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
Cumulative
Description
Adverse Event
Alias
- UMLS CUI-1
- C0877248
Description
Adverse event number
Data type
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C2349022
Description
main diagnosis, if possible
Data type
text
Alias
- UMLS CUI [1]
- C2826934
Description
AE Start date
Data type
date
Alias
- UMLS CUI [1]
- C2697888
Description
AE Start Time
Data type
time
Alias
- UMLS CUI [1,1]
- C1301880
- UMLS CUI [1,2]
- C0877248
Description
AE End date
Data type
date
Alias
- UMLS CUI [1]
- C2697886
Description
AE End Time
Data type
time
Alias
- UMLS CUI [1,1]
- C1522314
- UMLS CUI [1,2]
- C0877248
Description
AE ongoing
Data type
boolean
Alias
- UMLS CUI [1]
- C2826663
Description
AE intensity
Data type
integer
Alias
- UMLS CUI [1]
- C1710066
Description
Relationship to ATM / AVI
Data type
integer
Alias
- UMLS CUI [1,1]
- C0085978
- UMLS CUI [1,2]
- C0877248
- UMLS CUI [1,3]
- C0004521
- UMLS CUI [2,1]
- C0085978
- UMLS CUI [2,2]
- C0877248
- UMLS CUI [2,3]
- C3489748
Description
Treatment required?
Data type
boolean
Alias
- UMLS CUI [1,1]
- C2981656
- UMLS CUI [1,2]
- C1514873
Description
Treatment type
Data type
integer
Alias
- UMLS CUI [1,1]
- C0087111
- UMLS CUI [1,2]
- C0332307
Description
Action taken with drug
Data type
integer
Alias
- UMLS CUI [1]
- C1704758
Description
Event related to Metronidazole
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0025872
- UMLS CUI [1,2]
- C0085978
Description
Study Procedure causations
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0008976
- UMLS CUI [1,2]
- C0184661
- UMLS CUI [1,3]
- C0085978
Description
Specify Procedure
Data type
text
Alias
- UMLS CUI [1,1]
- C0008976
- UMLS CUI [1,2]
- C0184661
- UMLS CUI [1,3]
- C1521902
Description
Withdrawal from Study
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C0085978
Description
Event outcome
Data type
integer
Alias
- UMLS CUI [1]
- C1705586
Description
Serious Adverse Event (SAE)
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0684224
Description
Seriousness
Data type
boolean
Alias
- UMLS CUI [1]
- C1710056
Description
SAE Number
Data type
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2349022
Description
Start date SAE
Data type
date
Alias
- UMLS CUI [1,1]
- C2697888
- UMLS CUI [1,2]
- C1519255
Description
Start time SAE
Data type
time
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1301880
Description
Date Investigator became aware of serious AE
Data type
date
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0008961
- UMLS CUI [1,3]
- C0004448
- UMLS CUI [1,4]
- C0011008
Description
End date of SAE
Data type
date
Alias
- UMLS CUI [1,1]
- C0806020
- UMLS CUI [1,2]
- C1519255
Description
End Time Serious Adverse Event
Data type
time
Alias
- UMLS CUI [1,1]
- C2826658
- UMLS CUI [1,2]
- C1519255
Description
Outcome
Data type
integer
Alias
- UMLS CUI [1,1]
- C1705586
- UMLS CUI [1,2]
- C1519255
Description
Divergent Followup SAE Diagnosis
Data type
text
Alias
- UMLS CUI [1,1]
- C0443204
- UMLS CUI [1,2]
- C1519255
- UMLS CUI [1,3]
- C0011900
Description
Notification
Data type
text
Alias
- UMLS CUI [1]
- C0422202
Description
indicate all that apply
Data type
integer
Alias
- UMLS CUI [1,1]
- C0871902
- UMLS CUI [1,2]
- C0392360
Description
SAE description
Data type
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0678257
Description
MedDRA-Coding
Data type
text
Alias
- UMLS CUI [1,1]
- C1511731
- UMLS CUI [1,2]
- C0877248
- UMLS CUI [1,3]
- C0011900
Description
MedDRA-Coding
Data type
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0011900
Description
comment
Data type
text
Alias
- UMLS CUI [1]
- C0947611
Description
Prior and Concomitant Other Medication
Alias
- UMLS CUI-1
- C2826257
- UMLS CUI-2
- C2347852
Description
within the last two weeks before study
Data type
boolean
Alias
- UMLS CUI [1,1]
- C2826257
- UMLS CUI [1,2]
- C2347852
Description
Sequence number
Data type
integer
Alias
- UMLS CUI [1]
- C2348184
Description
Generic Name
Data type
text
Alias
- UMLS CUI [1]
- C0013227
Description
Indication
Data type
integer
Alias
- UMLS CUI [1,1]
- C3146298
- UMLS CUI [1,2]
- C0013227
Description
Referring Adverse Event Number
Data type
integer
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0205543
- UMLS CUI [1,3]
- C2349022
Description
Line number Medical History Form
