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ID
29207
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)
- 3/7/18 3/7/18 -
- 9/17/21 9/17/21 -
Copyright Holder
Pfizer
Uploaded on
March 7, 2018
DOI
10.21961/mdm:29207
License
Creative Commons BY-NC 3.0
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Screening Visit
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Trial name
Item
Trial
text
C1629065 (UMLS CUI [1])
CL Item
Surgical Incision Site (1)
CL Item
Laparoscopic Incision Site (2)
CL Item
Percutaneous Drainage Site (3)
CL Item
Other (99)
Study site
Item
Site name
text
C2825164 (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])
Superficial Infection
Item
Does the Patient have a Superficial Infection?
boolean
C0043241 (UMLS CUI [1,1])
C0205124 (UMLS CUI [1,2])
C0205124 (UMLS CUI [1,2])
Deep Wound Infection
Item
Does the Patient have a Deep Wound Infection?
boolean
C0406103 (UMLS CUI [1])
other Wound Type
Item
Kind of other Wound Type
text
C1276783 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
Patient Caption
Item
Patient Caption
text
C2825231 (UMLS CUI [1,1])
C0030705 (UMLS CUI [1,2])
C0030705 (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])
C0430400 (UMLS CUI [1,2])
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)
Visit Name
Item
Visit Name
text
C2826704 (UMLS CUI [1])
Visit Number
Item
Visit Number
integer
C1549755 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
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])
C0947611 (UMLS CUI [1,2])
not assessed,comment
Item
If not assessed, please provide a comment
text
C3846720 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
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])
C3845569 (UMLS CUI [1,2])
Comment
Item
CRF Comment
text
C0947611 (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])
C0543467 (UMLS CUI [1,2])
CL Item
Initial Procedure (1)
CL Item
Reintervention (2)
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])
Item Group
Alcohol and Smoking History
C0038586 (UMLS CUI-1)
C0262926 (UMLS CUI-2)
C0262926 (UMLS CUI-2)
CL Item
never (0)
CL Item
current (1)
CL Item
former (2)
CL Item
never smoker (1)
CL Item
ex-smoker (2)
CL Item
smoker (3)
Cumulative pack years
Item
Cumulative pack years
integer
C1277691 (UMLS CUI [1])
Time since Smoking Cessation
Item
Time since Smoking Cessation
integer
C0453997 (UMLS CUI [1])
Item
Time unit ex-smoker
integer
C0337671 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,3])
C1519795 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,3])
CL Item
Years (1)
CL Item
Months (2)
Comment
Item
CRF Comment
text
C0947611 (UMLS CUI [1])
Item
Type of Substance
integer
C0038586 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,2])
CL Item
Wine (1)
CL Item
Beer (2)
CL Item
Spirits (3)
CL Item
Other (4)
Alcohol Use
Item
Alcohol Use
boolean
C0001948 (UMLS CUI [1])
Kind of Other Substance
Item
Kind of Other Substance
text
C0439861 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
Cumulative Number of Units
Item
Cumulative Number of Units
integer
C2986497 (UMLS CUI [1,1])
C0449961 (UMLS CUI [1,2])
C0449961 (UMLS CUI [1,2])
CL Item
per Day (1)
CL Item
per Week (2)
Subject complies with all inclusion / exclusion criteria
Item
Subject complies with all inclusion / exclusion criteria
boolean
C0013893 (UMLS CUI [1])
Comment
Item
CRF Comment
text
C0947611 (UMLS CUI [1])
Failed eligibility criteria
Item
Failed criterion
text
C1516637 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,2])
CL Item
inclusion (1)
CL Item
exclusion (2)
Item Group
Medical and surgical history
C0262926 (UMLS CUI-1)
C0489540 (UMLS CUI-2)
C0489540 (UMLS CUI-2)
medical and surgical history
Item
Any relevant medical and surgical history?
