date

Data type

date

Alias
UMLS CUI [1]
C0808070
End Date
Description

End Date

Data type

date

Alias
UMLS CUI [1]
C0806020
Comment
Description

Comment

Data type

text

Alias
UMLS CUI [1]
C0947611
Liver signs and symptoms
Description

Liver signs and symptoms

Alias
UMLS CUI-1
C0037088
UMLS CUI-2
C0023884
Potential Hy's Law Case Number
Description

Potential Hy's Law Case Number

Data type

integer

Alias
UMLS CUI [1,1]
C0860207
UMLS CUI [1,2]
C1698493
UMLS CUI [1,3]
C0600091
CRF comment
Description

comment

Data type

text

Alias
UMLS CUI [1]
C0947611
Liver signs and symptoms
Description

Liver signs and symptoms

Alias
UMLS CUI-1
C0037088
UMLS CUI-2
C0023884
Signs and Symptoms
Description

Signs and Symptoms

Data type

integer

Alias
UMLS CUI [1]
C0037088
Occurrence
Description

Occurrence

Data type

boolean

Alias
UMLS CUI [1]
C2745955
Start Date
Description

Start Date

Data type

date

Alias
UMLS CUI [1]
C0808070
End Date
Description

End Date

Data type

date

Alias
UMLS CUI [1]
C0806020
Intermittent
Description

Intermittent

Data type

boolean

Alias
UMLS CUI [1]
C0205267
Other Liver Sign or Symptom
Description

Other Liver Sign or Symptom

Data type

text

Alias
UMLS CUI [1,1]
C0037088
UMLS CUI [1,2]
C0205394
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Similar models

