ID
29207
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
7 maart 2018
DOI
10.21961/mdm:29207
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
Cumulative
Beschrijving
Adverse Event
Alias
- UMLS CUI-1
- C0877248
Beschrijving
Adverse event number
Datatype
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C2349022
Beschrijving
main diagnosis, if possible
Datatype
text
Alias
- UMLS CUI [1]
- C2826934
Beschrijving
AE Start date
Datatype
date
Alias
- UMLS CUI [1]
- C2697888
Beschrijving
AE Start Time
Datatype
time
Alias
- UMLS CUI [1,1]
- C1301880
- UMLS CUI [1,2]
- C0877248
Beschrijving
AE End date
Datatype
date
Alias
- UMLS CUI [1]
- C2697886
Beschrijving
AE End Time
Datatype
time
Alias
- UMLS CUI [1,1]
- C1522314
- UMLS CUI [1,2]
- C0877248
Beschrijving
AE ongoing
Datatype
boolean
Alias
- UMLS CUI [1]
- C2826663
Beschrijving
AE intensity
Datatype
integer
Alias
- UMLS CUI [1]
- C1710066
Beschrijving
Relationship to ATM / AVI
Datatype
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
Beschrijving
Treatment required?
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C2981656
- UMLS CUI [1,2]
- C1514873
Beschrijving
Treatment type
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0087111
- UMLS CUI [1,2]
- C0332307
Beschrijving
Action taken with drug
Datatype
integer
Alias
- UMLS CUI [1]
- C1704758
Beschrijving
Event related to Metronidazole
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0025872
- UMLS CUI [1,2]
- C0085978
Beschrijving
Study Procedure causations
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0008976
- UMLS CUI [1,2]
- C0184661
- UMLS CUI [1,3]
- C0085978
Beschrijving
Specify Procedure
Datatype
text
Alias
- UMLS CUI [1,1]
- C0008976
- UMLS CUI [1,2]
- C0184661
- UMLS CUI [1,3]
- C1521902
Beschrijving
Withdrawal from Study
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C0085978
Beschrijving
Event outcome
Datatype
integer
Alias
- UMLS CUI [1]
- C1705586
Beschrijving
Serious Adverse Event (SAE)
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0684224
Beschrijving
Seriousness
Datatype
boolean
Alias
- UMLS CUI [1]
- C1710056
Beschrijving
SAE Number
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2349022
Beschrijving
Start date SAE
Datatype
date
Alias
- UMLS CUI [1,1]
- C2697888
- UMLS CUI [1,2]
- C1519255
Beschrijving
Start time SAE
Datatype
time
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1301880
Beschrijving
Date Investigator became aware of serious AE
Datatype
date
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0008961
- UMLS CUI [1,3]
- C0004448
- UMLS CUI [1,4]
- C0011008
Beschrijving
End date of SAE
Datatype
date
Alias
- UMLS CUI [1,1]
- C0806020
- UMLS CUI [1,2]
- C1519255
Beschrijving
End Time Serious Adverse Event
Datatype
time
Alias
- UMLS CUI [1,1]
- C2826658
- UMLS CUI [1,2]
- C1519255
Beschrijving
Outcome
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1705586
- UMLS CUI [1,2]
- C1519255
Beschrijving
Divergent Followup SAE Diagnosis
Datatype
text
Alias
- UMLS CUI [1,1]
- C0443204
- UMLS CUI [1,2]
- C1519255
- UMLS CUI [1,3]
- C0011900
Beschrijving
Notification
Datatype
text
Alias
- UMLS CUI [1]
- C0422202
Beschrijving
indicate all that apply
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0871902
- UMLS CUI [1,2]
- C0392360
Beschrijving
SAE description
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0678257
Beschrijving
MedDRA-Coding
Datatype
text
Alias
- UMLS CUI [1,1]
- C1511731
- UMLS CUI [1,2]
- C0877248
- UMLS CUI [1,3]
- C0011900
Beschrijving
MedDRA-Coding
Datatype
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0011900
Beschrijving
comment
Datatype
text
Alias
- UMLS CUI [1]
- C0947611
Beschrijving
Prior and Concomitant Other Medication
Alias
- UMLS CUI-1
- C2826257
- UMLS CUI-2
- C2347852
Beschrijving
within the last two weeks before study
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C2826257
- UMLS CUI [1,2]
- C2347852
Beschrijving
Sequence number
Datatype
integer
Alias
- UMLS CUI [1]
- C2348184
Beschrijving
