ID
42906
Beschrijving
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
Trefwoorden
Versies (2)
- 07-03-18 07-03-18 -
- 17-09-21 17-09-21 -
Houder van rechten
Pfizer
Geüploaded op
17 september 2021
DOI
Voor een aanvraag inloggen.
Licentie
Creative Commons BY-NC 3.0
Model Commentaren :
Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.
Itemgroep Commentaren voor :
Item Commentaren voor :
U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.
REJUVENATE NCT02655419
Treatment 1-3 Visit 3-5
Beschrijving
Infection-related Examination
Alias
- UMLS CUI-1
- C3714514
- UMLS CUI-2
- C0031809
Beschrijving
Infection related Signs and Symptoms
Alias
- UMLS CUI-1
- C0037088
- UMLS CUI-2
- C3714514
Beschrijving
Signs and Symptoms
Datatype
integer
Alias
- UMLS CUI [1]
- C0037088
Beschrijving
Other Sign or Symptom
Datatype
text
Alias
- UMLS CUI [1,1]
- C0037088
- UMLS CUI [1,2]
- C0205394
Beschrijving
Clinical Event Intensity
Datatype
integer
Alias
- UMLS CUI [1]
- C0518690
Beschrijving
Post-Operative Wound Examination
Alias
- UMLS CUI-1
- C2112579
- UMLS CUI-2
- C0886052
Beschrijving
Wound Infection
Alias
- UMLS CUI-1
- C0043241
Beschrijving
Superficial Infection
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0043241
- UMLS CUI [1,2]
- C0205124
Beschrijving
Deep Wound Infection
Datatype
boolean
Alias
- UMLS CUI [1]
- C0406103
Beschrijving
Wound type
Datatype
integer
Alias
- UMLS CUI [1]
- C1276783
Beschrijving
other Wound Type
Datatype
text
Alias
- UMLS CUI [1,1]
- C1276783
- UMLS CUI [1,2]
- C0205394
Beschrijving
Negative Pressure Wound Device
Datatype
boolean
Alias
- UMLS CUI [1]
- C1956078
Beschrijving
Specimen for Culture
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0430402
- UMLS CUI [1,2]
- C0370003
Beschrijving
Signs and Symptoms of Wound Infection
Alias
- UMLS CUI-1
- C0037088
- UMLS CUI-2
- C0043241
Beschrijving
Signs and Symptoms
Datatype
integer
Alias
- UMLS CUI [1]
- C0037088
Beschrijving
Other infection sign
Datatype
text
Alias
- UMLS CUI [1,1]
- C0037088
- UMLS CUI [1,2]
- C0205394
Beschrijving
Clinical Event Intensity
Datatype
integer
Alias
- UMLS CUI [1]
- C0518690
Beschrijving
comment
Datatype
text
Alias
- UMLS CUI [1]
- C0947611
Beschrijving
Comment
Datatype
text
Alias
- UMLS CUI [1]
- C0947611
Beschrijving
Vital Signs examination
Alias
- UMLS CUI-1
- C0518766
- UMLS CUI-2
- C0031809
Beschrijving
Examination performed
Datatype
boolean
Alias
- UMLS CUI [1]
- C0031809
Beschrijving
Not done reason
Datatype
text
Alias
- UMLS CUI [1]
- C2826287
Beschrijving
Supine Blood Pressure Systolic
Datatype
integer
Maateenheden
- mmHg
Alias
- UMLS CUI [1,1]
- C0871470
- UMLS CUI [1,2]
- C0038846
Beschrijving
Relevance
Datatype
boolean
Alias
- UMLS CUI [1]
- C2347946
Beschrijving
Supine Blood Pressure Diastolic
Datatype
integer
Maateenheden
- mmHg
Alias
- UMLS CUI [1,1]
- C0428883
- UMLS CUI [1,2]
- C0038846
Beschrijving
Relevance
Datatype
boolean
Alias
- UMLS CUI [1]
- C2347946
Beschrijving
Heart rate
Datatype
integer
Maateenheden
- bpm
Alias
- UMLS CUI [1]
- C0018810
Beschrijving
Relevance
Datatype
boolean
Alias
- UMLS CUI [1]
- C2347946
Beschrijving
Respiratory Rate
Datatype
integer
Maateenheden
- breaths/min
Alias
