ID
29207
Beschreibung
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
Stichworte
Versionen (2)
- 07.03.18 07.03.18 -
- 17.09.21 17.09.21 -
Rechteinhaber
Pfizer
Hochgeladen am
7. März 2018
DOI
10.21961/mdm:29207
Lizenz
Creative Commons BY-NC 3.0
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REJUVENATE NCT02655419
Treatment 1-3 Visit 3-5
Beschreibung
Infection-related Examination
Alias
- UMLS CUI-1
- C3714514
- UMLS CUI-2
- C0031809
Beschreibung
Infection related Signs and Symptoms
Alias
- UMLS CUI-1
- C0037088
- UMLS CUI-2
- C3714514
Beschreibung
Signs and Symptoms
Datentyp
integer
Alias
- UMLS CUI [1]
- C0037088
Beschreibung
Other Sign or Symptom
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0037088
- UMLS CUI [1,2]
- C0205394
Beschreibung
Clinical Event Intensity
Datentyp
integer
Alias
- UMLS CUI [1]
- C0518690
Beschreibung
Post-Operative Wound Examination
Alias
- UMLS CUI-1
- C2112579
- UMLS CUI-2
- C0886052
Beschreibung
Wound Infection
Alias
- UMLS CUI-1
- C0043241
Beschreibung
Superficial Infection
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0043241
- UMLS CUI [1,2]
- C0205124
Beschreibung
Deep Wound Infection
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0406103
Beschreibung
Wound type
Datentyp
integer
Alias
- UMLS CUI [1]
- C1276783
Beschreibung
other Wound Type
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1276783
- UMLS CUI [1,2]
- C0205394
Beschreibung
Negative Pressure Wound Device
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1956078
Beschreibung
Specimen for Culture
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0430402
- UMLS CUI [1,2]
- C0370003
Beschreibung
Signs and Symptoms of Wound Infection
Alias
- UMLS CUI-1
- C0037088
- UMLS CUI-2
- C0043241
Beschreibung
Signs and Symptoms
Datentyp
integer
Alias
- UMLS CUI [1]
- C0037088
Beschreibung
Other infection sign
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0037088
- UMLS CUI [1,2]
- C0205394
Beschreibung
Clinical Event Intensity
Datentyp
integer
Alias
- UMLS CUI [1]
- C0518690
Beschreibung
comment
Datentyp
text
Alias
- UMLS CUI [1]
- C0947611
Beschreibung
Comment
Datentyp
text
Alias
- UMLS CUI [1]
- C0947611
Beschreibung
Vital Signs examination
Alias
- UMLS CUI-1
- C0518766
- UMLS CUI-2
- C0031809
Beschreibung
Examination performed
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0031809
Beschreibung
Not done reason
Datentyp
text
Alias
- UMLS CUI [1]
- C2826287
Beschreibung
Supine Blood Pressure Systolic
Datentyp
integer
Maßeinheiten
- mmHg
Alias
- UMLS CUI [1,1]
- C0871470
- UMLS CUI [1,2]
- C0038846
Beschreibung
Relevance
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2347946
Beschreibung
Supine Blood Pressure Diastolic
Datentyp
integer
Maßeinheiten
- mmHg
Alias
- UMLS CUI [1,1]
- C0428883
- UMLS CUI [1,2]
- C0038846
Beschreibung
Relevance
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2347946
Beschreibung
Heart rate
Datentyp
integer
Maßeinheiten
- bpm
Alias
- UMLS CUI [1]
- C0018810
Beschreibung
Relevance
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2347946
Beschreibung
Respiratory Rate
Datentyp
integer
Maßeinheiten
- breaths/min
Alias
- UMLS CUI [1]
- C0231832
Beschreibung
Relevance
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2347946
Beschreibung
