ID

29207

Descripción

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

Palabras clave

Versiones (2)
  1. 7/3/18 7/3/18 -
  2. 17/9/21 17/9/21 -
Titular de derechos de autor

Pfizer

Subido en

7 de marzo de 2018

DOI

10.21961/mdm:29207

Licencia

Creative Commons BY-NC 3.0
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REJUVENATE NCT02655419

Inglés

Cumulative

8 formularios  
Administrative Information
Descripción

Administrative Information

Alias
UMLS CUI-1
C1320722
Patient Caption
Descripción

Patient Caption

Tipo de datos

text

Alias
UMLS CUI [1,1]
C2825231
UMLS CUI [1,2]
C0030705
Visit Number
Descripción

Visit Number

Tipo de datos

integer

Alias
UMLS CUI [1]
C1549755
Trial name
Descripción

Trial name

Tipo de datos

text

Alias
UMLS CUI [1]
C1629065
Visit Name
Descripción

Visit Name

Tipo de datos

text

Alias
UMLS CUI [1]
C2826704
Visit date
Descripción

Visit date

Tipo de datos

date

Alias
UMLS CUI [1]
C1320303
Site Name
Descripción

Study site

Tipo de datos

text

Alias
UMLS CUI [1]
C2825164
Adverse Event
Descripción

Adverse Event

Alias
UMLS CUI-1
C0877248
AE No.
Descripción

Adverse event number

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C2349022
AE Term
Descripción

main diagnosis, if possible

Tipo de datos

text

Alias
UMLS CUI [1]
C2826934
AE Start date
Descripción

AE Start date

Tipo de datos

date

Alias
UMLS CUI [1]
C2697888
Start Time
Descripción

AE Start Time

Tipo de datos

time

Alias
UMLS CUI [1,1]
C1301880
UMLS CUI [1,2]
C0877248
End date of AE
Descripción

AE End date

Tipo de datos

date

Alias
UMLS CUI [1]
C2697886
End Time
Descripción

AE End Time

Tipo de datos

time

Alias
UMLS CUI [1,1]
C1522314
UMLS CUI [1,2]
C0877248
AE ongoing at end of study
Descripción

AE ongoing

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2826663
Intensity of AE
Descripción

AE intensity

Tipo de datos

integer

Alias
UMLS CUI [1]
C1710066
Relationship to ATM / AVI
Descripción

Relationship to ATM / AVI

Tipo de datos

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
Treatment required?
Descripción

Treatment required?

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2981656
UMLS CUI [1,2]
C1514873
Kind of treatment
Descripción

Treatment type

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0332307
Action taken with drug
Descripción

Action taken with drug

Tipo de datos

integer

Alias
UMLS CUI [1]
C1704758
Event related to Metronidazole
Descripción

Event related to Metronidazole

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0025872
UMLS CUI [1,2]
C0085978
Event related to Study Procedure
Descripción

Study Procedure causations

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0008976
UMLS CUI [1,2]
C0184661
UMLS CUI [1,3]
C0085978
Specify Procedure
Descripción

Specify Procedure

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0008976
UMLS CUI [1,2]
C0184661
UMLS CUI [1,3]
C1521902
Event caused Subject's Withdrawal from Study
Descripción

Withdrawal from Study

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0085978
Outcome of Event
Descripción

Event outcome

Tipo de datos

integer

Alias
UMLS CUI [1]
C1705586
Serious Adverse Event (SAE)
Descripción

Serious Adverse Event (SAE)

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0684224
Seriousness
Descripción

Seriousness

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1710056
SAE Number
Descripción

SAE Number

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2349022
Date AE turned serious
Descripción

Start date SAE

Tipo de datos

date

Alias
UMLS CUI [1,1]
C2697888
UMLS CUI [1,2]
C1519255
Time AE turned serious
Descripción

Start time SAE

Tipo de datos

time

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1301880
Date Investigator became aware of serious AE
Descripción