- UMLS CUI [1]
- C0231832
Beschrijving
Relevance
Datatype
boolean
Alias
- UMLS CUI [1]
- C2347946
Beschrijving
Comment
Datatype
text
Alias
- UMLS CUI [1]
- C0947611
Beschrijving
Temperature
Alias
- UMLS CUI-1
- C0005903
Beschrijving
Temperature
Datatype
float
Maateenheden
- °C
Alias
- UMLS CUI [1]
- C0039476
Beschrijving
HH:MM
Datatype
time
Alias
- UMLS CUI [1,1]
- C0242485
- UMLS CUI [1,2]
- C0040223
Beschrijving
Method of Measurement
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1299991
- UMLS CUI [1,2]
- C0039476
Beschrijving
Other Method
Datatype
text
Alias
- UMLS CUI [1,1]
- C1299991
- UMLS CUI [1,2]
- C0205394
Beschrijving
Relevance
Datatype
boolean
Alias
- UMLS CUI [1]
- C2347946
Beschrijving
Temperature measurement
Datatype
float
Alias
- UMLS CUI [1]
- C0005903
Beschrijving
Unit
Datatype
text
Alias
- UMLS CUI [1]
- C1519795
Beschrijving
Comment
Datatype
text
Alias
- UMLS CUI [1]
- C0947611
Beschrijving
Study drug loading dose
Alias
- UMLS CUI-1
- C0304229
- UMLS CUI-2
- C3714444
Beschrijving
Start Date of ATM-AVI
Datatype
date
Alias
- UMLS CUI [1,1]
- C0004521
- UMLS CUI [1,2]
- C0808070
- UMLS CUI [2,1]
- C3489748
- UMLS CUI [2,2]
- C0808070
Beschrijving
End Date of ATM-AVI
Datatype
date
Alias
- UMLS CUI [1,1]
- C0004521
- UMLS CUI [1,2]
- C0806020
- UMLS CUI [2,1]
- C3489748
- UMLS CUI [2,2]
- C0806020
Beschrijving
End time of ATM-AVI
Datatype
time
Alias
- UMLS CUI [1,1]
- C0004521
- UMLS CUI [1,2]
- C1522314
- UMLS CUI [2,1]
- C3489748
- UMLS CUI [2,2]
- C1522314
Beschrijving
Infusion Rate (mL/min)
Datatype
integer
Alias
- UMLS CUI [1]
- C2964135
Beschrijving
Route of Study Drug Administration
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0013153
- UMLS CUI [1,2]
- C0304229
Beschrijving
Comment on Administration
Datatype
text
Alias
- UMLS CUI [1]
- C0947611
Beschrijving
Study drug administration ATM-AVI
Alias
- UMLS CUI-1
- C0304229
- UMLS CUI-2
- C3469597
- UMLS CUI-3
- C0004521
- UMLS CUI-4
- C3489748
Beschrijving
Infusion out of range referring to loading dose
Datatype
text
Alias
- UMLS CUI [1,1]
- C3845292
- UMLS CUI [1,2]
- C0574032
- UMLS CUI [1,3]
- C0205543
- UMLS CUI [1,4]
- C3714444
Beschrijving
Start Date of ATM-AVI
Datatype
date
Alias
- UMLS CUI [1,1]
- C0004521
- UMLS CUI [1,2]
- C0808070
- UMLS CUI [2,1]
- C3489748
- UMLS CUI [2,2]
- C0808070
Beschrijving
Start time of ATM-AVI
Datatype
time
Alias
- UMLS CUI [1,1]
- C0004521
- UMLS CUI [1,2]
- C1301880
- UMLS CUI [2,1]
- C3489748
- UMLS CUI [2,2]
- C1301880
Beschrijving
End Date of ATM-AVI
Datatype
date
Alias
- UMLS CUI [1,1]
- C0004521
- UMLS CUI [1,2]
- C0806020
- UMLS CUI [2,1]
- C3489748
- UMLS CUI [2,2]
- C0806020
Beschrijving
End time of ATM-AVI
Datatype
time
Alias
- UMLS CUI [1,1]
- C0004521
- UMLS CUI [1,2]
- C1522314
- UMLS CUI [2,1]
- C3489748
- UMLS CUI [2,2]
- C1522314
Beschrijving
ATM Dose (mg) to be given per protocol
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0040808
- UMLS CUI [1,2]
- C0178602
- UMLS CUI [1,3]
- C0004521
Beschrijving
AVI Dose (mg) to be given per protocol
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0040808
- UMLS CUI [1,2]
- C0178602
- UMLS CUI [1,3]
- C3489748
Beschrijving
ATM Batch No.