boolean
C0262926 (UMLS CUI [1,1])
C0489540 (UMLS CUI [1,2])
C0489540 (UMLS CUI [1,2])
Comment
Item
CRF Comment
text
C0947611 (UMLS CUI [1])
Item Group
Medical / surgical event
C1948041 (UMLS CUI-1)
C0262926 (UMLS CUI-2)
C0262926 (UMLS CUI-2)
Diagnosis
Item
Condition, Illness, Diagnosis for Surgical Procedure
text
C0011900 (UMLS CUI [1])
Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1])
End Date
Item
End Date
date
C0806020 (UMLS CUI [1])
Ongoing at screening visit
Item
Ongoing at screening visit
boolean
C0549178 (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])
Height
Item
Height
integer
C0005890 (UMLS CUI [1])
Comment
Item
CRF Comment
text
C0947611 (UMLS CUI [1])
CL Item
Other (10)
CL Item
Neurological (9)
CL Item
Musculoskeletal (8)
CL Item
Abdomen (Wound Exam. at sep.eCRF) (7)
CL Item
Cardiovascular (6)
CL Item
Respiratory (5)
CL Item
Lymph Nodes (4)
CL Item
Head, Eyes, Ears, Nose, Throat (3)
CL Item
Skin (2)
CL Item
General Appearance (1)
CL Item
not done (3)
CL Item
abnormal (2)
CL Item
normal (1)
Description of finding
Item
if 'abnormal', brief description
text
C0747585 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
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
Diagnosis of Current Intra-Abdominal Infection
C1112209 (UMLS CUI-1)
C0521116 (UMLS CUI-2)
C0521116 (UMLS CUI-2)
Item
Study Qualifying Intra-Abdominal Diagnosis
integer
C1514624 (UMLS CUI [1,1])
C1112209 (UMLS CUI [1,2])
C1112209 (UMLS CUI [1,2])
CL Item
cIAI Not Confirmed at Surgery (8)
CL Item
Intra-Abdominal Abscess (including of Liver and Spleen provided that there is Extension beyond the Organ with Evidence of Intraperitoneal Involvement) (7)
CL Item
Secondary Peritonitis (but not Spontaneous Bacterial Peritonitis sassociated with Cirrhosis and Chronic Ascites) (6)
CL Item
Traumatic Perforation of Intestines, only if operated > 12 Housr after Perforation occurs (5)
CL Item
Acute Gastric and Duodenal Perforations, only if operated on > 24 Hours after Perforartion occurs (4)
CL Item
Appendiceal Perforation or Peri-Appendiceal Abscess (3)
CL Item
Diverticular Disease with Perforation or Abscess (2)
CL Item
Cholecystitis with Gangrenous Rupture or Perforation or Progression of the Infection beyond the Gallbladder Wall (1)
CL Item
Multiple Abscesses (2)
CL Item
Single Abscess (1)
Cause of Infection
Item
Was this Infection a Complication of a Previous Abdominal Surgery?
boolean
C3714514 (UMLS CUI [1,1])
C0015127 (UMLS CUI [1,2])
C0015127 (UMLS CUI [1,2])
Cause of Infection
Item
Is this infection considered a failure of previous treatment?
boolean
C3714514 (UMLS CUI [1,1])
C0015127 (UMLS CUI [1,2])
C0015127 (UMLS CUI [1,2])
Date of Previous Surgery
Item
Date of Previous Surgery
date
C0011008 (UMLS CUI [1,1])
C0543467 (UMLS CUI [1,2])
C0543467 (UMLS CUI [1,2])
Item Group
Site of Source of Infection
C0449426 (UMLS CUI-1)
C1515974 (UMLS CUI-2)
C1515974 (UMLS CUI-2)
Item
Site of Source of Infection
integer
C0449426 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
C1515974 (UMLS CUI [1,2])
CL Item
Other (9)
CL Item
Large Intestine (8)
CL Item
Pancreas (7)
CL Item
Appendix (6)
CL Item
Small Intestine (5)
CL Item
Liver (4)
CL Item
Spleen (3)
CL Item
Gall Bladder (2)
CL Item
Stomach (1)
Other Location
Item
Other Location
text
C1515974 (UMLS CUI [1])
Radiological Examination
Item
Any Radiological Examination in Relation to the Diagnosis?
