ID
29207
Beskrivning
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
Nyckelord
Versioner (2)
- 2018-03-07 2018-03-07 -
- 2021-09-17 2021-09-17 -
Rättsinnehavare
Pfizer
Uppladdad den
7 mars 2018
DOI
10.21961/mdm:29207
Licens
Creative Commons BY-NC 3.0
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REJUVENATE NCT02655419
Baseline-Visit 2
Beskrivning
Eligibility determination
Alias
- UMLS CUI-1
- C0013893
Beskrivning
Failed IE criteria
Alias
- UMLS CUI-1
- C1516637
- UMLS CUI-2
- C0231175
Beskrivning
Infection-related Examination
Alias
- UMLS CUI-1
- C3714514
- UMLS CUI-2
- C0031809
Beskrivning
Infection related Signs and Symptoms
Alias
- UMLS CUI-1
- C0037088
- UMLS CUI-2
- C3714514
Beskrivning
Signs and Symptoms
Datatyp
integer
Alias
- UMLS CUI [1]
- C0037088
Beskrivning
Other Sign or Symptom
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0037088
- UMLS CUI [1,2]
- C0205394
Beskrivning
Clinical Event Intensity
Datatyp
integer
Alias
- UMLS CUI [1]
- C0518690
Beskrivning
not assessed,comment
Datatyp
text
Alias
- UMLS CUI [1,1]
- C3846720
- UMLS CUI [1,2]
- C0947611
Beskrivning
Post-Operative Wound Examination
Alias
- UMLS CUI-1
- C2112579
- UMLS CUI-2
- C0886052
Beskrivning
Examination performed
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0031809
Beskrivning
Not done reason
Datatyp
text
Alias
- UMLS CUI [1]
- C2826287
Beskrivning
Superficial Infection
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0043241
- UMLS CUI [1,2]
- C0205124
Beskrivning
Deep Wound Infection
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0406103
Beskrivning
Type of Wound
Datatyp
integer
Alias
- UMLS CUI [1]
- C1276783
Beskrivning
other Wound Type
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1276783
- UMLS CUI [1,2]
- C0205394
Beskrivning
Negative Pressure Wound Device
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1956078
Beskrivning
Specimen collection for culture
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0200345
- UMLS CUI [1,2]
- C0430400
Beskrivning
Comment
Datatyp
text
Alias
- UMLS CUI [1]
- C0947611
Beskrivning
Signs and Symptoms of Wound Infection
Alias
- UMLS CUI-1
- C0043241
- UMLS CUI-2
- C0037088
Beskrivning
Signs and Symptoms
Datatyp
integer
Alias
- UMLS CUI [1]
- C0037088
Beskrivning
Event Intensity
Datatyp
integer
Alias
- UMLS CUI [1]
- C0518690
Beskrivning
not assessed,comment
Datatyp
text
Alias
- UMLS CUI [1,1]
- C3846720
- UMLS CUI [1,2]
- C0947611
Beskrivning
Other Sign or Symptom,specify
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0037088
- UMLS CUI [1,2]
- C3845569
Beskrivning
Vital Signs examination
Alias
- UMLS CUI-1
- C0518766
- UMLS CUI-2
- C0031809
Beskrivning
Examination performed
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0031809
Beskrivning
Not done reason
Datatyp
text
Alias
- UMLS CUI [1]
- C2826287
Beskrivning
Supine Blood Pressure Systolic
Datatyp
integer
Måttenheter
- mmHg
Alias
- UMLS CUI [1,1]
- C0871470
- UMLS CUI [1,2]
- C0038846
Beskrivning
Relevance
Datatyp
boolean
Alias
- UMLS CUI [1]
- C2347946
Beskrivning
Supine Blood Pressure Diastolic
Datatyp
integer
Måttenheter
- mmHg
Alias
- UMLS CUI [1,1]
