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Informações:
Falhas:
ID
29207
Descrição
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
Palavras-chave
Versões (2)
- 07/03/2018 07/03/2018 -
- 17/09/2021 17/09/2021 -
Titular dos direitos
Pfizer
Transferido a
7 de março de 2018
DOI
10.21961/mdm:29207
Licença
Creative Commons BY-NC 3.0
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Similar models
Cumulative
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Patient Caption
Item
Patient Caption
text
C2825231 (UMLS CUI [1,1])
C0030705 (UMLS CUI [1,2])
C0030705 (UMLS CUI [1,2])
Visit Number
Item
Visit Number
integer
C1549755 (UMLS CUI [1])
Trial name
Item
Trial name
text
C1629065 (UMLS CUI [1])
Visit Name
Item
Visit Name
text
C2826704 (UMLS CUI [1])
Visit date
Item
Visit date
date
C1320303 (UMLS CUI [1])
Study site
Item
Site Name
text
C2825164 (UMLS CUI [1])
Adverse event number
Item
AE No.
text
C0877248 (UMLS CUI [1,1])
C2349022 (UMLS CUI [1,2])
C2349022 (UMLS CUI [1,2])
Adverse event term
Item
AE Term
text
C2826934 (UMLS CUI [1])
AE Start date
Item
AE Start date
date
C2697888 (UMLS CUI [1])
AE Start Time
Item
Start Time
time
C1301880 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,2])
AE End date
Item
End date of AE
date
C2697886 (UMLS CUI [1])
AE End Time
Item
End Time
time
C1522314 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,2])
AE ongoing
Item
AE ongoing at end of study
boolean
C2826663 (UMLS CUI [1])
CL Item
mild (1)
CL Item
moderate (2)
CL Item
severe (3)
Item
Relationship to ATM / AVI
integer
C0085978 (UMLS CUI [1,1])
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])
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])
CL Item
related (1)
CL Item
unrelated (2)
Treatment required?
Item
Treatment required?
boolean
C2981656 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C1514873 (UMLS CUI [1,2])
CL Item
Medication Therapy (1)
CL Item
Non-Medication Therapy (2)
CL Item
permanently discontinued (1)
CL Item
dose reduced (2)
CL Item
dose increased (3)
CL Item
dose not changed (4)
CL Item
drug interrupted (5)
CL Item
not applicable (6)
Event related to Metronidazole
Item
Event related to Metronidazole
boolean
C0025872 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C0085978 (UMLS CUI [1,2])
Study Procedure causations
Item
Event related to Study Procedure
boolean
C0008976 (UMLS CUI [1,1])
C0184661 (UMLS CUI [1,2])
C0085978 (UMLS CUI [1,3])
C0184661 (UMLS CUI [1,2])
C0085978 (UMLS CUI [1,3])
Specify Procedure
Item
Specify Procedure
text
C0008976 (UMLS CUI [1,1])
C0184661 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C0184661 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
Withdrawal from Study
Item
Event caused Subject's Withdrawal from Study
boolean
C0422727 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C0085978 (UMLS CUI [1,2])
CL Item
resolved without sequelae (1)
CL Item
resolved with sequelae (2)
CL Item
condition improving (3)
CL Item
not yet resolved (4)
CL Item
fatal (5)
CL Item
unknown (6)
Seriousness
Item
Seriousness
boolean
C1710056 (UMLS CUI [1])
SAE Number
Item
SAE Number
text
C1519255 (UMLS CUI [1,1])
C2349022 (UMLS CUI [1,2])
C2349022 (UMLS CUI [1,2])
Start date SAE
Item
Date AE turned serious
date
C2697888 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
Start time SAE
Item
Time AE turned serious
time
C1519255 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,2])
Date Investigator became aware of serious AE
Item
Date Investigator became aware of serious AE
date
C1519255 (UMLS CUI [1,1])
C0008961 (UMLS CUI [1,2])
C0004448 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
C0008961 (UMLS CUI [1,2])
C0004448 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
End date of SAE
Item
End date of SAE
date
C0806020 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
End Time Serious Adverse Event
Item
End Time Serious Adverse Event
time
C2826658 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
CL Item
recovered/resolved (1)
CL Item
recovering/resolving (2)
CL Item
recovered/resolved with sequelae (3)
CL Item
not recovered/resolved (4)
CL Item
fatal (5)
Divergent Followup SAE Diagnosis
