ID

32294

Descrição

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 https://clinicaltrials.gov/ct2/show/NCT00466947 Clinicaltrials.gov Identifier: 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 form of acute otitis media (AOM). It has to be filled in if an AOM case is confirmed during study. It's only for workbook 2.

Link

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

Palavras-chave

Akute Krankheit

Klinische Studie [Dokumenttyp]

D022242

Otitis Media

D011014

25/10/2018 25/10/2018 -
26/10/2018 26/10/2018 -

Titular dos direitos

GlaxoSmithKline

Transferido a

26 de outubro de 2018

DOI

Para um pedido faça login.

Licença

Creative Commons BY-NC 3.0

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Vaccination against pneumonia and otitis media, NCT00466947

model
Detalhes

AOM

1 Formulários

StudyEvent: ODM
1. AOM

Name

Tipo

Description | Question | Decode (Coded Value)

Tipo de dados

Alias

Administrative data

Item Group

Administrative data

C1320722 (UMLS CUI-1)

Subject number

Item

Subject number

text

C2348585 (UMLS CUI [1])

Date of AOM suspicion case

Item

Date of AOM suspicion case

date

C0205178 (UMLS CUI [1,1])
C0029882 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0242114 (UMLS CUI [1,4])

Case number

Item

Case number

integer

C1698493 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])

HEALTH CARE FACILITIES

Item Group

HEALTH CARE FACILITIES

C0018704 (UMLS CUI-1)

Health care facility: Ambulatory / Outpatient

Item

In which health care facilities Acute Otitis Media (AOM) was detected? Ambulatory / Outpatient

boolean

C1511790 (UMLS CUI [1,1])
C0205178 (UMLS CUI [1,2])
C0029882 (UMLS CUI [1,3])
C0018704 (UMLS CUI [1,4])
C0439841 (UMLS CUI [2])
C0029921 (UMLS CUI [3])

Health care facility: Emergency room

Item

In which health care facilities Acute Otitis Media (AOM) was detected? Emergency room

boolean

C1511790 (UMLS CUI [1,1])
C0205178 (UMLS CUI [1,2])
C0029882 (UMLS CUI [1,3])
C0018704 (UMLS CUI [1,4])
C0583237 (UMLS CUI [2])

Health care facility: Hospital

Item

In which health care facilities Acute Otitis Media (AOM) was detected? Hospital

boolean

C1511790 (UMLS CUI [1,1])
C0205178 (UMLS CUI [1,2])
C0029882 (UMLS CUI [1,3])
C0018704 (UMLS CUI [1,4])
C0019994 (UMLS CUI [2])

Health care facility: Other

Item

In which health care facilities Acute Otitis Media (AOM) was detected? Other

boolean

C1511790 (UMLS CUI [1,1])
C0205178 (UMLS CUI [1,2])
C0029882 (UMLS CUI [1,3])
C0018704 (UMLS CUI [1,4])
C0205394 (UMLS CUI [2])

Other health care facility

Item

If there is an other health care facility please specify

text

C0018704 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])

Hospitalization of patient during AOM case

Item

Has the patient been hospitalized due to this AOM case?

boolean

C0019993 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C0205178 (UMLS CUI [1,3])
C0029882 (UMLS CUI [1,4])

Number of days in hospital

Item

If the patient was hospitalized please note number of days

integer

C0019993 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C0439228 (UMLS CUI [1,3])

PRIMARY HEALTH CARE PHYSICIAN CLINICAL ASSESSMENT

Item Group

PRIMARY HEALTH CARE PHYSICIAN CLINICAL ASSESSMENT

C0033131 (UMLS CUI-1)
C3845884 (UMLS CUI-2)

Has a primary health care physician done an assessment?

