ID

32101

Beschreibung

Study ID: 109563 Clinical Study ID: 109563 Study Title: COMPAS:A phase III study to demonstrate efficacy of GSK Biologicals' 10-valent pneumococcal vaccine (GSK1024850A) against Community Acquired Pneumonia and Acute Otitis Media Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00466947; https://clinicaltrials.gov/ct2/show/NCT00466947 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Pneumococcal Polysaccharide Conjugate Vaccine (Adsorbed) Trade Name: BIO 10PN-PD-DIT; Synflorix Study Indication: Infections, Streptococcal The Study consists of three workbooks. Workbook 1: Argentina, all subjects + immuno & reacto subset Workbook 2: Panama, all subjects + immuno & reacto subset + carriage subset + additional immuno subset Workbook 3: Colombia, all subjects The protocol number for all workbooks: 109563 (10Pn-PD-DiT-028) There are ten visits in workbook 1 and 2, eight for workbook 3 (there are no visits 4 and 7): Visit 1: month 0, dose 1, 6-16 weeks of age Visit 2: month 2, dose 2, +/- 4 months of age, 49-83 days after visit 1 Visit 3: month 4, dose 3, +/- 6 months of age, 49-83 days after visit 2 Visit 4: month 5, +/- 7 months of age, 28-42 days after visit 3. Only for immuno & reacto subset + carriage subset. Visit 5: month 10-13, 12-15 months of age Visit 6: month 13-16, booster dose, 15-18 months of age, ≥ 28 days after visit 5 Visit 7: month 14-17, 16-19 months of age, 28-42 days after visit 6. Only for immuno & reacto subset, additional immuno subset + carriage subset. Visit 8: month 16-19, 18-21 months of age, ≥ 28 days after visit 6 Visit 9: month 22-25, 24-27 months of age Visit 10: Contact This document contains the invasive diseases (ID) form. It has to be filled in if an ID was confirmed during study. It's for all workbooks for visit 1-9

Link

https://clinicaltrials.gov/ct2/show/NCT00466947

Stichworte

Versionen (1)
  1. 17.10.18 17.10.18 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

17. Oktober 2018

DOI

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Lizenz

Creative Commons BY-NC 3.0
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Vaccination against pneumonia and otitis media, NCT00466947

Englisch

Invasive Disease (ID)

1 Formulare  
  1. StudyEvent: ODM
    1. Invasive Disease (ID)
Administrative data
Beschreibung

Administrative data

Alias
UMLS CUI-1
C1320722
Subject number
Beschreibung

Subject number

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Date of ID case
Beschreibung

Date by when the ID was diagnosed or by when the positive culture was ordered

Datentyp

date

Alias
UMLS CUI [1,1]
C4285937
UMLS CUI [1,2]
C0011008
Workbook number
Beschreibung

Workbook number

Datentyp

integer

Alias
UMLS CUI [1]
C2986015
Case number
Beschreibung

Case number

Datentyp

text

Alias
UMLS CUI [1,1]
C1698493
UMLS CUI [1,2]
C0600091
Health care facilities
Beschreibung

Health care facilities

Alias
UMLS CUI-1
C0018704
In which health care facilities Invasive Disease (ID) was detected? Ambulatory / Outpatient
Beschreibung

ID detected in health care falicilies: Ambulatory / Outpatient

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0018704
UMLS CUI [1,2]
C4285937
UMLS CUI [1,3]
C1511790
UMLS CUI [2,1]
C0439841
UMLS CUI [2,2]
C0029921
In which health care facilities Invasive Disease (ID) was detected? Emergency room
Beschreibung

ID detected in health care falicilies: Emergency room

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0018704
UMLS CUI [1,2]
C4285937
UMLS CUI [1,3]
C1511790
UMLS CUI [2]
C0583237
In which health care facilities Invasive Disease (ID) was detected? Hospital
Beschreibung

ID detected in health care falicilies: Hospital

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0018704
UMLS CUI [1,2]
C4285937
UMLS CUI [1,3]
C1511790
UMLS CUI [2]
C0019994
In which health care facilities Invasive Disease (ID) was detected? Other
Beschreibung

