ID
29207
Description
A Phase IIa prospective, open-label, multicenter study to determine the pharmacokinetics (PK) and safety and tolerability of aztreonam-avibactam (ATM-AVI) for the treatment of complicated Intra-Abdominal Infections (cIAIs) in hospitalized adults. NCT02655419 Sponsors and Collaborators: Pfizer Innovative Medicines Initiative (IMI) COMBACTE-CARE Investigators: Study Director:Pfizer CT.gov Call Center;Pfizer Principal Investigator:Oliver Cornely;Clinical Trials Centre Cologne
Keywords
Versions (2)
- 3/7/18 3/7/18 -
- 9/17/21 9/17/21 -
Copyright Holder
Pfizer
Uploaded on
March 7, 2018
DOI
10.21961/mdm:29207
License
Creative Commons BY-NC 3.0
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REJUVENATE NCT02655419
Treatment 1-3 Visit 3-5
Description
Infection-related Examination
Alias
- UMLS CUI-1
- C3714514
- UMLS CUI-2
- C0031809
Description
Infection related Signs and Symptoms
Alias
- UMLS CUI-1
- C0037088
- UMLS CUI-2
- C3714514
Description
Signs and Symptoms
Data type
integer
Alias
- UMLS CUI [1]
- C0037088
Description
Other Sign or Symptom
Data type
text
Alias
- UMLS CUI [1,1]
- C0037088
- UMLS CUI [1,2]
- C0205394
Description
Clinical Event Intensity
Data type
integer
Alias
- UMLS CUI [1]
- C0518690
Description
Post-Operative Wound Examination
Alias
- UMLS CUI-1
- C2112579
- UMLS CUI-2
- C0886052
Description
Wound Infection
Alias
- UMLS CUI-1
- C0043241
Description
Superficial Infection
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0043241
- UMLS CUI [1,2]
- C0205124
Description
Deep Wound Infection
Data type
boolean
Alias
- UMLS CUI [1]
- C0406103
Description
Wound type
Data type
integer
Alias
- UMLS CUI [1]
- C1276783
Description
other Wound Type
Data type
text
Alias
- UMLS CUI [1,1]
- C1276783
- UMLS CUI [1,2]
- C0205394
Description
Negative Pressure Wound Device
Data type
boolean
Alias
- UMLS CUI [1]
- C1956078
Description
Specimen for Culture
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0430402
- UMLS CUI [1,2]
- C0370003
Description
Signs and Symptoms of Wound Infection
Alias
- UMLS CUI-1
- C0037088
- UMLS CUI-2
- C0043241
Description
Signs and Symptoms
Data type
integer
Alias
- UMLS CUI [1]
- C0037088
Description
Other infection sign
Data type
text
Alias
- UMLS CUI [1,1]
- C0037088
- UMLS CUI [1,2]
- C0205394
Description
Clinical Event Intensity
Data type
integer
Alias
- UMLS CUI [1]
- C0518690
Description
comment
Data type
text
Alias
- UMLS CUI [1]
- C0947611
Description
Comment
Data type
text
Alias
- UMLS CUI [1]
- C0947611
Description
Vital Signs examination
Alias
- UMLS CUI-1
- C0518766
- UMLS CUI-2
- C0031809
Description
Examination performed
Data type
boolean
Alias
- UMLS CUI [1]
- C0031809
Description
Not done reason
Data type
text
Alias
- UMLS CUI [1]
- C2826287
Description
Supine Blood Pressure Systolic
Data type
integer
Measurement units
- mmHg
Alias
- UMLS CUI [1,1]
- C0871470
- UMLS CUI [1,2]
- C0038846
Description
Relevance
Data type
boolean
Alias
- UMLS CUI [1]
- C2347946
Description
Supine Blood Pressure Diastolic
Data type
integer
Measurement units
- mmHg
Alias
- UMLS CUI [1,1]
- C0428883
- UMLS CUI [1,2]
- C0038846
Description
Relevance
Data type
boolean
Alias
- UMLS CUI [1]
- C2347946
Description
Heart rate
Data type
integer
Measurement units
- bpm
Alias
- UMLS CUI [1]
- C0018810
