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

  1. 3/7/18 3/7/18 -
  2. 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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REJUVENATE NCT02655419

Baseline-Visit 2

Patient Information
Description

Patient Information

Alias
UMLS CUI-1
C1955348
Patient Caption
Description

Patient Caption

Data type

text

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

Visit Name

Data type

text

Alias
UMLS CUI [1]
C2826704
Visit Number
Description

Visit Number

Data type

integer

Alias
UMLS CUI [1]
C1549755
Visit Date
Description

Visit Date

Data type

date

Alias
UMLS CUI [1]
C1320303
Trial
Description

Trial name

Data type

text

Alias
UMLS CUI [1]
C1629065
Site name
Description

Study site

Data type

text

Alias
UMLS CUI [1]
C2825164
Eligibility determination
Description

Eligibility determination

Alias
UMLS CUI-1
C0013893
Subject complies with all inclusion / exclusion criteria
Description

In case of failed criterion, please complete 'Completion / Withdrawal form'

Data type

boolean

Alias
UMLS CUI [1]
C0013893
CRF Comment
Description

Comment

Data type

text

Alias
UMLS CUI [1]
C0947611
Failed IE criteria
Description

Failed IE criteria

Alias
UMLS CUI-1
C1516637
UMLS CUI-2
C0231175
Failed criterion
Description

e.g. 2, 3a etc.

Data type

text

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C0231175
Criteria type
Description

Criteria type

Data type

integer

Alias
UMLS CUI [1]
C1516637
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
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
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
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]
C0025948
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
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
Study drug loading dose
Description

Study drug loading dose

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C3714444
Start Date of ATM-AVI
Description

Start Date of ATM-AVI

Data type

date

Alias
UMLS CUI [1,1]
C0004521
UMLS CUI [1,2]
C0808070
UMLS CUI [2,1]
C3489748
UMLS CUI [2,2]
C0808070
End Date of ATM-AVI
Description

End Date of ATM-AVI

Data type

date

Alias
UMLS CUI [1,1]
C0004521
UMLS CUI [1,2]
C0806020
UMLS CUI [2,1]
C3489748
UMLS CUI [2,2]
C0806020
End time of ATM-AVI
Description

End time of ATM-AVI

Data type

time

Alias
UMLS CUI [1,1]
C0004521
UMLS CUI [1,2]
C1522314
UMLS CUI [2,1]
C3489748
UMLS CUI [2,2]
C1522314
Infusion Rate (mL/min)
Description

Infusion Rate (mL/min)

Data type

integer

Alias
UMLS CUI [1]
C2964135
Route of Study Drug Administration
Description

Route of Study Drug Administration

Data type

integer

Alias
UMLS CUI [1,1]
C0013153
UMLS CUI [1,2]
C0304229
Comment on Administration
Description

Comment on Administration

Data type

text

Alias
UMLS CUI [1]
C0947611
Study drug administration ATM-AVI
Description

Study drug administration ATM-AVI

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C3469597
UMLS CUI-3
C0004521
UMLS CUI-4
C3489748
Infusion out of range referring to loading dose
Description

Infusion out of range referring to loading dose

Data type

text

Alias
UMLS CUI [1,1]
C3845292
UMLS CUI [1,2]
C0574032
UMLS CUI [1,3]
C0205543
UMLS CUI [1,4]
C3714444
Start Date of ATM-AVI
Description

Start Date of ATM-AVI

Data type

date

Alias
UMLS CUI [1,1]
C0004521
UMLS CUI [1,2]
C0808070
UMLS CUI [2,1]
C3489748
UMLS CUI [2,2]
C0808070
Start time of ATM-AVI
Description

Start time of ATM-AVI

Data type

time

Alias
UMLS CUI [1,1]
C0004521
UMLS CUI [1,2]
C1301880
UMLS CUI [2,1]
C3489748
UMLS CUI [2,2]
C1301880
End Date of ATM-AVI
Description

End Date of ATM-AVI

Data type

date

Alias
UMLS CUI [1,1]
C0004521
UMLS CUI [1,2]
C0806020
UMLS CUI [2,1]
C3489748
UMLS CUI [2,2]
C0806020
End time of ATM-AVI
Description