Item

Has a primary health care physician done an assessment?

boolean

C0033131 (UMLS CUI [1,1])
C3845884 (UMLS CUI [1,2])

Clinical signs and symptoms

Item

Clinical signs and symptoms noted at the primary health care physician assessment

boolean

C0037088 (UMLS CUI [1,1])
C0033131 (UMLS CUI [1,2])
C1516048 (UMLS CUI [1,3])

visual appearance of the tympanic membrane (i.e. redness, bulging, loss of light reflex)

Item

The visual appearance of the tympanic membrane (i.e. redness, bulging, loss of light reflex)

boolean

C0037088 (UMLS CUI [1,1])
C0041445 (UMLS CUI [1,2])
C0700364 (UMLS CUI [1,3])
C0332575 (UMLS CUI [2])
C0857010 (UMLS CUI [3])
C0576887 (UMLS CUI [4])

middle ear fluid effusion (simple or pneumatic otoscopy or by microscopy)

Item

The presence of middle ear fluid effusion (as demonstrated by simple or pneumatic otoscopy or by microscopy)

boolean

C0037088 (UMLS CUI [1])
C0456498 (UMLS CUI [2])
C1112284 (UMLS CUI [3])
C0444678 (UMLS CUI [4])
C0026018 (UMLS CUI [5])

Symptoms: Fever

Item

Fever

boolean

C1457887 (UMLS CUI [1,1])
C0015967 (UMLS CUI [1,2])

Fever measurement

Item

If Fever, measurement

float

C0015967 (UMLS CUI [1,1])
C0242485 (UMLS CUI [1,2])

Measurement location

Item

measurement location/route

text

C0449687 (UMLS CUI [1,1])
C0005903 (UMLS CUI [1,2])

Measurement location

Code List

measurement location/route

CL Item

Axillary (A)

CL Item

Oral (O)

CL Item

Rectal (R)

Symptoms: Ear pain

Item

Ear pain

boolean

C1457887 (UMLS CUI [1,1])
C0013456 (UMLS CUI [1,2])

Symptoms: Ear discharge

Item

Ear discharge

boolean

C1457887 (UMLS CUI [1,1])
C0155540 (UMLS CUI [1,2])

Symptoms: Hearing loss

Item

Hearing loss

boolean

C1457887 (UMLS CUI [1,1])
C3887873 (UMLS CUI [1,2])

Symptoms: Lethargy

Item

Lethargy

boolean

C1457887 (UMLS CUI [1,1])
C0023380 (UMLS CUI [1,2])

Symptoms: Irritability

Item

Irritability

boolean

C1457887 (UMLS CUI [1,1])
C0022107 (UMLS CUI [1,2])

Symptoms: Anorexia

Item

Anorexia

boolean

C1457887 (UMLS CUI [1,1])
C0003123 (UMLS CUI [1,2])

Symptoms: Vomiting

Item

Vomiting

boolean

C1457887 (UMLS CUI [1,1])
C0042963 (UMLS CUI [1,2])

Symptoms: Diarrhoea

Item

Diarrhoea

boolean

C1457887 (UMLS CUI [1,1])
C0011991 (UMLS CUI [1,2])

PRIMARY HEALTH CARE PHYSICIAN ASSESSMENT OF AOM SEVERITY

Item Group

PRIMARY HEALTH CARE PHYSICIAN ASSESSMENT OF AOM SEVERITY

C0033131 (UMLS CUI-1)
C1516048 (UMLS CUI-2)
C0439793 (UMLS CUI-3)
C0205178 (UMLS CUI-4)
C0029882 (UMLS CUI-5)

Temperature

Item

Temperature

float

C0005903 (UMLS CUI [1])

Measurement location

Item

measurement location/route

text

C0449687 (UMLS CUI [1,1])
C0005903 (UMLS CUI [1,2])

Measurement location

Code List

measurement location/route

CL Item

Axillary (A)

CL Item

Oral (O)

CL Item

Rectal (R)

Irritability

Item

Irritability severity

integer

C0022107 (UMLS CUI [1,1])
C0439793 (UMLS CUI [1,2])

Irritability

Code List

Irritability severity

CL Item

Absent (1)

CL Item

Occasional (2)

CL Item

Frequent (3)

Severity of occasional/frequent

Item

If occasional/frequent, specify severity

integer

C0439793 (UMLS CUI [1])

Severity of occasional/frequent

Code List

If occasional/frequent, specify severity

CL Item

Mild (1)

CL Item

Moderate (2)

CL Item

Severe (3)

Ear Ache

Item

Ear Ache

integer

C0013456 (UMLS CUI [1])

undefined item

Code List

Ear Ache

CL Item

Absent (1)

CL Item

Occasional (2)

CL Item

Frequent (3)

Pulling at ears

Item

Tugging

integer

C0847233 (UMLS CUI [1])

Tugging

Code List

Tugging

CL Item

Absent (1)