Description
Relevance
Data type
boolean
Alias
- UMLS CUI [1]
- C2347946
Description
Respiratory Rate
Data type
integer
Measurement units
- breaths/min
Alias
- UMLS CUI [1]
- C0231832
Description
Relevance
Data type
boolean
Alias
- UMLS CUI [1]
- C2347946
Description
Comment
Data type
text
Alias
- UMLS CUI [1]
- C0947611
Description
Temperature
Alias
- UMLS CUI-1
- C0005903
Description
Temperature
Data type
float
Measurement units
- °C
Alias
- UMLS CUI [1]
- C0039476
Description
HH:MM
Data type
time
Alias
- UMLS CUI [1,1]
- C0242485
- UMLS CUI [1,2]
- C0040223
Description
Method of Measurement
Data type
integer
Alias
- UMLS CUI [1,1]
- C1299991
- UMLS CUI [1,2]
- C0039476
Description
Other Method
Data type
text
Alias
- UMLS CUI [1,1]
- C1299991
- UMLS CUI [1,2]
- C0205394
Description
Relevance
Data type
boolean
Alias
- UMLS CUI [1]
- C2347946
Description
Temperature measurement
Data type
float
Alias
- UMLS CUI [1]
- C0005903
Description
Unit
Data type
text
Alias
- UMLS CUI [1]
- C1519795
Description
Comment
Data type
text
Alias
- UMLS CUI [1]
- C0947611
Description
Study drug loading dose
Alias
- UMLS CUI-1
- C0304229
- UMLS CUI-2
- C3714444
Description
Start Date of ATM-AVI
Data type
date
Alias
- UMLS CUI [1,1]
- C0004521
- UMLS CUI [1,2]
- C0808070
- UMLS CUI [2,1]
- C3489748
- UMLS CUI [2,2]
- C0808070
Description
End Date of ATM-AVI
Data type
date
Alias
- UMLS CUI [1,1]
- C0004521
- UMLS CUI [1,2]
- C0806020
- UMLS CUI [2,1]
- C3489748
- UMLS CUI [2,2]
- C0806020
Description
End time of ATM-AVI
Data type
time
Alias
- UMLS CUI [1,1]
- C0004521
- UMLS CUI [1,2]
- C1522314
- UMLS CUI [2,1]
- C3489748
- UMLS CUI [2,2]
- C1522314
Description
Infusion Rate (mL/min)
Data type
integer
Alias
- UMLS CUI [1]
- C2964135
Description
Route of Study Drug Administration
Data type
integer
Alias
- UMLS CUI [1,1]
- C0013153
- UMLS CUI [1,2]
- C0304229
Description
Comment on Administration
Data type
text
Alias
- UMLS CUI [1]
- C0947611
Description
Study drug administration ATM-AVI
Alias
- UMLS CUI-1
- C0304229
- UMLS CUI-2
- C3469597
- UMLS CUI-3
- C0004521
- UMLS CUI-4
- C3489748
Description
Infusion out of range referring to loading dose
Data type
text
Alias
- UMLS CUI [1,1]
- C3845292
- UMLS CUI [1,2]
- C0574032
- UMLS CUI [1,3]
- C0205543
- UMLS CUI [1,4]
- C3714444
Description
Start Date of ATM-AVI
Data type
date
Alias
- UMLS CUI [1,1]
- C0004521
- UMLS CUI [1,2]
- C0808070
- UMLS CUI [2,1]
- C3489748
- UMLS CUI [2,2]
- C0808070
Description
Start time of ATM-AVI
Data type
time
Alias
- UMLS CUI [1,1]
- C0004521
- UMLS CUI [1,2]
- C1301880
- UMLS CUI [2,1]
- C3489748
- UMLS CUI [2,2]
- C1301880
Description
End Date of ATM-AVI
Data type
date
Alias
- UMLS CUI [1,1]
- C0004521
- UMLS CUI [1,2]
- C0806020
- UMLS CUI [2,1]
- C3489748
- UMLS CUI [2,2]
- C0806020
Description
End time of ATM-AVI
Data type
time
Alias
- UMLS CUI [1,1]
- C0004521
- UMLS CUI [1,2]
- C1522314
- UMLS CUI [2,1]
- C3489748
- UMLS CUI [2,2]
- C1522314
Description
ATM Dose (mg) to be given per protocol
Data type
integer
Alias
- UMLS CUI [1,1]
- C0040808
- UMLS CUI [1,2]
- C0178602
- UMLS CUI [1,3]
- C0004521
Description
AVI Dose (mg) to be given per protocol
Data type
integer
Alias
- UMLS CUI [1,1]
- C0040808
- UMLS CUI [1,2]
- C0178602
- UMLS CUI [1,3]
- C3489748
Description
ATM Batch No.