boolean
C0043299 (UMLS CUI [1])
Radiological Examination
Item
Kind of Radiological Examination
text
C0043299 (UMLS CUI [1])
Radiological Findings
Item
Radiological Findings
text
C0043299 (UMLS CUI [1,1])
C0243095 (UMLS CUI [1,2])
C0243095 (UMLS CUI [1,2])
Comment
Item
CRF Comment
text
C0947611 (UMLS CUI [1])
Item Group
Infection-related Examination
C3714514 (UMLS CUI-1)
C0031809 (UMLS CUI-2)
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)
C3714514 (UMLS CUI-2)
CL Item
Other,specify (10)
CL Item
Chills and rigors (9)
CL Item
Ascites (8)
CL Item
Abdominal mass (7)
CL Item
Abdominal guarding (6)
CL Item
Rebound tenderness (5)
CL Item
Tenderness to palpation (4)
CL Item
Vomiting (3)
CL Item
Nausea (2)
CL Item
Abdominal Pain (1)
Other Sign or Symptom
Item
Please specify Other Sign or Symptom
text
C0037088 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
CL Item
Not Assessed (99)
CL Item
Severe (3)
CL Item
Moderate (2)
CL Item
Mild (1)
CL Item
Absent (0)
Item Group
Vital Signs examination
C0518766 (UMLS CUI-1)
C0031809 (UMLS CUI-2)
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])
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])
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])
C0040223 (UMLS CUI [1,2])
Item
Method of Measurement
integer
C1299991 (UMLS CUI [1,1])
C0039476 (UMLS CUI [1,2])
C0039476 (UMLS CUI [1,2])
CL Item
Other (99)
(Comment:en)
CL Item
Tympanic (4)
(Comment:en)
CL Item
Rectal (3)
(Comment:en)
CL Item
Axillary (2)
(Comment:en)
CL Item
Oral (1)
(Comment:en)
Other Method
Item
Kind of Other Method
text
C1299991 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
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])
C0008000 (UMLS CUI [1,2])
CL Item
Other (99)
CL Item
Missed sample collection (5)
CL Item
Patient not able to provide urine sample (4)
CL Item
Unable to obtain venous access (3)
CL Item
Hemolyzed sample (2)
CL Item
Insufficient amount collected (1)
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])
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])
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])
C0018941 (UMLS CUI [1,2])
CL Item
Other (99)
CL Item
Missed sample collection (5)
CL Item
Patient not able to provide urine sample (4)
CL Item
Unable to obtain venous access (3)
CL Item
Hemolyzed sample (2)
CL Item
Insufficient amount collected (1)
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])
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])
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])
C0042014 (UMLS CUI [1,2])
CL Item
Other (99)
CL Item
Missed sample collection (5)
CL Item
Patient not able to provide urine sample (4)
CL Item
Unable to obtain venous access (3)
CL Item
Hemolyzed sample (2)
CL Item
Insufficient amount collected (1)
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])
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])
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])
Clinical Chemistry sample collected
Item
Clinical Chemistry sample collected
boolean
C0200345 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C0008000 (UMLS CUI [1,2])
CL Item
Other (99)
CL Item
Missed sample collection (5)
CL Item
Patient not able to provide urine sample (4)
CL Item
Unable to obtain venous access (3)
CL Item
Hemolyzed sample (2)
CL Item
Insufficient amount collected (1)
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])
Serum Creatinine
Item
Serum Creatinine
float
C0201976 (UMLS CUI [1])
not done
Item
not done
boolean
C1272696 (UMLS CUI [1])
CL Item
other (99)
CL Item
microKat/L (8)
CL Item
L/L (7)
CL Item
g/L (6)
CL Item
mg/dL (5)
CL Item
g/dL (4)
CL Item
μmol/L (3)
CL Item
mmol/L (2)
CL Item
U/L (IU/L) (1)
other unit
Item
other lab unit
text
C1519795 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
lower limit of normal
Item
lower limit of normal
integer
C1518030 (UMLS CUI [1])
ULN
Item
Upper limit of normal
integer
C1519815 (UMLS CUI [1])
Significance
Item
Was this value clinically signifcant?