- C0428883
- UMLS CUI [1,2]
- C0038846
Beskrivning
Relevance
Datatyp
boolean
Alias
- UMLS CUI [1]
- C2347946
Beskrivning
Heart rate
Datatyp
integer
Måttenheter
- bpm
Alias
- UMLS CUI [1]
- C0018810
Beskrivning
Relevance
Datatyp
boolean
Alias
- UMLS CUI [1]
- C2347946
Beskrivning
Respiratory Rate
Datatyp
integer
Måttenheter
- breaths/min
Alias
- UMLS CUI [1]
- C0231832
Beskrivning
Relevance
Datatyp
boolean
Alias
- UMLS CUI [1]
- C2347946
Beskrivning
Comment
Datatyp
text
Alias
- UMLS CUI [1]
- C0947611
Beskrivning
Temperature
Alias
- UMLS CUI-1
- C0005903
Beskrivning
Temperature
Datatyp
float
Måttenheter
- °C
Alias
- UMLS CUI [1]
- C0039476
Beskrivning
HH:MM
Datatyp
time
Alias
- UMLS CUI [1,1]
- C0242485
- UMLS CUI [1,2]
- C0040223
Beskrivning
Method of Measurement
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1299991
- UMLS CUI [1,2]
- C0039476
Beskrivning
Other Method
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1299991
- UMLS CUI [1,2]
- C0205394
Beskrivning
Relevance
Datatyp
boolean
Alias
- UMLS CUI [1]
- C2347946
Beskrivning
Laboratory Tests
Alias
- UMLS CUI-1
- C1880016
- UMLS CUI-2
- C0022885
Beskrivning
Clinical Chemistry sample collected
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0200345
- UMLS CUI [1,2]
- C0008000
Beskrivning
Not done reason
Datatyp
integer
Alias
- UMLS CUI [1]
- C2826287
Beskrivning
Other, please specify
Datatyp
text
Alias
- UMLS CUI [1]
- C3845569
Beskrivning
Collection Date
Datatyp
date
Alias
- UMLS CUI [1]
- C1302413
Beskrivning
Collection time
Datatyp
time
Alias
- UMLS CUI [1]
- C4064021
Beskrivning
Central Laboratory ID
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1880016
- UMLS CUI [1,2]
- C2986056
Beskrivning
Sample sent to central lab
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0370003
- UMLS CUI [1,2]
- C1515023
- UMLS CUI [1,3]
- C1880016
Beskrivning
Not done reason
Datatyp
text
Alias
- UMLS CUI [1]
- C2826287
Beskrivning
Hematology sample collected
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0200345
- UMLS CUI [1,2]
- C0018941
Beskrivning
Not done reason
Datatyp
integer
Alias
- UMLS CUI [1]
- C2826287
Beskrivning
Other, please specify
Datatyp
text
Alias
- UMLS CUI [1]
- C3845569
Beskrivning
Collection Date
Datatyp
date
Alias
- UMLS CUI [1]
- C1302413
Beskrivning
Collection time
Datatyp
time
Alias
- UMLS CUI [1]
- C4064021
Beskrivning
Central Laboratory ID
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1880016
- UMLS CUI [1,2]
- C2986056
Beskrivning
Sample sent to central lab
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0370003
- UMLS CUI [1,2]
- C1515023
- UMLS CUI [1,3]
- C1880016
Beskrivning
Not done reason
Datatyp
text
Alias
- UMLS CUI [1]
- C2826287
Beskrivning
Urinalysis sample collected
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0200345
- UMLS CUI [1,2]
- C0042014
Beskrivning
Not done reason
Datatyp
integer
Alias
- UMLS CUI [1]
- C2826287
Beskrivning
Other, please specify
Datatyp
text
Alias
- UMLS CUI [1]
- C3845569
Beskrivning
Collection Date
Datatyp
date
Alias
- UMLS CUI [1]
- C1302413
Beskrivning
Collection time
Datatyp
time
Alias
- UMLS CUI [1]
- C4064021
Beskrivning