Data type
text
Alias
- UMLS CUI [1,1]
- C0004521
- UMLS CUI [1,2]
- C3641829
Description
AVI Batch No.
Data type
text
Alias
- UMLS CUI [1,1]
- C3489748
- UMLS CUI [1,2]
- C3641829
Description
Start Volume
Data type
integer
Alias
- UMLS CUI [1,1]
- C0574032
- UMLS CUI [1,2]
- C2700258
Description
End Volume
Data type
integer
Alias
- UMLS CUI [1,1]
- C0574032
- UMLS CUI [1,2]
- C2700258
Description
Infusion Rate (mL/min)
Data type
integer
Alias
- UMLS CUI [1]
- C2964135
Description
Route of Study Drug Administration
Data type
integer
Alias
- UMLS CUI [1,1]
- C0013153
- UMLS CUI [1,2]
- C0304229
Description
Comment on Administration
Data type
text
Alias
- UMLS CUI [1]
- C0947611
Description
Study drug administration Metronidazole
Alias
- UMLS CUI-1
- C0304229
- UMLS CUI-2
- C3469597
- UMLS CUI-3
- C0025872
Description
Infusion out of range referring to loading dose
Data type
text
Alias
- UMLS CUI [1,1]
- C3845292
- UMLS CUI [1,2]
- C0574032
- UMLS CUI [1,3]
- C0205543
- UMLS CUI [1,4]
- C3714444
Description
Start Date of Metronidazole
Data type
date
Alias
- UMLS CUI [1,1]
- C0025872
- UMLS CUI [1,2]
- C0808070
Description
Start time of Metronidazole
Data type
time
Alias
- UMLS CUI [1,1]
- C0025872
- UMLS CUI [1,2]
- C1301880
Description
End Date of Metronidazole
Data type
date
Alias
- UMLS CUI [1,1]
- C0025872
- UMLS CUI [1,2]
- C0806020
Description
End time of Metronidazole
Data type
time
Alias
- UMLS CUI [1,1]
- C0025872
- UMLS CUI [1,2]
- C1522314
Description
Metronidazole Dose (mg) to be given per protocol
Data type
integer
Alias
- UMLS CUI [1,1]
- C0040808
- UMLS CUI [1,2]
- C0178602
- UMLS CUI [1,3]
- C0025872
Description
Metronidazole Batch No.