Test of Cure-Visit 17

8 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Test of Cure Visit
C0679252 (UMLS CUI-1)
C0220825 (UMLS CUI-2)
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Expected Visit Date
Item
Expected Visit Date
date
C1320303 (UMLS CUI [1,1])
C1517001 (UMLS CUI [1,2])
Earliest Expected Visit Date
Item
Earliest Expected Visit Date
date
C1320303 (UMLS CUI [1,1])
C1517001 (UMLS CUI [1,2])
C1279919 (UMLS CUI [1,3])
Latest Expected Visit Date
Item
Latest Expected Visit Date
date
C1320303 (UMLS CUI [1,1])
C1517001 (UMLS CUI [1,2])
C0205087 (UMLS CUI [1,3])
Item Group
Administrative Information
C1320722 (UMLS CUI-1)
Patient Caption
Item
Patient Caption
text
C2825231 (UMLS CUI [1,1])
C0030705 (UMLS CUI [1,2])
Visit Number
Item
Visit Number
integer
C1549755 (UMLS CUI [1])
Trial name
Item
Trial name
text
C1629065 (UMLS CUI [1])
Visit Name
Item
Visit Name
text
C2826704 (UMLS CUI [1])
Visit date
Item
Visit date
date
C1320303 (UMLS CUI [1])
Study site
Item
Site Name
text
C2825164 (UMLS CUI [1])
Item Group
Physical Examination
C0031809 (UMLS CUI-1)
Examination performed
Item
Examination performed
boolean
C0031809 (UMLS CUI [1])
Not done reason
Item
if 'no', provide reason
text
C2826287 (UMLS CUI [1])
Patient Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Item Group
Physical examination
C0031809 (UMLS CUI-1)
Item
Body system
integer
C0460002 (UMLS CUI [1,1])
C0031809 (UMLS CUI [1,2])
Body system
Code List
Body system
CL Item
General Appearance (1)
CL Item
Skin (2)
CL Item
Head, Eyes, Ears, Nose, Throat (3)
CL Item
Lymph Nodes (4)
CL Item
Respiratory (5)
CL Item
Cardiovascular (6)
CL Item
Abdomen (Wound Exam. at sep.eCRF) (7)
CL Item
Musculoskeletal (8)
CL Item
Neurological (9)
CL Item
Other (10)
Item
Result
integer
C1274040 (UMLS CUI [1])
Result
Code List
Result
CL Item
normal (1)
(Comment:en)
CL Item
abnormal (2)
(Comment:en)
CL Item
not done (99)
(Comment:en)
Description of finding
Item
if 'abnormal', brief description
text
C0747585 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
clinical significance
Item
if 'abnormal', assessment of clinical significance
boolean
C2826293 (UMLS CUI [1])
other examination
Item
Kind of other examination
text
C0260879 (UMLS CUI [1])
Item Group
Infection-related Examination
C3714514 (UMLS CUI-1)
C0031809 (UMLS CUI-2)
Examination performed
Item
Examination performed
boolean
C0031809 (UMLS CUI [1])
Not done reason
Item
if 'no', provide reason
text
C2826287 (UMLS CUI [1])
Comment
Item
CRF Comment
text
C0947611 (UMLS CUI [1])
Item Group
Infection related Signs and Symptoms
C0037088 (UMLS CUI-1)
C3714514 (UMLS CUI-2)
Item
Signs and Symptoms
integer
C0037088 (UMLS CUI [1])
Signs and Symptoms
Code List
Signs and Symptoms
CL Item
Abdominal Pain (1)
CL Item
Nausea (2)
CL Item
Vomiting (3)
CL Item
Tenderness to palpation (4)
CL Item
Rebound tenderness (5)
CL Item
Abdominal guarding (6)
CL Item
Abdominal mass (7)
CL Item
Ascites (8)
CL Item
Chills and rigors (9)
CL Item
Other,specify (10)
Other Sign or Symptom
Item
Please specify Other Sign or Symptom
text
C0037088 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Item
Clinical Event Intensity
integer
C0518690 (UMLS CUI [1])
Clinical Event Intensity
Code List
Clinical Event Intensity
CL Item
Absent (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Not Assessed (99)
Item Group
Post-Operative Wound Examination
C2112579 (UMLS CUI-1)
C0886052 (UMLS CUI-2)
Examination performed
Item
Examination performed
boolean
C0031809 (UMLS CUI [1])
Not done reason
Item
If no, provide reason
text
C2826287 (UMLS CUI [1])
Superficial Infection
Item
Does the Patient have a Superficial Infection?
boolean
C0043241 (UMLS CUI [1,1])
C0205124 (UMLS CUI [1,2])
Deep Wound Infection
Item
Does the Patient have a Deep Wound Infection?
boolean