Central Laboratory ID
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1880016
- UMLS CUI [1,2]
- C2986056
Beskrivning
Sample sent to central lab
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0370003
- UMLS CUI [1,2]
- C1515023
- UMLS CUI [1,3]
- C1880016
Beskrivning
Not done reason
Datatyp
text
Alias
- UMLS CUI [1]
- C2826287
Beskrivning
Comment
Datatyp
text
Alias
- UMLS CUI [1]
- C0947611
Beskrivning
Microbiology
Alias
- UMLS CUI-1
- C0085672
Beskrivning
Microbiology specimen collection
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0200345
- UMLS CUI [1,2]
- C0025952
Beskrivning
Not done reason
Datatyp
integer
Alias
- UMLS CUI [1]
- C2826287
Beskrivning
inability
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1299582
- UMLS CUI [1,2]
- C0200345
- UMLS CUI [1,3]
- C1521902
Beskrivning
inability
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1299582
- UMLS CUI [1,2]
- C0200345
- UMLS CUI [1,3]
- C3845569
Beskrivning
Specimen collection date
Datatyp
date
Alias
- UMLS CUI [1]
- C1302413
Beskrivning
Specimen collection time
Datatyp
time
Alias
- UMLS CUI [1]
- C4064021
Beskrivning
Culture Processing Type
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0200949
- UMLS CUI [1,2]
- C0037793
- UMLS CUI [1,3]
- C0332307
Beskrivning
Specimen collection site
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0200345
- UMLS CUI [1,2]
- C1515974
Beskrivning
Intra-Abdominal, please specify
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1512910
- UMLS CUI [1,2]
- C1521902
Beskrivning
Other site, please specify
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1515974
- UMLS CUI [1,2]
- C3845569
Beskrivning
Culture outcome
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C2242979
- UMLS CUI [1,2]
- C0587081
Beskrivning
Isolate name
Datatyp
text
Alias
- UMLS CUI [1]
- C1764827
Beskrivning
Pathogen Type
Datatyp
integer
Alias
- UMLS CUI [1]
- C0450254
Beskrivning
Isolate Classification
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1764827
- UMLS CUI [1,2]
- C0008902
Beskrivning
(mm, Aerobic Pathogens only)
Datatyp
text
Alias
- UMLS CUI [1]
- C0025948
Beskrivning
Sample sent to Central Lab
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1880016
- UMLS CUI [1,2]
- C0370003
- UMLS CUI [1,3]
- C1515023
Beskrivning
Central Laboratory Accession ID Number
Datatyp
text
Alias
- UMLS CUI [1,1]
- C2826726
- UMLS CUI [1,2]
- C1880016
Beskrivning
Not done reason
Datatyp
text
Alias
- UMLS CUI [1]
- C2826287
Beskrivning
Backup Sample sent to Central Laboratory
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0370003
- UMLS CUI [1,2]
- C1515023
- UMLS CUI [1,3]
- C1880016
Beskrivning
Comment
Datatyp
text
Alias
- UMLS CUI [1]
- C0947611
Beskrivning
Surgical Procedure
Alias
- UMLS CUI-1
- C0543467
Beskrivning
Surgery performed
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0543467
Beskrivning
Surgery time
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0683312
- UMLS CUI [1,2]
- C0543467
Beskrivning
Surgical Procedure
Datatyp
integer
Alias
- UMLS CUI [1]
- C0543467
Beskrivning
Other procedure
Datatyp
text
Alias
- UMLS CUI [1]
- C0543467
Beskrivning
Start Date (incision)