CL Item

Mild (2)

CL Item

Moderate (3)

CL Item

Severe (4)

Feeding

Item

Feeding

integer

C0015745 (UMLS CUI [1])

Feeding

Code List

Feeding

CL Item

Feeds well (1)

CL Item

Mild (2)

CL Item

Very poor appetite (3)

Sleeping

Item

Sleeping

integer

C0474396 (UMLS CUI [1])

Sleeping

Code List

Sleeping

CL Item

Normal (1)

CL Item

Some restless (2)

CL Item

Very poor sleep (3)

CLINICAL SIGNS NOTED DURING OTOSCOPY AT THE ENT SPECIALIST ASSESSMENT

Item Group

CLINICAL SIGNS NOTED DURING OTOSCOPY AT THE ENT SPECIALIST ASSESSMENT

C0037088 (UMLS CUI-1)
C1112284 (UMLS CUI-2)
C0150934 (UMLS CUI-3)
C2348234 (UMLS CUI-4)
C3845884 (UMLS CUI-5)

ENT

Item

Was the child seen by ENT?

boolean

C0150934 (UMLS CUI [1])

visual appearance of the tympanic membrane (i.e. redness, bulging, loss of light reflex)

Item

The visual appearance of the tympanic membrane (i.e. redness, bulging, loss of light reflex)

boolean

C0037088 (UMLS CUI [1,1])
C0041445 (UMLS CUI [1,2])
C0700364 (UMLS CUI [1,3])
C0332575 (UMLS CUI [2])
C0857010 (UMLS CUI [3])
C0576887 (UMLS CUI [4])

middle ear fluid effusion (simple or pneumatic otoscopy or by microscopy)

Item

The presence of middle ear fluid effusion (as demonstrated by simple or pneumatic otoscopy or by microscopy)

boolean

C0037088 (UMLS CUI [1])
C0456498 (UMLS CUI [2])
C1112284 (UMLS CUI [3])
C0444678 (UMLS CUI [4])
C0026018 (UMLS CUI [5])

OTOSCOPY

Item Group

OTOSCOPY

C1112284 (UMLS CUI-1)

Side of otoscopy

Item

Side of otoscopy

text

C0441987 (UMLS CUI [1,1])
C1112284 (UMLS CUI [1,2])

Side of otoscopy

Code List

Side of otoscopy

CL Item

Right side (R)

CL Item

Left side (L)

AOM confirm

Item

Does the ENT specialist clinically confirm AOM?

boolean

C0205178 (UMLS CUI [1,1])
C0029882 (UMLS CUI [1,2])
C0750484 (UMLS CUI [1,3])

ENT ASSESSMENT

Item Group

ENT ASSESSMENT

C0150934 (UMLS CUI-1)
C1516048 (UMLS CUI-2)

Side of ENT assessment

Item

Side of ENT assessment

text

C0441987 (UMLS CUI [1,1])
C0150934 (UMLS CUI [1,2])
C1516048 (UMLS CUI [1,3])

Side of ENT assessment

Code List

Side of ENT assessment

CL Item

right (R)

CL Item

left (L)

Appearance of ENT assessment

Item

Appearance of ENT assessment

text

C1148438 (UMLS CUI [1,1])
C0150934 (UMLS CUI [1,2])
C1516048 (UMLS CUI [1,3])

Appearance of ENT assessment

Code List

Appearance of ENT assessment

CL Item

Redness (1)

CL Item

Bulging (2)

Severity of apperance

Item

Severity of apperance

text

C0439793 (UMLS CUI [1,1])
C1148438 (UMLS CUI [1,2])

Severity of apperance

Code List

Severity of apperance

CL Item

Absent (1)

CL Item

Mild (2)

CL Item

Moderate (3)

CL Item

Severe (4)

Spontaneous perforation

Item

Spontaneous perforation

boolean

C0205359 (UMLS CUI [1,1])
C0549099 (UMLS CUI [1,2])

GRADE

Item Group

GRADE

C0441800 (UMLS CUI-1)

Side of grade

Item

Side of grade

text

C0441987 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])

Side of grade

Code List

Side of grade

CL Item

right (R)

CL Item

left (L)

OS-8 Scale

Item

OS-8 Scale (Friedman/McCormick scale)

integer

C0681889 (UMLS CUI [1,1])
C0041445 (UMLS CUI [1,2])
C0441469 (UMLS CUI [1,3])