End time of ATM-AVI

Data type

time

Alias
UMLS CUI [1,1]
C0004521
UMLS CUI [1,2]
C1522314
UMLS CUI [2,1]
C3489748
UMLS CUI [2,2]
C1522314
ATM Dose (mg) to be given per protocol
Description

ATM Dose (mg) to be given per protocol

Data type

integer

Alias
UMLS CUI [1,1]
C0040808
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0004521
AVI Dose (mg) to be given per protocol
Description

AVI Dose (mg) to be given per protocol

Data type

integer

Alias
UMLS CUI [1,1]
C0040808
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C3489748
ATM Batch No.
Description

ATM Batch No.

Data type

text

Alias
UMLS CUI [1,1]
C0004521
UMLS CUI [1,2]
C3641829
AVI Batch No.
Description

AVI Batch No.

Data type

text

Alias
UMLS CUI [1,1]
C3489748
UMLS CUI [1,2]
C3641829
StartVol Bag (mL)
Description

Start Volume

Data type

integer

Alias
UMLS CUI [1,1]
C0574032
UMLS CUI [1,2]
C2700258
EndVol Bag (mL)
Description

End Volume

Data type

integer

Alias
UMLS CUI [1,1]
C0574032
UMLS CUI [1,2]
C2700258
Infusion Rate (mL/min)
Description

Infusion Rate (mL/min)

Data type

integer

Alias
UMLS CUI [1]
C2964135
Route of Study Drug Administration
Description

Route of Study Drug Administration

Data type

integer

Alias
UMLS CUI [1,1]
C0013153
UMLS CUI [1,2]
C0304229
Comment on Administration
Description

Comment on Administration

Data type

text

Alias
UMLS CUI [1]
C0947611
Study drug administration Metronidazole
Description

Study drug administration Metronidazole

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C3469597
UMLS CUI-3
C0025872
Infusion out of range referring to loading dose
Description

Infusion out of range referring to loading dose

Data type

text

Alias
UMLS CUI [1,1]
C3845292
UMLS CUI [1,2]
C0574032
UMLS CUI [1,3]
C0205543
UMLS CUI [1,4]
C3714444
Start Date of Metronidazole
Description

Start Date of Metronidazole

Data type

date

Alias
UMLS CUI [1,1]
C0025872
UMLS CUI [1,2]
C0808070
Start time of Metronidazole
Description

Start time of Metronidazole

Data type

time

Alias
UMLS CUI [1,1]
C0025872
UMLS CUI [1,2]
C1301880
End Date of Metronidazole
Description

End Date of Metronidazole

Data type

date

Alias
UMLS CUI [1,1]
C0025872
UMLS CUI [1,2]
C0806020
End time of Metronidazole
Description

End time of Metronidazole

Data type

time

Alias
UMLS CUI [1,1]
C0025872
UMLS CUI [1,2]
C1522314
Metronidazole Dose (mg) to be given per protocol
Description

Metronidazole Dose (mg) to be given per protocol

Data type

integer

Alias
UMLS CUI [1,1]
C0040808
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0025872
Metronidazole Batch No.
Description

Metronidazole Batch No.

Data type

text

Alias
UMLS CUI [1,1]
C0025872
UMLS CUI [1,2]
C3641829
StartVol Bag (mL)
Description

Start Volume

Data type

integer

Alias
UMLS CUI [1,1]
C0574032
UMLS CUI [1,2]
C2700258
EndVol Bag (mL)
Description

End Volume

Data type

integer

Alias
UMLS CUI [1,1]
C0574032
UMLS CUI [1,2]
C2700258
Infusion Rate (mL/min)
Description

Infusion Rate (mL/min)

Data type

integer

Alias
UMLS CUI [1]
C2964135
Comment on Administration
Description

Comment on Administration

Data type

text

Alias
UMLS CUI [1]
C0947611
Electrocardiogram (ECG)
Description

Electrocardiogram (ECG)