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0808070
- UMLS CUI [1,2]
- C0184898
Beskrivning
Start Time (incision)
Datatyp
time
Alias
- UMLS CUI [1,1]
- C1301880
- UMLS CUI [1,2]
- C0184898
Beskrivning
End Date (suture)
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0806020
- UMLS CUI [1,2]
- C0038969
Beskrivning
End Time (suture)
Datatyp
time
Alias
- UMLS CUI [1,1]
- C1522314
- UMLS CUI [1,2]
- C0038969
Beskrivning
Reason for Procedure
Datatyp
integer
Alias
- UMLS CUI [1]
- C3258099
Beskrivning
Other reason
Datatyp
text
Alias
- UMLS CUI [1]
- C3840932
Beskrivning
Comment
Datatyp
text
Alias
- UMLS CUI [1]
- C0947611
Beskrivning
Description of Findings
Alias
- UMLS CUI-1
- C0678257
- UMLS CUI-2
- C0243095
Beskrivning
Study drug loading dose
Alias
- UMLS CUI-1
- C0304229
- UMLS CUI-2
- C3714444
Beskrivning
Start Date of ATM-AVI
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0004521
- UMLS CUI [1,2]
- C0808070
- UMLS CUI [2,1]
- C3489748
- UMLS CUI [2,2]
- C0808070
Beskrivning
End Date of ATM-AVI
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0004521
- UMLS CUI [1,2]
- C0806020
- UMLS CUI [2,1]
- C3489748
- UMLS CUI [2,2]
- C0806020
Beskrivning
End time of ATM-AVI
Datatyp
time
Alias
- UMLS CUI [1,1]
- C0004521
- UMLS CUI [1,2]
- C1522314
- UMLS CUI [2,1]
- C3489748
- UMLS CUI [2,2]
- C1522314
Beskrivning
Infusion Rate (mL/min)
Datatyp
integer
Alias
- UMLS CUI [1]
- C2964135
Beskrivning
Route of Study Drug Administration
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0013153
- UMLS CUI [1,2]
- C0304229
Beskrivning
Comment on Administration
Datatyp
text
Alias
- UMLS CUI [1]
- C0947611
Beskrivning
Study drug administration ATM-AVI
Alias
- UMLS CUI-1
- C0304229
- UMLS CUI-2
- C3469597
- UMLS CUI-3
- C0004521
- UMLS CUI-4
- C3489748
Beskrivning
Infusion out of range referring to loading dose
Datatyp
text
Alias
- UMLS CUI [1,1]
- C3845292
- UMLS CUI [1,2]
- C0574032
- UMLS CUI [1,3]
- C0205543
- UMLS CUI [1,4]
- C3714444
Beskrivning
Start Date of ATM-AVI
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0004521
- UMLS CUI [1,2]
- C0808070
- UMLS CUI [2,1]
- C3489748
- UMLS CUI [2,2]
- C0808070
Beskrivning
Start time of ATM-AVI
Datatyp
time
Alias
- UMLS CUI [1,1]
- C0004521
- UMLS CUI [1,2]
- C1301880
- UMLS CUI [2,1]
- C3489748
- UMLS CUI [2,2]
- C1301880
Beskrivning
End Date of ATM-AVI
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0004521
- UMLS CUI [1,2]
- C0806020
- UMLS CUI [2,1]
- C3489748
- UMLS CUI [2,2]
- C0806020
Beskrivning
End time of ATM-AVI
Datatyp
time
Alias
- UMLS CUI [1,1]
- C0004521
- UMLS CUI [1,2]
- C1522314
- UMLS CUI [2,1]
- C3489748
- UMLS CUI [2,2]
- C1522314
Beskrivning
ATM Dose (mg) to be given per protocol
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0040808
- UMLS CUI [1,2]
- C0178602
- UMLS CUI [1,3]
- C0004521
Beskrivning
AVI Dose (mg) to be given per protocol
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0040808
- UMLS CUI [1,2]
- C0178602
- UMLS CUI [1,3]
- C3489748
Beskrivning
ATM Batch No.
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0004521
- UMLS CUI [1,2]
- C3641829
Beskrivning
AVI Batch No.
