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