ID detected in health care falicilies: other

Datentyp

text

Alias
UMLS CUI [1,1]
C0018704
UMLS CUI [1,2]
C4285937
UMLS CUI [1,3]
C1511790
UMLS CUI [2]
C0205394
Has the patient been hospitalized due to this ID case?
Beschreibung

Hospital stay

Datentyp

boolean

Alias
UMLS CUI [1]
C3489408
If there was a stay in hospital please give the number of days
Beschreibung

Not necessarily consecutive days

Datentyp

integer

Alias
UMLS CUI [1]
C3694481
Has the patient been hospitalized in the Intensive Care Unit (ICU) due to this ID case?
Beschreibung

Stay in hospital in ICU

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3489408
UMLS CUI [1,2]
C0021708
If there was a stay in hospital in ICU please give the number of days
Beschreibung

Not necessarily consecutive days

Datentyp

integer

Alias
UMLS CUI [1]
C3694481
Chest x-ray
Beschreibung

Chest x-ray

Alias
UMLS CUI-1
C0039985
Has a chest X-Ray been performed in the context of a suspected CAP?
Beschreibung

If yes please fill in the CAP section

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0039985
UMLS CUI [1,2]
C1518965
UMLS CUI [1,3]
C0242114
UMLS CUI [1,4]
C0694549
Laboratory tests: bacteriology normally sterile body fluid culture
Beschreibung

Laboratory tests: bacteriology normally sterile body fluid culture

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0367249
Has a NSBF been cultured? If yes please complete the table below, list all applicable
Beschreibung

NSBF culture

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0205307
UMLS CUI [1,2]
C0232920
UMLS CUI [1,3]
C0005889
UMLS CUI [2]
C0430400
NSBF
Beschreibung

NSBF

Datentyp

integer

Alias
UMLS CUI [1,1]
C0205307
UMLS CUI [1,2]
C0232920
UMLS CUI [1,3]
C0005889
Other NSBF, please specify
Beschreibung

Other NSBF, specify

Datentyp

text

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C0205307
UMLS CUI [1,3]
C0232920
UMLS CUI [1,4]
C0005889
Date of NSBF
Beschreibung

Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0205307
UMLS CUI [1,3]
C0232920
UMLS CUI [1,4]
C0005889
Antibiotic administered within the 3 days before culture?
Beschreibung

Antibiotic administered

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0338237
UMLS CUI [1,2]
C0332152
UMLS CUI [1,3]
C0430400
Culture result. If positive please tick the following list
Beschreibung

Culture result

Datentyp

integer

Alias
UMLS CUI [1,1]
C0430400
UMLS CUI [1,2]
C1274040
Associated pathogen(s) if positive culture
Beschreibung

Reminder: If identification of Haemophilus influenzae or Streptococcus pneumoniae, please send a sample to Reference Lab for confirmation.

Datentyp

integer

Alias
UMLS CUI [1]
C0450254
Other pathogens, specify
Beschreibung

Other pathogens, specify

Datentyp

text

Alias
UMLS CUI [1,1]
C0450254
UMLS CUI [1,2]
C0205394
Sample Code
Beschreibung

Sample Code

Datentyp

text

Alias
UMLS CUI [1,1]
C0200345
UMLS CUI [1,2]
C0805701
CLINICAL DIAGNOSIS OF INVASIVE DISEASE (ID)
Beschreibung

CLINICAL DIAGNOSIS OF INVASIVE DISEASE (ID)

Alias
UMLS CUI-1
C0332140
UMLS CUI-2
C4285937
What kind of Invasive disease is this case?
Beschreibung

If "with focus" please tick following clinical syndrome(s)

Datentyp

integer

Alias
UMLS CUI [1,1]
C0332307
UMLS CUI [1,2]
C4285937
With focus → Which clinical syndrome(s)? Bacteremic pneumonia
Beschreibung

Reminder: (*) Please complete the CAP section.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0205210
UMLS CUI [1,2]
C0039082
UMLS CUI [1,3]
C0521009
UMLS CUI [1,4]
C0032285
With focus → Which clinical syndrome(s)? Meningitis
Beschreibung

Reminder: (**) Please complete an SAE report, the meningitis report and the lumbar puncture part.