Data type
integer
Alias
- UMLS CUI [1,1]
- C0025102
- UMLS CUI [1,2]
- C2348184
Description
Total daily dose
Data type
integer
Alias
- UMLS CUI [1,1]
- C2348070
- UMLS CUI [1,2]
- C1511559
Description
Unit
Data type
text
Alias
- UMLS CUI [1]
- C0439148
Description
Administration Route
Data type
integer
Alias
- UMLS CUI [1]
- C0013153
Description
Other Administration route
Data type
text
Alias
- UMLS CUI [1,1]
- C0013153
- UMLS CUI [1,2]
- C0205394
Description
Start Date
Data type
date
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0808070
Description
Start date unknown
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0808070
- UMLS CUI [1,2]
- C0439673
Description
End Date
Data type
date
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0806020
Description
ongoing
Data type
boolean
Alias
- UMLS CUI [1]
- C0549178
Description
comment
Data type
text
Alias
- UMLS CUI [1]
- C0947611
Description
Prior and Concomitant Antibiotic Medication
Alias
- UMLS CUI-1
- C2826257
- UMLS CUI-2
- C2347852
- UMLS CUI-3
- C0003232
Description
within the last two weeks before study
Data type
boolean
Alias
- UMLS CUI [1,1]
- C2826257
- UMLS CUI [1,2]
- C2347852
Description
Sequence number
Data type
integer
Alias
- UMLS CUI [1]
- C2348184
Description
Generic Name
Data type
text
Alias
- UMLS CUI [1]
- C0013227
Description
Indication
Data type
integer
Alias
- UMLS CUI [1,1]
- C3146298
- UMLS CUI [1,2]
- C0013227
Description
Referring Adverse Event Number
Data type
integer
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0205543
- UMLS CUI [1,3]
- C2349022
Description
Line number Medical History Form
Data type
integer
Alias
- UMLS CUI [1,1]
- C0025102
- UMLS CUI [1,2]
- C2348184
Description
Total daily dose
Data type
integer
Alias
- UMLS CUI [1,1]
- C2348070
- UMLS CUI [1,2]
- C1511559
Description
Unit
Data type
text
Alias
- UMLS CUI [1]
- C0439148
Description
Administration Route
Data type
integer
Alias
- UMLS CUI [1]
- C0013153
Description
other Administration Route
Data type
text
Alias
- UMLS CUI [1,1]
- C0013153
- UMLS CUI [1,2]
- C0205394
Description
Start Date
Data type
date
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0808070
Description
Start date unknown
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0808070
- UMLS CUI [1,2]
- C0439673
Description
End Date
Data type
date
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0806020
Description
ongoing
Data type
boolean
Alias
- UMLS CUI [1]
- C0549178
Description
comment
Data type
text
Alias
- UMLS CUI [1]
- C0947611
Description
Study Drug Discontinuation
Alias
- UMLS CUI-1
- C0457454
- UMLS CUI-2
- C0304229
Description
Study Drug Discontinued
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0457454
- UMLS CUI [1,2]
- C0304229
Description
Date of Discontinuation
Data type
date
Alias
- UMLS CUI [1,1]
- C0457454
- UMLS CUI [1,2]
- C0011008
Description
Time of Discontinuation
Data type
time
Alias
- UMLS CUI [1,1]
- C0457454
- UMLS CUI [1,2]
- C0040223
Description
Reason for Discontinuation
Data type
integer
Alias
- UMLS CUI [1,1]
- C0392360
- UMLS CUI [1,2]
- C0457454
Description
Other Reason for Discontinuation
Data type
text
Alias
- UMLS CUI [1,1]
- C0457454
- UMLS CUI [1,2]
- C3840932
Description
comment
Data type
text
Alias
- UMLS CUI [1]
- C0947611
Description
Completion / Withdrawal from Study
Alias
- UMLS CUI-1
- C2349954
- UMLS CUI-2
- C2826674
Description
Date of completion/withdrawal from study
Data type
date
Alias
- UMLS CUI [1,1]
- C2348577
- UMLS CUI [1,2]
- C0011008
- UMLS CUI [2,1]
- C0422727
- UMLS CUI [2,2]
- C0011008
Description
Was Subject prematurely withdrawn from Study?
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C1279919
Description
Main reason for premature withdrawal
Data type
integer
Alias
- UMLS CUI [1,1]
- C2349954
- UMLS CUI [1,2]
- C0392360
- UMLS CUI [1,3]
- C1279919
Description
Other reason for discontinuation
Data type
text
Alias
- UMLS CUI [1,1]
- C0457454
- UMLS CUI [1,2]
- C0392360
- UMLS CUI [1,3]
- C3840932
Description
in case of premature withdrawal
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0200345
- UMLS CUI [1,2]
- C0085672
- UMLS CUI [1,3]
- C2709088
Description
comment
Data type
text
Alias
- UMLS CUI [1]
- C0947611
Description
Death Report
Alias
- UMLS CUI-1
- C0011065
- UMLS CUI-2
- C1516308
Description
Patient died during study?