Alias
UMLS CUI-1
C1623258
Examination performed
Description

Examination performed

Data type

boolean

Alias
UMLS CUI [1]
C2826672
If 'no', please provide reason
Description

Not done reason

Data type

text

Alias
UMLS CUI [1]
C2826287
ECG at Day 1 and EOT
Description

ECG at Day 1 and EOT

Data type

boolean

Alias
UMLS CUI [1]
C1623258
Date of ECG
Description

Date of ECG

Data type

date

Alias
UMLS CUI [1]
C2826640
Time of ECG
Description

Time of ECG

Data type

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0013798
ECG at Day 3
Description

ECG at Day 3

Data type

boolean

Alias
UMLS CUI [1]
C1623258
Date of ECG
Description

Date of ECG

Data type

date

Alias
UMLS CUI [1]
C2826640
Time of ECG
Description

Time of ECG

Data type

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0013798
Date of ECG
Description

Date of ECG

Data type

date

Alias
UMLS CUI [1]
C2826640
Time of ECG
Description

Time of ECG

Data type

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0013798
CRF Comment
Description

Comment

Data type

text

Alias
UMLS CUI [1]
C0947611
PK Day 1
Description

PK Day 1

Alias
UMLS CUI-1
C0031327
PK Sampling Day 1: Sparse Sample, All Patients Scheduled Sample
Description

PK Sampling Day 1: Sparse Sample, All Patients Scheduled Sample

Data type

integer

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0086960
Sample Collected?
Description

Specimen Collection

Data type

boolean

Alias
UMLS CUI [1]
C0200345
Specimen Condition
Description

Specimen Condition

Data type

integer

Alias
UMLS CUI [1]
C1547869
Specimen Condition, Other
Description

Specimen Condition, Other

Data type

text

Alias
UMLS CUI [1,1]
C1547869
UMLS CUI [1,2]
C0205394
Date of PK collection
Description

Date of PK collection

Data type

date

Alias
UMLS CUI [1]
C1317250
Actual Time of PK Collection
Description

Actual Time of PK Collection

Data type

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0200345
Site of Collection
Description

Sample collection site

Data type

integer

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C1515974
Date aliquots stored in freezer
Description

Storing date

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0370003
UMLS CUI [1,3]
C1698986
Time aliquots stored in freezer
Description

Storing time

Data type

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0370003
UMLS CUI [1,3]
C1698986
PK Specimen Identifier ATM plasma
Description

Specimen Identifier

Data type

text

Alias
UMLS CUI [1,1]
C1299222
UMLS CUI [1,2]
C0004521
PK Specimen Identifier AVI plasma
Description

Specimen Identifier

Data type

text

Alias
UMLS CUI [1,1]
C1299222
UMLS CUI [1,2]
C3489748
Backup Identifier ATM plasma
Description

Backup Identifier

Data type

text

Alias
UMLS CUI [1,1]
C1552560
UMLS CUI [1,2]
C1299222
UMLS CUI [1,3]
C0004521
Backup Identifier AVI plasma
Description

Backup Identifier

Data type

text

Alias
UMLS CUI [1,1]
C1552560
UMLS CUI [1,2]
C1299222
UMLS CUI [1,3]
C3489748
Specimen collection category
Description

Specimen collection category

Data type

integer

Alias
UMLS CUI [1,1]
C0200345
UMLS CUI [1,2]
C0683312
System
Description

System

Data type

integer

Alias
UMLS CUI [1]
C0449913
Biofluid collected
Description

Biofluid collected

Data type

integer

Alias
UMLS CUI [1]
C0200345
Biofluid processed
Description

Biofluid processed

Data type

integer

Alias
UMLS CUI [1,1]
C0370003
UMLS CUI [1,2]
C1709694
Main consent category
Description

Main consent category

Data type

integer

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0683312
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 Laboratory 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
New Central Lab Accession ID Number
Description

New Central Lab 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
Overdose Report
Description

Overdose Report

Alias
UMLS CUI-1
C4018909
UMLS CUI-2
C0684224
Any overdose at this treatment?
Description