Datentyp

boolean

Alias
UMLS CUI [1]
C0025289
With focus → Which clinical syndrome(s)? Empyema
Beschreibung

Clinical syndrome: Empyema

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0205210
UMLS CUI [1,2]
C0039082
UMLS CUI [1,3]
C0014009
With focus → Which clinical syndrome(s)? Septic arthritis
Beschreibung

Clinical syndrome: Septic arthritis

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0205210
UMLS CUI [1,2]
C0039082
UMLS CUI [1,3]
C0333534
UMLS CUI [1,4]
C0003864
With focus → Which clinical syndrome(s)? Peritonitis
Beschreibung

Clinical syndrome: Peritonitis

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0205210
UMLS CUI [1,2]
C0039082
UMLS CUI [1,3]
C0031154
With focus → Which clinical syndrome(s)? Osteomyelitis
Beschreibung

Clinical syndrome: Osteomyelitis

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0205210
UMLS CUI [1,2]
C0039082
UMLS CUI [1,3]
C0029443
With focus → Which clinical syndrome(s)? Pericarditis
Beschreibung

Clinical syndrome: Pericarditis

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0205210
UMLS CUI [1,2]
C0039082
UMLS CUI [1,3]
C0031046
With focus → Which clinical syndrome(s)? Infection of soft tissues
Beschreibung

Clinical syndrome: Infection of soft tissues

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0205210
UMLS CUI [1,2]
C0039082
UMLS CUI [1,3]
C0149778
Please confirm, that there is more than one focus
Beschreibung

Number of clinical syndromes

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0205210
UMLS CUI [1,2]
C0039082
UMLS CUI [1,3]
C0750480
CLINICAL SEVERITY OF ID BASED ON SIRS
Beschreibung

CLINICAL SEVERITY OF ID BASED ON SIRS

Alias
UMLS CUI-1
C0439793
UMLS CUI-2
C4285937
UMLS CUI-3
C0242966
Does the child meet the concensus definition of Systemic Inflammatory Response Syndrome (SIRS) as mentioned in the protocol?
Beschreibung

Definition of Systemic Inflammatory Response Syndrome (SIRS)

Datentyp

integer

Alias
UMLS CUI [1,1]
C0242966
UMLS CUI [1,2]
C0442825
UMLS CUI [1,3]
C1507394
SEPSIS
Beschreibung

SEPSIS

Alias
UMLS CUI-1
C0243026
Does the child meet one of the sepsis categories defined in the protocol?
Beschreibung

If yes, please tick following boxes

Datentyp

integer

Alias
UMLS CUI [1,1]
C0243026
UMLS CUI [1,2]
C0683312
UMLS CUI [1,3]
C0442825
UMLS CUI [1,4]
C1507394
Which SEPSIS
Beschreibung

only one box must be ticked

Datentyp

integer

Alias
UMLS CUI [1,1]
C0243026
UMLS CUI [1,2]
C0332307
MEDICATION
Beschreibung

MEDICATION

Alias
UMLS CUI-1
C0013227
Has any medication been administered due to this ID case?
Beschreibung

If yes please complete the following table.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C4285937
Trade/Generic name of medication
Beschreibung

Trade/Generic name of medication

Datentyp

text

Alias
UMLS CUI [1]
C2360065
Reason for medication
Beschreibung

Reason for medication

Datentyp

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0013227
Route of medication
Beschreibung

Route of medication

Datentyp

text

Alias
UMLS CUI [1]
C0013153
Total daily dose
Beschreibung

Total daily dose

Datentyp

float

Alias
UMLS CUI [1]
C2348070
Start date of medication
Beschreibung

Start date of medication

Datentyp

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0808070
End date of medication
Beschreibung

tick following box if continuing

Datentyp

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0806020
Medication continuing
Beschreibung

Medication continuing

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0549178
LUMBAR PUNCTURE
Beschreibung

LUMBAR PUNCTURE

Alias
UMLS CUI-1
C0007806
Was a lumbar puncture been performed?
Beschreibung

Lumbar puncture performance

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0007806
UMLS CUI [1,2]
C1518965
Date of puncture
Beschreibung

Date of puncture

Datentyp

date

Alias
UMLS CUI [1,1]
C0037943
UMLS CUI [1,2]
C0011008
Result clear
Beschreibung

Result: CSF appearance: Clear

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1274040
UMLS CUI [1,2]
C0007806
UMLS CUI [1,3]
C2963144
Results turbid
Beschreibung