Datatyp
text
Alias
- UMLS CUI [1,1]
- C3489748
- UMLS CUI [1,2]
- C3641829
Beskrivning
Start Volume
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0574032
- UMLS CUI [1,2]
- C2700258
Beskrivning
End Volume
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0574032
- UMLS CUI [1,2]
- C2700258
Beskrivning
Infusion Rate (mL/min)
Datatyp
integer
Alias
- UMLS CUI [1]
- C2964135
Beskrivning
Route of Study Drug Administration
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0013153
- UMLS CUI [1,2]
- C0304229
Beskrivning
Comment on Administration
Datatyp
text
Alias
- UMLS CUI [1]
- C0947611
Beskrivning
Study drug administration Metronidazole
Alias
- UMLS CUI-1
- C0304229
- UMLS CUI-2
- C3469597
- UMLS CUI-3
- C0025872
Beskrivning
Infusion out of range referring to loading dose
Datatyp
text
Alias
- UMLS CUI [1,1]
- C3845292
- UMLS CUI [1,2]
- C0574032
- UMLS CUI [1,3]
- C0205543
- UMLS CUI [1,4]
- C3714444
Beskrivning
Start Date of Metronidazole
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0025872
- UMLS CUI [1,2]
- C0808070
Beskrivning
Start time of Metronidazole
Datatyp
time
Alias
- UMLS CUI [1,1]
- C0025872
- UMLS CUI [1,2]
- C1301880
Beskrivning
End Date of Metronidazole
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0025872
- UMLS CUI [1,2]
- C0806020
Beskrivning
End time of Metronidazole
Datatyp
time
Alias
- UMLS CUI [1,1]
- C0025872
- UMLS CUI [1,2]
- C1522314
Beskrivning
Metronidazole Dose (mg) to be given per protocol
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0040808
- UMLS CUI [1,2]
- C0178602
- UMLS CUI [1,3]
- C0025872
Beskrivning
Metronidazole Batch No.
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0025872
- UMLS CUI [1,2]
- C3641829
Beskrivning
Start Volume
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0574032
- UMLS CUI [1,2]
- C2700258
Beskrivning
End Volume
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0574032
- UMLS CUI [1,2]
- C2700258
Beskrivning
Infusion Rate (mL/min)
Datatyp
integer
Alias
- UMLS CUI [1]
- C2964135
Beskrivning
Comment on Administration
Datatyp
text
Alias
- UMLS CUI [1]
- C0947611
Beskrivning
Electrocardiogram (ECG)
Alias
- UMLS CUI-1
- C1623258
Beskrivning
Examination performed
Datatyp
boolean
Alias
- UMLS CUI [1]
- C2826672
Beskrivning
Not done reason
Datatyp
text
Alias
- UMLS CUI [1]
- C2826287
Beskrivning
ECG at Day 1 and EOT
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1623258
Beskrivning
Date of ECG
Datatyp
date
Alias
- UMLS CUI [1]
- C2826640
Beskrivning
Time of ECG
Datatyp
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0013798
Beskrivning
ECG at Day 3
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1623258
Beskrivning
Date of ECG
Datatyp
date
Alias
- UMLS CUI [1]
- C2826640
Beskrivning
Time of ECG
Datatyp
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0013798
Beskrivning
Date of ECG
Datatyp
date
Alias
- UMLS CUI [1]
- C2826640
Beskrivning
Time of ECG
Datatyp
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0013798
Beskrivning
Comment
Datatyp
text
Alias
- UMLS CUI [1]
- C0947611
Beskrivning
PK Day 1
Alias
- UMLS CUI-1
- C0031327
Beskrivning
PK Sampling Day 1: Sparse Sample, All Patients Scheduled Sample
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0086960