Overdose

Data type

boolean

Alias
UMLS CUI [1]
C4018909
Overdose Report
Description

Overdose Report

Alias
UMLS CUI-1
C4018909
UMLS CUI-2
C0684224
Medication overdose
Description

Medication overdose

Data type

integer

Alias
UMLS CUI [1,1]
C4018909
UMLS CUI [1,2]
C0013227
overdose
Description

Overdose

Data type

boolean

Alias
UMLS CUI [1]
C4018909
Route
Description

Administration Route

Data type

integer

Alias
UMLS CUI [1]
C0013153
Other Route
Description

Administration Route

Data type

text

Alias
UMLS CUI [1]
C0013153
Total Daily Dose
Description

Total Daily Dose

Data type

integer

Alias
UMLS CUI [1]
C2986497
Dose unit
Description

Unit used

Data type

text

Alias
UMLS CUI [1]
C1519795
Date of Overdose
Description

Date of Overdose

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C4018909
Intentional overdose
Description

Intentional overdose

Data type

boolean

Alias
UMLS CUI [1,1]
C4018909
UMLS CUI [1,2]
C1283828
Overdose associated with AE
Description

Overdose associated with AE

Data type

boolean

Alias
UMLS CUI [1,1]
C4018909
UMLS CUI [1,2]
C0877248
AE-Term
Description

(please fill in an AE-Form)

