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
Treatment 1-3 Visit 3-5
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
Post-Operative Wound Examination
Alias
- UMLS CUI-1
- C2112579
- UMLS CUI-2
- C0886052
Beskrivning
Wound Infection
Alias
- UMLS CUI-1
- C0043241
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
Wound type
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 for Culture
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0430402
- UMLS CUI [1,2]
- C0370003
Beskrivning
Signs and Symptoms of Wound Infection
Alias
- UMLS CUI-1
- C0037088
- UMLS CUI-2
- C0043241
Beskrivning
Signs and Symptoms
Datatyp
integer
Alias
- UMLS CUI [1]
- C0037088
Beskrivning
Other infection sign
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
comment
Datatyp
text
Alias
- UMLS CUI [1]
- C0947611
Beskrivning
Comment
Datatyp
text
Alias
- UMLS CUI [1]
- C0947611
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
Temperature measurement
Datatyp
float
Alias
- UMLS CUI [1]
- C0005903
Beskrivning
Unit
Datatyp
text
Alias
- UMLS CUI [1]
- C1519795
Beskrivning
Comment
Datatyp
text
Alias
- UMLS CUI [1]
- C0947611
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
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
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
Central Laboratory 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
Beskrivning
Intensive Monitoring Lab Values
Alias
- UMLS CUI-1
- C2346633
Beskrivning
Laboratory procedure
Datatyp
integer
Alias
- UMLS CUI [1]
- C0022885
Beskrivning
Specimen collection
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0200345
Beskrivning
Not done reason
Datatyp
integer
Alias
- UMLS CUI [1]
- C2826287
Beskrivning
Specify other
Datatyp
text
Alias
- UMLS CUI [1]
- C3845569
Beskrivning
Laboratory value
Datatyp
text
Alias
- UMLS CUI [1]
- C0587081
Beskrivning
Lab Unit
Datatyp
integer
Alias
- UMLS CUI [1]
- C1519795
Beskrivning
Other lab unit
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519795
- UMLS CUI [1,2]
- C0205394
Beskrivning
Clinical significance
Datatyp
boolean
Alias
- UMLS CUI [1]
- C2826293
Beskrivning
AST (GOT),ALT (GPT),Total Bilirubin
Datatyp
text
Alias
- UMLS CUI [1]
- C1519815
Beskrivning
AST (GOT),ALT (GPT),Total Bilirubin
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0587081
- UMLS CUI [1,2]
- C0205217
Beskrivning
Potential Hy's Law
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0860207
- UMLS CUI [1,2]
- C0332149
Beskrivning
Notification
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0422202
- UMLS CUI [1,2]
- C0023884
Beskrivning
Laboratory procedures
Alias
- UMLS CUI-1
- C0022885
Beskrivning
Examination performed
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0022885
Beskrivning
Not done reason
Datatyp
text
Alias
- UMLS CUI [1]
- C2826287
Beskrivning
Intensive monitoring is to be done every 24h if protocol criteria are fulfilled. Samples must be analysed at local lab and results must be entered IMMEDIATELY upon availability.
Datatyp
date
Alias
- UMLS CUI [1]
- C1302413
Beskrivning
Intensive monitoring is to be done every 24h if protocol criteria are fulfilled. Samples must be analysed at local lab and results must be entered IMMEDIATELY upon availability.
Datatyp
time
Alias
- UMLS CUI [1]
- C4064021
Beskrivning
Creatinine Clearance
Datatyp
integer
Måttenheter
- (mL/min)
Alias
- UMLS CUI [1]
- C0373595
Beskrivning
Clinical significance
Datatyp
boolean
Alias
- UMLS CUI [1]
- C2826293
Beskrivning
Comment
Datatyp
text
Alias
- UMLS CUI [1]
- C0947611
Beskrivning
Liver Diagnostic Assessments
Alias
- UMLS CUI-1
- C0232741
- UMLS CUI-2
- C0022885
Beskrivning
Potential Hy's Law Examination
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0860207
- UMLS CUI [1,2]
- C0332149
- UMLS CUI [1,3]
- C0220825
Beskrivning
Potential Hy's Law Case Number
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0860207
- UMLS CUI [1,2]
- C1698493
- UMLS CUI [1,3]
- C0600091
Beskrivning
Comment
Datatyp
text
Alias
- UMLS CUI [1]
- C0947611
Beskrivning
Liver Diagnostic
Alias
- UMLS CUI-1
- C0023884
- UMLS CUI-2
- C0430022
Beskrivning
Liver Diagnostic instrument
Datatyp
integer
Alias
- UMLS CUI [1]
- C0193374
Beskrivning
Examination performed
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C2985643
- UMLS CUI [1,2]
- C0430022
Beskrivning
Date of Assessment
Datatyp
date
Alias
- UMLS CUI [1]
- C2985720
Beskrivning
Liver Diagnostic Result
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0430022
- UMLS CUI [1,2]
- C1274040
Beskrivning
Tox Screening, Other; Serology for Hepatitis,CMV,EBV,autoimmune;other diagnostic investigation
Datatyp
text
Alias
- UMLS CUI [1,1]
- C2348235
- UMLS CUI [1,2]
- C1261322
Beskrivning
Liver risk factors
Alias
- UMLS CUI-1
- C0035648
- UMLS CUI-2
- C0023884
Beskrivning
Liver risk factors
Alias
- UMLS CUI-1
- C0035648
- UMLS CUI-2
- C0023884
Beskrivning
Risk factor
Datatyp
integer
Alias
- UMLS CUI [1]
- C0035648