Datatype
text
Alias
- UMLS CUI [1,1]
- C0004521
- UMLS CUI [1,2]
- C3641829
Beschrijving
AVI Batch No.
Datatype
text
Alias
- UMLS CUI [1,1]
- C3489748
- UMLS CUI [1,2]
- C3641829
Beschrijving
Start Volume
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0574032
- UMLS CUI [1,2]
- C2700258
Beschrijving
End Volume
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0574032
- UMLS CUI [1,2]
- C2700258
Beschrijving
Infusion Rate (mL/min)
Datatype
integer
Alias
- UMLS CUI [1]
- C2964135
Beschrijving
Route of Study Drug Administration
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0013153
- UMLS CUI [1,2]
- C0304229
Beschrijving
Comment on Administration
Datatype
text
Alias
- UMLS CUI [1]
- C0947611
Beschrijving
Study drug administration Metronidazole
Alias
- UMLS CUI-1
- C0304229
- UMLS CUI-2
- C3469597
- UMLS CUI-3
- C0025872
Beschrijving
Infusion out of range referring to loading dose
Datatype
text
Alias
- UMLS CUI [1,1]
- C3845292
- UMLS CUI [1,2]
- C0574032
- UMLS CUI [1,3]
- C0205543
- UMLS CUI [1,4]
- C3714444
Beschrijving
Start Date of Metronidazole
Datatype
date
Alias
- UMLS CUI [1,1]
- C0025872
- UMLS CUI [1,2]
- C0808070
Beschrijving
Start time of Metronidazole
Datatype
time
Alias
- UMLS CUI [1,1]
- C0025872
- UMLS CUI [1,2]
- C1301880
Beschrijving
End Date of Metronidazole
Datatype
date
Alias
- UMLS CUI [1,1]
- C0025872
- UMLS CUI [1,2]
- C0806020
Beschrijving
End time of Metronidazole
Datatype
time
Alias
- UMLS CUI [1,1]
- C0025872
- UMLS CUI [1,2]
- C1522314
Beschrijving
Metronidazole Dose (mg) to be given per protocol
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0040808
- UMLS CUI [1,2]
- C0178602
- UMLS CUI [1,3]
- C0025872
Beschrijving
Metronidazole Batch No.
Datatype
text
Alias
- UMLS CUI [1,1]
- C0025872
- UMLS CUI [1,2]
- C3641829
Beschrijving
Start Volume
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0574032
- UMLS CUI [1,2]
- C2700258
Beschrijving
End Volume
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0574032
- UMLS CUI [1,2]
- C2700258
Beschrijving
Infusion Rate (mL/min)
Datatype
integer
Alias
- UMLS CUI [1]
- C2964135
Beschrijving
Comment on Administration
Datatype
text
Alias
- UMLS CUI [1]
- C0947611
Beschrijving
Surgical Procedure
Alias
- UMLS CUI-1
- C0543467
Beschrijving
Surgery performed
Datatype
boolean
Alias
- UMLS CUI [1]
- C0543467
Beschrijving
Surgery time
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0683312
- UMLS CUI [1,2]
- C0543467
Beschrijving
Surgical Procedure
Datatype
integer
Alias
- UMLS CUI [1]
- C0543467
Beschrijving
Other procedure
Datatype
text
Alias
- UMLS CUI [1]
- C0543467
Beschrijving
Start Date (incision)
Datatype
date
Alias
- UMLS CUI [1,1]
- C0808070
- UMLS CUI [1,2]
- C0184898
Beschrijving
Start Time (incision)
Datatype
time
Alias
- UMLS CUI [1,1]
- C1301880
- UMLS CUI [1,2]
- C0184898
Beschrijving
End Date (suture)
Datatype
date
Alias
- UMLS CUI [1,1]