Date Investigator became aware of serious AE

Tipo de datos

date

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0008961
UMLS CUI [1,3]
C0004448
UMLS CUI [1,4]
C0011008
End date of SAE
Descripción

End date of SAE

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C1519255
End Time Serious Adverse Event
Descripción

End Time Serious Adverse Event

Tipo de datos

time

Alias
UMLS CUI [1,1]
C2826658
UMLS CUI [1,2]
C1519255
Outcome of SAE
Descripción

Outcome

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1705586
UMLS CUI [1,2]
C1519255
Divergent Followup SAE Diagnosis
Descripción

Divergent Followup SAE Diagnosis

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0443204
UMLS CUI [1,2]
C1519255
UMLS CUI [1,3]
C0011900
Notification
Descripción

Notification

Tipo de datos

text

Alias
UMLS CUI [1]
C0422202
Seriousness criteria or reportable reason
Descripción

indicate all that apply

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0871902
UMLS CUI [1,2]
C0392360
Description of event
Descripción

SAE description

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0678257
Derivated AE Diagnosis
Descripción

MedDRA-Coding

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1511731
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C0011900
AE Diagnosis saved last at
Descripción

MedDRA-Coding

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0011900
CRF comment
Descripción

comment

Tipo de datos

text

Alias
UMLS CUI [1]
C0947611
Prior and Concomitant Other Medication
Descripción

Prior and Concomitant Other Medication

Alias
UMLS CUI-1
C2826257
UMLS CUI-2
C2347852
Concomitant or Prior Medication
Descripción

within the last two weeks before study

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2826257
UMLS CUI [1,2]
C2347852
No
Descripción

Sequence number

Tipo de datos

integer

Alias
UMLS CUI [1]
C2348184
Medication
Descripción

Generic Name

Tipo de datos

text

Alias
UMLS CUI [1]
C0013227
Reason for Therapy
Descripción

Indication

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0013227
Referring AE No.
Descripción

Referring Adverse Event Number

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0205543
UMLS CUI [1,3]
C2349022
Referring Line on Medical History Form
Descripción

Line number Medical History Form

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0025102
UMLS CUI [1,2]
C2348184
Total daily dose
Descripción

Total daily dose

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C2348070
UMLS CUI [1,2]
C1511559
Unit
Descripción

Unit

Tipo de datos

text

Alias
UMLS CUI [1]
C0439148
Route
Descripción

Administration Route

Tipo de datos

integer

Alias
UMLS CUI [1]
C0013153
Other route
Descripción

Other Administration route

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0013153
UMLS CUI [1,2]
C0205394
Start Date
Descripción

Start Date

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0808070
Unknown
Descripción

Start date unknown

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C0439673
End Date
Descripción

End Date

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0806020
ongoing at end of study
Descripción

ongoing

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0549178
CRF comment
Descripción

comment

Tipo de datos

text

Alias
UMLS CUI [1]
C0947611
Prior and Concomitant Antibiotic Medication
Descripción

Prior and Concomitant Antibiotic Medication

Alias
UMLS CUI-1
C2826257
UMLS CUI-2
C2347852
UMLS CUI-3
C0003232
Concomitant or Prior Medication
Descripción

within the last two weeks before study

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2826257
UMLS CUI [1,2]
C2347852
No
Descripción

Sequence number

Tipo de datos

integer

Alias
UMLS CUI [1]
C2348184
Medication
Descripción

Generic Name

Tipo de datos

text

Alias
UMLS CUI [1]
C0013227
Reason for Therapy
Descripción

Indication

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0013227
Referring AE No.
Descripción

Referring Adverse Event Number

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0205543
UMLS CUI [1,3]
C2349022
Referring Line on Medical History Form
Descripción

Line number Medical History Form

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0025102
UMLS CUI [1,2]
C2348184
Total daily dose
Descripción

Total daily dose

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C2348070
UMLS CUI [1,2]
C1511559
Unit
Descripción