Data type

text

Alias
UMLS CUI [1]
C2826934
Reason for Overdose
Description

Reason for Overdose

Data type

text

Alias
UMLS CUI [1,1]
C4018909
UMLS CUI [1,2]
C0392360

Similar models

Baseline-Visit 2

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Patient Information
C1955348 (UMLS CUI-1)
Patient Caption
Item
Patient Caption
text
C2825231 (UMLS CUI [1,1])
C0030705 (UMLS CUI [1,2])
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])
Trial name
Item
Trial
text
C1629065 (UMLS CUI [1])
Study site
Item
Site name
text
C2825164 (UMLS CUI [1])
Item Group
Eligibility determination
C0013893 (UMLS CUI-1)
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])
Item Group
Failed IE criteria
C1516637 (UMLS CUI-1)
C0231175 (UMLS CUI-2)
Failed eligibility criteria
Item
Failed criterion
text
C1516637 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
Item
Criteria type
integer
C1516637 (UMLS CUI [1])
Code List
Criteria type
CL Item
inclusion (1)
CL Item
exclusion (2)
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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
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])
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])
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])
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])
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])
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])
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])
Code List
Isolate Classification
CL Item
Pathogen (1)
CL Item
Contaminant (2)
Disc Zone ATM-AVI
Item
Disc Zone ATM-AVI
text
C0025948 (UMLS CUI [1])
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])
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])
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
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])
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
Study drug loading dose
C0304229 (UMLS CUI-1)
C3714444 (UMLS CUI-2)
Start Date of ATM-AVI
Item
Start Date of ATM-AVI
date
C0004521 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C3489748 (UMLS CUI [2,1])
C0808070 (UMLS CUI [2,2])
End Date of ATM-AVI
Item
End Date of ATM-AVI
date
C0004521 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C3489748 (UMLS CUI [2,1])
C0806020 (UMLS CUI [2,2])
End time of ATM-AVI
Item
End time of ATM-AVI
time
C0004521 (UMLS CUI [1,1])
C1522314 (UMLS CUI [1,2])
C3489748 (UMLS CUI [2,1])
C1522314 (UMLS CUI [2,2])
Infusion Rate (mL/min)
Item
Infusion Rate (mL/min)
integer
C2964135 (UMLS CUI [1])
Item
Route of Study Drug Administration
integer
C0013153 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Code List
Route of Study Drug Administration
CL Item
Monoluminal Central Line (1)
(Comment:en)
CL Item
Biluminal Central Line (2)
(Comment:en)
CL Item
Triluminal Central Line (3)
(Comment:en)
CL Item
Multiluminal Central Line (4)
(Comment:en)
CL Item
PICC Line (5)
(Comment:en)
CL Item
Peripheral IV Catheter left (6)
(Comment:en)
CL Item
Peripheral IV Catheter right (7)
(Comment:en)
CL Item
Other (99)
(Comment:en)
Comment on Administration
Item
Comment on Administration
text
C0947611 (UMLS CUI [1])
Item Group
Study drug administration ATM-AVI
C0304229 (UMLS CUI-1)
C3469597 (UMLS CUI-2)
C0004521 (UMLS CUI-3)
C3489748 (UMLS CUI-4)
Infusion out of range referring to loading dose
Item
Infusion out of range referring to loading dose
text
C3845292 (UMLS CUI [1,1])
C0574032 (UMLS CUI [1,2])
C0205543 (UMLS CUI [1,3])
C3714444 (UMLS CUI [1,4])
Start Date of ATM-AVI
Item
Start Date of ATM-AVI
date
C0004521 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C3489748 (UMLS CUI [2,1])
C0808070 (UMLS CUI [2,2])
Start time of ATM-AVI
Item
Start time of ATM-AVI
time
C0004521 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
C3489748 (UMLS CUI [2,1])
C1301880 (UMLS CUI [2,2])
End Date of ATM-AVI
Item
End Date of ATM-AVI
date
C0004521 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C3489748 (UMLS CUI [2,1])
C0806020 (UMLS CUI [2,2])
End time of ATM-AVI
Item
End time of ATM-AVI
time
C0004521 (UMLS CUI [1,1])
C1522314 (UMLS CUI [1,2])
C3489748 (UMLS CUI [2,1])
C1522314 (UMLS CUI [2,2])
ATM Dose (mg) to be given per protocol
Item
ATM Dose (mg) to be given per protocol
integer
C0040808 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0004521 (UMLS CUI [1,3])