OS-8 Scale

Code List

OS-8 Scale (Friedman/McCormick scale)

CL Item

0 (0)

CL Item

1 (1)

CL Item

2 (2)

CL Item

3 (3)

CL Item

4 (4)

CL Item

5 (5)

CL Item

6 (6)

CL Item

7 (7)

EAR, NOSE AND THROAT (ENT) CLINICAL SPECIALIST ASSESSMENT

Item Group

EAR, NOSE AND THROAT (ENT) CLINICAL SPECIALIST ASSESSMENT

C0150934 (UMLS CUI-1)
C2348234 (UMLS CUI-2)
C3845884 (UMLS CUI-3)

Middle ear fluid (MEF) - side

Item

Middle ear fluid (MEF) - side

text

C0456498 (UMLS CUI [1,1])
C0441987 (UMLS CUI [1,2])

Middle ear fluid (MEF) - side

Code List

Middle ear fluid (MEF) - side

CL Item

right (R)

CL Item

left (L)

MEF sample collection

Item

Has a MEF sample been collected?

boolean

C0456498 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])

MEF sample collection, Date

Item

If MEF sample has been collected, date of Informed Consent

date

C0456498 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C0021430 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])

Way of MEF sample collection

Item

How has MEF sample been collected?

text

C0456498 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C0184661 (UMLS CUI [1,3])

Way of MEF sample collection

Code List

How has MEF sample been collected?

CL Item

Tympanocentesis (1)

CL Item

Spontaneous drainage (2)

Start of spontaneous drainage

Item

If spontaneous drainage, date by when it started

date

C0808070 (UMLS CUI [1,1])
C0205359 (UMLS CUI [1,2])
C0012621 (UMLS CUI [1,3])

Macroscopic aspect of fluid: Serous

Item

How was the macroscopic aspect of the fluid? Serous

boolean

C0456498 (UMLS CUI [1,1])
C0440743 (UMLS CUI [1,2])

Macroscopic aspect of fluid: Bloody

Item

How was the macroscopic aspect of the fluid? Bloody

boolean

C0456498 (UMLS CUI [1,1])
C0333275 (UMLS CUI [1,2])

Macroscopic aspect of fluid: Purulent

Item

How was the macroscopic aspect of the fluid? Purulent

boolean

C0456498 (UMLS CUI [1,1])
C0439665 (UMLS CUI [1,2])

Macroscopic aspect of fluid: Other

Item

How was the macroscopic aspect of the fluid? Other

boolean

C0456498 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])

Other macroscopic aspect of fluid

Item

If other macroscopic aspect of fluid

text

C0456498 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])

Results

Item

Results

integer

C1254595 (UMLS CUI [1])

Results

Code List

Results

CL Item

Negative (1)

CL Item

Positive (2)

Positive results

Item

If positive please tick that apply

integer

C1254595 (UMLS CUI [1])

Positive results

Code List

If positive please tick that apply

CL Item

Streptococcus pneumoniae (1)

CL Item

Haemophilus influenzae (2)

CL Item

Staphylococcus aureus (3)

CL Item

Streptococcus pyogenes (group A) (4)

CL Item

Moraxella Catarrhalis (5)

CL Item

Other (6)

Streptococcus pneumoniae, sample code

Item

Streptococcus pneumoniae, sample code

text

C0038410 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])

Haemophilus influenzae, sample code

Item

Haemophilus influenzae, sample code

text

C0018483 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])

Other results

Item

Other results

text

C0205394 (UMLS CUI [1,1])
C1254595 (UMLS CUI [1,2])

Antibiotic therapy

Item

Did the subject take antibiotic before the sample was obtained?

integer

C0338237 (UMLS CUI [1])

Antibiotic therapy

Code List

Did the subject take antibiotic before the sample was obtained?

CL Item

Yes (1)

CL Item

No (2)

CL Item

Unknown (3)

MEDICATION

Item Group

MEDICATION

C0013227 (UMLS CUI-1)

Medication AOM

Item

Has any medication been administered due to this AOM case?

boolean

C0205178 (UMLS CUI [1,1])
C0029882 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])

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

text

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])

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Vaccination against pneumonia and otitis media, NCT00466947

AOM

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Unidades de medida

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