Unit

Tipo de datos

text

Alias
UMLS CUI [1]
C0439148
Route
Descripción

Administration Route

Tipo de datos

integer

Alias
UMLS CUI [1]
C0013153
other Administration Route
Descripción

other Administration Route

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0013153
UMLS CUI [1,2]
C0205394
Start Date
Descripción

Start Date

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0808070
Unknown
Descripción

Start date unknown

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C0439673
End Date
Descripción

End Date

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0806020
ongoing at end of study
Descripción

ongoing

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0549178
CRF comment
Descripción

comment

Tipo de datos

text

Alias
UMLS CUI [1]
C0947611
Study Drug Discontinuation
Descripción

Study Drug Discontinuation

Alias
UMLS CUI-1
C0457454
UMLS CUI-2
C0304229
Study Drug Prematurely and Permanently Discontinued?
Descripción

Study Drug Discontinued

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0457454
UMLS CUI [1,2]
C0304229
Date of Study Drug Discontinuation
Descripción

Date of Discontinuation

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0457454
UMLS CUI [1,2]
C0011008
Time of Study Drug Discontinuation
Descripción

Time of Discontinuation

Tipo de datos

time

Alias
UMLS CUI [1,1]
C0457454
UMLS CUI [1,2]
C0040223
Reason for Discontinuation
Descripción

Reason for Discontinuation

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0457454
Other Reason for Discontinuation
Descripción

Other Reason for Discontinuation

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0457454
UMLS CUI [1,2]
C3840932
CRF comment
Descripción

comment

Tipo de datos

text

Alias
UMLS CUI [1]
C0947611
Completion / Withdrawal from Study
Descripción

Completion / Withdrawal from Study

Alias
UMLS CUI-1
C2349954
UMLS CUI-2
C2826674
Date subject completed study / withdrew from study
Descripción

Date of completion/withdrawal from study

Tipo de datos

date

Alias
UMLS CUI [1,1]
C2348577
UMLS CUI [1,2]
C0011008
UMLS CUI [2,1]
C0422727
UMLS CUI [2,2]
C0011008
Was Subject prematurely withdrawn from Study?
Descripción

Was Subject prematurely withdrawn from Study?

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C1279919
Main reason for premature withdrawal
Descripción

Main reason for premature withdrawal

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C0392360
UMLS CUI [1,3]
C1279919
Other reason for discontinuation
Descripción

Other reason for discontinuation

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0457454
UMLS CUI [1,2]
C0392360
UMLS CUI [1,3]
C3840932
Microbiological Sample collected after last treatment
Descripción

in case of premature withdrawal

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0200345
UMLS CUI [1,2]
C0085672
UMLS CUI [1,3]
C2709088
CRF comment
Descripción

comment

Tipo de datos

text

Alias
UMLS CUI [1]
C0947611
Death Report
Descripción

Death Report

Alias
UMLS CUI-1
C0011065
UMLS CUI-2
C1516308
Patient died during study?
Descripción

Patient died during study?

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1546956
UMLS CUI [1,2]
C0008976
UMLS CUI [1,3]
C0347984
Date of Death
Descripción

Date of Death

Tipo de datos

date

Alias
UMLS CUI [1]
C1148348
Autopsy performed?
Descripción

Autopsy performed?

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3656695
Death related to Disease under Investigation
Descripción

Causation with investigated disease

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0085978
UMLS CUI [1,2]
C4316939
Primary Cause of Death
Descripción

Primary Cause of Death

Tipo de datos

text

Alias
UMLS CUI [1]
C3262229
Cause of Death Narrative
Descripción

Cause of Death Narrative

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0007465
UMLS CUI [1,2]
C1521902
Secondary Cause of Death
Descripción

Secondary Cause of Death

Tipo de datos

text

Alias
UMLS CUI [1]
C3262233
Cause of Death Narrative
Descripción

Cause of Death Narrative

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0007465
UMLS CUI [1,2]
C1521902
CRF comment
Descripción

comment

Tipo de datos

text

Alias
UMLS CUI [1]
C0947611
Pregnancy Report
Descripción

Pregnancy Report

Alias
UMLS CUI-1
C0032961
UMLS CUI-2
C0684224
Pregnancy occured during study?
Descripción

Pregnancy occured during study?