Item
Divergent Followup SAE Diagnosis
text
C0443204 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,3])
C1519255 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,3])
Notification
Item
Notification
text
C0422202 (UMLS CUI [1])
Item
Seriousness criteria or reportable reason
integer
C0871902 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,2])
CL Item
Results in death (1)
CL Item
Life-threatening (2)
CL Item
Requires in-patient hospitalisation or prolongation of existing hospitalisation excluding hospitalization due to worsening or failure of treatment for primary infection under study (3)
CL Item
Results in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions (4)
CL Item
Congenital anomaly / birth defect (5)
CL Item
Important medical event that may jeopardise the subject or may require medical intervention to prevent one of the outcomes listed above, including suspected transmission of an infectious agent via the IV study therapy (6)
SAE description
Item
Description of event
text
C1519255 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
C0678257 (UMLS CUI [1,2])
Derivated AE Diagnosis
Item
Derivated AE Diagnosis
text
C1511731 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,3])
C0877248 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,3])
AE Diagnosis saved last at
Item
AE Diagnosis saved last at
text
C0877248 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,2])
comment
Item
CRF comment
text
C0947611 (UMLS CUI [1])
Item Group
Prior and Concomitant Other Medication
C2826257 (UMLS CUI-1)
C2347852 (UMLS CUI-2)
C2347852 (UMLS CUI-2)
Concomitant or Prior Medication
Item
Concomitant or Prior Medication
boolean
C2826257 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,2])
Sequence number
Item
No
integer
C2348184 (UMLS CUI [1])
Pharmaceutical Preparations
Item
Medication
text
C0013227 (UMLS CUI [1])
CL Item
Disease Under Study (1)
CL Item
Prophylaxis (2)
CL Item
Medical History (3)
CL Item
Physicians Preference (not AE) (4)
CL Item
Adverse event (5)
CL Item
LAB Abnormality (6)
CL Item
Vital Signs Abnormality (7)
CL Item
Other (8)
Referring Adverse Event Number
Item
Referring AE No.
integer
C0877248 (UMLS CUI [1,1])
C0205543 (UMLS CUI [1,2])
C2349022 (UMLS CUI [1,3])
C0205543 (UMLS CUI [1,2])
C2349022 (UMLS CUI [1,3])
Line number Medical History Form
Item
Referring Line on Medical History Form
integer
C0025102 (UMLS CUI [1,1])
C2348184 (UMLS CUI [1,2])
C2348184 (UMLS CUI [1,2])
Total daily dose
Item
Total daily dose
integer
C2348070 (UMLS CUI [1,1])
C1511559 (UMLS CUI [1,2])
C1511559 (UMLS CUI [1,2])
Unit
Item
Unit
text
C0439148 (UMLS CUI [1])
CL Item
Intravenous (1)
CL Item
Intramuscular (2)
CL Item
Subcutaneous (3)
CL Item
Per Oral (4)
CL Item
Topical (5)
CL Item
Peritoneal Lavage (6)
CL Item
other (7)
Other Administration route
Item
Other route
text
C0013153 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
Start Date
Item
Start Date
date
C0013227 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
Start date unknown
Item
Unknown
boolean
C0808070 (UMLS CUI [1,1])
C0439673 (UMLS CUI [1,2])
C0439673 (UMLS CUI [1,2])
End Date
Item
End Date
date
C0013227 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
ongoing
Item
ongoing at end of study
boolean
C0549178 (UMLS CUI [1])
comment
Item
CRF comment
text
C0947611 (UMLS CUI [1])
Item Group
Prior and Concomitant Antibiotic Medication
C2826257 (UMLS CUI-1)
C2347852 (UMLS CUI-2)
C0003232 (UMLS CUI-3)
C2347852 (UMLS CUI-2)
C0003232 (UMLS CUI-3)
Concomitant or Prior Medication
Item
Concomitant or Prior Medication
boolean
C2826257 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,2])
Sequence number
Item
No
integer
C2348184 (UMLS CUI [1])
Pharmaceutical Preparations
Item
Medication
text
C0013227 (UMLS CUI [1])
CL Item
Disease Under Study (1)
(Comment:en)
CL Item
Prophylaxis (2)
(Comment:en)
CL Item
Medical History (3)
(Comment:en)
CL Item
Physicians Preference (not AE) (4)
(Comment:en)
CL Item
Adverse event (5)
(Comment:en)
CL Item
LAB Abnormality (6)
(Comment:en)
CL Item
Vital Signs Abnormality (7)
(Comment:en)
CL Item
Other (99)
(Comment:en)
Referring Adverse Event Number
Item
Referring AE No.