Comment
Datentyp
text
Alias
- UMLS CUI [1]
- C0947611
Beschreibung
Temperature
Alias
- UMLS CUI-1
- C0005903
Beschreibung
Temperature
Datentyp
float
Maßeinheiten
- °C
Alias
- UMLS CUI [1]
- C0039476
Beschreibung
HH:MM
Datentyp
time
Alias
- UMLS CUI [1,1]
- C0242485
- UMLS CUI [1,2]
- C0040223
Beschreibung
Method of Measurement
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1299991
- UMLS CUI [1,2]
- C0039476
Beschreibung
Other Method
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1299991
- UMLS CUI [1,2]
- C0205394
Beschreibung
Relevance
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2347946
Beschreibung
Temperature measurement
Datentyp
float
Alias
- UMLS CUI [1]
- C0005903
Beschreibung
Unit
Datentyp
text
Alias
- UMLS CUI [1]
- C1519795
Beschreibung
Comment
Datentyp
text
Alias
- UMLS CUI [1]
- C0947611
Beschreibung
Study drug loading dose
Alias
- UMLS CUI-1
- C0304229
- UMLS CUI-2
- C3714444
Beschreibung
Start Date of ATM-AVI
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0004521
- UMLS CUI [1,2]
- C0808070
- UMLS CUI [2,1]
- C3489748
- UMLS CUI [2,2]
- C0808070
Beschreibung
End Date of ATM-AVI
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0004521
- UMLS CUI [1,2]
- C0806020
- UMLS CUI [2,1]
- C3489748
- UMLS CUI [2,2]
- C0806020
Beschreibung
End time of ATM-AVI
Datentyp
time
Alias
- UMLS CUI [1,1]
- C0004521
- UMLS CUI [1,2]
- C1522314
- UMLS CUI [2,1]
- C3489748
- UMLS CUI [2,2]
- C1522314
Beschreibung
Infusion Rate (mL/min)
Datentyp
integer
Alias
- UMLS CUI [1]
- C2964135
Beschreibung
Route of Study Drug Administration
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0013153
- UMLS CUI [1,2]
- C0304229
Beschreibung
Comment on Administration
Datentyp
text
Alias
- UMLS CUI [1]
- C0947611
Beschreibung
Study drug administration ATM-AVI
Alias
- UMLS CUI-1
- C0304229
- UMLS CUI-2
- C3469597
- UMLS CUI-3
- C0004521
- UMLS CUI-4
- C3489748
Beschreibung
Infusion out of range referring to loading dose
Datentyp
text
Alias
- UMLS CUI [1,1]
- C3845292
- UMLS CUI [1,2]
- C0574032
- UMLS CUI [1,3]
- C0205543
- UMLS CUI [1,4]
- C3714444
Beschreibung
Start Date of ATM-AVI
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0004521
- UMLS CUI [1,2]
- C0808070
- UMLS CUI [2,1]
- C3489748
- UMLS CUI [2,2]
- C0808070
Beschreibung
Start time of ATM-AVI
Datentyp
time
Alias
- UMLS CUI [1,1]
- C0004521
- UMLS CUI [1,2]
- C1301880
- UMLS CUI [2,1]
- C3489748
- UMLS CUI [2,2]
- C1301880
Beschreibung
End Date of ATM-AVI
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0004521
- UMLS CUI [1,2]
- C0806020
- UMLS CUI [2,1]
- C3489748
- UMLS CUI [2,2]
- C0806020
Beschreibung
End time of ATM-AVI
Datentyp
time
Alias
- UMLS CUI [1,1]
- C0004521
- UMLS CUI [1,2]
- C1522314
- UMLS CUI [2,1]
- C3489748
- UMLS CUI [2,2]
- C1522314
Beschreibung
ATM Dose (mg) to be given per protocol
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0040808
- UMLS CUI [1,2]
- C0178602
- UMLS CUI [1,3]
- C0004521
Beschreibung
AVI Dose (mg) to be given per protocol
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0040808
- UMLS CUI [1,2]
- C0178602
- UMLS CUI [1,3]
- C3489748
Beschreibung
ATM Batch No.
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0004521
- UMLS CUI [1,2]
- C3641829
Beschreibung
AVI Batch No.