boolean
C2826633 (UMLS CUI [1])
AST (GOT)
Item
AST (GOT)
integer
C0201899 (UMLS CUI [1])
not done
Item
not done
boolean
C1272696 (UMLS CUI [1])
other unit
Item
other lab unit
text
C1519795 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
lower limit of normal
Item
lower limit of normal
integer
C1518030 (UMLS CUI [1])
ULN
Item
Upper limit of normal
integer
C1519815 (UMLS CUI [1])
Significance
Item
Was this value clinically signifcant?
boolean
C2826633 (UMLS CUI [1])
ALT (GPT)
Item
ALT (GPT)
integer
C0201836 (UMLS CUI [1])
not done
Item
not done
boolean
C1272696 (UMLS CUI [1])
other unit
Item
other lab unit
text
C1519795 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
lower limit of normal
Item
lower limit of normal
integer
C1518030 (UMLS CUI [1])
ULN
Item
Upper limit of normal
integer
C1519815 (UMLS CUI [1])
Significance
Item
Was this value clinically signifcant?
boolean
C2826633 (UMLS CUI [1])
ALP
Item
ALP
integer
C0201850 (UMLS CUI [1])
not done
Item
not done
boolean
C1272696 (UMLS CUI [1])
other unit
Item
other lab unit
text
C1519795 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
lower limit of normal
Item
lower limit of normal
integer
C1518030 (UMLS CUI [1])
ULN
Item
Upper limit of normal
integer
C1519815 (UMLS CUI [1])
Significance
Item
Was this value clinically signifcant?
boolean
C2826633 (UMLS CUI [1])
Total Bilirubin
Item
Total Bilirubin
float
C0201913 (UMLS CUI [1])
not done
Item
not done
boolean
C1272696 (UMLS CUI [1])
other unit
Item
other lab unit
text
C1519795 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
lower limit of normal
Item
lower limit of normal
integer
C1518030 (UMLS CUI [1])
ULN
Item
Upper limit of normal
integer
C1519815 (UMLS CUI [1])
Significance
Item
Was this value clinically signifcant?
boolean
C2826633 (UMLS CUI [1])
Creatinine Clearance
Item
Creatinine Clearance
float
C0373595 (UMLS CUI [1])
Significance
Item
Was this value clinically signifcant?
boolean
C2826633 (UMLS CUI [1])
Hematology sample collected
Item
Hematology sample collected
boolean
C0200345 (UMLS CUI [1,1])
C0018941 (UMLS CUI [1,2])
C0018941 (UMLS CUI [1,2])
CL Item
Other (99)
CL Item
Missed sample collection (5)
CL Item
Patient not able to provide urine sample (4)
CL Item
Unable to obtain venous access (3)
CL Item
Hemolyzed sample (2)
CL Item
Insufficient amount collected (1)
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])
WBC
Item
WBC
float
C0023508 (UMLS CUI [1])
not done
Item
not done
boolean
C1272696 (UMLS CUI [1])
other unit
Item
other lab unit
text
C1519795 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
lower limit of normal
Item
lower limit of normal
integer
C1518030 (UMLS CUI [1])
ULN
Item
Upper limit of normal
integer
C1519815 (UMLS CUI [1])
Significance
Item
Was this value clinically signifcant?
boolean
C2826633 (UMLS CUI [1])
Neutrophil count
Item
Neutrophil count
float
C0948762 (UMLS CUI [1])
not done
Item
not done
boolean
C1272696 (UMLS CUI [1])
other unit
Item
other lab unit
text
C1519795 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
lower limit of normal
Item
lower limit of normal
integer
C1518030 (UMLS CUI [1])
ULN
Item
Upper limit of normal
integer
C1519815 (UMLS CUI [1])
Significance
Item
Was this value clinically signifcant?