C0406103 (UMLS CUI [1])
Item
Type of Wound
integer
C1276783 (UMLS CUI [1])
Type of Wound
Code List
Type of Wound
CL Item
Surgical Incision Site (1)
CL Item
Laparoscopic Incision Site (2)
CL Item
Percutaneous Drainage Site (3)
CL Item
Other (99)
other Wound Type
Item
Kind of other Wound Type
text
C1276783 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Negative Pressure Wound Device
Item
Negative Pressure Wound Device present
boolean
C1956078 (UMLS CUI [1])
Specimen collection for culture
Item
Specimen for Culture obtained
boolean
C0200345 (UMLS CUI [1,1])
C0430400 (UMLS CUI [1,2])
Comment
Item
CRF Comment
text
C0947611 (UMLS CUI [1])
Item Group
Signs and Symptoms of Wound Infection
C0043241 (UMLS CUI-1)
C0037088 (UMLS CUI-2)
Item
Signs and Symptoms
integer
C0037088 (UMLS CUI [1])
Signs and Symptoms
Code List
Signs and Symptoms
CL Item
Erythema (1)
CL Item
Induration (2)
CL Item
Tenderness (3)
CL Item
Warmth (4)
CL Item
Fluctuation (5)
CL Item
Swelling (6)
CL Item
Wound Pain (7)
CL Item
Dehiscence (8)
CL Item
Purulent Discharge (9)
CL Item
Non Purulent Discharge (10)
CL Item
Other (11)
Item
Clinical Event Intensity
integer
C0518690 (UMLS CUI [1])
Clinical Event Intensity
Code List
Clinical Event Intensity
CL Item
Absent (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Not Assessed (99)
not assessed,comment
Item
If not assessed, please provide a comment
text
C3846720 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
Other Sign or Symptom,specify
Item
Please specify Other Sign or Symptom
text
C0037088 (UMLS CUI [1,1])
C3845569 (UMLS CUI [1,2])
Item Group
Vital Signs examination
C0518766 (UMLS CUI-1)
C0031809 (UMLS CUI-2)
Examination performed
Item
Examination performed
boolean
C0031809 (UMLS CUI [1])
Not done reason
Item
if 'no', provide reason
text
C2826287 (UMLS CUI [1])
Supine Blood Pressure Systolic
Item
Supine Blood Pressure Systolic
integer
C0871470 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
Relevance
Item
Clinically relevant?
boolean
C2347946 (UMLS CUI [1])
Supine Blood Pressure Diastolic
Item
Supine Blood Pressure Diastolic
integer
C0428883 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
Relevance
Item
Clinically relevant?
boolean
C2347946 (UMLS CUI [1])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Relevance
Item
Clinically relevant?
boolean
C2347946 (UMLS CUI [1])
Respiratory Rate
Item
Respiratory Rate
integer
C0231832 (UMLS CUI [1])
Relevance
Item
Clinically relevant?
boolean
C2347946 (UMLS CUI [1])
Comment
Item
CRF Comment
text
C0947611 (UMLS CUI [1])
Item Group
Temperature
C0005903 (UMLS CUI-1)
Temperature
Item
Temperature
float
C0039476 (UMLS CUI [1])
Time of measurement
Item
Time of measurement
time
C0242485 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Item
Method of Measurement
integer
C1299991 (UMLS CUI [1,1])
C0039476 (UMLS CUI [1,2])
Method of Measurement
Code List
Method of Measurement
CL Item
Oral (1)
(Comment:en)
CL Item
Axillary (2)
(Comment:en)
CL Item
Rectal (3)
(Comment:en)
CL Item
Tympanic (4)
(Comment:en)
CL Item
Other (99)
(Comment:en)
Other Method
Item
Kind of Other Method
text
C1299991 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Relevance
Item
Clinically relevant?
boolean
C2347946 (UMLS CUI [1])
Item Group
Laboratory Tests
C1880016 (UMLS CUI-1)
C0022885 (UMLS CUI-2)
Clinical Chemistry sample collected
Item
Clinical Chemistry sample collected
boolean
C0200345 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
Item
If 'no', please provide reason
integer
C2826287 (UMLS CUI [1])
Not done reason
Code List
If 'no', please provide reason
CL Item
Insufficient amount collected (1)
CL Item
Hemolyzed sample (2)
CL Item
Unable to obtain venous access (3)
CL Item
Patient not able to provide urine sample (4)
CL Item
Missed sample collection (5)
CL Item
Other (99)