Datentyp
text
Alias
- UMLS CUI [1,1]
- C3489748
- UMLS CUI [1,2]
- C3641829
Beschreibung
Start Volume
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0574032
- UMLS CUI [1,2]
- C2700258
Beschreibung
End Volume
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0574032
- UMLS CUI [1,2]
- C2700258
Beschreibung
Infusion Rate (mL/min)
Datentyp
integer
Alias
- UMLS CUI [1]
- C2964135
Beschreibung
Route of Study Drug Administration
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0013153
- UMLS CUI [1,2]
- C0304229
Beschreibung
Comment on Administration
Datentyp
text
Alias
- UMLS CUI [1]
- C0947611
Beschreibung
Study drug administration Metronidazole
Alias
- UMLS CUI-1
- C0304229
- UMLS CUI-2
- C3469597
- UMLS CUI-3
- C0025872
Beschreibung
Infusion out of range referring to loading dose
Datentyp
text
Alias
- UMLS CUI [1,1]
- C3845292
- UMLS CUI [1,2]
- C0574032
- UMLS CUI [1,3]
- C0205543
- UMLS CUI [1,4]
- C3714444
Beschreibung
Start Date of Metronidazole
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0025872
- UMLS CUI [1,2]
- C0808070
Beschreibung
Start time of Metronidazole
Datentyp
time
Alias
- UMLS CUI [1,1]
- C0025872
- UMLS CUI [1,2]
- C1301880
Beschreibung
End Date of Metronidazole
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0025872
- UMLS CUI [1,2]
- C0806020
Beschreibung
End time of Metronidazole
Datentyp
time
Alias
- UMLS CUI [1,1]
- C0025872
- UMLS CUI [1,2]
- C1522314
Beschreibung
Metronidazole Dose (mg) to be given per protocol
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0040808
- UMLS CUI [1,2]
- C0178602
- UMLS CUI [1,3]
- C0025872
Beschreibung
Metronidazole Batch No.
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0025872
- UMLS CUI [1,2]
- C3641829
Beschreibung
Start Volume
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0574032
- UMLS CUI [1,2]
- C2700258
Beschreibung
End Volume
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0574032
- UMLS CUI [1,2]
- C2700258
Beschreibung
Infusion Rate (mL/min)
Datentyp
integer
Alias
- UMLS CUI [1]
- C2964135
Beschreibung
Comment on Administration
Datentyp
text
Alias
- UMLS CUI [1]
- C0947611
Beschreibung
Surgical Procedure
Alias
- UMLS CUI-1
- C0543467
Beschreibung
Surgery performed
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0543467
Beschreibung
Surgery time
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0683312
- UMLS CUI [1,2]
- C0543467
Beschreibung
Surgical Procedure
Datentyp
integer
Alias
- UMLS CUI [1]
- C0543467
Beschreibung
Other procedure
Datentyp
text
Alias
- UMLS CUI [1]
- C0543467
Beschreibung
Start Date (incision)
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0808070
- UMLS CUI [1,2]
- C0184898
Beschreibung
Start Time (incision)
Datentyp
time
Alias
- UMLS CUI [1,1]
- C1301880
- UMLS CUI [1,2]
- C0184898
Beschreibung
End Date (suture)
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0806020
- UMLS CUI [1,2]
- C0038969
Beschreibung
End Time (suture)
Datentyp
time
Alias
- UMLS CUI [1,1]
- C1522314
- UMLS CUI [1,2]
- C0038969
Beschreibung
Reason for Procedure
Datentyp
integer
Alias
- UMLS CUI [1]
- C3258099
Beschreibung
Other reason
Datentyp
text
Alias
- UMLS CUI [1]
- C3840932
Beschreibung
Comment
Datentyp
text
Alias
- UMLS CUI [1]
- C0947611
Beschreibung
Description of Findings
Alias
- UMLS CUI-1
- C0678257
- UMLS CUI-2
- C0243095
Beschreibung
Microbiology
Alias
- UMLS CUI-1
- C0085672
Beschreibung
Microbiology specimen collection
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0200345
- UMLS CUI [1,2]
- C0025952
Beschreibung
Not done reason
Datentyp
integer
Alias
- UMLS CUI [1]
- C2826287
Beschreibung
inability
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1299582
- UMLS CUI [1,2]
- C0200345
- UMLS CUI [1,3]
- C1521902
Beschreibung
inability
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1299582
- UMLS CUI [1,2]
- C0200345
- UMLS CUI [1,3]
- C3845569
Beschreibung
Specimen collection date
Datentyp
date
Alias
- UMLS CUI [1]
- C1302413
Beschreibung
Specimen collection time
Datentyp
time
Alias
- UMLS CUI [1]
- C4064021
Beschreibung
Culture Processing Type
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0200949
- UMLS CUI [1,2]
- C0037793
- UMLS CUI [1,3]
- C0332307
Beschreibung
Specimen collection site
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0200345
- UMLS CUI [1,2]
- C1515974
