ID

22993

Beschrijving

Study ID: 100484 Clinical Study ID: 100484 (DTPa) Study Title: An open prospective study of immunogenicity and reactogenicity of DTPa vaccine (Infanrix) given as a booster to healthy school children 10 to 12 years of age Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 4 Study Recruitment Status: Completed Generic Name: Diphtheria, Tetanus, Acellular Pertussis Vaccine Adsorbed Trade Name: BIO DTPA (INFANRIX); Infanrix Study Indication: Acellular Pertussis; Diphtheria; Tetanus; acellular pertussis Documentation: Dose 1

Trefwoorden

Pertussis-Vakzine

Symptombewertung

19-06-17 19-06-17 -

Houder van rechten

GlaxoSmithKline

Geüploaded op

19 juni 2017

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY-NC 3.0

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Dose 1: GSK DTPa vaccine (Infanrix) 100484

model
Details

Study ID: 100484 Dose 1

StudyEvent: ODM
1. Study ID: 100484 Dose 1

Name

Type

Description | Question | Decode (Coded Value)

Datatype

Alias

Solicited Adverse Events - Local Symptoms

Item Group

Solicited Adverse Events - Local Symptoms

C0877248 (UMLS CUI-1)
C1457887 (UMLS CUI-2)
C0042196 (UMLS CUI-3)

signs/symptoms at the administration site

Item

Has the subject experienced any of the following signs/symptoms at the administration site during the solicited period?

text

C1457887 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1515974 (UMLS CUI [2,1])
C0042196 (UMLS CUI [2,2])

signs/symptoms at the administration site

Code List

Has the subject experienced any of the following signs/symptoms at the administration site during the solicited period?

CL Item

Information not retrievable (1)

CL Item

No (2)

CL Item

Yes, please tick No/Yes for each symptom. If Yes is ticked, please complete all items. (3)

Redness

Item

Redness

boolean

C0332575 (UMLS CUI [1,1])
C2700396 (UMLS CUI [1,2])

Redness

Item

Redness, size (mm)

float

C0332575 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])

Redness on Day 0

Item

Redness on Day 0

float

C0332575 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])

Redness on Day 1

Item

Redness on Day 1

float

C0332575 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])

Redness on Day 2

Item

Redness on Day 2

float

C0332575 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])

Redness on Day 3

Item

Redness on Day 3

float

C0332575 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])

Redness ongoing after day 3

Item

Redness ongoing after day 3?

boolean

C0332575 (UMLS CUI [1,1])
C2700396 (UMLS CUI [1,2])

Date of last day of symptoms

Item

Date of last day of symptoms

date

C0011008 (UMLS CUI [1,1])
C0332575 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])

Medical advice

Item

Medical advice

boolean

C1386497 (UMLS CUI [1])
C0332575 (UMLS CUI [2])

Medical advice Type

Item

Medical advice Type

text

C0332307 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C0332575 (UMLS CUI [2])

Medical advice Type

Code List

Medical advice Type

CL Item

Hospitalization (HO)

CL Item

Emergency room (ER)

CL Item

Medical doctor (MD)

Swelling

Item

Swelling

boolean

C0038999 (UMLS CUI [1,1])
C2700396 (UMLS CUI [1,2])

Swelling

Item

Swelling, size (mm)

float

C0038999 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])

Swelling on Day 0

Item

Swelling on Day 0

float

C0038999 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])

Swelling on Day 1

Item

Swelling on Day 1

float

C0038999 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])

Swelling on Day 2

Item

Swelling on Day 2

float

C0038999 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])

Swelling on Day 3

Item

Swelling on Day 3

float

C0038999 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])

Swelling ongoing after day 3

Item

Swelling ongoing after day 3?

boolean

C0038999 (UMLS CUI [1,1])
C2700396 (UMLS CUI [1,2])

Date of last day of symptoms

Item

Date of last day of symptoms

date

C0011008 (UMLS CUI [1,1])
C0038999 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])

Medical advice

Item

Medical advice

boolean

C1386497 (UMLS CUI [1])
C0038999 (UMLS CUI [2])

Medical advice Type

Item

Medical advice Type

text

C0332307 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C0038999 (UMLS CUI [2])

Medical advice Type

Code List

Medical advice Type

CL Item

Hospitalization (HO)

CL Item

Emergency room (ER)

CL Item

Medical doctor (MD)

Pain

Item

Pain

boolean

C0030193 (UMLS CUI [1,1])
C2700396 (UMLS CUI [1,2])

Item

Pain, intensity

integer

C0030193 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])

Code List

Pain, intensity

CL Item

None (0)

CL Item

Mild (1)