Result: CSF appearance: Turbid

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1274040
UMLS CUI [1,2]
C0007806
UMLS CUI [1,3]
C0311420
Results purulent
Beschreibung

Result: CSF appearance: purulent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1274040
UMLS CUI [1,2]
C0007806
UMLS CUI [1,3]
C0439665
Results hematic
Beschreibung

Result: CSF appearance: Hematic

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1274040
UMLS CUI [1,2]
C0007806
UMLS CUI [1,3]
C0333275
WBC count in CSF: Total
Beschreibung

WBC count in CSF: Total

Datentyp

float

Maßeinheiten
  • x 10^6/L
Alias
UMLS CUI [1,1]
C0023508
UMLS CUI [1,2]
C0007806
x 10^6/L
WBC count in CSF: Polymorphonuclears (PMNs)
Beschreibung

WBC count in CSF: Polymorphonuclears (PMNs)

Datentyp

float

Maßeinheiten
  • x 10^6/L
Alias
UMLS CUI [1,1]
C1168338
UMLS CUI [1,2]
C0007806
x 10^6/L
WBC count in CSF: Lymphocytes
Beschreibung

WBC count in CSF: Lymphocytes

Datentyp

float

Maßeinheiten
  • x 10^6/L
Alias
UMLS CUI [1,1]
C0200635
UMLS CUI [1,2]
C0007806
x 10^6/L
RBC count in CSF: Total
Beschreibung

RBC count in CSF: Total

Datentyp

float

Maßeinheiten
  • x 10^6/L
Alias
UMLS CUI [1,1]
C0014772
UMLS CUI [1,2]
C0007806
x 10^6/L
Protein content, CSF
Beschreibung

Protein content

Datentyp

float

Maßeinheiten
  • g/L
Alias
UMLS CUI [1,1]
C0555903
UMLS CUI [1,2]
C0007806
g/L
Glucose content, CSF
Beschreibung

Please tick unit of measure

Datentyp

float

Alias
UMLS CUI [1,1]
C0337438
UMLS CUI [1,2]
C0007806
Unit of glucose content, CSF
Beschreibung

Unit of measure, glucose content

Datentyp

integer

Alias
UMLS CUI [1,1]
C0337438
UMLS CUI [1,2]
C0007806
Plasma glucose concentration
Beschreibung

Please tick unit of measure

Datentyp

float

Alias
UMLS CUI [1,1]
C0202042
UMLS CUI [1,2]
C1446561
Unit of plasma glucose concentration
Beschreibung

Unit of measure, plasma glucose concentration

Datentyp

integer

Alias
UMLS CUI [1,1]
C0202042
UMLS CUI [1,2]
C1446561
% plasma glucose concentration
Beschreibung

% plasma glucose concentration

Datentyp

float

Maßeinheiten
  • %
Alias
UMLS CUI [1]
C0369269
%
Binax
Beschreibung

Binax

Datentyp

integer

Alias
UMLS CUI [1,1]
C0430022
UMLS CUI [1,2]
C0032269
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Ähnliche Modelle

Invasive Disease (ID)