Beschreibung
Intra-Abdominal, please specify
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1512910
- UMLS CUI [1,2]
- C1521902
Beschreibung
Other site, please specify
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1515974
- UMLS CUI [1,2]
- C3845569
Beschreibung
Culture outcome
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C2242979
- UMLS CUI [1,2]
- C0587081
Beschreibung
Isolate name
Datentyp
text
Alias
- UMLS CUI [1]
- C1764827
Beschreibung
Pathogen Type
Datentyp
integer
Alias
- UMLS CUI [1]
- C0450254
Beschreibung
Isolate Classification
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1764827
- UMLS CUI [1,2]
- C0008902
Beschreibung
(mm, Aerobic Pathogens only)
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1283010
- UMLS CUI [1,2]
- C0004521
- UMLS CUI [2,1]
- C1283010
- UMLS CUI [2,2]
- C3489748
Beschreibung
Sample sent to Central Lab
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1880016
- UMLS CUI [1,2]
- C0370003
- UMLS CUI [1,3]
- C1515023
Beschreibung
Central Laboratory Accession ID Number
Datentyp
text
Alias
- UMLS CUI [1,1]
- C2826726
- UMLS CUI [1,2]
- C1880016
Beschreibung
Not done reason
Datentyp
text
Alias
- UMLS CUI [1]
- C2826287
Beschreibung
Backup Sample sent to Central Laboratory
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0370003
- UMLS CUI [1,2]
- C1515023
- UMLS CUI [1,3]
- C1880016
Beschreibung
Central Laboratory Accession ID Number
Datentyp
text
Alias
- UMLS CUI [1,1]
- C2826726
- UMLS CUI [1,2]
- C1880016
Beschreibung
Comment
Datentyp
text
Alias
- UMLS CUI [1]
- C0947611
Beschreibung
Overdose Report
Alias
- UMLS CUI-1
- C4018909
- UMLS CUI-2
- C0684224
Beschreibung
Overdose Report
Alias
- UMLS CUI-1
- C4018909
- UMLS CUI-2
- C0684224
Beschreibung
Medication overdose
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C4018909
- UMLS CUI [1,2]
- C0013227
Beschreibung
Overdose
Datentyp
boolean
Alias
- UMLS CUI [1]
- C4018909
Beschreibung
Administration Route
Datentyp
integer
Alias
- UMLS CUI [1]
- C0013153
Beschreibung
Administration Route
Datentyp
text
Alias
- UMLS CUI [1]
- C0013153
Beschreibung
Total Daily Dose
Datentyp
integer
Alias
- UMLS CUI [1]
- C2986497
Beschreibung
Unit used
Datentyp
text
Alias
- UMLS CUI [1]
- C1519795
Beschreibung
Date of Overdose
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C4018909
Beschreibung
Intentional overdose
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C4018909
- UMLS CUI [1,2]
- C1283828
Beschreibung
Overdose associated with AE
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C4018909
- UMLS CUI [1,2]
- C0877248
Beschreibung
(please fill in an AE-Form)
Datentyp
text
Alias
- UMLS CUI [1]
- C2826934
Beschreibung
Reason for Overdose
Datentyp
text
Alias
- UMLS CUI [1,1]
- C4018909
- UMLS CUI [1,2]
- C0392360
Beschreibung
Intensive Monitoring Lab Values
Alias
- UMLS CUI-1
- C2346633
Beschreibung
Laboratory procedure
Datentyp
integer
Alias
- UMLS CUI [1]
- C0022885
Beschreibung
Specimen collection
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0200345
Beschreibung
Not done reason
Datentyp
integer
Alias
- UMLS CUI [1]
- C2826287
Beschreibung
Specify other
Datentyp
text
Alias
- UMLS CUI [1]
- C3845569
Beschreibung
Laboratory value
Datentyp
text
Alias
- UMLS CUI [1]
- C0587081
Beschreibung
Lab Unit
Datentyp
integer
Alias
- UMLS CUI [1]
- C1519795
Beschreibung
Other lab unit
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1519795
- UMLS CUI [1,2]
- C0205394
Beschreibung
Clinical significance
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2826293
Beschreibung
AST (GOT),ALT (GPT),Total Bilirubin
Datentyp
text
Alias
- UMLS CUI [1]
- C1519815
Beschreibung
AST (GOT),ALT (GPT),Total Bilirubin
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0587081
- UMLS CUI [1,2]
- C0205217
Beschreibung
Potential Hy's Law
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0860207
- UMLS CUI [1,2]
- C0332149
Beschreibung
Notification
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0422202
- UMLS CUI [1,2]
- C0023884
Beschreibung
Laboratory procedures
Alias
- UMLS CUI-1
- C0022885
Beschreibung
Examination performed
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0022885
Beschreibung
Not done reason
Datentyp
text
Alias
- UMLS CUI [1]
- C2826287
Beschreibung
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.