- C0806020
- UMLS CUI [1,2]
- C0038969
Beschrijving
End Time (suture)
Datatype
time
Alias
- UMLS CUI [1,1]
- C1522314
- UMLS CUI [1,2]
- C0038969
Beschrijving
Reason for Procedure
Datatype
integer
Alias
- UMLS CUI [1]
- C3258099
Beschrijving
Other reason
Datatype
text
Alias
- UMLS CUI [1]
- C3840932
Beschrijving
Comment
Datatype
text
Alias
- UMLS CUI [1]
- C0947611
Beschrijving
Description of Findings
Alias
- UMLS CUI-1
- C0678257
- UMLS CUI-2
- C0243095
Beschrijving
Microbiology
Alias
- UMLS CUI-1
- C0085672
Beschrijving
Microbiology specimen collection
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0200345
- UMLS CUI [1,2]
- C0025952
Beschrijving
Not done reason
Datatype
integer
Alias
- UMLS CUI [1]
- C2826287
Beschrijving
inability
Datatype
text
Alias
- UMLS CUI [1,1]
- C1299582
- UMLS CUI [1,2]
- C0200345
- UMLS CUI [1,3]
- C1521902
Beschrijving
inability
Datatype
text
Alias
- UMLS CUI [1,1]
- C1299582
- UMLS CUI [1,2]
- C0200345
- UMLS CUI [1,3]
- C3845569
Beschrijving
Specimen collection date
Datatype
date
Alias
- UMLS CUI [1]
- C1302413
Beschrijving
Specimen collection time
Datatype
time
Alias
- UMLS CUI [1]
- C4064021
Beschrijving
Culture Processing Type
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0200949
- UMLS CUI [1,2]
- C0037793
- UMLS CUI [1,3]
- C0332307
Beschrijving
Specimen collection site
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0200345
- UMLS CUI [1,2]
- C1515974
Beschrijving
Intra-Abdominal, please specify
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1512910
- UMLS CUI [1,2]
- C1521902
Beschrijving
Other site, please specify
Datatype
text
Alias
- UMLS CUI [1,1]
- C1515974
- UMLS CUI [1,2]
- C3845569
Beschrijving
Culture outcome
Datatype
integer
Alias
- UMLS CUI [1,1]
- C2242979
- UMLS CUI [1,2]
- C0587081
Beschrijving
Isolate name
Datatype
text
Alias
- UMLS CUI [1]
- C1764827
Beschrijving
Pathogen Type
Datatype
integer
Alias
- UMLS CUI [1]
- C0450254
Beschrijving
Isolate Classification
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1764827
- UMLS CUI [1,2]
- C0008902
Beschrijving
(mm, Aerobic Pathogens only)
Datatype
text
Alias
- UMLS CUI [1,1]
- C1283010
- UMLS CUI [1,2]
- C0004521
- UMLS CUI [2,1]
- C1283010
- UMLS CUI [2,2]
- C3489748
Beschrijving
Sample sent to Central Lab
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1880016
- UMLS CUI [1,2]
- C0370003
- UMLS CUI [1,3]
- C1515023
Beschrijving
Central Laboratory Accession ID Number
Datatype
text
Alias
- UMLS CUI [1,1]
- C2826726
- UMLS CUI [1,2]
- C1880016
Beschrijving
Not done reason
Datatype
text
Alias
- UMLS CUI [1]
- C2826287
Beschrijving
Backup Sample sent to Central Laboratory
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0370003
- UMLS CUI [1,2]
- C1515023
- UMLS CUI [1,3]
- C1880016
Beschrijving
Central Laboratory Accession ID Number
Datatype
text
Alias
- UMLS CUI [1,1]
- C2826726
- UMLS CUI [1,2]