Data type
text
Alias
- UMLS CUI [1,1]
- C0025872
- UMLS CUI [1,2]
- C3641829
Description
Start Volume
Data type
integer
Alias
- UMLS CUI [1,1]
- C0574032
- UMLS CUI [1,2]
- C2700258
Description
End Volume
Data type
integer
Alias
- UMLS CUI [1,1]
- C0574032
- UMLS CUI [1,2]
- C2700258
Description
Infusion Rate (mL/min)
Data type
integer
Alias
- UMLS CUI [1]
- C2964135
Description
Comment on Administration
Data type
text
Alias
- UMLS CUI [1]
- C0947611
Description
Surgical Procedure
Alias
- UMLS CUI-1
- C0543467
Description
Surgery performed
Data type
boolean
Alias
- UMLS CUI [1]
- C0543467
Description
Surgery time
Data type
integer
Alias
- UMLS CUI [1,1]
- C0683312
- UMLS CUI [1,2]
- C0543467
Description
Surgical Procedure
Data type
integer
Alias
- UMLS CUI [1]
- C0543467
Description
Other procedure
Data type
text
Alias
- UMLS CUI [1]
- C0543467
Description
Start Date (incision)
Data type
date
Alias
- UMLS CUI [1,1]
- C0808070
- UMLS CUI [1,2]
- C0184898
Description
Start Time (incision)
Data type
time
Alias
- UMLS CUI [1,1]
- C1301880
- UMLS CUI [1,2]
- C0184898
Description
End Date (suture)
Data type
date
Alias
- UMLS CUI [1,1]
- C0806020
- UMLS CUI [1,2]
- C0038969
Description
End Time (suture)
Data type
time
Alias
- UMLS CUI [1,1]
- C1522314
- UMLS CUI [1,2]
- C0038969
Description
Reason for Procedure
Data type
integer
Alias
- UMLS CUI [1]
- C3258099
Description
Other reason
Data type
text
Alias
- UMLS CUI [1]
- C3840932
Description
Comment
Data type
text
Alias
- UMLS CUI [1]
- C0947611
Description
Description of Findings
Alias
- UMLS CUI-1
- C0678257
- UMLS CUI-2
- C0243095
Description
Microbiology
Alias
- UMLS CUI-1
- C0085672
Description
Microbiology specimen collection
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0200345
- UMLS CUI [1,2]
- C0025952
Description
Not done reason
Data type
integer
Alias
- UMLS CUI [1]
- C2826287
Description
inability
Data type
text
Alias
- UMLS CUI [1,1]
- C1299582
- UMLS CUI [1,2]
- C0200345
- UMLS CUI [1,3]
- C1521902
Description
inability
Data type
text
Alias
- UMLS CUI [1,1]
- C1299582
- UMLS CUI [1,2]
- C0200345
- UMLS CUI [1,3]
- C3845569
Description
Specimen collection date
Data type
date
Alias
- UMLS CUI [1]
- C1302413
Description
Specimen collection time
Data type
time
Alias
- UMLS CUI [1]
- C4064021
Description
Culture Processing Type
Data type
integer
Alias
- UMLS CUI [1,1]
- C0200949
- UMLS CUI [1,2]
- C0037793
- UMLS CUI [1,3]
- C0332307
Description
Specimen collection site
Data type
integer
Alias
- UMLS CUI [1,1]
- C0200345
- UMLS CUI [1,2]
- C1515974
Description
Intra-Abdominal, please specify
Data type
integer
Alias
- UMLS CUI [1,1]
- C1512910
- UMLS CUI [1,2]
- C1521902
Description
Other site, please specify
Data type
text
Alias
- UMLS CUI [1,1]
- C1515974
- UMLS CUI [1,2]
- C3845569
Description
Culture outcome
Data type
integer
Alias
- UMLS CUI [1,1]
- C2242979
- UMLS CUI [1,2]
- C0587081
Description
Isolate name
Data type
text
Alias
- UMLS CUI [1]
- C1764827
Description
Pathogen Type
Data type
integer
Alias
- UMLS CUI [1]
- C0450254
Description
Isolate Classification
Data type
integer
Alias
- UMLS CUI [1,1]
- C1764827
- UMLS CUI [1,2]
- C0008902
Description
(mm, Aerobic Pathogens only)
Data type
text
Alias
- UMLS CUI [1,1]
- C1283010
- UMLS CUI [1,2]
- C0004521
- UMLS CUI [2,1]
- C1283010
- UMLS CUI [2,2]
- C3489748
Description
Sample sent to Central Lab
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1880016