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1546956
- UMLS CUI [1,2]
- C0008976
- UMLS CUI [1,3]
- C0347984
Description
Date of Death
Data type
date
Alias
- UMLS CUI [1]
- C1148348
Description
Autopsy performed?
Data type
boolean
Alias
- UMLS CUI [1]
- C3656695
Description
Causation with investigated disease
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0085978
- UMLS CUI [1,2]
- C4316939
Description
Primary Cause of Death
Data type
text
Alias
- UMLS CUI [1]
- C3262229
Description
Cause of Death Narrative
Data type
text
Alias
- UMLS CUI [1,1]
- C0007465
- UMLS CUI [1,2]
- C1521902
Description
Secondary Cause of Death
Data type
text
Alias
- UMLS CUI [1]
- C3262233
Description
Cause of Death Narrative
Data type
text
Alias
- UMLS CUI [1,1]
- C0007465
- UMLS CUI [1,2]
- C1521902
Description
comment
Data type
text
Alias
- UMLS CUI [1]
- C0947611
Description
Pregnancy Report
Alias
- UMLS CUI-1
- C0032961
- UMLS CUI-2
- C0684224
Description
Pregnancy occured during study?
Data type
boolean
Alias
- UMLS CUI [1]
- C3828490
Description
Last Menstruation date
Data type
date
Alias
- UMLS CUI [1,1]
- C0025344
- UMLS CUI [1,2]
- C0808070
Description
Expected Date of Birth
Data type
date
Alias
- UMLS CUI [1]
- C2825543
Description
Contraceptive method
Data type
integer
Alias
- UMLS CUI [1]
- C0700589
Description
Other contraceptive method
Data type
text
Alias
- UMLS CUI [1,1]
- C0700589
- UMLS CUI [1,2]
- C0205394
Description
Number of Previous Pregnancies
Data type
integer
Alias
- UMLS CUI [1]
- C0422807
Description
Number of Births
Data type
integer
Alias
- UMLS CUI [1]
- C3172256
Description
Number of Spontaneous Miscarriages
Data type
integer
Alias
- UMLS CUI [1,1]
- C0429916
- UMLS CUI [1,2]
- C0205359
Description
Number of Others
Data type
integer
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C0449788
Description
Specify other
Data type
text
Alias
- UMLS CUI [1]
- C3845569
Description
comment
Data type
text
Alias
- UMLS CUI [1]
- C0947611
Similar models
Cumulative
C0030705 (UMLS CUI [1,2])
C2349022 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,2])
C0004521 (UMLS CUI [1,3])
C0085978 (UMLS CUI [2,1])
C0877248 (UMLS CUI [2,2])
C3489748 (UMLS CUI [2,3])
C1514873 (UMLS CUI [1,2])
C0085978 (UMLS CUI [1,2])
C0184661 (UMLS CUI [1,2])
C0085978 (UMLS CUI [1,3])
C0184661 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C0085978 (UMLS CUI [1,2])
C2349022 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,2])
C0008961 (UMLS CUI [1,2])
C0004448 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,3])
C0392360 (UMLS CUI [1,2])
C0678257 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,3])
C0011900 (UMLS CUI [1,2])
C2347852 (UMLS CUI-2)
C2347852 (UMLS CUI [1,2])
C0205543 (UMLS CUI [1,2])
C2349022 (UMLS CUI [1,3])
C2348184 (UMLS CUI [1,2])
C1511559 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
C0439673 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
C2347852 (UMLS CUI-2)
C0003232 (UMLS CUI-3)
C2347852 (UMLS CUI [1,2])
C0205543 (UMLS CUI [1,2])
C2349022 (UMLS CUI [1,3])
C2348184 (UMLS CUI [1,2])
C1511559 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
C0439673 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
C0304229 (UMLS CUI-2)
C0304229 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
C0457454 (UMLS CUI [1,2])
C3840932 (UMLS CUI [1,2])
C2826674 (UMLS CUI-2)
C0011008 (UMLS CUI [1,2])
C0422727 (UMLS CUI [2,1])
C0011008 (UMLS CUI [2,2])
C1279919 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,2])
C1279919 (UMLS CUI [1,3])
C0392360 (UMLS CUI [1,2])
C3840932 (UMLS CUI [1,3])
C0085672 (UMLS CUI [1,2])
C2709088 (UMLS CUI [1,3])
C0008976 (UMLS CUI [1,2])
C0347984 (UMLS CUI [1,3])
C4316939 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
C0205359 (UMLS CUI [1,2])
C0449788 (UMLS CUI [1,2])