Beskrivning
Specimen Collection
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0200345
Beskrivning
Specimen Condition
Datatyp
integer
Alias
- UMLS CUI [1]
- C1547869
Beskrivning
Specimen Condition, Other
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1547869
- UMLS CUI [1,2]
- C0205394
Beskrivning
Date of PK collection
Datatyp
date
Alias
- UMLS CUI [1]
- C1317250
Beskrivning
Actual Time of PK Collection
Datatyp
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0200345
Beskrivning
Sample collection site
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C1515974
Beskrivning
Storing date
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0370003
- UMLS CUI [1,3]
- C1698986
Beskrivning
Storing time
Datatyp
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0370003
- UMLS CUI [1,3]
- C1698986
Beskrivning
Specimen Identifier
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1299222
- UMLS CUI [1,2]
- C0004521
Beskrivning
Specimen Identifier
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1299222
- UMLS CUI [1,2]
- C3489748
Beskrivning
Backup Identifier
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1552560
- UMLS CUI [1,2]
- C1299222
- UMLS CUI [1,3]
- C0004521
Beskrivning
Backup Identifier
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1552560
- UMLS CUI [1,2]
- C1299222
- UMLS CUI [1,3]
- C3489748
Beskrivning
Specimen collection category
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0200345
- UMLS CUI [1,2]
- C0683312
Beskrivning
System
Datatyp
integer
Alias
- UMLS CUI [1]
- C0449913
Beskrivning
Biofluid collected
Datatyp
integer
Alias
- UMLS CUI [1]
- C0200345
Beskrivning
Biofluid processed
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0370003
- UMLS CUI [1,2]
- C1709694
Beskrivning
Main consent category
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0021430
- UMLS CUI [1,2]
- C0683312
Beskrivning
Microbiology
Alias
- UMLS CUI-1
- C0085672
Beskrivning
Microbiology specimen collection
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0200345
- UMLS CUI [1,2]
- C0025952
Beskrivning
Not done reason
Datatyp
integer
Alias
- UMLS CUI [1]
- C2826287
Beskrivning
inability
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1299582
- UMLS CUI [1,2]
- C0200345
- UMLS CUI [1,3]
- C1521902
Beskrivning
inability
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1299582
- UMLS CUI [1,2]
- C0200345
- UMLS CUI [1,3]
- C3845569
Beskrivning
Specimen collection date
Datatyp
date
Alias
- UMLS CUI [1]
- C1302413
Beskrivning
Specimen collection time
Datatyp
time
Alias
- UMLS CUI [1]
- C4064021
Beskrivning
Culture Processing Type
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0200949
- UMLS CUI [1,2]
- C0037793
- UMLS CUI [1,3]
- C0332307
Beskrivning
Specimen collection site
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0200345
- UMLS CUI [1,2]
- C1515974
Beskrivning
Intra-Abdominal, please specify
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1512910
- UMLS CUI [1,2]
- C1521902
Beskrivning
Other site, please specify
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1515974
- UMLS CUI [1,2]
- C3845569
Beskrivning
Culture outcome
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C2242979