AVI Dose (mg) to be given per protocol
Item
AVI Dose (mg) to be given per protocol
integer
C0040808 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C3489748 (UMLS CUI [1,3])
ATM Batch No.
Item
ATM Batch No.
text
C0004521 (UMLS CUI [1,1])
C3641829 (UMLS CUI [1,2])
AVI Batch No.
Item
AVI Batch No.
text
C3489748 (UMLS CUI [1,1])
C3641829 (UMLS CUI [1,2])
Start Volume
Item
StartVol Bag (mL)
integer
C0574032 (UMLS CUI [1,1])
C2700258 (UMLS CUI [1,2])
End Volume
Item
EndVol Bag (mL)
integer
C0574032 (UMLS CUI [1,1])
C2700258 (UMLS CUI [1,2])
Infusion Rate (mL/min)
Item
Infusion Rate (mL/min)
integer
C2964135 (UMLS CUI [1])
Item
Route of Study Drug Administration
integer
C0013153 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Code List
Route of Study Drug Administration
CL Item
Monoluminal Central Line (1)
(Comment:en)
CL Item
Biluminal Central Line (2)
(Comment:en)
CL Item
Triluminal Central Line (3)
(Comment:en)
CL Item
Multiluminal Central Line (4)
(Comment:en)
CL Item
PICC Line (5)
(Comment:en)
CL Item
Peripheral IV Catheter left (6)
(Comment:en)
CL Item
Peripheral IV Catheter right (7)
(Comment:en)
CL Item
Other (99)
(Comment:en)
Comment on Administration
Item
Comment on Administration
text
C0947611 (UMLS CUI [1])
Item Group
Study drug administration Metronidazole
C0304229 (UMLS CUI-1)
C3469597 (UMLS CUI-2)
C0025872 (UMLS CUI-3)
Infusion out of range referring to loading dose
Item
Infusion out of range referring to loading dose
text
C3845292 (UMLS CUI [1,1])
C0574032 (UMLS CUI [1,2])
C0205543 (UMLS CUI [1,3])
C3714444 (UMLS CUI [1,4])
Start Date of Metronidazole
Item
Start Date of Metronidazole
date
C0025872 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Start time of Metronidazole
Item
Start time of Metronidazole
time
C0025872 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
End Date of Metronidazole
Item
End Date of Metronidazole
date
C0025872 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
End time of Metronidazole
Item
End time of Metronidazole
time
C0025872 (UMLS CUI [1,1])
C1522314 (UMLS CUI [1,2])
Metronidazole Dose (mg) to be given per protocol
Item
Metronidazole Dose (mg) to be given per protocol
integer
C0040808 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0025872 (UMLS CUI [1,3])
Metronidazole Batch No.
Item
Metronidazole Batch No.
text
C0025872 (UMLS CUI [1,1])
C3641829 (UMLS CUI [1,2])
Start Volume
Item
StartVol Bag (mL)
integer
C0574032 (UMLS CUI [1,1])
C2700258 (UMLS CUI [1,2])
End Volume
Item
EndVol Bag (mL)
integer
C0574032 (UMLS CUI [1,1])
C2700258 (UMLS CUI [1,2])
Infusion Rate (mL/min)
Item
Infusion Rate (mL/min)
integer
C2964135 (UMLS CUI [1])
Comment on Administration
Item
Comment on Administration
text
C0947611 (UMLS CUI [1])
Item Group
Electrocardiogram (ECG)
C1623258 (UMLS CUI-1)
Examination performed
Item
Examination performed
boolean
C2826672 (UMLS CUI [1])
Not done reason
Item
If 'no', please provide reason
text
C2826287 (UMLS CUI [1])
ECG at Day 1 and EOT
Item
ECG at Day 1 and EOT
boolean
C1623258 (UMLS CUI [1])
Date of ECG
Item
Date of ECG
date
C2826640 (UMLS CUI [1])
Time of ECG
Item
Time of ECG
time
C0040223 (UMLS CUI [1,1])
C0013798 (UMLS CUI [1,2])
ECG at Day 3
Item
ECG at Day 3
boolean
C1623258 (UMLS CUI [1])
Date of ECG
Item
Date of ECG
date
C2826640 (UMLS CUI [1])
Time of ECG
Item
Time of ECG
time
C0040223 (UMLS CUI [1,1])
C0013798 (UMLS CUI [1,2])
Date of ECG
Item
Date of ECG
date
C2826640 (UMLS CUI [1])
Time of ECG
Item
Time of ECG
time
C0040223 (UMLS CUI [1,1])
C0013798 (UMLS CUI [1,2])
Comment
Item
CRF Comment
text
C0947611 (UMLS CUI [1])
Item Group
PK Day 1
C0031327 (UMLS CUI-1)
Item
PK Sampling Day 1: Sparse Sample, All Patients Scheduled Sample
integer
C0005834 (UMLS CUI [1,1])
C0086960 (UMLS CUI [1,2])
Code List
PK Sampling Day 1: Sparse Sample, All Patients Scheduled Sample
CL Item
within 1 h before start of loading dose (1)
CL Item
within 5 min. before end of loading dose (2)
CL Item
within 15 min. prior to end of 2nd infusion (3)
CL Item
5-6 h after start of loading dose (4)
Specimen Collection
Item
Sample Collected?
boolean
C0200345 (UMLS CUI [1])
Item
Specimen Condition
integer
C1547869 (UMLS CUI [1])
Code List
Specimen Condition
CL Item
Sample Acceptable (0)
CL Item
Hemolyzed (1)
CL Item
Clotted (2)
CL Item