Generic Name
Datatype
text
Alias
- UMLS CUI [1]
- C0013227
Beschrijving
Indication
Datatype
integer
Alias
- UMLS CUI [1,1]
- C3146298
- UMLS CUI [1,2]
- C0013227
Beschrijving
Referring Adverse Event Number
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0205543
- UMLS CUI [1,3]
- C2349022
Beschrijving
Line number Medical History Form
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0025102
- UMLS CUI [1,2]
- C2348184
Beschrijving
Total daily dose
Datatype
integer
Alias
- UMLS CUI [1,1]
- C2348070
- UMLS CUI [1,2]
- C1511559
Beschrijving
Unit
Datatype
text
Alias
- UMLS CUI [1]
- C0439148
Beschrijving
Administration Route
Datatype
integer
Alias
- UMLS CUI [1]
- C0013153
Beschrijving
Other Administration route
Datatype
text
Alias
- UMLS CUI [1,1]
- C0013153
- UMLS CUI [1,2]
- C0205394
Beschrijving
Start Date
Datatype
date
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0808070
Beschrijving
Start date unknown
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0808070
- UMLS CUI [1,2]
- C0439673
Beschrijving
End Date
Datatype
date
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0806020
Beschrijving
ongoing
Datatype
boolean
Alias
- UMLS CUI [1]
- C0549178
Beschrijving
comment
Datatype
text
Alias
- UMLS CUI [1]
- C0947611
Beschrijving
Prior and Concomitant Antibiotic Medication
Alias
- UMLS CUI-1
- C2826257
- UMLS CUI-2
- C2347852
- UMLS CUI-3
- C0003232
Beschrijving
within the last two weeks before study
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C2826257
- UMLS CUI [1,2]
- C2347852
Beschrijving
Sequence number
Datatype
integer
Alias
- UMLS CUI [1]
- C2348184
Beschrijving
Generic Name
Datatype
text
Alias
- UMLS CUI [1]
- C0013227
Beschrijving
Indication
Datatype
integer
Alias
- UMLS CUI [1,1]
- C3146298
- UMLS CUI [1,2]
- C0013227
Beschrijving
Referring Adverse Event Number
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0205543
- UMLS CUI [1,3]
- C2349022
Beschrijving
Line number Medical History Form
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0025102
- UMLS CUI [1,2]
- C2348184
Beschrijving
Total daily dose
Datatype
integer
Alias
- UMLS CUI [1,1]
- C2348070
- UMLS CUI [1,2]
- C1511559
Beschrijving
Unit
Datatype
text
Alias
- UMLS CUI [1]
- C0439148
Beschrijving
Administration Route
Datatype
integer
Alias
- UMLS CUI [1]
- C0013153
Beschrijving
other Administration Route
Datatype
text
Alias
- UMLS CUI [1,1]
- C0013153
- UMLS CUI [1,2]
- C0205394
Beschrijving
Start Date
Datatype
date
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0808070
Beschrijving
Start date unknown
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0808070
- UMLS CUI [1,2]
- C0439673
Beschrijving
End Date
Datatype
date
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0806020
Beschrijving
ongoing
Datatype
boolean
Alias
- UMLS CUI [1]
- C0549178
Beschrijving
comment
Datatype
text
Alias
- UMLS CUI [1]
- C0947611
Beschrijving
Study Drug Discontinuation
Alias
- UMLS CUI-1
- C0457454
- UMLS CUI-2
- C0304229
Beschrijving
Study Drug Discontinued
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0457454
- UMLS CUI [1,2]
- C0304229
Beschrijving
Date of Discontinuation
Datatype
date
Alias
- UMLS CUI [1,1]
- C0457454
- UMLS CUI [1,2]
- C0011008
Beschrijving
Time of Discontinuation
Datatype
time
Alias
- UMLS CUI [1,1]
- C0457454
- UMLS CUI [1,2]
- C0040223
Beschrijving
Reason for Discontinuation
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0392360
- UMLS CUI [1,2]
- C0457454
Beschrijving
Other Reason for Discontinuation
Datatype
text
Alias
- UMLS CUI [1,1]
- C0457454
- UMLS CUI [1,2]
- C3840932
Beschrijving
comment
Datatype
text
Alias
- UMLS CUI [1]
- C0947611
Beschrijving
Completion / Withdrawal from Study
Alias
- UMLS CUI-1
- C2349954
- UMLS CUI-2
- C2826674
Beschrijving
Date of completion/withdrawal from study
Datatype
date
Alias
- UMLS CUI [1,1]
- C2348577
- UMLS CUI [1,2]
- C0011008
- UMLS CUI [2,1]
- C0422727
- UMLS CUI [2,2]
- C0011008
Beschrijving
Was Subject prematurely withdrawn from Study?
