ID
29207
Beskrivning
A Phase IIa prospective, open-label, multicenter study to determine the pharmacokinetics (PK) and safety and tolerability of aztreonam-avibactam (ATM-AVI) for the treatment of complicated Intra-Abdominal Infections (cIAIs) in hospitalized adults. NCT02655419 Sponsors and Collaborators: Pfizer Innovative Medicines Initiative (IMI) COMBACTE-CARE Investigators: Study Director:Pfizer CT.gov Call Center;Pfizer Principal Investigator:Oliver Cornely;Clinical Trials Centre Cologne
Nyckelord
Versioner (2)
- 2018-03-07 2018-03-07 -
- 2021-09-17 2021-09-17 -
Rättsinnehavare
Pfizer
Uppladdad den
7 mars 2018
DOI
10.21961/mdm:29207
Licens
Creative Commons BY-NC 3.0
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REJUVENATE NCT02655419
Cumulative
Beskrivning
Adverse Event
Alias
- UMLS CUI-1
- C0877248
Beskrivning
Adverse event number
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C2349022
Beskrivning
main diagnosis, if possible
Datatyp
text
Alias
- UMLS CUI [1]
- C2826934
Beskrivning
AE Start date
Datatyp
date
Alias
- UMLS CUI [1]
- C2697888
Beskrivning
AE Start Time
Datatyp
time
Alias
- UMLS CUI [1,1]
- C1301880
- UMLS CUI [1,2]
- C0877248
Beskrivning
AE End date
Datatyp
date
Alias
- UMLS CUI [1]
- C2697886
Beskrivning
AE End Time
Datatyp
time
Alias
- UMLS CUI [1,1]
- C1522314
- UMLS CUI [1,2]
- C0877248
Beskrivning
AE ongoing
Datatyp
boolean
Alias
- UMLS CUI [1]
- C2826663
Beskrivning
AE intensity
Datatyp
integer
Alias
- UMLS CUI [1]
- C1710066
Beskrivning
Relationship to ATM / AVI
Datatyp
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
Beskrivning
Treatment required?
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C2981656
- UMLS CUI [1,2]
- C1514873
Beskrivning
Treatment type
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0087111
- UMLS CUI [1,2]
- C0332307
Beskrivning
Action taken with drug
Datatyp
integer
Alias
- UMLS CUI [1]
- C1704758
Beskrivning
Event related to Metronidazole
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0025872
- UMLS CUI [1,2]
- C0085978
Beskrivning
Study Procedure causations
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0008976
- UMLS CUI [1,2]
- C0184661
- UMLS CUI [1,3]
- C0085978
Beskrivning
Specify Procedure
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0008976
- UMLS CUI [1,2]
- C0184661
- UMLS CUI [1,3]
- C1521902
Beskrivning
Withdrawal from Study
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C0085978
Beskrivning
Event outcome
Datatyp
integer
Alias
- UMLS CUI [1]
- C1705586
Beskrivning
Serious Adverse Event (SAE)
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0684224
Beskrivning
Seriousness
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1710056
Beskrivning
SAE Number
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2349022
Beskrivning
Start date SAE
Datatyp
date
Alias
- UMLS CUI [1,1]
- C2697888
- UMLS CUI [1,2]
- C1519255
Beskrivning
Start time SAE
Datatyp
time
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1301880
Beskrivning
Date Investigator became aware of serious AE
Datatyp
date
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0008961
- UMLS CUI [1,3]
- C0004448
- UMLS CUI [1,4]
- C0011008
Beskrivning
End date of SAE
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0806020
- UMLS CUI [1,2]
- C1519255
Beskrivning
End Time Serious Adverse Event
Datatyp
time
Alias
- UMLS CUI [1,1]
- C2826658
- UMLS CUI [1,2]
- C1519255
Beskrivning
Outcome
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1705586
- UMLS CUI [1,2]
- C1519255
Beskrivning
Divergent Followup SAE Diagnosis
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0443204
- UMLS CUI [1,2]
- C1519255
- UMLS CUI [1,3]
- C0011900
Beskrivning
Notification
Datatyp
text
Alias
- UMLS CUI [1]
- C0422202
Beskrivning
indicate all that apply
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0871902
- UMLS CUI [1,2]
- C0392360
Beskrivning
SAE description
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0678257
Beskrivning
MedDRA-Coding
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1511731
- UMLS CUI [1,2]
- C0877248
- UMLS CUI [1,3]
- C0011900
Beskrivning
MedDRA-Coding
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0011900
Beskrivning
comment
Datatyp
text
Alias
- UMLS CUI [1]
- C0947611
Beskrivning
Prior and Concomitant Other Medication