Lipemic (3)
CL Item
Quantity Less than Expected (50)
CL Item
Sample Discarded (51)
CL Item
Other (99)
Specimen Condition, Other
Item
Specimen Condition, Other
text
C1547869 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Date of PK collection
Item
Date of PK collection
date
C1317250 (UMLS CUI [1])
Actual Time of PK Collection
Item
Actual Time of PK Collection
time
C0040223 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
Item
Site of Collection
integer
C0005834 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
Code List
Site of Collection
CL Item
Monoluminal Central Line (1)
CL Item
Biluminal Central Line (2)
CL Item
Triluminal Central Line (3)
CL Item
Multiluminal Central Line (4)
CL Item
PICC Line (5)
CL Item
Peripheral IV Catheter left (6)
CL Item
Peripheral IV Catheter right (7)
CL Item
Direct Venipuncture (8)
CL Item
Other (99)
Storing date
Item
Date aliquots stored in freezer
date
C0011008 (UMLS CUI [1,1])
C0370003 (UMLS CUI [1,2])
C1698986 (UMLS CUI [1,3])
Storing time
Item
Time aliquots stored in freezer
time
C0040223 (UMLS CUI [1,1])
C0370003 (UMLS CUI [1,2])
C1698986 (UMLS CUI [1,3])
Specimen Identifier
Item
PK Specimen Identifier ATM plasma
text
C1299222 (UMLS CUI [1,1])
C0004521 (UMLS CUI [1,2])
Specimen Identifier
Item
PK Specimen Identifier AVI plasma
text
C1299222 (UMLS CUI [1,1])
C3489748 (UMLS CUI [1,2])
Backup Identifier
Item
Backup Identifier ATM plasma
text
C1552560 (UMLS CUI [1,1])
C1299222 (UMLS CUI [1,2])
C0004521 (UMLS CUI [1,3])
Backup Identifier
Item
Backup Identifier AVI plasma
text
C1552560 (UMLS CUI [1,1])
C1299222 (UMLS CUI [1,2])
C3489748 (UMLS CUI [1,3])
Item
Specimen collection category
integer
C0200345 (UMLS CUI [1,1])
C0683312 (UMLS CUI [1,2])
Code List
Specimen collection category
CL Item
PK, Biofluid (5)
Item
System
integer
C0449913 (UMLS CUI [1])
Code List
System
CL Item
Not applicable (98)
Item
Biofluid collected
integer
C0200345 (UMLS CUI [1])
Code List
Biofluid collected
CL Item
Blood (4)
Item
Biofluid processed
integer
C0370003 (UMLS CUI [1,1])
C1709694 (UMLS CUI [1,2])
Code List
Biofluid processed
CL Item
Plasma (21)
Item
Main consent category
integer
C0021430 (UMLS CUI [1,1])
C0683312 (UMLS CUI [1,2])
Code List
Main consent category
CL Item
Main Consent Excluding Genetics (2)
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])
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])
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])
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])
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])
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])
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])
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 Laboratory 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])
New Central Lab Accession ID Number
Item
New 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
Overdose Report
C4018909 (UMLS CUI-1)
C0684224 (UMLS CUI-2)
Overdose
Item
Any overdose at this treatment?
boolean
C4018909 (UMLS CUI [1])
Item Group
Overdose Report
C4018909 (UMLS CUI-1)
C0684224 (UMLS CUI-2)
Item
Medication overdose
integer
C4018909 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Code List
Medication overdose
CL Item
ATM (1)
CL Item
AVI (2)
CL Item
Metronidazole (3)
Overdose
Item
overdose
boolean
C4018909 (UMLS CUI [1])
Item
Route
integer
C0013153 (UMLS CUI [1])
Code List
Route
CL Item
Intravenous (1)
CL Item
Intramuscular (2)
CL Item
Subcutaneous (3)
CL Item
Per Oral (4)
CL Item
Topical (5)
CL Item
Peritoneal Lavage (6)
CL Item
Other (99)
Administration Route
Item
Other Route
text
C0013153 (UMLS CUI [1])
Total Daily Dose
Item
Total Daily Dose
integer
C2986497 (UMLS CUI [1])
Unit used
Item
Dose unit
text
C1519795 (UMLS CUI [1])
Date of Overdose
Item
Date of Overdose
date
C0011008 (UMLS CUI [1,1])
C4018909 (UMLS CUI [1,2])
Intentional overdose
Item
Intentional overdose
boolean
C4018909 (UMLS CUI [1,1])
C1283828 (UMLS CUI [1,2])
Overdose associated with AE
Item
Overdose associated with AE
boolean
C4018909 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
AE-Term
Item
AE-Term
text
C2826934 (UMLS CUI [1])
Reason for Overdose
Item
Reason for Overdose
text
C4018909 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])

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