Other, please specify
Item
Other, please specify
text
C3845569 (UMLS CUI [1])
Collection Date
Item
Collection Date
date
C1302413 (UMLS CUI [1])
Collection time
Item
Collection time
time
C4064021 (UMLS CUI [1])
Central Laboratory ID
Item
Central Lab ID
text
C1880016 (UMLS CUI [1,1])
C2986056 (UMLS CUI [1,2])
Sample sent to central lab
Item
Sample sent to central lab
boolean
C0370003 (UMLS CUI [1,1])
C1515023 (UMLS CUI [1,2])
C1880016 (UMLS CUI [1,3])
Not done reason
Item
If 'no', please provide reason
text
C2826287 (UMLS CUI [1])
Hematology sample collected
Item
Hematology sample collected
boolean
C0200345 (UMLS CUI [1,1])
C0018941 (UMLS CUI [1,2])
Item
If 'no', please provide reason
integer
C2826287 (UMLS CUI [1])
Not done reason
Code List
If 'no', please provide reason
CL Item
Insufficient amount collected (1)
CL Item
Hemolyzed sample (2)
CL Item
Unable to obtain venous access (3)
CL Item
Patient not able to provide urine sample (4)
CL Item
Missed sample collection (5)
CL Item
Other (99)
Other, please specify
Item
Other, please specify
text
C3845569 (UMLS CUI [1])
Collection Date
Item
Collection Date
date
C1302413 (UMLS CUI [1])
Collection time
Item
Collection time
time
C4064021 (UMLS CUI [1])
Central Laboratory ID
Item
Central Lab ID
text
C1880016 (UMLS CUI [1,1])
C2986056 (UMLS CUI [1,2])
Sample sent to central lab
Item
Sample sent to central lab
boolean
C0370003 (UMLS CUI [1,1])
C1515023 (UMLS CUI [1,2])
C1880016 (UMLS CUI [1,3])
Not done reason
Item
If 'no', please provide reason
text
C2826287 (UMLS CUI [1])
Urinalysis sample collected
Item
Urinalysis sample collected
boolean
C0200345 (UMLS CUI [1,1])
C0042014 (UMLS CUI [1,2])
Item
If 'no', please provide reason
integer
C2826287 (UMLS CUI [1])
Not done reason
Code List
If 'no', please provide reason
CL Item
Insufficient amount collected (1)
CL Item
Hemolyzed sample (2)
CL Item
Unable to obtain venous access (3)
CL Item
Patient not able to provide urine sample (4)
CL Item
Missed sample collection (5)
CL Item
Other (99)
Other, please specify
Item
Other, please specify
text
C3845569 (UMLS CUI [1])
Collection Date
Item
Collection Date
date
C1302413 (UMLS CUI [1])
Collection time
Item
Collection time
time
C4064021 (UMLS CUI [1])
Central Laboratory ID
Item
Central Lab ID
text
C1880016 (UMLS CUI [1,1])
C2986056 (UMLS CUI [1,2])
Sample sent to central lab
Item
Sample sent to central lab
boolean
C0370003 (UMLS CUI [1,1])
C1515023 (UMLS CUI [1,2])
C1880016 (UMLS CUI [1,3])
Not done reason
Item
If 'no', please provide reason
text
C2826287 (UMLS CUI [1])
Comment
Item
CRF Comment
text
C0947611 (UMLS CUI [1])
Item Group
Clinical Response Assessment
C0521982 (UMLS CUI-1)
C0220825 (UMLS CUI-2)
Item
Clinical response
integer
C0521982 (UMLS CUI [1])
Clinical response
Code List
Clinical response
CL Item
Cure (1)
CL Item
Failure (2)
CL Item
Indeterminate (3)
lost to follow up
Item
Patient lost to follow up
boolean
C1302313 (UMLS CUI [1])
Not done
Item
Assessment not undertaken
boolean
C1272696 (UMLS CUI [1])
Other reason for indeterminate clinical response
Item
Other reason for indeterminate clinical response
boolean
C3840932 (UMLS CUI [1,1])
C0205258 (UMLS CUI [1,2])
C4055223 (UMLS CUI [1,3])
Comment
Item
CRF Comment
text
C0947611 (UMLS CUI [1])
Item Group
Surgical Procedure
C0543467 (UMLS CUI-1)
Surgery performed
Item
Surgery performed
boolean
C0543467 (UMLS CUI [1])
Item
Kind of Surgical Procedure
integer
C0683312 (UMLS CUI [1,1])
C0543467 (UMLS CUI [1,2])
Kind of Surgical Procedure
Code List
Kind of Surgical Procedure
CL Item
Initial Procedure (1)
CL Item
Reintervention (2)
Item
Surgical Procedure
integer
C0543467 (UMLS CUI [1])
Surgical Procedure
Code List
Surgical Procedure
CL Item
Laparotomy (1)
CL Item
Percutaneous Draingae of Abscess (2)
CL Item
Laparoscopy (3)
CL Item