- C1880016
Beschrijving
Comment
Datatype
text
Alias
- UMLS CUI [1]
- C0947611
Beschrijving
Overdose Report
Alias
- UMLS CUI-1
- C4018909
- UMLS CUI-2
- C0684224
Beschrijving
Overdose Report
Alias
- UMLS CUI-1
- C4018909
- UMLS CUI-2
- C0684224
Beschrijving
Medication overdose
Datatype
integer
Alias
- UMLS CUI [1,1]
- C4018909
- UMLS CUI [1,2]
- C0013227
Beschrijving
Overdose
Datatype
boolean
Alias
- UMLS CUI [1]
- C4018909
Beschrijving
Administration Route
Datatype
integer
Alias
- UMLS CUI [1]
- C0013153
Beschrijving
Administration Route
Datatype
text
Alias
- UMLS CUI [1]
- C0013153
Beschrijving
Total Daily Dose
Datatype
integer
Alias
- UMLS CUI [1]
- C2986497
Beschrijving
Unit used
Datatype
text
Alias
- UMLS CUI [1]
- C1519795
Beschrijving
Date of Overdose
Datatype
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C4018909
Beschrijving
Intentional overdose
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C4018909
- UMLS CUI [1,2]
- C1283828
Beschrijving
Overdose associated with AE
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C4018909
- UMLS CUI [1,2]
- C0877248
Beschrijving
(please fill in an AE-Form)
Datatype
text
Alias
- UMLS CUI [1]
- C2826934
Beschrijving
Reason for Overdose
Datatype
text
Alias
- UMLS CUI [1,1]
- C4018909
- UMLS CUI [1,2]
- C0392360
Beschrijving
Intensive Monitoring Lab Values
Alias
- UMLS CUI-1
- C2346633
Beschrijving
Laboratory procedure
Datatype
integer
Alias
- UMLS CUI [1]
- C0022885
Beschrijving
Specimen collection
Datatype
boolean
Alias
- UMLS CUI [1]
- C0200345
Beschrijving
Not done reason
Datatype
integer
Alias
- UMLS CUI [1]
- C2826287
Beschrijving
Specify other
Datatype
text
Alias
- UMLS CUI [1]
- C3845569
Beschrijving
Laboratory value
Datatype
text
Alias
- UMLS CUI [1]
- C0587081
Beschrijving
Lab Unit
Datatype
integer
Alias
- UMLS CUI [1]
- C1519795
Beschrijving
Other lab unit
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519795
- UMLS CUI [1,2]
- C0205394
Beschrijving
Clinical significance
Datatype
boolean
Alias
- UMLS CUI [1]
- C2826293
Beschrijving
AST (GOT),ALT (GPT),Total Bilirubin
Datatype
text
Alias
- UMLS CUI [1]
- C1519815
Beschrijving
AST (GOT),ALT (GPT),Total Bilirubin
Datatype
text
Alias
- UMLS CUI [1,1]
- C0587081
- UMLS CUI [1,2]
- C0205217
Beschrijving
Potential Hy's Law
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0860207
- UMLS CUI [1,2]
- C0332149
Beschrijving
Notification
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0422202
- UMLS CUI [1,2]
- C0023884
Beschrijving
Laboratory procedures
Alias
- UMLS CUI-1
- C0022885
Beschrijving
Examination performed
Datatype
boolean
Alias
- UMLS CUI [1]
- C0022885
Beschrijving
Not done reason
Datatype
text
Alias
- UMLS CUI [1]
- C2826287
Beschrijving
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.
Datatype
date
Alias
- UMLS CUI [1]
- C1302413
Beschrijving
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.