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3828490
Last Menstruation (Start Date)
Descripción

Last Menstruation date

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0025344
UMLS CUI [1,2]
C0808070
Expected Date of Birth
Descripción

Expected Date of Birth

Tipo de datos

date

Alias
UMLS CUI [1]
C2825543
Method of Contraception
Descripción

Contraceptive method

Tipo de datos

integer

Alias
UMLS CUI [1]
C0700589
Kind of Other Method
Descripción

Other contraceptive method

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0700589
UMLS CUI [1,2]
C0205394
Number of Previous Pregnancies
Descripción

Number of Previous Pregnancies

Tipo de datos

integer

Alias
UMLS CUI [1]
C0422807
Number of Births
Descripción

Number of Births

Tipo de datos

integer

Alias
UMLS CUI [1]
C3172256
Number of Spontaneous Miscarriages
Descripción

Number of Spontaneous Miscarriages

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0429916
UMLS CUI [1,2]
C0205359
Number of Others
Descripción

Number of Others

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C0449788
If Others, please specify
Descripción

Specify other

Tipo de datos

text

Alias
UMLS CUI [1]
C3845569
CRF comment
Descripción

comment

Tipo de datos

text

Alias
UMLS CUI [1]
C0947611
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Similar models

Cumulative

8 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Administrative Information
C1320722 (UMLS CUI-1)
Patient Caption
Item
Patient Caption
text
C2825231 (UMLS CUI [1,1])
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])
Item Group
Adverse Event
C0877248 (UMLS CUI-1)
Adverse event number
Item
AE No.
text
C0877248 (UMLS CUI [1,1])
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])
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])
AE ongoing
Item
AE ongoing at end of study
boolean
C2826663 (UMLS CUI [1])
Item
Intensity of AE
integer
C1710066 (UMLS CUI [1])
AE intensity
Code List
Intensity of AE
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])
Relationship to ATM / AVI
Code List
Relationship to ATM / AVI
CL Item
related (1)
CL Item
unrelated (2)
Treatment required?
Item
Treatment required?
boolean
C2981656 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
Item
Kind of treatment
integer
C0087111 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Treatment type
Code List
Kind of treatment
CL Item
Medication Therapy (1)
CL Item
Non-Medication Therapy (2)
Item
Action taken with drug
integer
C1704758 (UMLS CUI [1])
Action taken with drug
Code List
Action taken with drug
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])
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])
Specify Procedure
Item
Specify Procedure
text
C0008976 (UMLS CUI [1,1])
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])
Item
Outcome of Event
integer
C1705586 (UMLS CUI [1])
Event outcome
Code List
Outcome of Event
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)
Item Group
Serious Adverse Event (SAE)
C1519255 (UMLS CUI-1)
C0684224 (UMLS CUI-2)
Seriousness
Item
Seriousness
boolean
C1710056 (UMLS CUI [1])
SAE Number
Item
SAE Number
text
C1519255 (UMLS CUI [1,1])
C2349022 (UMLS CUI [1,2])
Start date SAE
Item
Date AE turned serious
date
C2697888 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Start time SAE
Item
Time AE turned serious
time
C1519255 (UMLS CUI [1,1])
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])
End date of SAE
Item
End date of SAE
date
C0806020 (UMLS CUI [1,1])
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])
Item
Outcome of SAE
integer
C1705586 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Outcome
Code List
Outcome of SAE
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])
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])
Seriousness criteria or reportable reason
Code List
Seriousness criteria or reportable reason
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])
Derivated AE Diagnosis
Item
Derivated AE Diagnosis
text
C1511731 (UMLS CUI [1,1])
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])
comment
Item
CRF comment
text
C0947611 (UMLS CUI [1])
Item Group
Prior and Concomitant Other Medication
C2826257 (UMLS CUI-1)
C2347852 (UMLS CUI-2)
Concomitant or Prior Medication
Item
Concomitant or Prior Medication
boolean