Wound Debridement without Laparotomy (4)
CL Item
Other (99)
Other procedure
Item
Other procedure
text
C0543467 (UMLS CUI [1])
Start Date (incision)
Item
Start Date (incision)
date
C0808070 (UMLS CUI [1,1])
C0184898 (UMLS CUI [1,2])
Start Time (incision)
Item
Start Time (incision)
time
C1301880 (UMLS CUI [1,1])
C0184898 (UMLS CUI [1,2])
End Date (suture)
Item
End Date (suture)
date
C0806020 (UMLS CUI [1,1])
C0038969 (UMLS CUI [1,2])
End Time (suture)
Item
End Time (suture)
time
C1522314 (UMLS CUI [1,1])
C0038969 (UMLS CUI [1,2])
Item
Reason for Procedure
integer
C3258099 (UMLS CUI [1])
Reason for Procedure
Code List
Reason for Procedure
CL Item
Persistent or recurrent infection in the abdomen (1)
CL Item
Superficial wound infection (2)
CL Item
Deep wound infection (3)
CL Item
Adverse Event (4)
CL Item
Other (99)
Other reason
Item
Other reason
text
C3840932 (UMLS CUI [1])
Comment
Item
CRF Comment
text
C0947611 (UMLS CUI [1])
Item Group
Description of Findings
C0678257 (UMLS CUI-1)
C0243095 (UMLS CUI-2)
Description of Findings during Surgical Procedure
Item
Description of Findings during Surgical Procedure
text
C0543467 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
C0243095 (UMLS CUI [1,3])
Item Group
Microbiology
C0085672 (UMLS CUI-1)
Microbiology specimen collection
Item
Was a specimen collected?
boolean
C0200345 (UMLS CUI [1,1])
C0025952 (UMLS CUI [1,2])
Item
If no, please provide reason
integer
C2826287 (UMLS CUI [1])
Not done reason
Code List
If no, please provide reason
CL Item
Attempt made but unable to obtain/produce sample (1)
CL Item
Other (99)
inability
Item
Please specify inability
text
C1299582 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
inability
Item
Please specify other reason
text
C1299582 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C3845569 (UMLS CUI [1,3])
Specimen collection date
Item
Date of collection
date
C1302413 (UMLS CUI [1])
Specimen collection time
Item
Time of Collection
time
C4064021 (UMLS CUI [1])
Item
Culture Processing Type
integer
C0200949 (UMLS CUI [1,1])
C0037793 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,3])
Culture Processing Type
Code List
Culture Processing Type
CL Item
Aerobic (1)
CL Item
Anaerobic (2)
Item
Site of sample
integer
C0200345 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
Specimen collection site
Code List
Site of sample
CL Item
Intra-Abdominal  (1)
CL Item
Blood  (2)
CL Item
Other (99)
Item
Intra-Abdominal, please specify
integer
C1512910 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
Intra-Abdominal, please specify
Code List
Intra-Abdominal, please specify
CL Item
Pus (1)
CL Item
Tissue (2)
CL Item
Peritoneal Fluid (3)
CL Item
Surgical Swab (4)
CL Item
Other (99)
Other site, please specify
Item
Other site, please specify
text
C1515974 (UMLS CUI [1,1])
C3845569 (UMLS CUI [1,2])
Item
Culture outcome
integer
C2242979 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
Culture outcome
Code List
Culture outcome
CL Item
No Growth (1)
CL Item
Growth (2)
CL Item
Not done (99)
Isolate name
Item
Isolate name
text
C1764827 (UMLS CUI [1])
Item
Pathogen Type
integer
C0450254 (UMLS CUI [1])
Pathogen Type
Code List
Pathogen Type
CL Item
Bacterial (1)
CL Item
Fungal (2)
Item
Isolate Classification
integer
C1764827 (UMLS CUI [1,1])
C0008902 (UMLS CUI [1,2])
Isolate Classification
Code List
Isolate Classification
CL Item
Pathogen (1)
CL Item
Contaminant (2)
Disc Zone ATM-AVI
Item
Disc Zone ATM-AVI
text
C1283010 (UMLS CUI [1,1])
C0004521 (UMLS CUI [1,2])
C1283010 (UMLS CUI [2,1])
C3489748 (UMLS CUI [2,2])
Sample sent to Central Lab
Item
Sample sent to Central Lab?
boolean
C1880016 (UMLS CUI [1,1])
C0370003 (UMLS CUI [1,2])
C1515023 (UMLS CUI [1,3])
Central Laboratory Accession ID Number
Item
Central Lab Accession ID Number
text