Beskrivning
Occurrence
Datatyp
boolean
Alias
- UMLS CUI [1]
- C2745955
Beskrivning
Risk Factor Details
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0035648
- UMLS CUI [1,2]
- C1522508
Beskrivning
Reference Period
Datatyp
integer
Alias
- UMLS CUI [1]
- C1709877
Beskrivning
Start Date
Datatyp
date
Alias
- UMLS CUI [1]
- C0808070
Beskrivning
End Date
Datatyp
date
Alias
- UMLS CUI [1]
- C0806020
Beskrivning
Comment
Datatyp
text
Alias
- UMLS CUI [1]
- C0947611
Beskrivning
Liver signs and symptoms
Alias
- UMLS CUI-1
- C0037088
- UMLS CUI-2
- C0023884
Beskrivning
Liver signs and symptoms
Alias
- UMLS CUI-1
- C0037088
- UMLS CUI-2
- C0023884
Beskrivning
Signs and Symptoms
Datatyp
integer
Alias
- UMLS CUI [1]
- C0037088
Beskrivning
Occurrence
Datatyp
boolean
Alias
- UMLS CUI [1]
- C2745955
Beskrivning
Start Date
Datatyp
date
Alias
- UMLS CUI [1]
- C0808070
Beskrivning
End Date
Datatyp
date
Alias
- UMLS CUI [1]
- C0806020
Beskrivning
Intermittent
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0205267
Beskrivning
Other Liver Sign or Symptom
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0037088
- UMLS CUI [1,2]
- C0205394
Beskrivning
Administrative Information
Alias
- UMLS CUI-1
- C1320722
Beskrivning
Patient Caption
Datatyp
text
Alias
- UMLS CUI [1,1]
- C2825231
- UMLS CUI [1,2]
- C0030705
Beskrivning
Visit Number
Datatyp
integer
Alias
- UMLS CUI [1]
- C1549755
Beskrivning
Trial name
Datatyp
text
Alias
- UMLS CUI [1]
- C1629065
Beskrivning
Visit Name
Datatyp
text
Alias
- UMLS CUI [1]
- C2826704
Beskrivning
Visit date
Datatyp
date
Alias
- UMLS CUI [1]
- C1320303
Beskrivning
Study site
Datatyp
text
Alias
- UMLS CUI [1]
- C2825164
Beskrivning
Electrocardiogram (ECG)
Alias
- UMLS CUI-1
- C0013798
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 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
Administrative Information
Alias
- UMLS CUI-1
- C1320722
Beskrivning
Patient Caption
Datatyp
text
Alias
- UMLS CUI [1,1]
- C2825231
- UMLS CUI [1,2]
- C0030705
Beskrivning
Visit Number
Datatyp
integer
Alias
- UMLS CUI [1]
- C1549755
Beskrivning
Trial name
Datatyp
text
Alias
- UMLS CUI [1]
- C1629065
Beskrivning
Visit Name
Datatyp
text
Alias
- UMLS CUI [1]
- C2826704
Beskrivning
Visit date
Datatyp
date
Alias
- UMLS CUI [1]
- C1320303
Beskrivning
Study site
Datatyp
text
Alias
- UMLS CUI [1]
- C2825164
Beskrivning
PK sample sent to Central Lab
Alias
- UMLS CUI-1
- C1880016
- UMLS CUI-2
- C0370003
- UMLS CUI-3
- C1515023
Beskrivning
Sampling schedule
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0086960
Beskrivning
Start Date experimental drug
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0808070
- UMLS CUI [1,2]
- C0304229
Beskrivning
Start time experimental drug
Datatyp
time
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C1301880
Beskrivning
End Date experimental drug
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0806020
Beskrivning
End time experimental drug
Datatyp
time
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C1522314
Beskrivning
Samples sent to Central Lab?
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1880016
- UMLS CUI [1,2]
- C0370003
- UMLS CUI [1,3]
- C1515023
Beskrivning
Not done reason
Datatyp
text
Alias
- UMLS CUI [1]
- C2826287
Beskrivning
comment
Datatyp
text
Alias
- UMLS CUI [1]
- C0947611
Beskrivning
Pharmakokinetics Sampling at Day 4
Alias
- UMLS CUI-1
- C0005834
- UMLS CUI-2
- C0031327
Beskrivning
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
Similar models
Treatment 1-3 Visit 3-5
C0030705 (UMLS CUI [1,2])
C0031809 (UMLS CUI-2)
C3714514 (UMLS CUI-2)
C0205394 (UMLS CUI [1,2])
C0886052 (UMLS CUI-2)
C0886052 (UMLS CUI [1,2])
C0205124 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
C0370003 (UMLS CUI [1,2])
C0043241 (UMLS CUI-2)
C0205394 (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])
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])
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])
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])
C0205394 (UMLS CUI [1,2])
C0205217 (UMLS CUI [1,2])
C0332149 (UMLS CUI [1,2])
C0023884 (UMLS CUI [1,2])
C0022885 (UMLS CUI-2)
C0332149 (UMLS CUI [1,2])
C0220825 (UMLS CUI [1,3])
C1698493 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,3])
C0430022 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,2])
C1261322 (UMLS CUI [1,2])
C1698493 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,3])
C1522508 (UMLS CUI [1,2])
C0023884 (UMLS CUI-2)
C1698493 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,3])
C0023884 (UMLS CUI-2)
C0205394 (UMLS CUI [1,2])
C0030705 (UMLS CUI [1,2])
C0013798 (UMLS CUI [1,2])
C0013798 (UMLS CUI [1,2])
C0030705 (UMLS CUI [1,2])
C0370003 (UMLS CUI-2)
C1515023 (UMLS CUI-3)
C0086960 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,2])
C0370003 (UMLS CUI [1,2])
C1515023 (UMLS CUI [1,3])
C0031327 (UMLS CUI-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])