C2826257 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Sequence number
Item
No
integer
C2348184 (UMLS CUI [1])
Pharmaceutical Preparations
Item
Medication
text
C0013227 (UMLS CUI [1])
Item
Reason for Therapy
integer
C3146298 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Indication
Code List
Reason for Therapy
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])
Line number Medical History Form
Item
Referring Line on Medical History Form
integer
C0025102 (UMLS CUI [1,1])
C2348184 (UMLS CUI [1,2])
Total daily dose
Item
Total daily dose
integer
C2348070 (UMLS CUI [1,1])
C1511559 (UMLS CUI [1,2])
Unit
Item
Unit
text
C0439148 (UMLS CUI [1])
Item
Route
integer
C0013153 (UMLS CUI [1])
Administration Route
Code List
Route
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])
Start Date
Item
Start Date
date
C0013227 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Start date unknown
Item
Unknown
boolean
C0808070 (UMLS CUI [1,1])
C0439673 (UMLS CUI [1,2])
End Date
Item
End Date
date
C0013227 (UMLS CUI [1,1])
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)
Concomitant or Prior Medication
Item
Concomitant or Prior Medication
boolean
C2826257 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Sequence number
Item
No
integer
C2348184 (UMLS CUI [1])
Pharmaceutical Preparations
Item
Medication
text
C0013227 (UMLS CUI [1])
Item
Reason for Therapy
integer
C3146298 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Indication
Code List
Reason for Therapy
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])
Line number Medical History Form
Item
Referring Line on Medical History Form
integer
C0025102 (UMLS CUI [1,1])
C2348184 (UMLS CUI [1,2])
Total daily dose
Item
Total daily dose
integer
C2348070 (UMLS CUI [1,1])
C1511559 (UMLS CUI [1,2])
Unit
Item
Unit
text
C0439148 (UMLS CUI [1])
Item
Route
integer
C0013153 (UMLS CUI [1])
Administration Route
Code List
Route
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])
Start Date
Item
Start Date
date
C0013227 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Start date unknown
Item
Unknown
boolean
C0808070 (UMLS CUI [1,1])
C0439673 (UMLS CUI [1,2])
End Date
Item
End Date
date
C0013227 (UMLS CUI [1,1])
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)
Study Drug Discontinued
Item
Study Drug Prematurely and Permanently Discontinued?
boolean
C0457454 (UMLS CUI [1,1])
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])
Time of Discontinuation
Item
Time of Study Drug Discontinuation
time
C0457454 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Item
Reason for Discontinuation
integer
C0392360 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
Reason for Discontinuation
Code List
Reason for Discontinuation
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])
comment
Item
CRF comment
text
C0947611 (UMLS CUI [1])
Item Group
Completion / Withdrawal from Study
C2349954 (UMLS CUI-1)
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])
Was Subject prematurely withdrawn from Study?
Item
Was Subject prematurely withdrawn from Study?
boolean
C0422727 (UMLS CUI [1,1])
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])
Main reason for premature withdrawal
Code List
Main reason for premature withdrawal
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])
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])
comment
Item
CRF comment
text
C0947611 (UMLS CUI [1])
Item Group
Death Report
C0011065 (UMLS CUI-1)
C1516308 (UMLS CUI-2)
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])
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])
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])
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])
comment
Item
CRF comment
text
C0947611 (UMLS CUI [1])
Item Group
Pregnancy Report
C0032961 (UMLS CUI-1)
C0684224 (UMLS CUI-2)
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])
Expected Date of Birth
Item
Expected Date of Birth
date
C2825543 (UMLS CUI [1])
Item
Method of Contraception
integer
C0700589 (UMLS CUI [1])
Contraceptive method
Code List
Method of Contraception
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])
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])
Number of Others
Item
Number of Others
integer
C0205394 (UMLS CUI [1,1])
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])
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