C2826726 (UMLS CUI [1,1])
C1880016 (UMLS CUI [1,2])
Not done reason
Item
If no, reason
text
C2826287 (UMLS CUI [1])
Backup Sample sent to Central Laboratory
Item
Backup Sample sent to Central Lab (if necessary)?
boolean
C0370003 (UMLS CUI [1,1])
C1515023 (UMLS CUI [1,2])
C1880016 (UMLS CUI [1,3])
Central Laboratory Accession ID Number
Item
Central Lab Accession ID Number
text
C2826726 (UMLS CUI [1,1])
C1880016 (UMLS CUI [1,2])
Comment
Item
CRF Comment
text
C0947611 (UMLS CUI [1])
Item Group
Intensive Monitoring Lab Values
C2346633 (UMLS CUI-1)
Item
Test Name
integer
C0022885 (UMLS CUI [1])
Laboratory procedure
Code List
Test Name
CL Item
Serum Creatinine (1)
CL Item
AST (GOT) (2)
CL Item
ALT (GPT) (3)
CL Item
ALP (4)
CL Item
Total Bilirubin (5)
CL Item
GGT (6)
CL Item
INR (7)
Specimen collection
Item
Sample collected
boolean
C0200345 (UMLS CUI [1])
Item
If 'no', please provide reason
integer
C2826287 (UMLS CUI [1])
Not done reason
Code List
If 'no', please provide reason
CL Item
Insufficient amount collected (1)
CL Item
Hemolyzed sample (2)
CL Item
Unable to obtain venous access (3)
CL Item
Patient not able to provide urine sample (4)
CL Item
Missed sample collection (5)
CL Item
Other (99)
Specify other
Item
Other, please specify
text
C3845569 (UMLS CUI [1])
Laboratory value
Item
Laboratory value
text
C0587081 (UMLS CUI [1])
Item
Lab Unit
integer
C1519795 (UMLS CUI [1])
Lab Unit
Code List
Lab Unit
CL Item
U/L (IU/L) (1)
CL Item
mmol/L (2)
CL Item
μmol/L (3)
CL Item
g/dL (4)
CL Item
mg/dL (5)
CL Item
g/L (6)
CL Item
L/L (7)
CL Item
microKat/L (8)
CL Item
Other (99)
Other lab unit
Item
Other lab unit
text
C1519795 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Clinical significance
Item
Was this value clinically signifcant?
boolean
C2826293 (UMLS CUI [1])
Upper limit of normal
Item
Upper limit of normal
text
C1519815 (UMLS CUI [1])
Increased LAB value
Item
Increased LAB value (3xULN;2xULN)
text
C0587081 (UMLS CUI [1,1])
C0205217 (UMLS CUI [1,2])
Potential Hy's Law
Item
Potential Hy's Law
boolean
C0860207 (UMLS CUI [1,1])
C0332149 (UMLS CUI [1,2])
Notification
Item
Notification Lab Liver
boolean
C0422202 (UMLS CUI [1,1])
C0023884 (UMLS CUI [1,2])
Item Group
Laboratory procedures
C0022885 (UMLS CUI-1)
Examination performed
Item
Examination performed
boolean
C0022885 (UMLS CUI [1])
Not done reason
Item
if 'no', provide reason
text
C2826287 (UMLS CUI [1])
Collection Date
Item
Collection Date
date
C1302413 (UMLS CUI [1])
Collection time
Item
Collection time
time
C4064021 (UMLS CUI [1])
Creatinine Clearance
Item
Creatinine Clearance
integer
C0373595 (UMLS CUI [1])
Clinical significance
Item
Was this value clinically signifcant?
boolean
C2826293 (UMLS CUI [1])
Comment
Item
CRF Comment
text
C0947611 (UMLS CUI [1])
Item Group
Liver Diagnostic Assessments
C0232741 (UMLS CUI-1)
C0022885 (UMLS CUI-2)
Potential Hy's Law Examination
Item
Potential Hy's Law Examination performed
boolean
C0860207 (UMLS CUI [1,1])
C0332149 (UMLS CUI [1,2])
C0220825 (UMLS CUI [1,3])
Potential Hy's Law Case Number
Item
Potential Hy's Law Case Number
integer
C0860207 (UMLS CUI [1,1])
C1698493 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,3])
Comment
Item
CRF comment
text
C0947611 (UMLS CUI [1])
Item Group
Liver Diagnostic
C0023884 (UMLS CUI-1)
C0430022 (UMLS CUI-2)
Item
Liver Diagnostic Investigation
integer
C0193374 (UMLS CUI [1])
Liver Diagnostic instrument
Code List
Liver Diagnostic Investigation
CL Item
Ultrasound (1)
CL Item
CT (2)
CL Item
MRI/MRCP (3)
CL Item
ERCP (4)
CL Item
Liver Biopsy (5)
CL Item
X-Ray (6)
CL Item
Tox Screening for Acetaminophen/Paracetamol (7)
CL Item
Tox Screening for Ethanol (8)
CL Item
Tox Screening, Other (9)
CL Item
Serology for Hepatitis A (10)
CL Item
Serology for Hepatitis B (11)
CL Item
Serology for Hepatitis C (12)