1 Formulare
  1. StudyEvent: ODM
    1. Invasive Disease (ID)
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Subject number
Item
Subject number
text
C2348585 (UMLS CUI [1])
Date of ID case
Item
Date of ID case
date
C4285937 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Workbook number
integer
C2986015 (UMLS CUI [1])
Workbook number
Code List
Workbook number
CL Item
workbook 1  (1)
CL Item
workbook 2  (2)
CL Item
workbook 3 (3)
Case number
Item
Case number
text
C1698493 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Item Group
Health care facilities
C0018704 (UMLS CUI-1)
ID detected in health care falicilies: Ambulatory / Outpatient
Item
In which health care facilities Invasive Disease (ID) was detected? Ambulatory / Outpatient
boolean
C0018704 (UMLS CUI [1,1])
C4285937 (UMLS CUI [1,2])
C1511790 (UMLS CUI [1,3])
C0439841 (UMLS CUI [2,1])
C0029921 (UMLS CUI [2,2])
ID detected in health care falicilies: Emergency room
Item
In which health care facilities Invasive Disease (ID) was detected? Emergency room
boolean
C0018704 (UMLS CUI [1,1])
C4285937 (UMLS CUI [1,2])
C1511790 (UMLS CUI [1,3])
C0583237 (UMLS CUI [2])
ID detected in health care falicilies: Hospital
Item
In which health care facilities Invasive Disease (ID) was detected? Hospital
boolean
C0018704 (UMLS CUI [1,1])
C4285937 (UMLS CUI [1,2])
C1511790 (UMLS CUI [1,3])
C0019994 (UMLS CUI [2])
ID detected in health care falicilies: other
Item
In which health care facilities Invasive Disease (ID) was detected? Other
text
C0018704 (UMLS CUI [1,1])
C4285937 (UMLS CUI [1,2])
C1511790 (UMLS CUI [1,3])
C0205394 (UMLS CUI [2])
Hospital stay
Item
Has the patient been hospitalized due to this ID case?
boolean
C3489408 (UMLS CUI [1])
Days in hospital
Item
If there was a stay in hospital please give the number of days
integer
C3694481 (UMLS CUI [1])
Stay in hospital in ICU
Item
Has the patient been hospitalized in the Intensive Care Unit (ICU) due to this ID case?
boolean
C3489408 (UMLS CUI [1,1])
C0021708 (UMLS CUI [1,2])
Days in hospital, ICU
Item
If there was a stay in hospital in ICU please give the number of days
integer
C3694481 (UMLS CUI [1])
Item Group
Chest x-ray
C0039985 (UMLS CUI-1)
Chest x-ray performance
Item
Has a chest X-Ray been performed in the context of a suspected CAP?
boolean
C0039985 (UMLS CUI [1,1])
C1518965 (UMLS CUI [1,2])
C0242114 (UMLS CUI [1,3])
C0694549 (UMLS CUI [1,4])
Item Group
Laboratory tests: bacteriology normally sterile body fluid culture
C0022885 (UMLS CUI-1)
C0367249 (UMLS CUI-2)
NSBF culture
Item
Has a NSBF been cultured? If yes please complete the table below, list all applicable
boolean
C0205307 (UMLS CUI [1,1])
C0232920 (UMLS CUI [1,2])
C0005889 (UMLS CUI [1,3])
C0430400 (UMLS CUI [2])
Item
NSBF
integer
C0205307 (UMLS CUI [1,1])
C0232920 (UMLS CUI [1,2])
C0005889 (UMLS CUI [1,3])
NSBF
Code List
NSBF
CL Item
Blood (1)
CL Item
CSF (Cerebrospinal fluid) (2)
CL Item
Pleural fluid (3)
CL Item
Synovial fluid (4)
CL Item
Peritoneal fluid (5)
CL Item
Pericardial fluid (6)
CL Item
Other (7)
Other NSBF, specify
Item
Other NSBF, please specify
text
C0205394 (UMLS CUI [1,1])
C0205307 (UMLS CUI [1,2])
C0232920 (UMLS CUI [1,3])
C0005889 (UMLS CUI [1,4])
Date
Item
Date of NSBF
date
C0011008 (UMLS CUI [1,1])
C0205307 (UMLS CUI [1,2])
C0232920 (UMLS CUI [1,3])
C0005889 (UMLS CUI [1,4])
Antibiotic administered
Item
Antibiotic administered within the 3 days before culture?
boolean
C0338237 (UMLS CUI [1,1])
C0332152 (UMLS CUI [1,2])
C0430400 (UMLS CUI [1,3])
Item
Culture result. If positive please tick the following list
integer