Datentyp
date
Alias
- UMLS CUI [1]
- C1302413
Beschreibung
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.
Datentyp
time
Alias
- UMLS CUI [1]
- C4064021
Beschreibung
Creatinine Clearance
Datentyp
integer
Maßeinheiten
- (mL/min)
Alias
- UMLS CUI [1]
- C0373595
Beschreibung
Clinical significance
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2826293
Beschreibung
Comment
Datentyp
text
Alias
- UMLS CUI [1]
- C0947611
Beschreibung
Liver Diagnostic Assessments
Alias
- UMLS CUI-1
- C0232741
- UMLS CUI-2
- C0022885
Beschreibung
Potential Hy's Law Examination
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0860207
- UMLS CUI [1,2]
- C0332149
- UMLS CUI [1,3]
- C0220825
Beschreibung
Potential Hy's Law Case Number
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0860207
- UMLS CUI [1,2]
- C1698493
- UMLS CUI [1,3]
- C0600091
Beschreibung
Comment
Datentyp
text
Alias
- UMLS CUI [1]
- C0947611
Beschreibung
Liver Diagnostic
Alias
- UMLS CUI-1
- C0023884
- UMLS CUI-2
- C0430022
Beschreibung
Liver Diagnostic instrument
Datentyp
integer
Alias
- UMLS CUI [1]
- C0193374
Beschreibung
Examination performed
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C2985643
- UMLS CUI [1,2]
- C0430022
Beschreibung
Date of Assessment
Datentyp
date
Alias
- UMLS CUI [1]
- C2985720
Beschreibung
Liver Diagnostic Result
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0430022
- UMLS CUI [1,2]
- C1274040
Beschreibung
Tox Screening, Other; Serology for Hepatitis,CMV,EBV,autoimmune;other diagnostic investigation
Datentyp
text
Alias
- UMLS CUI [1,1]
- C2348235
- UMLS CUI [1,2]
- C1261322
Beschreibung
Liver risk factors
Alias
- UMLS CUI-1
- C0035648
- UMLS CUI-2
- C0023884
Beschreibung
Liver risk factors
Alias
- UMLS CUI-1
- C0035648
- UMLS CUI-2
- C0023884
Beschreibung
Risk factor
Datentyp
integer
Alias
- UMLS CUI [1]
- C0035648
Beschreibung
Occurrence
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2745955
Beschreibung
Risk Factor Details
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0035648
- UMLS CUI [1,2]
- C1522508
Beschreibung
Reference Period
Datentyp
integer
Alias
- UMLS CUI [1]
- C1709877
Beschreibung
Start Date
Datentyp
date
Alias
- UMLS CUI [1]
- C0808070
Beschreibung
End Date
Datentyp
date
Alias
- UMLS CUI [1]
- C0806020
Beschreibung
Comment
Datentyp
text
Alias
- UMLS CUI [1]
- C0947611
Beschreibung
Liver signs and symptoms
Alias
- UMLS CUI-1
- C0037088
- UMLS CUI-2
- C0023884
Beschreibung
Liver signs and symptoms
Alias
- UMLS CUI-1
- C0037088
- UMLS CUI-2
- C0023884
Beschreibung
Signs and Symptoms
Datentyp
integer
Alias
- UMLS CUI [1]
- C0037088
Beschreibung
Occurrence
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2745955
Beschreibung
Start Date
Datentyp
date
Alias
- UMLS CUI [1]
- C0808070
Beschreibung
End Date
Datentyp
date
Alias
- UMLS CUI [1]
- C0806020
Beschreibung
Intermittent
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0205267
Beschreibung
Other Liver Sign or Symptom
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0037088
- UMLS CUI [1,2]
- C0205394
Beschreibung
Administrative Information
Alias
- UMLS CUI-1
- C1320722
Beschreibung
Patient Caption
Datentyp
text
Alias
- UMLS CUI [1,1]
- C2825231
- UMLS CUI [1,2]
- C0030705
Beschreibung
Visit Number
Datentyp
integer
Alias
- UMLS CUI [1]
- C1549755
Beschreibung
Trial name
Datentyp
text
Alias
- UMLS CUI [1]
- C1629065
Beschreibung
Visit Name
Datentyp
text
Alias
- UMLS CUI [1]
- C2826704
Beschreibung
Visit date
Datentyp
date
Alias
- UMLS CUI [1]
- C1320303
Beschreibung
Study site
Datentyp
text
Alias
- UMLS CUI [1]
- C2825164
Beschreibung
Electrocardiogram (ECG)
Alias
- UMLS CUI-1
- C0013798
Beschreibung
Examination performed
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2826672
Beschreibung
Not done reason
Datentyp
text
Alias
- UMLS CUI [1]
- C2826287
Beschreibung
ECG at Day 3
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1623258
Beschreibung
Date of ECG
Datentyp
date
Alias
- UMLS CUI [1]
- C2826640
Beschreibung