Datatype
time
Alias
- UMLS CUI [1]
- C4064021
Beschrijving
Creatinine Clearance
Datatype
integer
Maateenheden
- (mL/min)
Alias
- UMLS CUI [1]
- C0373595
Beschrijving
Clinical significance
Datatype
boolean
Alias
- UMLS CUI [1]
- C2826293
Beschrijving
Comment
Datatype
text
Alias
- UMLS CUI [1]
- C0947611
Beschrijving
Liver Diagnostic Assessments
Alias
- UMLS CUI-1
- C0232741
- UMLS CUI-2
- C0022885
Beschrijving
Potential Hy's Law Examination
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0860207
- UMLS CUI [1,2]
- C0332149
- UMLS CUI [1,3]
- C0220825
Beschrijving
Potential Hy's Law Case Number
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0860207
- UMLS CUI [1,2]
- C1698493
- UMLS CUI [1,3]
- C0600091
Beschrijving
Comment
Datatype
text
Alias
- UMLS CUI [1]
- C0947611
Beschrijving
Liver Diagnostic
Alias
- UMLS CUI-1
- C0023884
- UMLS CUI-2
- C0430022
Beschrijving
Liver Diagnostic instrument
Datatype
integer
Alias
- UMLS CUI [1]
- C0193374
Beschrijving
Examination performed
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C2985643
- UMLS CUI [1,2]
- C0430022
Beschrijving
Date of Assessment
Datatype
date
Alias
- UMLS CUI [1]
- C2985720
Beschrijving
Liver Diagnostic Result
Datatype
text
Alias
- UMLS CUI [1,1]
- C0430022
- UMLS CUI [1,2]
- C1274040
Beschrijving
Tox Screening, Other; Serology for Hepatitis,CMV,EBV,autoimmune;other diagnostic investigation
Datatype
text
Alias
- UMLS CUI [1,1]
- C2348235
- UMLS CUI [1,2]
- C1261322
Beschrijving
Liver risk factors
Alias
- UMLS CUI-1
- C0035648
- UMLS CUI-2
- C0023884
Beschrijving
Liver risk factors
Alias
- UMLS CUI-1
- C0035648
- UMLS CUI-2
- C0023884
Beschrijving
Risk factor
Datatype
integer
Alias
- UMLS CUI [1]
- C0035648
Beschrijving
Occurrence
Datatype
boolean
Alias
- UMLS CUI [1]
- C2745955
Beschrijving
Risk Factor Details
Datatype
text
Alias
- UMLS CUI [1,1]
- C0035648
- UMLS CUI [1,2]
- C1522508
Beschrijving
Reference Period
Datatype
integer
Alias
- UMLS CUI [1]
- C1709877
Beschrijving
Start Date
Datatype
date
Alias
- UMLS CUI [1]
- C0808070
Beschrijving
End Date
Datatype
date
Alias
- UMLS CUI [1]
- C0806020
Beschrijving
Comment
Datatype
text
Alias
- UMLS CUI [1]
- C0947611
Beschrijving
Liver signs and symptoms
Alias
- UMLS CUI-1
- C0037088
- UMLS CUI-2
- C0023884
Beschrijving
Liver signs and symptoms
Alias
- UMLS CUI-1
- C0037088
- UMLS CUI-2
- C0023884
Beschrijving
Signs and Symptoms
Datatype
integer
Alias
- UMLS CUI [1]
- C0037088
Beschrijving
Occurrence
Datatype
boolean
Alias
- UMLS CUI [1]
- C2745955
Beschrijving
Start Date
Datatype
date
Alias
- UMLS CUI [1]
- C0808070
Beschrijving
End Date
Datatype
date
Alias
- UMLS CUI [1]
- C0806020
Beschrijving
Intermittent
Datatype
boolean
Alias
- UMLS CUI [1]
- C0205267
Beschrijving
Other Liver Sign or Symptom
Datatype
text
Alias
- UMLS CUI [1,1]
- C0037088
- UMLS CUI [1,2]
- C0205394
Beschrijving
Administrative Information
Alias
- UMLS CUI-1
- C1320722
Beschrijving
Patient Caption
Datatype
text
Alias
- UMLS CUI [1,1]
- C2825231
- UMLS CUI [1,2]
- C0030705
Beschrijving
Visit Number
Datatype
integer
Alias
- UMLS CUI [1]
- C1549755
Beschrijving
Trial name
Datatype
text
Alias
- UMLS CUI [1]
- C1629065
Beschrijving
Visit Name
Datatype
text
Alias
- UMLS CUI [1]
- C2826704
Beschrijving
Visit date
Datatype
date
Alias
- UMLS CUI [1]
- C1320303
Beschrijving
Study site
Datatype
text
Alias
- UMLS CUI [1]
- C2825164
Beschrijving
Electrocardiogram (ECG)
Alias
- UMLS CUI-1
- C0013798
Beschrijving
Examination performed
Datatype
boolean
Alias
- UMLS CUI [1]
- C2826672
Beschrijving
Not done reason
Datatype
text
Alias
- UMLS CUI [1]
- C2826287
Beschrijving
ECG at Day 3
Datatype
boolean
Alias
- UMLS CUI [1]
- C1623258
Beschrijving
Date of ECG
Datatype
date
Alias
- UMLS CUI [1]
- C2826640
Beschrijving
Time of ECG
Datatype