- UMLS CUI [1,2]
- C0370003
- UMLS CUI [1,3]
- C1515023
Description
Central Laboratory Accession ID Number
Data type
text
Alias
- UMLS CUI [1,1]
- C2826726
- UMLS CUI [1,2]
- C1880016
Description
Not done reason
Data type
text
Alias
- UMLS CUI [1]
- C2826287
Description
Backup Sample sent to Central Laboratory
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0370003
- UMLS CUI [1,2]
- C1515023
- UMLS CUI [1,3]
- C1880016
Description
Central Laboratory Accession ID Number
Data type
text
Alias
- UMLS CUI [1,1]
- C2826726
- UMLS CUI [1,2]
- C1880016
Description
Comment
Data type
text
Alias
- UMLS CUI [1]
- C0947611
Description
Overdose Report
Alias
- UMLS CUI-1
- C4018909
- UMLS CUI-2
- C0684224
Description
Overdose Report
Alias
- UMLS CUI-1
- C4018909
- UMLS CUI-2
- C0684224
Description
Medication overdose
Data type
integer
Alias
- UMLS CUI [1,1]
- C4018909
- UMLS CUI [1,2]
- C0013227
Description
Overdose
Data type
boolean
Alias
- UMLS CUI [1]
- C4018909
Description
Administration Route
Data type
integer
Alias
- UMLS CUI [1]
- C0013153
Description
Administration Route
Data type
text
Alias
- UMLS CUI [1]
- C0013153
Description
Total Daily Dose
Data type
integer
Alias
- UMLS CUI [1]
- C2986497
Description
Unit used
Data type
text
Alias
- UMLS CUI [1]
- C1519795
Description
Date of Overdose
Data type
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C4018909
Description
Intentional overdose
Data type
boolean
Alias
- UMLS CUI [1,1]
- C4018909
- UMLS CUI [1,2]
- C1283828
Description
Overdose associated with AE
Data type
boolean
Alias
- UMLS CUI [1,1]
- C4018909
- UMLS CUI [1,2]
- C0877248
Description
(please fill in an AE-Form)
Data type
text
Alias
- UMLS CUI [1]
- C2826934
Description
Reason for Overdose
Data type
text
Alias
- UMLS CUI [1,1]
- C4018909
- UMLS CUI [1,2]
- C0392360
Description
Intensive Monitoring Lab Values
Alias
- UMLS CUI-1
- C2346633
Description
Laboratory procedure
Data type
integer
Alias
- UMLS CUI [1]
- C0022885
Description
Specimen collection
Data type
boolean
Alias
- UMLS CUI [1]
- C0200345
Description
Not done reason
Data type
integer
Alias
- UMLS CUI [1]
- C2826287
Description
Specify other
Data type
text
Alias
- UMLS CUI [1]
- C3845569
Description
Laboratory value
Data type
text
Alias
- UMLS CUI [1]
- C0587081
Description
Lab Unit
Data type
integer
Alias
- UMLS CUI [1]
- C1519795
Description
Other lab unit
Data type
text
Alias
- UMLS CUI [1,1]
- C1519795
- UMLS CUI [1,2]
- C0205394
Description
Clinical significance
Data type
boolean
Alias
- UMLS CUI [1]
- C2826293
Description
AST (GOT),ALT (GPT),Total Bilirubin
Data type
text
Alias
- UMLS CUI [1]
- C1519815
Description
AST (GOT),ALT (GPT),Total Bilirubin
Data type
text
Alias
- UMLS CUI [1,1]
- C0587081
- UMLS CUI [1,2]
- C0205217
Description
Potential Hy's Law
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0860207
- UMLS CUI [1,2]
- C0332149
Description
Notification
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0422202
- UMLS CUI [1,2]
- C0023884
Description
Laboratory procedures
Alias
- UMLS CUI-1
- C0022885
Description
Examination performed
Data type
boolean
Alias
- UMLS CUI [1]
- C0022885
Description
Not done reason
Data type
text
Alias
- UMLS CUI [1]
- C2826287
Description
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.
Data type
date
Alias
- UMLS CUI [1]
- C1302413
Description
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.