- UMLS CUI [1,2]
- C0587081
Beskrivning
Isolate name
Datatyp
text
Alias
- UMLS CUI [1]
- C1764827
Beskrivning
Pathogen Type
Datatyp
integer
Alias
- UMLS CUI [1]
- C0450254
Beskrivning
Isolate Classification
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1764827
- UMLS CUI [1,2]
- C0008902
Beskrivning
(mm, Aerobic Pathogens only)
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1283010
- UMLS CUI [1,2]
- C0004521
- UMLS CUI [2,1]
- C1283010
- UMLS CUI [2,2]
- C3489748
Beskrivning
Sample sent to Central Lab
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1880016
- UMLS CUI [1,2]
- C0370003
- UMLS CUI [1,3]
- C1515023
Beskrivning
Central Laboratory Accession ID Number
Datatyp
text
Alias
- UMLS CUI [1,1]
- C2826726
- UMLS CUI [1,2]
- C1880016
Beskrivning
Not done reason
Datatyp
text
Alias
- UMLS CUI [1]
- C2826287
Beskrivning
Backup Sample sent to Central Laboratory
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0370003
- UMLS CUI [1,2]
- C1515023
- UMLS CUI [1,3]
- C1880016
Beskrivning
New Central Lab Accession ID Number
Datatyp
text
Alias
- UMLS CUI [1,1]
- C2826726
- UMLS CUI [1,2]
- C1880016
Beskrivning
Comment
Datatyp
text
Alias
- UMLS CUI [1]
- C0947611
Beskrivning
Overdose Report
Alias
- UMLS CUI-1
- C4018909
- UMLS CUI-2
- C0684224
Beskrivning
Overdose Report
Alias
- UMLS CUI-1
- C4018909
- UMLS CUI-2
- C0684224
Beskrivning
Medication overdose
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C4018909
- UMLS CUI [1,2]
- C0013227
Beskrivning
Overdose
Datatyp
boolean
Alias
- UMLS CUI [1]
- C4018909
Beskrivning
Administration Route
Datatyp
integer
Alias
- UMLS CUI [1]
- C0013153
Beskrivning
Administration Route
Datatyp
text
Alias
- UMLS CUI [1]
- C0013153
Beskrivning
Total Daily Dose
Datatyp
integer
Alias
- UMLS CUI [1]
- C2986497
Beskrivning
Unit used
Datatyp
text
Alias
- UMLS CUI [1]
- C1519795
Beskrivning
Date of Overdose
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C4018909
Beskrivning
Intentional overdose
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C4018909
- UMLS CUI [1,2]
- C1283828
Beskrivning
Overdose associated with AE
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C4018909
- UMLS CUI [1,2]
- C0877248
Beskrivning
(please fill in an AE-Form)
Datatyp
text
Alias
- UMLS CUI [1]
- C2826934
Beskrivning
Reason for Overdose
Datatyp
text
Alias
- UMLS CUI [1,1]
- C4018909
- UMLS CUI [1,2]
- C0392360
Similar models
Baseline-Visit 2
C0030705 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,2])
C0031809 (UMLS CUI-2)
C3714514 (UMLS CUI-2)
C0205394 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,2])
C0886052 (UMLS CUI-2)
C0205124 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
C0430400 (UMLS CUI [1,2])
C0037088 (UMLS CUI-2)
C0947611 (UMLS CUI [1,2])
C3845569 (UMLS CUI [1,2])
C0031809 (UMLS CUI-2)
C0038846 (UMLS CUI [1,2])
C0038846 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
C0039476 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
C0008000 (UMLS CUI [1,2])
C2986056 (UMLS CUI [1,2])
C1515023 (UMLS CUI [1,2])
C1880016 (UMLS CUI [1,3])
C0018941 (UMLS CUI [1,2])
C2986056 (UMLS CUI [1,2])
C1515023 (UMLS CUI [1,2])
C1880016 (UMLS CUI [1,3])
C0042014 (UMLS CUI [1,2])
C2986056 (UMLS CUI [1,2])