CL Item

Moderate (2)

CL Item

Severe (3)

Item

Pain on Day 0

integer

C0030193 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])

Code List

Pain on Day 0

CL Item

None (0)

CL Item

Mild (1)

CL Item

Moderate (2)

CL Item

Severe (3)

Item

Pain on Day 1

integer

C0030193 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])

Code List

Pain on Day 1

CL Item

None (0)

CL Item

Mild (1)

CL Item

Moderate (2)

CL Item

Severe (3)

Item

Pain on Day 2

integer

C0030193 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])

Code List

Pain on Day 2

CL Item

None (0)

CL Item

Mild (1)

CL Item

Moderate (2)

CL Item

Severe (3)

Item

Pain on Day 3

integer

C0030193 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])

Code List

Pain on Day 3

CL Item

None (0)

CL Item

Mild (1)

CL Item

Moderate (2)

CL Item

Severe (3)

Pain ongoing after day 3

Item

Pain ongoing after day 3?

boolean

C0030193 (UMLS CUI [1,1])
C2700396 (UMLS CUI [1,2])

Date of last day of symptoms

Item

Date of last day of symptoms

date

C0011008 (UMLS CUI [1,1])
C0030193 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])

Medical advice

Item

Medical advice

boolean

C1386497 (UMLS CUI [1])
C0030193 (UMLS CUI [2])

Medical advice Type

Item

Medical advice Type

text

C0332307 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C0030193 (UMLS CUI [2])

Medical advice Type

Code List

Medical advice Type

CL Item

Hospitalization (HO)

CL Item

Emergency room (ER)

CL Item

Medical doctor (MD)

Fever

Item

Fever

boolean

C0015967 (UMLS CUI [1])

Fever

Item

Fever

float

C0015967 (UMLS CUI [1])

Site of measurement

Item

Fever, Site of measurement

text

C0449687 (UMLS CUI [1,1])
C0015967 (UMLS CUI [1,2])

Site of measurement

Code List

Fever, Site of measurement

CL Item

Axillary (A)

CL Item

Oral (O)

CL Item

Rectal (R)

Item

Fever on Day 0

integer

C0015967 (UMLS CUI [1])

Code List

Fever on Day 0

CL Item

taken (1)

CL Item

not taken (2)

Fever on Day 0

Item

Fever on Day 0

float

C0005903 (UMLS CUI [1,1])
C0015967 (UMLS CUI [1,2])

Item

Fever on Day 1

integer

C0015967 (UMLS CUI [1])

Code List

Fever on Day 1

CL Item

taken (1)

CL Item

not taken (2)

Fever on Day 1

Item

Fever on Day 1

float

C0005903 (UMLS CUI [1,1])
C0015967 (UMLS CUI [1,2])

Item

Fever on Day 2

integer

C0015967 (UMLS CUI [1])

Code List

Fever on Day 2

CL Item

taken (1)

CL Item

not taken (2)

Fever on Day 2

Item

Fever on Day 2

float

C0005903 (UMLS CUI [1,1])
C0015967 (UMLS CUI [1,2])

Item

Fever on Day 3

integer

C0015967 (UMLS CUI [1])

Code List

Fever on Day 3

CL Item

taken (1)

CL Item

not taken (2)

Fever on Day 3

Item

Fever on Day 3

float

C0005903 (UMLS CUI [1,1])
C0015967 (UMLS CUI [1,2])

Fever ongoing after day 3

Item

Fever ongoing after day 3?

boolean

C0015967 (UMLS CUI [1])

Date of last day of symptoms

Item

Date of last day of symptoms

date

C0011008 (UMLS CUI [1,1])
C0015967 (UMLS CUI [1,2])

Causality

Item

Causality?

boolean

C0015127 (UMLS CUI [1])
C0015967 (UMLS CUI [2])

Medical advice

Item

Medical advice

boolean

C1386497 (UMLS CUI [1])
C0015967 (UMLS CUI [2])

Medical advice Type

Item

Medical advice Type

text

C0332307 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C0015967 (UMLS CUI [2])

Medical advice Type

Code List

Medical advice Type

CL Item

Hospitalization (HO)

CL Item

Emergency room (ER)

CL Item

Medical doctor (MD)

Fatigue

Item

Fatigue

boolean

C0015672 (UMLS CUI [1])

Item

Fatigue, Intensity

integer

C0522510 (UMLS CUI [1,1])
C0015672 (UMLS CUI [1,2])

Code List

Fatigue, Intensity

CL Item

None (0)

CL Item

Mild (1)

CL Item

Moderate (2)

CL Item

Severe (3)