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C1279919
Beschrijving
Main reason for premature withdrawal
Datatype
integer
Alias
- UMLS CUI [1,1]
- C2349954
- UMLS CUI [1,2]
- C0392360
- UMLS CUI [1,3]
- C1279919
Beschrijving
Other reason for discontinuation
Datatype
text
Alias
- UMLS CUI [1,1]
- C0457454
- UMLS CUI [1,2]
- C0392360
- UMLS CUI [1,3]
- C3840932
Beschrijving
in case of premature withdrawal
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0200345
- UMLS CUI [1,2]
- C0085672
- UMLS CUI [1,3]
- C2709088
Beschrijving
comment
Datatype
text
Alias
- UMLS CUI [1]
- C0947611
Beschrijving
Death Report
Alias
- UMLS CUI-1
- C0011065
- UMLS CUI-2
- C1516308
Beschrijving
Patient died during study?
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1546956
- UMLS CUI [1,2]
- C0008976
- UMLS CUI [1,3]
- C0347984
Beschrijving
Date of Death
Datatype
date
Alias
- UMLS CUI [1]
- C1148348
Beschrijving
Autopsy performed?
Datatype
boolean
Alias
- UMLS CUI [1]
- C3656695
Beschrijving
Causation with investigated disease
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0085978
- UMLS CUI [1,2]
- C4316939
Beschrijving
Primary Cause of Death
Datatype
text
Alias
- UMLS CUI [1]
- C3262229
Beschrijving
Cause of Death Narrative
Datatype
text
Alias
- UMLS CUI [1,1]
- C0007465
- UMLS CUI [1,2]
- C1521902
Beschrijving
Secondary Cause of Death
Datatype
text
Alias
- UMLS CUI [1]
- C3262233
Beschrijving
Cause of Death Narrative
Datatype
text
Alias
- UMLS CUI [1,1]
- C0007465
- UMLS CUI [1,2]
- C1521902
Beschrijving
comment
Datatype
text
Alias
- UMLS CUI [1]
- C0947611
Beschrijving
Pregnancy Report
Alias
- UMLS CUI-1
- C0032961
- UMLS CUI-2
- C0684224
Beschrijving
Pregnancy occured during study?
Datatype
boolean
Alias
- UMLS CUI [1]
- C3828490
Beschrijving
Last Menstruation date
Datatype
date
Alias
- UMLS CUI [1,1]
- C0025344
- UMLS CUI [1,2]
- C0808070
Beschrijving
Expected Date of Birth
Datatype
date
Alias
- UMLS CUI [1]
- C2825543
Beschrijving
Contraceptive method
Datatype
integer
Alias
- UMLS CUI [1]
- C0700589
Beschrijving
Other contraceptive method
Datatype
text
Alias
- UMLS CUI [1,1]
- C0700589
- UMLS CUI [1,2]
- C0205394
Beschrijving
Number of Previous Pregnancies
Datatype
integer
Alias
- UMLS CUI [1]
- C0422807
Beschrijving
Number of Births
Datatype
integer
Alias
- UMLS CUI [1]
- C3172256
Beschrijving
Number of Spontaneous Miscarriages
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0429916
- UMLS CUI [1,2]
- C0205359
Beschrijving
Number of Others
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C0449788
Beschrijving
Specify other
Datatype
text
Alias
- UMLS CUI [1]
- C3845569
Beschrijving
comment
Datatype
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])