C0430400 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Culture result
Code List
Culture result. If positive please tick the following list
CL Item
Positive (1)
CL Item
Negative (2)
Item
Associated pathogen(s) if positive culture
integer
C0450254 (UMLS CUI [1])
Associated pathogen(s) if positive culture
Code List
Associated pathogen(s) if positive culture
CL Item
Streptococcus pneumoniae (1)
CL Item
Haemophilus influenzae (2)
CL Item
other (3)
Other pathogens, specify
Item
Other pathogens, specify
text
C0450254 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Sample Code
Item
Sample Code
text
C0200345 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
Item Group
CLINICAL DIAGNOSIS OF INVASIVE DISEASE (ID)
C0332140 (UMLS CUI-1)
C4285937 (UMLS CUI-2)
Item
What kind of Invasive disease is this case?
integer
C0332307 (UMLS CUI [1,1])
C4285937 (UMLS CUI [1,2])
Kind of Invasive disease
Code List
What kind of Invasive disease is this case?
CL Item
Without obvious focus (Bacteremia) (1)
CL Item
With focus (2)
Clinical syndrome: Bacteremic pneumonia
Item
With focus → Which clinical syndrome(s)? Bacteremic pneumonia
boolean
C0205210 (UMLS CUI [1,1])
C0039082 (UMLS CUI [1,2])
C0521009 (UMLS CUI [1,3])
C0032285 (UMLS CUI [1,4])
Clinical syndrome: Meningitis
Item
With focus → Which clinical syndrome(s)? Meningitis
boolean
C0025289 (UMLS CUI [1])
Clinical syndrome: Empyema
Item
With focus → Which clinical syndrome(s)? Empyema
boolean
C0205210 (UMLS CUI [1,1])
C0039082 (UMLS CUI [1,2])
C0014009 (UMLS CUI [1,3])
Clinical syndrome: Septic arthritis
Item
With focus → Which clinical syndrome(s)? Septic arthritis
boolean
C0205210 (UMLS CUI [1,1])
C0039082 (UMLS CUI [1,2])
C0333534 (UMLS CUI [1,3])
C0003864 (UMLS CUI [1,4])
Clinical syndrome: Peritonitis
Item
With focus → Which clinical syndrome(s)? Peritonitis
boolean
C0205210 (UMLS CUI [1,1])
C0039082 (UMLS CUI [1,2])
C0031154 (UMLS CUI [1,3])
Clinical syndrome: Osteomyelitis
Item
With focus → Which clinical syndrome(s)? Osteomyelitis
boolean
C0205210 (UMLS CUI [1,1])
C0039082 (UMLS CUI [1,2])
C0029443 (UMLS CUI [1,3])
Clinical syndrome: Pericarditis
Item
With focus → Which clinical syndrome(s)? Pericarditis
boolean
C0205210 (UMLS CUI [1,1])
C0039082 (UMLS CUI [1,2])
C0031046 (UMLS CUI [1,3])
Clinical syndrome: Infection of soft tissues
Item
With focus → Which clinical syndrome(s)? Infection of soft tissues
boolean
C0205210 (UMLS CUI [1,1])
C0039082 (UMLS CUI [1,2])
C0149778 (UMLS CUI [1,3])
Number of clinical syndromes
Item
Please confirm, that there is more than one focus
boolean
C0205210 (UMLS CUI [1,1])
C0039082 (UMLS CUI [1,2])
C0750480 (UMLS CUI [1,3])
Item Group
CLINICAL SEVERITY OF ID BASED ON SIRS
C0439793 (UMLS CUI-1)
C4285937 (UMLS CUI-2)
C0242966 (UMLS CUI-3)
Item
Does the child meet the concensus definition of Systemic Inflammatory Response Syndrome (SIRS) as mentioned in the protocol?
integer
C0242966 (UMLS CUI [1,1])
C0442825 (UMLS CUI [1,2])
C1507394 (UMLS CUI [1,3])
Definition of Systemic Inflammatory Response Syndrome (SIRS)
Code List
Does the child meet the concensus definition of Systemic Inflammatory Response Syndrome (SIRS) as mentioned in the protocol?
CL Item
No (1)
CL Item
Yes (2)
CL Item
Data not available/ not done (3)
Item Group
SEPSIS
C0243026 (UMLS CUI-1)
Item
Does the child meet one of the sepsis categories defined in the protocol?
integer
C0243026 (UMLS CUI [1,1])
C0683312 (UMLS CUI [1,2])
C0442825 (UMLS CUI [1,3])
C1507394 (UMLS CUI [1,4])
undefined item
Code List
Does the child meet one of the sepsis categories defined in the protocol?
