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])
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
Body system
integer
C0460002 (UMLS CUI [1,1])
C0031809 (UMLS CUI [1,2])
CL Item
General Appearance (1)
CL Item
Head, Eyes, Ears, Nose, Throat (3)
CL Item
Cardiovascular (6)
CL Item
Abdomen (Wound Exam. at sep.eCRF) (7)
CL Item
Musculoskeletal (8)
Item
Result
integer
C1274040 (UMLS CUI [1])
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
Signs and Symptoms
integer
C0037088 (UMLS CUI [1])
Code List
Signs and Symptoms
CL Item
Abdominal Pain (1)
CL Item
Tenderness to palpation (4)
CL Item
Rebound tenderness (5)
CL Item
Abdominal guarding (6)
CL Item
Abdominal mass (7)
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])
Code List
Clinical Event Intensity
CL Item
Not Assessed (99)
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])
CL Item
Surgical Incision Site (1)
CL Item
Laparoscopic Incision Site (2)
CL Item
Percutaneous Drainage Site (3)
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
Signs and Symptoms
integer
C0037088 (UMLS CUI [1])
Code List
Signs and Symptoms
CL Item
Purulent Discharge (9)
CL Item
Non Purulent Discharge (10)
Item
Clinical Event Intensity
integer
C0518690 (UMLS CUI [1])
Code List
Clinical Event Intensity
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])
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])
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])
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])
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])
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)
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])
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)
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])
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)
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])
Comment
Item
CRF Comment
text
C0947611 (UMLS CUI [1])
Item
Clinical response
integer
C0521982 (UMLS CUI [1])
Code List
Clinical response
CL Item
Indeterminate (3)
Cause of death
Item
Death related to intra-abdominal infection
boolean
C0007465 (UMLS CUI [1,1])
C1112209 (UMLS CUI [1,2])
Antibiotics ongoing
Item
Additional antibiotics for ongoing cIAI
boolean
C0003232 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Early failure
Item
Patient previously met criteria for failure
boolean
C0162643 (UMLS CUI [1,1])
C1279919 (UMLS CUI [1,2])
Abdominal infection persistent or recurrent
Item
Persisting or recurrent infection within the abdomen
boolean
C1112209 (UMLS CUI [1,1])
C1264606 (UMLS CUI [1,2])
C1112209 (UMLS CUI [2,1])
C2945760 (UMLS CUI [2,2])
Post surgical wound infection
Item
Post surgical wound infection
boolean
C0038941 (UMLS CUI [1])
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])
other reason
Item
Kind of other reason
text
C3840932 (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])
Code List
Kind of Surgical Procedure
CL Item
Initial Procedure (1)
CL Item
Reintervention (2)
Item
Surgical Procedure
integer
C0543467 (UMLS CUI [1])
Code List
Surgical Procedure
CL Item
Percutaneous Draingae of Abscess (2)
CL Item
Wound Debridement without Laparotomy (4)
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])
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)
Other reason
Item
Other reason
text
C3840932 (UMLS CUI [1])
Comment
Item
CRF Comment
text
C0947611 (UMLS CUI [1])
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])
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])
Code List
If no, please provide reason
CL Item
Attempt made but unable to obtain/produce sample (1)
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])
Code List
Culture Processing Type
Item
Site of sample
integer
C0200345 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
CL Item
Intra-Abdominal (1)
Item
Intra-Abdominal, please specify
integer
C1512910 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
Code List
Intra-Abdominal, please specify
CL Item
Peritoneal Fluid (3)
CL Item
Surgical Swab (4)
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])
Code List
Culture outcome
Isolate name
Item
Isolate name
text
C1764827 (UMLS CUI [1])
Item
Pathogen Type
integer
C0450254 (UMLS CUI [1])
Item
Isolate Classification
integer
C1764827 (UMLS CUI [1,1])
C0008902 (UMLS CUI [1,2])
Code List
Isolate Classification
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
Test Name
integer
C0022885 (UMLS CUI [1])
CL Item
Serum Creatinine (1)
CL Item
Total Bilirubin (5)
Specimen collection
Item
Sample collected
boolean
C0200345 (UMLS CUI [1])
Item
If 'no', please provide reason
integer
C2826287 (UMLS CUI [1])
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)
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])
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])
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])
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
Liver Diagnostic Investigation
integer
C0193374 (UMLS CUI [1])
Code List
Liver Diagnostic Investigation
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)
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])
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
Liver risk factor
integer
C0035648 (UMLS CUI [1])
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
Sexual transmitted diseases (6)
CL Item
Toxic/Chemical Agent Exposure (7)
CL Item
Travel (Areas at Risk within last Year) (8)
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)
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])
Code List
Reference Period
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])
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
Signs and Symptoms
integer
C0037088 (UMLS CUI [1])
Code List
Signs and Symptoms
CL Item
Abdominal Pain (2)
CL Item
Confusional State (9)
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
Biliary Obstruction (22)
CL Item
Eosinophilia (23)
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])