C1515023 (UMLS CUI [1,2])
C1880016 (UMLS CUI [1,3])
C0025952 (UMLS CUI [1,2])
C0200345 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C0200345 (UMLS CUI [1,2])
C3845569 (UMLS CUI [1,3])
C0037793 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,3])
C1515974 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,2])
C3845569 (UMLS CUI [1,2])
C0008902 (UMLS CUI [1,2])
C0370003 (UMLS CUI [1,2])
C1515023 (UMLS CUI [1,3])
C1880016 (UMLS CUI [1,2])
C1515023 (UMLS CUI [1,2])
C1880016 (UMLS CUI [1,3])
C0543467 (UMLS CUI [1,2])
C0184898 (UMLS CUI [1,2])
C0184898 (UMLS CUI [1,2])
C0038969 (UMLS CUI [1,2])
C0038969 (UMLS CUI [1,2])
C0243095 (UMLS CUI-2)
C0678257 (UMLS CUI [1,2])
C0243095 (UMLS CUI [1,3])
C3714444 (UMLS CUI-2)
C0808070 (UMLS CUI [1,2])
C3489748 (UMLS CUI [2,1])
C0808070 (UMLS CUI [2,2])
C0806020 (UMLS CUI [1,2])
C3489748 (UMLS CUI [2,1])
C0806020 (UMLS CUI [2,2])
C1522314 (UMLS CUI [1,2])
C3489748 (UMLS CUI [2,1])
C1522314 (UMLS CUI [2,2])
C0304229 (UMLS CUI [1,2])
C3469597 (UMLS CUI-2)
C0004521 (UMLS CUI-3)
C3489748 (UMLS CUI-4)
C0574032 (UMLS CUI [1,2])
C0205543 (UMLS CUI [1,3])
C3714444 (UMLS CUI [1,4])
C0808070 (UMLS CUI [1,2])
C3489748 (UMLS CUI [2,1])
C0808070 (UMLS CUI [2,2])
C1301880 (UMLS CUI [1,2])
C3489748 (UMLS CUI [2,1])
C1301880 (UMLS CUI [2,2])
C0806020 (UMLS CUI [1,2])
C3489748 (UMLS CUI [2,1])
C0806020 (UMLS CUI [2,2])
C1522314 (UMLS CUI [1,2])
C3489748 (UMLS CUI [2,1])
C1522314 (UMLS CUI [2,2])
C0178602 (UMLS CUI [1,2])
C0004521 (UMLS CUI [1,3])
C0178602 (UMLS CUI [1,2])
C3489748 (UMLS CUI [1,3])
C3641829 (UMLS CUI [1,2])
C3641829 (UMLS CUI [1,2])
C2700258 (UMLS CUI [1,2])
C2700258 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,2])
C3469597 (UMLS CUI-2)
C0025872 (UMLS CUI-3)
C0574032 (UMLS CUI [1,2])
C0205543 (UMLS CUI [1,3])
C3714444 (UMLS CUI [1,4])
C0808070 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,2])
C0025872 (UMLS CUI [1,3])
C3641829 (UMLS CUI [1,2])
C2700258 (UMLS CUI [1,2])
C2700258 (UMLS CUI [1,2])
C0013798 (UMLS CUI [1,2])
C0013798 (UMLS CUI [1,2])
C0013798 (UMLS CUI [1,2])
C0086960 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
C0200345 (UMLS CUI [1,2])
C1515974 (UMLS CUI [1,2])
C0370003 (UMLS CUI [1,2])
C1698986 (UMLS CUI [1,3])
C0370003 (UMLS CUI [1,2])
C1698986 (UMLS CUI [1,3])
C0004521 (UMLS CUI [1,2])
C3489748 (UMLS CUI [1,2])
C1299222 (UMLS CUI [1,2])
C0004521 (UMLS CUI [1,3])
C1299222 (UMLS CUI [1,2])
C3489748 (UMLS CUI [1,3])
C0683312 (UMLS CUI [1,2])
C1709694 (UMLS CUI [1,2])
C0683312 (UMLS CUI [1,2])
C0025952 (UMLS CUI [1,2])
C0200345 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C0200345 (UMLS CUI [1,2])
C3845569 (UMLS CUI [1,3])
C0037793 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,3])
C1515974 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,2])
C3845569 (UMLS CUI [1,2])
C0008902 (UMLS CUI [1,2])
C0004521 (UMLS CUI [1,2])
C1283010 (UMLS CUI [2,1])
C3489748 (UMLS CUI [2,2])
C0370003 (UMLS CUI [1,2])
C1515023 (UMLS CUI [1,3])
C1880016 (UMLS CUI [1,2])
C1515023 (UMLS CUI [1,2])
C1880016 (UMLS CUI [1,3])
C1880016 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,2])
C4018909 (UMLS CUI [1,2])
C1283828 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,2])