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0013798
Beschrijving
Date of ECG
Datatype
date
Alias
- UMLS CUI [1]
- C2826640
Beschrijving
Time of ECG
Datatype
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0013798
Beschrijving
Comment
Datatype
text
Alias
- UMLS CUI [1]
- C0947611
Beschrijving
Administrative Information
Alias
- UMLS CUI-1
- C1320722
Beschrijving
Patient Caption
Datatype
text
Alias
- UMLS CUI [1,1]
- C2825231
- UMLS CUI [1,2]
- C0030705
Beschrijving
Visit Number
Datatype
integer
Alias
- UMLS CUI [1]
- C1549755
Beschrijving
Trial name
Datatype
text
Alias
- UMLS CUI [1]
- C1629065
Beschrijving
Visit Name
Datatype
text
Alias
- UMLS CUI [1]
- C2826704
Beschrijving
Visit date
Datatype
date
Alias
- UMLS CUI [1]
- C1320303
Beschrijving
Study site
Datatype
text
Alias
- UMLS CUI [1]
- C2825164
Beschrijving
PK sample sent to Central Lab
Alias
- UMLS CUI-1
- C1880016
- UMLS CUI-2
- C0370003
- UMLS CUI-3
- C1515023
Beschrijving
Sampling schedule
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0086960
Beschrijving
Start Date experimental drug
Datatype
date
Alias
- UMLS CUI [1,1]
- C0808070
- UMLS CUI [1,2]
- C0304229
Beschrijving
Start time experimental drug
Datatype
time
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C1301880
Beschrijving
End Date experimental drug
Datatype
date
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0806020
Beschrijving
End time experimental drug
Datatype
time
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C1522314
Beschrijving
Samples sent to Central Lab?
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1880016
- UMLS CUI [1,2]
- C0370003
- UMLS CUI [1,3]
- C1515023
Beschrijving
Not done reason
Datatype
text
Alias
- UMLS CUI [1]
- C2826287
Beschrijving
comment
Datatype
text
Alias
- UMLS CUI [1]
- C0947611
Beschrijving
Pharmakokinetics Sampling at Day 4
Alias
- UMLS CUI-1
- C0005834
- UMLS CUI-2
- C0031327
Beschrijving
Scheduled Sample
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0086960
Beschrijving
Specimen Collection
Datatype
boolean
Alias
- UMLS CUI [1]
- C0200345
Beschrijving
Specimen Condition
Datatype
integer
Alias
- UMLS CUI [1]
- C1547869
Beschrijving
Specimen Condition, Other
Datatype
text
Alias
- UMLS CUI [1,1]
- C1547869
- UMLS CUI [1,2]
- C0205394
Beschrijving
Date of PK collection
Datatype
date
Alias
- UMLS CUI [1]
- C1317250
Beschrijving
Actual Time of PK Collection
Datatype
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0200345
Beschrijving
Sample collection site
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C1515974
Beschrijving
Storing date
Datatype
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0370003
- UMLS CUI [1,3]
- C1698986
Beschrijving
Storing time
Datatype
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0370003
- UMLS CUI [1,3]
- C1698986
Beschrijving
Specimen Identifier
Datatype
text
Alias
- UMLS CUI [1,1]
- C1299222
- UMLS CUI [1,2]
- C0004521
Beschrijving
Specimen Identifier
Datatype
text
Alias
- UMLS CUI [1,1]
- C1299222
- UMLS CUI [1,2]
- C3489748
Beschrijving
Backup Identifier
Datatype
text
Alias
- UMLS CUI [1,1]
- C1552560
- UMLS CUI [1,2]
- C1299222
- UMLS CUI [1,3]
- C0004521
Beschrijving
Backup Identifier
Datatype
text
Alias
- UMLS CUI [1,1]
- C1552560
- UMLS CUI [1,2]
- C1299222
- UMLS CUI [1,3]
- C3489748
Beschrijving
Specimen collection category
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0200345
- UMLS CUI [1,2]
- C0683312
Beschrijving
System
Datatype
integer
Alias
- UMLS CUI [1]
- C0449913
Beschrijving
Biofluid collected
Datatype
integer
Alias
- UMLS CUI [1]
- C0200345
Beschrijving
Biofluid processed
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0370003
- UMLS CUI [1,2]
- C1709694
Beschrijving
Main consent category
Datatype
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])