integer
C0877248 (UMLS CUI [1,1])
C0205543 (UMLS CUI [1,2])
C2349022 (UMLS CUI [1,3])
C0205543 (UMLS CUI [1,2])
C2349022 (UMLS CUI [1,3])
Line number Medical History Form
Item
Referring Line on Medical History Form
integer
C0025102 (UMLS CUI [1,1])
C2348184 (UMLS CUI [1,2])
C2348184 (UMLS CUI [1,2])
Total daily dose
Item
Total daily dose
integer
C2348070 (UMLS CUI [1,1])
C1511559 (UMLS CUI [1,2])
C1511559 (UMLS CUI [1,2])
Unit
Item
Unit
text
C0439148 (UMLS CUI [1])
CL Item
Intravenous (1)
(Comment:en)
CL Item
Intramuscular (2)
(Comment:en)
CL Item
Subcutaneous (3)
(Comment:en)
CL Item
Per Oral (4)
(Comment:en)
CL Item
Topical (5)
(Comment:en)
CL Item
Peritoneal Lavage (6)
(Comment:en)
CL Item
other (99)
(Comment:en)
other Administration Route
Item
other Administration Route
text
C0013153 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
Start Date
Item
Start Date
date
C0013227 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
Start date unknown
Item
Unknown
boolean
C0808070 (UMLS CUI [1,1])
C0439673 (UMLS CUI [1,2])
C0439673 (UMLS CUI [1,2])
End Date
Item
End Date
date
C0013227 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
ongoing
Item
ongoing at end of study
boolean
C0549178 (UMLS CUI [1])
comment
Item
CRF comment
text
C0947611 (UMLS CUI [1])
Item Group
Study Drug Discontinuation
C0457454 (UMLS CUI-1)
C0304229 (UMLS CUI-2)
C0304229 (UMLS CUI-2)
Study Drug Discontinued
Item
Study Drug Prematurely and Permanently Discontinued?
boolean
C0457454 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,2])
Date of Discontinuation
Item
Date of Study Drug Discontinuation
date
C0457454 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Time of Discontinuation
Item
Time of Study Drug Discontinuation
time
C0457454 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
Item
Reason for Discontinuation
integer
C0392360 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C0457454 (UMLS CUI [1,2])
CL Item
Subject Decision (1)
(Comment:en)
CL Item
Adverse Event (2)
(Comment:en)
CL Item
Severe Non-Compliance to Protocol (3)
(Comment:en)
CL Item
Lack of Therapeutic Response (4)
(Comment:en)
CL Item
Subject Recovered (5)
(Comment:en)
CL Item
Lost to Follow-up (6)
(Comment:en)
CL Item
Other (99)
(Comment:en)
Other Reason for Discontinuation
Item
Other Reason for Discontinuation
text
C0457454 (UMLS CUI [1,1])
C3840932 (UMLS CUI [1,2])
C3840932 (UMLS CUI [1,2])
comment
Item
CRF comment
text
C0947611 (UMLS CUI [1])
Item Group
Completion / Withdrawal from Study
C2349954 (UMLS CUI-1)
C2826674 (UMLS CUI-2)
C2826674 (UMLS CUI-2)
Date of completion/withdrawal from study
Item
Date subject completed study / withdrew from study
date
C2348577 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0422727 (UMLS CUI [2,1])
C0011008 (UMLS CUI [2,2])
C0011008 (UMLS CUI [1,2])
C0422727 (UMLS CUI [2,1])
C0011008 (UMLS CUI [2,2])
Was Subject prematurely withdrawn from Study?