boolean
C2826633 (UMLS CUI [1])
Hematocrit
Item
Hematocrit
float
C0518014 (UMLS CUI [1])
not done
Item
not done
boolean
C1272696 (UMLS CUI [1])
other unit
Item
other lab unit
text
C1519795 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
lower limit of normal
Item
lower limit of normal
integer
C1518030 (UMLS CUI [1])
ULN
Item
Upper limit of normal
integer
C1519815 (UMLS CUI [1])
Significance
Item
Was this value clinically signifcant?
boolean
C2826633 (UMLS CUI [1])
Hemoglobin
Item
Hemoglobin
float
C0019046 (UMLS CUI [1])
not done
Item
not done
boolean
C1272696 (UMLS CUI [1])
other unit
Item
other lab unit
text
C1519795 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
lower limit of normal
Item
lower limit of normal
integer
C1518030 (UMLS CUI [1])
ULN
Item
Upper limit of normal
integer
C1519815 (UMLS CUI [1])
Significance
Item
Was this value clinically signifcant?
boolean
C2826633 (UMLS CUI [1])
Platelets
Item
Platelet count
float
C0005821 (UMLS CUI [1])
not done
Item
not done
boolean
C1272696 (UMLS CUI [1])
other unit
Item
other lab unit
text
C1519795 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
lower limit of normal
Item
lower limit of normal
integer
C1518030 (UMLS CUI [1])
ULN
Item
Upper limit of normal
integer
C1519815 (UMLS CUI [1])
Significance
Item
Was this value clinically signifcant?
boolean
C2826633 (UMLS CUI [1])
Pregnancy Test done
Item
Pregnancy Test done
boolean
C0032976 (UMLS CUI [1])
CL Item
Other (2)
CL Item
Menopausal (1)
Other reason
Item
Other reason
text
C3840932 (UMLS CUI [1])
CL Item
urine (2)
CL Item
serum (1)
CL Item
positive (2)
CL Item
negative (1)
Comment
Item
CRF Comment
text
C0947611 (UMLS CUI [1])
Microbiology specimen collection
Item
Was a specimen collected?
boolean
C0200345 (UMLS CUI [1,1])
C0025952 (UMLS CUI [1,2])
C0025952 (UMLS CUI [1,2])
CL Item
Other (99)
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])
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])
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])
C0037793 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,3])
CL Item
Anaerobic (2)
CL Item
Aerobic (1)
Item
Site of sample
integer
C0200345 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
C1515974 (UMLS CUI [1,2])
CL Item
Other (99)
CL Item
Blood (2)
CL Item
Intra-Abdominal (1)
Item
Intra-Abdominal, please specify
integer
C1512910 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,2])
CL Item
Other (99)
CL Item
Surgical Swab (4)
CL Item
Peritoneal Fluid (3)
CL Item
Tissue (2)
CL Item
Pus (1)
Other site, please specify
Item
Other site, please specify
text
C1515974 (UMLS CUI [1,1])
C3845569 (UMLS CUI [1,2])
C3845569 (UMLS CUI [1,2])
CL Item
Not done (99)
CL Item
Growth (2)
CL Item
No Growth (1)
Isolate name
Item
Isolate name
text
C1764827 (UMLS CUI [1])
CL Item
Fungal (2)
CL Item
Bacterial (1)
Item
Isolate Classification
integer
C1764827 (UMLS CUI [1,1])
C0008902 (UMLS CUI [1,2])
C0008902 (UMLS CUI [1,2])
CL Item
Contaminant (2)
CL Item
Pathogen (1)
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])
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])
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])
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])
C1515023 (UMLS CUI [1,2])
C1880016 (UMLS CUI [1,3])
Comment
Item
CRF Comment
text
C0947611 (UMLS CUI [1])