CL Item
No (1)
CL Item
Yes  (2)
CL Item
Data not available/ not done (3)
Item
Which SEPSIS
integer
C0243026 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Which SEPSIS
Code List
Which SEPSIS
CL Item
Sepsis (1)
CL Item
Severe sepsis (2)
CL Item
Septic shock (3)
Item Group
MEDICATION
C0013227 (UMLS CUI-1)
Medication administrated to ID
Item
Has any medication been administered due to this ID case?
boolean
C0013227 (UMLS CUI [1,1])
C4285937 (UMLS CUI [1,2])
Trade/Generic name of medication
Item
Trade/Generic name of medication
text
C2360065 (UMLS CUI [1])
Reason for medication
Item
Reason for medication
text
C0392360 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Route of medication
Item
Route of medication
text
C0013153 (UMLS CUI [1])
Total daily dose
Item
Total daily dose
float
C2348070 (UMLS CUI [1])
Start date of medication
Item
Start date of medication
date
C0013227 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
End date of medication
Item
End date of medication
date
C0013227 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Medication continuing
Item
Medication continuing
boolean
C0013227 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Item Group
LUMBAR PUNCTURE
C0007806 (UMLS CUI-1)
Lumbar puncture performance
Item
Was a lumbar puncture been performed?
boolean
C0007806 (UMLS CUI [1,1])
C1518965 (UMLS CUI [1,2])
Date of puncture
Item
Date of puncture
date
C0037943 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Result: CSF appearance: Clear
Item
Result clear
boolean
C1274040 (UMLS CUI [1,1])
C0007806 (UMLS CUI [1,2])
C2963144 (UMLS CUI [1,3])
Result: CSF appearance: Turbid
Item
Results turbid
boolean
C1274040 (UMLS CUI [1,1])
C0007806 (UMLS CUI [1,2])
C0311420 (UMLS CUI [1,3])
Result: CSF appearance: purulent
Item
Results purulent
boolean
C1274040 (UMLS CUI [1,1])
C0007806 (UMLS CUI [1,2])
C0439665 (UMLS CUI [1,3])
Result: CSF appearance: Hematic
Item
Results hematic
boolean
C1274040 (UMLS CUI [1,1])
C0007806 (UMLS CUI [1,2])
C0333275 (UMLS CUI [1,3])
WBC count in CSF: Total
Item
WBC count in CSF: Total
float
C0023508 (UMLS CUI [1,1])
C0007806 (UMLS CUI [1,2])
WBC count in CSF: Polymorphonuclears (PMNs)
Item
WBC count in CSF: Polymorphonuclears (PMNs)
float
C1168338 (UMLS CUI [1,1])
C0007806 (UMLS CUI [1,2])
WBC count in CSF: Lymphocytes
Item
WBC count in CSF: Lymphocytes
float
C0200635 (UMLS CUI [1,1])
C0007806 (UMLS CUI [1,2])
RBC count in CSF: Total
Item
RBC count in CSF: Total
float
C0014772 (UMLS CUI [1,1])
C0007806 (UMLS CUI [1,2])
Protein content
Item
Protein content, CSF
float
C0555903 (UMLS CUI [1,1])
C0007806 (UMLS CUI [1,2])
Glucose content
Item
Glucose content, CSF
float
C0337438 (UMLS CUI [1,1])
C0007806 (UMLS CUI [1,2])
Item
Unit of glucose content, CSF
integer
C0337438 (UMLS CUI [1,1])
C0007806 (UMLS CUI [1,2])
Unit of measure, glucose content
Code List
Unit of glucose content, CSF
CL Item
mmol/L (1)
CL Item
g/L (2)
Plasma glucose concentration
Item
Plasma glucose concentration
float
C0202042 (UMLS CUI [1,1])
C1446561 (UMLS CUI [1,2])
Item
Unit of plasma glucose concentration
integer
C0202042 (UMLS CUI [1,1])
C1446561 (UMLS CUI [1,2])
Unit of measure, plasma glucose concentration
Code List
Unit of plasma glucose concentration
CL Item
g/L (1)
CL Item
mmol/L (2)
% plasma glucose concentration
Item
% plasma glucose concentration
float
C0369269 (UMLS CUI [1])
Item
Binax
integer
C0430022 (UMLS CUI [1,1])
C0032269 (UMLS CUI [1,2])
Binax
Code List
Binax
CL Item
Positive (1)
CL Item
Negative (2)
CL Item
Not done (3)
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