Item
Was Subject prematurely withdrawn from Study?
boolean
C0422727 (UMLS CUI [1,1])
C1279919 (UMLS CUI [1,2])
C1279919 (UMLS CUI [1,2])
Item
Main reason for premature withdrawal
integer
C2349954 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C1279919 (UMLS CUI [1,3])
C0392360 (UMLS CUI [1,2])
C1279919 (UMLS CUI [1,3])
CL Item
Withdrawal of Consent (1)
(Comment:en)
CL Item
Eligibility criteria not fulfilled (2)
(Comment:en)
CL Item
AE (3)
(Comment:en)
CL Item
Death (4)
(Comment:en)
CL Item
Lost to Follow-up (5)
(Comment:en)
CL Item
Other (99)
(Comment:en)
Other reason for discontinuation
Item
Other reason for discontinuation
text
C0457454 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C3840932 (UMLS CUI [1,3])
C0392360 (UMLS CUI [1,2])
C3840932 (UMLS CUI [1,3])
Microbiological Sample collected after last treatment
Item
Microbiological Sample collected after last treatment
boolean
C0200345 (UMLS CUI [1,1])
C0085672 (UMLS CUI [1,2])
C2709088 (UMLS CUI [1,3])
C0085672 (UMLS CUI [1,2])
C2709088 (UMLS CUI [1,3])
comment
Item
CRF comment
text
C0947611 (UMLS CUI [1])
Patient died during study?
Item
Patient died during study?
boolean
C1546956 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C0347984 (UMLS CUI [1,3])
C0008976 (UMLS CUI [1,2])
C0347984 (UMLS CUI [1,3])
Date of Death
Item
Date of Death
date
C1148348 (UMLS CUI [1])
Autopsy performed?
Item
Autopsy performed?
boolean
C3656695 (UMLS CUI [1])
Causation with investigated disease
Item
Death related to Disease under Investigation
boolean
C0085978 (UMLS CUI [1,1])
C4316939 (UMLS CUI [1,2])
C4316939 (UMLS CUI [1,2])
Primary Cause of Death
Item
Primary Cause of Death
text
C3262229 (UMLS CUI [1])
Cause of Death Narrative
Item
Cause of Death Narrative
text
C0007465 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,2])
Secondary Cause of Death
Item
Secondary Cause of Death
text
C3262233 (UMLS CUI [1])
Cause of Death Narrative
Item
Cause of Death Narrative
text
C0007465 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,2])
comment
Item
CRF comment
text
C0947611 (UMLS CUI [1])
Pregnancy occured during study?
Item
Pregnancy occured during study?
boolean
C3828490 (UMLS CUI [1])
Last Menstruation date
Item
Last Menstruation (Start Date)
date
C0025344 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
Expected Date of Birth
Item
Expected Date of Birth
date
C2825543 (UMLS CUI [1])
CL Item
Hormonal Method (1)
(Comment:en)
CL Item
Barrier Method (2)
(Comment:en)
CL Item
Intrauterine Method (3)
(Comment:en)
CL Item
Emergency Method (4)
(Comment:en)
CL Item
Sterilization (5)
(Comment:en)
CL Item
Other (99)
(Comment:en)
Other contraceptive method
Item
Kind of Other Method
text
C0700589 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
Number of Previous Pregnancies
Item
Number of Previous Pregnancies
integer
C0422807 (UMLS CUI [1])
Number of Births
Item
Number of Births
integer
C3172256 (UMLS CUI [1])
Number of Spontaneous Miscarriages
Item
Number of Spontaneous Miscarriages
integer
C0429916 (UMLS CUI [1,1])
C0205359 (UMLS CUI [1,2])
C0205359 (UMLS CUI [1,2])
Number of Others
Item
Number of Others
integer
C0205394 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
C0449788 (UMLS CUI [1,2])
Specify other
Item
If Others, please specify
text
C3845569 (UMLS CUI [1])
comment
Item
CRF comment
text
C0947611 (UMLS CUI [1])