Data type
time
Alias
- UMLS CUI [1]
- C4064021
Description
Creatinine Clearance
Data type
integer
Measurement units
- (mL/min)
Alias
- UMLS CUI [1]
- C0373595
Description
Clinical significance
Data type
boolean
Alias
- UMLS CUI [1]
- C2826293
Description
Comment
Data type
text
Alias
- UMLS CUI [1]
- C0947611
Description
Liver Diagnostic Assessments
Alias
- UMLS CUI-1
- C0232741
- UMLS CUI-2
- C0022885
Description
Potential Hy's Law Examination
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0860207
- UMLS CUI [1,2]
- C0332149
- UMLS CUI [1,3]
- C0220825
Description
Potential Hy's Law Case Number
Data type
integer
Alias
- UMLS CUI [1,1]
- C0860207
- UMLS CUI [1,2]
- C1698493
- UMLS CUI [1,3]
- C0600091
Description
Comment
Data type
text
Alias
- UMLS CUI [1]
- C0947611
Description
Liver Diagnostic
Alias
- UMLS CUI-1
- C0023884
- UMLS CUI-2
- C0430022
Description
Liver Diagnostic instrument
Data type
integer
Alias
- UMLS CUI [1]
- C0193374
Description
Examination performed
Data type
boolean
Alias
- UMLS CUI [1,1]
- C2985643
- UMLS CUI [1,2]
- C0430022
Description
Date of Assessment
Data type
date
Alias
- UMLS CUI [1]
- C2985720
Description
Liver Diagnostic Result
Data type
text
Alias
- UMLS CUI [1,1]
- C0430022
- UMLS CUI [1,2]
- C1274040
Description
Tox Screening, Other; Serology for Hepatitis,CMV,EBV,autoimmune;other diagnostic investigation
Data type
text
Alias
- UMLS CUI [1,1]
- C2348235
- UMLS CUI [1,2]
- C1261322
Description
Liver risk factors
Alias
- UMLS CUI-1
- C0035648
- UMLS CUI-2
- C0023884
Description
Liver risk factors
Alias
- UMLS CUI-1
- C0035648
- UMLS CUI-2
- C0023884
Description
Risk factor
Data type
integer
Alias
- UMLS CUI [1]
- C0035648
Description
Occurrence
Data type
boolean
Alias
- UMLS CUI [1]
- C2745955
Description
Risk Factor Details
Data type
text
Alias
- UMLS CUI [1,1]
- C0035648
- UMLS CUI [1,2]
- C1522508
Description
Reference Period
Data type
integer
Alias
- UMLS CUI [1]
- C1709877
Description
Start Date
Data type
date
Alias
- UMLS CUI [1]
- C0808070
Description
End Date
Data type
date
Alias
- UMLS CUI [1]
- C0806020
Description
Comment
Data type
text
Alias
- UMLS CUI [1]
- C0947611
Description
Liver signs and symptoms
Alias
- UMLS CUI-1
- C0037088
- UMLS CUI-2
- C0023884
Description
Liver signs and symptoms
Alias
- UMLS CUI-1
- C0037088
- UMLS CUI-2
- C0023884
Description
Signs and Symptoms
Data type
integer
Alias
- UMLS CUI [1]
- C0037088
Description
Occurrence
Data type
boolean
Alias
- UMLS CUI [1]
- C2745955
Description
Start Date
Data type
date
Alias
- UMLS CUI [1]
- C0808070
Description
End Date
Data type
date
Alias
- UMLS CUI [1]
- C0806020
Description
Intermittent
Data type
boolean
Alias
- UMLS CUI [1]
- C0205267
Description
Other Liver Sign or Symptom
Data type
text
Alias
- UMLS CUI [1,1]
- C0037088
- UMLS CUI [1,2]
- C0205394
Description
Administrative Information
Alias
- UMLS CUI-1
- C1320722
Description
Patient Caption
Data type
text
Alias
- UMLS CUI [1,1]
- C2825231
- UMLS CUI [1,2]
- C0030705
Description
Visit Number
Data type
integer
Alias
- UMLS CUI [1]
- C1549755
Description
Trial name
Data type
text
Alias
- UMLS CUI [1]
- C1629065
Description
Visit Name
Data type
text
Alias
- UMLS CUI [1]
- C2826704
Description
Visit date
Data type
date
Alias
- UMLS CUI [1]
- C1320303
Description
Study site
Data type
text
Alias
- UMLS CUI [1]
- C2825164
Description
Electrocardiogram (ECG)
Alias
- UMLS CUI-1
- C0013798
Description
Examination performed
Data type
boolean
Alias
- UMLS CUI [1]
- C2826672
Description
Not done reason
Data type
text
Alias
- UMLS CUI [1]
- C2826287
Description
ECG at Day 3
Data type
boolean
Alias
- UMLS CUI [1]
- C1623258
Description
Date of ECG
Data type
date
Alias
- UMLS CUI [1]
- C2826640
Description
Time of ECG
Data type
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0013798