Time of ECG
Datentyp
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0013798
Beschreibung
Date of ECG
Datentyp
date
Alias
- UMLS CUI [1]
- C2826640
Beschreibung
Time of ECG
Datentyp
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0013798
Beschreibung
Comment
Datentyp
text
Alias
- UMLS CUI [1]
- C0947611
Beschreibung
Administrative Information
Alias
- UMLS CUI-1
- C1320722
Beschreibung
Patient Caption
Datentyp
text
Alias
- UMLS CUI [1,1]
- C2825231
- UMLS CUI [1,2]
- C0030705
Beschreibung
Visit Number
Datentyp
integer
Alias
- UMLS CUI [1]
- C1549755
Beschreibung
Trial name
Datentyp
text
Alias
- UMLS CUI [1]
- C1629065
Beschreibung
Visit Name
Datentyp
text
Alias
- UMLS CUI [1]
- C2826704
Beschreibung
Visit date
Datentyp
date
Alias
- UMLS CUI [1]
- C1320303
Beschreibung
Study site
Datentyp
text
Alias
- UMLS CUI [1]
- C2825164
Beschreibung
PK sample sent to Central Lab
Alias
- UMLS CUI-1
- C1880016
- UMLS CUI-2
- C0370003
- UMLS CUI-3
- C1515023
Beschreibung
Sampling schedule
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0086960
Beschreibung
Start Date experimental drug
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0808070
- UMLS CUI [1,2]
- C0304229
Beschreibung
Start time experimental drug
Datentyp
time
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C1301880
Beschreibung
End Date experimental drug
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0806020
Beschreibung
End time experimental drug
Datentyp
time
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C1522314
Beschreibung
Samples sent to Central Lab?
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1880016
- UMLS CUI [1,2]
- C0370003
- UMLS CUI [1,3]
- C1515023
Beschreibung
Not done reason
Datentyp
text
Alias
- UMLS CUI [1]
- C2826287
Beschreibung
comment
Datentyp
text
Alias
- UMLS CUI [1]
- C0947611
Beschreibung
Pharmakokinetics Sampling at Day 4
Alias
- UMLS CUI-1
- C0005834
- UMLS CUI-2
- C0031327
Beschreibung
Scheduled Sample
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0086960
Beschreibung
Specimen Collection
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0200345
Beschreibung
Specimen Condition
Datentyp
integer
Alias
- UMLS CUI [1]
- C1547869
Beschreibung
Specimen Condition, Other
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1547869
- UMLS CUI [1,2]
- C0205394
Beschreibung
Date of PK collection
Datentyp
date
Alias
- UMLS CUI [1]
- C1317250
Beschreibung
Actual Time of PK Collection
Datentyp
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0200345
Beschreibung
Sample collection site
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C1515974
Beschreibung
Storing date
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0370003
- UMLS CUI [1,3]
- C1698986
Beschreibung
Storing time
Datentyp
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0370003
- UMLS CUI [1,3]
- C1698986
Beschreibung
Specimen Identifier
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1299222
- UMLS CUI [1,2]
- C0004521
Beschreibung
Specimen Identifier
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1299222
- UMLS CUI [1,2]
- C3489748
Beschreibung
Backup Identifier
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1552560
- UMLS CUI [1,2]
- C1299222
- UMLS CUI [1,3]
- C0004521
Beschreibung
Backup Identifier
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1552560
- UMLS CUI [1,2]
- C1299222
- UMLS CUI [1,3]
- C3489748
Beschreibung
Specimen collection category
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0200345
- UMLS CUI [1,2]
- C0683312
Beschreibung
System
Datentyp
integer
Alias
- UMLS CUI [1]
- C0449913
Beschreibung
Biofluid collected
Datentyp
integer
Alias
- UMLS CUI [1]
- C0200345
Beschreibung
Biofluid processed
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0370003
- UMLS CUI [1,2]
- C1709694
Beschreibung
Main consent category
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0021430
- UMLS CUI [1,2]
- C0683312
Ähnliche Modelle
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])