Alias
- UMLS CUI-1
- C2826257
- UMLS CUI-2
- C2347852
Beskrivning
within the last two weeks before study
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C2826257
- UMLS CUI [1,2]
- C2347852
Beskrivning
Sequence number
Datatyp
integer
Alias
- UMLS CUI [1]
- C2348184
Beskrivning
Generic Name
Datatyp
text
Alias
- UMLS CUI [1]
- C0013227
Beskrivning
Indication
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C3146298
- UMLS CUI [1,2]
- C0013227
Beskrivning
Referring Adverse Event Number
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0205543
- UMLS CUI [1,3]
- C2349022
Beskrivning
Line number Medical History Form
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0025102
- UMLS CUI [1,2]
- C2348184
Beskrivning
Total daily dose
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C2348070
- UMLS CUI [1,2]
- C1511559
Beskrivning
Unit
Datatyp
text
Alias
- UMLS CUI [1]
- C0439148
Beskrivning
Administration Route
Datatyp
integer
Alias
- UMLS CUI [1]
- C0013153
Beskrivning
Other Administration route
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0013153
- UMLS CUI [1,2]
- C0205394
Beskrivning
Start Date
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0808070
Beskrivning
Start date unknown
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0808070
- UMLS CUI [1,2]
- C0439673
Beskrivning
End Date
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0806020
Beskrivning
ongoing
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0549178
Beskrivning
comment
Datatyp
text
Alias
- UMLS CUI [1]
- C0947611
Beskrivning
Prior and Concomitant Antibiotic Medication
Alias
- UMLS CUI-1
- C2826257
- UMLS CUI-2
- C2347852
- UMLS CUI-3
- C0003232
Beskrivning
within the last two weeks before study
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C2826257
- UMLS CUI [1,2]
- C2347852
Beskrivning
Sequence number
Datatyp
integer
Alias
- UMLS CUI [1]
- C2348184
Beskrivning
Generic Name
Datatyp
text
Alias
- UMLS CUI [1]
- C0013227
Beskrivning
Indication
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C3146298
- UMLS CUI [1,2]
- C0013227
Beskrivning
Referring Adverse Event Number
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0205543
- UMLS CUI [1,3]
- C2349022
Beskrivning
Line number Medical History Form
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0025102
- UMLS CUI [1,2]
- C2348184
Beskrivning
Total daily dose
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C2348070
- UMLS CUI [1,2]
- C1511559
Beskrivning
Unit
Datatyp
text
Alias
- UMLS CUI [1]
- C0439148
Beskrivning
Administration Route
Datatyp
integer
Alias
- UMLS CUI [1]
- C0013153
Beskrivning
other Administration Route
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0013153
- UMLS CUI [1,2]
- C0205394
Beskrivning
Start Date
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0808070
Beskrivning
Start date unknown
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0808070
- UMLS CUI [1,2]
- C0439673
Beskrivning
End Date
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0806020
Beskrivning
ongoing
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0549178
Beskrivning
comment
Datatyp
text
Alias
- UMLS CUI [1]
- C0947611
Beskrivning
Study Drug Discontinuation
Alias
- UMLS CUI-1
- C0457454
- UMLS CUI-2
- C0304229
Beskrivning
Study Drug Discontinued
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0457454
- UMLS CUI [1,2]
- C0304229
Beskrivning
Date of Discontinuation
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0457454
- UMLS CUI [1,2]
- C0011008
Beskrivning
Time of Discontinuation
Datatyp
time
Alias
- UMLS CUI [1,1]
- C0457454
- UMLS CUI [1,2]
- C0040223
Beskrivning
Reason for Discontinuation
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0392360
- UMLS CUI [1,2]
- C0457454
Beskrivning
Other Reason for Discontinuation
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0457454
- UMLS CUI [1,2]
- C3840932
Beskrivning
comment
Datatyp
text
Alias
- UMLS CUI [1]
- C0947611
Beskrivning
Completion / Withdrawal from Study
Alias
- UMLS CUI-1
- C2349954
- UMLS CUI-2
- C2826674
Beskrivning
Date of completion/withdrawal from study
Datatyp
date
Alias
- UMLS CUI [1,1]
- C2348577
- UMLS CUI [1,2]
- C0011008
- UMLS CUI [2,1]
- C0422727
- UMLS CUI [2,2]
- C0011008
Beskrivning
Was Subject prematurely withdrawn from Study?