Description
Date of ECG
Data type
date
Alias
- UMLS CUI [1]
- C2826640
Description
Time of ECG
Data type
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0013798
Description
Comment
Data type
text
Alias
- UMLS CUI [1]
- C0947611
Description
Administrative Information
Alias
- UMLS CUI-1
- C1320722
Description
Patient Caption
Data type
text
Alias
- UMLS CUI [1,1]
- C2825231
- UMLS CUI [1,2]
- C0030705
Description
Visit Number
Data type
integer
Alias
- UMLS CUI [1]
- C1549755
Description
Trial name
Data type
text
Alias
- UMLS CUI [1]
- C1629065
Description
Visit Name
Data type
text
Alias
- UMLS CUI [1]
- C2826704
Description
Visit date
Data type
date
Alias
- UMLS CUI [1]
- C1320303
Description
Study site
Data type
text
Alias
- UMLS CUI [1]
- C2825164
Description
PK sample sent to Central Lab
Alias
- UMLS CUI-1
- C1880016
- UMLS CUI-2
- C0370003
- UMLS CUI-3
- C1515023
Description
Sampling schedule
Data type
integer
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0086960
Description
Start Date experimental drug
Data type
date
Alias
- UMLS CUI [1,1]
- C0808070
- UMLS CUI [1,2]
- C0304229
Description
Start time experimental drug
Data type
time
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C1301880
Description
End Date experimental drug
Data type
date
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0806020
Description
End time experimental drug
Data type
time
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C1522314
Description
Samples sent to Central Lab?
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1880016
- UMLS CUI [1,2]
- C0370003
- UMLS CUI [1,3]
- C1515023
Description
Not done reason
Data type
text
Alias
- UMLS CUI [1]
- C2826287
Description
comment
Data type
text
Alias
- UMLS CUI [1]
- C0947611
Description
Pharmakokinetics Sampling at Day 4
Alias
- UMLS CUI-1
- C0005834
- UMLS CUI-2
- C0031327
Description
Scheduled Sample
Data type
integer
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0086960
Description
Specimen Collection
Data type
boolean
Alias
- UMLS CUI [1]
- C0200345
Description
Specimen Condition
Data type
integer
Alias
- UMLS CUI [1]
- C1547869
Description
Specimen Condition, Other
Data type
text
Alias
- UMLS CUI [1,1]
- C1547869
- UMLS CUI [1,2]
- C0205394
Description
Date of PK collection
Data type
date
Alias
- UMLS CUI [1]
- C1317250
Description
Actual Time of PK Collection
Data type
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0200345
Description
Sample collection site
Data type
integer
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C1515974
Description
Storing date
Data type
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0370003
- UMLS CUI [1,3]
- C1698986
Description
Storing time
Data type
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0370003
- UMLS CUI [1,3]
- C1698986
Description
Specimen Identifier
Data type
text
Alias
- UMLS CUI [1,1]
- C1299222
- UMLS CUI [1,2]
- C0004521
Description
Specimen Identifier
Data type
text
Alias
- UMLS CUI [1,1]
- C1299222
- UMLS CUI [1,2]
- C3489748
Description
Backup Identifier
Data type
text
Alias
- UMLS CUI [1,1]
- C1552560
- UMLS CUI [1,2]
- C1299222
- UMLS CUI [1,3]
- C0004521
Description
Backup Identifier
Data type
text
Alias
- UMLS CUI [1,1]
- C1552560
- UMLS CUI [1,2]
- C1299222
- UMLS CUI [1,3]
- C3489748
Description
Specimen collection category
Data type
integer
Alias
- UMLS CUI [1,1]
- C0200345
- UMLS CUI [1,2]
- C0683312
Description
System
Data type
integer
Alias
- UMLS CUI [1]
- C0449913
Description
Biofluid collected
Data type
integer
Alias
- UMLS CUI [1]
- C0200345
Description
Biofluid processed
Data type
integer
Alias
- UMLS CUI [1,1]
- C0370003
- UMLS CUI [1,2]
- C1709694
Description
Main consent category
Data type
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])