CL Item
Serology for Hepatitis D (13)
CL Item
Serology for Hepatitis E (14)
CL Item
Serology for Cytomegalovirus (15)
CL Item
Serology for Epstein Barr Virus (16)
CL Item
Autoimmune Serology (17)
CL Item
Specialist consulted (18)
CL Item
Other (19)
Examination performed
Item
Assessment performed
boolean
C2985643 (UMLS CUI [1,1])
C0430022 (UMLS CUI [1,2])
Date of Assessment
Item
Date of Assessment
date
C2985720 (UMLS CUI [1])
Liver Diagnostic Result
Item
Liver Diagnostic Result
text
C0430022 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Investigation Specification
Item
Investigation Specification
text
C2348235 (UMLS CUI [1,1])
C1261322 (UMLS CUI [1,2])
Item Group
Liver risk factors
C0035648 (UMLS CUI-1)
C0023884 (UMLS CUI-2)
Potential Hy's Law Case Number
Item
Potential Hy's Law Case Number
integer
C0860207 (UMLS CUI [1,1])
C1698493 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,3])
comment
Item
CRF comment
text
C0947611 (UMLS CUI [1])
Item Group
Liver risk factors
C0035648 (UMLS CUI-1)
C0023884 (UMLS CUI-2)
Item
Liver risk factor
integer
C0035648 (UMLS CUI [1])
Risk factor
Code List
Liver risk factor
CL Item
Alcohol abuse (1)
CL Item
Increased Alcohol Consumption (within 1 Month) (2)
CL Item
IV Drug Abuse (3)
CL Item
Tattoo (4)
CL Item
Acupuncture (5)
CL Item
Sexual transmitted diseases (6)
CL Item
Toxic/Chemical Agent Exposure (7)
CL Item
Travel (Areas at Risk within last Year) (8)
CL Item
Pregnancy (9)
CL Item
Parenteral Nutrition (10)
CL Item
Excessive Physical Exercise (11)
CL Item
Changesdiet/Fasting Episodes/Weight Loss Diet (12)
CL Item
Previous Drug Reaction (Elevation of Liver Tests) (13)
CL Item
Blood Transfusion (14)
CL Item
Exposure to Anyone with Jaundince within last Month (15)
CL Item
History of Hypotension (16)
CL Item
Low Blood Pressure/Abnormal Liver Lab Value (17)
CL Item
Other (18)
Occurrence
Item
Occurrence
boolean
C2745955 (UMLS CUI [1])
Risk Factor Details
Item
Risk Factor Details
text
C0035648 (UMLS CUI [1,1])
C1522508 (UMLS CUI [1,2])
Item
Reference Period
integer
C1709877 (UMLS CUI [1])
Reference Period
Code List
Reference Period
CL Item
Past (1)
CL Item
Current (2)
Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1])
End Date
Item
End Date
date
C0806020 (UMLS CUI [1])
Comment
Item
Comment
text
C0947611 (UMLS CUI [1])
Item Group
Liver signs and symptoms
C0037088 (UMLS CUI-1)
C0023884 (UMLS CUI-2)
Potential Hy's Law Case Number
Item
Potential Hy's Law Case Number
integer
C0860207 (UMLS CUI [1,1])
C1698493 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,3])
comment
Item
CRF comment
text
C0947611 (UMLS CUI [1])
Item Group
Liver signs and symptoms
C0037088 (UMLS CUI-1)
C0023884 (UMLS CUI-2)
Item
Signs and Symptoms
integer
C0037088 (UMLS CUI [1])
Signs and Symptoms
Code List
Signs and Symptoms
CL Item
Anorexia (1)
CL Item
Abdominal Pain (2)
CL Item
Nausea (3)
CL Item
Vomiting (4)
CL Item
Pruritis (5)
CL Item
Dark Urine (6)
CL Item
Arthralgia (7)
CL Item
Coma (8)
CL Item
Confusional State (9)
CL Item
Rash (10)
CL Item
Purpura (11)
CL Item
Jaundice (12)
CL Item
Mucosa Inflammation (13)
CL Item
Lymphadenopathy (14)
CL Item
Abdominal Tenderness (15)
CL Item
Upper Quadrant Tenderness (16)
CL Item
Hepatomegaly (17)
CL Item
Splenomegaly (18)
CL Item
Ascites (19)
CL Item
Asthenia (20)
CL Item
Pyrexia (21)
CL Item
Biliary Obstruction (22)
CL Item
Eosinophilia (23)
CL Item
Other (24)
Occurrence
Item
Occurrence
boolean
C2745955 (UMLS CUI [1])
Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1])
End Date
Item
End Date
date
C0806020 (UMLS CUI [1])
Intermittent
Item
Intermittent
boolean
C0205267 (UMLS CUI [1])
Other Liver Sign or Symptom
Item
Other Liver Sign or Symptom
text
C0037088 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
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