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C1279919
Beskrivning
Main reason for premature withdrawal
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C2349954
- UMLS CUI [1,2]
- C0392360
- UMLS CUI [1,3]
- C1279919
Beskrivning
Other reason for discontinuation
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0457454
- UMLS CUI [1,2]
- C0392360
- UMLS CUI [1,3]
- C3840932
Beskrivning
in case of premature withdrawal
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0200345
- UMLS CUI [1,2]
- C0085672
- UMLS CUI [1,3]
- C2709088
Beskrivning
comment
Datatyp
text
Alias
- UMLS CUI [1]
- C0947611
Beskrivning
Death Report
Alias
- UMLS CUI-1
- C0011065
- UMLS CUI-2
- C1516308
Beskrivning
Patient died during study?
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1546956
- UMLS CUI [1,2]
- C0008976
- UMLS CUI [1,3]
- C0347984
Beskrivning
Date of Death
Datatyp
date
Alias
- UMLS CUI [1]
- C1148348
Beskrivning
Autopsy performed?
Datatyp
boolean
Alias
- UMLS CUI [1]
- C3656695
Beskrivning
Causation with investigated disease
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0085978
- UMLS CUI [1,2]
- C4316939
Beskrivning
Primary Cause of Death
Datatyp
text
Alias
- UMLS CUI [1]
- C3262229
Beskrivning
Cause of Death Narrative
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0007465
- UMLS CUI [1,2]
- C1521902
Beskrivning
Secondary Cause of Death
Datatyp
text
Alias
- UMLS CUI [1]
- C3262233
Beskrivning
Cause of Death Narrative
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0007465
- UMLS CUI [1,2]
- C1521902
Beskrivning
comment
Datatyp
text
Alias
- UMLS CUI [1]
- C0947611
Beskrivning
Pregnancy Report
Alias
- UMLS CUI-1
- C0032961
- UMLS CUI-2
- C0684224
Beskrivning
Pregnancy occured during study?
Datatyp
boolean
Alias
- UMLS CUI [1]
- C3828490
Beskrivning
Last Menstruation date
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0025344
- UMLS CUI [1,2]
- C0808070
Beskrivning
Expected Date of Birth
Datatyp
date
Alias
- UMLS CUI [1]
- C2825543
Beskrivning
Contraceptive method
Datatyp
integer
Alias
- UMLS CUI [1]
- C0700589
Beskrivning
Other contraceptive method
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0700589
- UMLS CUI [1,2]
- C0205394
Beskrivning
Number of Previous Pregnancies
Datatyp
integer
Alias
- UMLS CUI [1]
- C0422807
Beskrivning
Number of Births
Datatyp
integer
Alias
- UMLS CUI [1]
- C3172256
Beskrivning
Number of Spontaneous Miscarriages
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0429916
- UMLS CUI [1,2]
- C0205359
Beskrivning
Number of Others
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C0449788
Beskrivning
Specify other
Datatyp
text
Alias
- UMLS CUI [1]
- C3845569
Beskrivning
comment
Datatyp
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])