Fatigue on Day 0

Item

Fatigue on Day 0

integer

C0015672 (UMLS CUI [1])

Code List

Fatigue on Day 0

CL Item

None (0)

CL Item

Mild (1)

CL Item

Moderate (2)

CL Item

Severe (3)

Fatigue on Day 1

Item

Fatigue on Day 1

integer

C0015672 (UMLS CUI [1])

Code List

Fatigue on Day 1

CL Item

None (0)

CL Item

Mild (1)

CL Item

Moderate (2)

CL Item

Severe (3)

Fatigue on Day 2

Item

Fatigue on Day 2

integer

C0015672 (UMLS CUI [1])

Code List

Fatigue on Day 2

CL Item

None (0)

CL Item

Mild (1)

CL Item

Moderate (2)

CL Item

Severe (3)

Fatigue on Day 3

Item

Fatigue on Day 3

integer

C0015672 (UMLS CUI [1])

Code List

Fatigue on Day 3

CL Item

None (0)

CL Item

Mild (1)

CL Item

Moderate (2)

CL Item

Severe (3)

Fatigue ongoing after day 3

Item

Fatigue ongoing after day 3?

boolean

C0015672 (UMLS CUI [1])

Date of last day of symptoms

Item

Date of last day of symptoms

date

C0011008 (UMLS CUI [1,1])
C0015672 (UMLS CUI [1,2])

Causality

Item

Causality?

boolean

C0015127 (UMLS CUI [1])
C0015672 (UMLS CUI [2])

Medical advice

Item

Medical advice

boolean

C1386497 (UMLS CUI [1])
C0015672 (UMLS CUI [2])

Medical advice Type

Item

Medical advice Type

text

C0332307 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C0015672 (UMLS CUI [2])

Medical advice Type

Code List

Medical advice Type

CL Item

Hospitalization (HO)

CL Item

Emergency room (ER)

CL Item

Medical doctor (MD)

Headache

Item

Headache

boolean

C0018681 (UMLS CUI [1])

Item

Headache, Intensity

integer

C0522510 (UMLS CUI [1,1])
C0018681 (UMLS CUI [1,2])

Code List

Headache, Intensity

CL Item

None (0)

CL Item

Mild (1)

CL Item

Moderate (2)

CL Item

Severe (3)

Headache on Day 0

Item

Headache on Day 0

integer

C0018681 (UMLS CUI [1])

Code List

Headache on Day 0

CL Item

None (0)

CL Item

Mild (1)

CL Item

Moderate (2)

CL Item

Severe (3)

Headache on Day 1

Item

Headache on Day 1

integer

C0018681 (UMLS CUI [1])

Code List

Headache on Day 1

CL Item

None (0)

CL Item

Mild (1)

CL Item

Moderate (2)

CL Item

Severe (3)

Headache on Day 2

Item

Headache on Day 2

integer

C0018681 (UMLS CUI [1])

Code List

Headache on Day 2

CL Item

None (0)

CL Item

Mild (1)

CL Item

Moderate (2)

CL Item

Severe (3)

Headache on Day 3

Item

Headache on Day 3

integer

C0018681 (UMLS CUI [1])

Code List

Headache on Day 3

CL Item

None (0)

CL Item

Mild (1)

CL Item

Moderate (2)

CL Item

Severe (3)

Headache ongoing after day 3

Item

Headache ongoing after day 3?

boolean

C0018681 (UMLS CUI [1])

Date of last day of symptoms

Item

Date of last day of symptoms

date

C0011008 (UMLS CUI [1,1])
C0018681 (UMLS CUI [1,2])

Causality

Item

Causality

boolean

C0015127 (UMLS CUI [1])
C0018681 (UMLS CUI [2])

Medical advice

Item

Medical advice

boolean

C1386497 (UMLS CUI [1])
C0018681 (UMLS CUI [2])

Medical advice Type

Item

Medical advice Type

text

C0332307 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C0018681 (UMLS CUI [2])

Medical advice Type

Code List

Medical advice Type

CL Item

Hospitalization (HO)

CL Item

Emergency room (ER)

CL Item

Medical doctor (MD)

Nausea

Item

Nausea

boolean

C0027497 (UMLS CUI [1])

Item

Nausea, Intensity

integer

C0522510 (UMLS CUI [1,1])
C0027497 (UMLS CUI [1,2])

Code List

Nausea, Intensity

CL Item

None (0)

CL Item

Mild (1)

CL Item

Moderate (2)

CL Item

Severe (3)

Nausea on Day 0

Item

Nausea on Day 0

integer

C0027497 (UMLS CUI [1])

Code List

Nausea on Day 0

CL Item

None (0)

CL Item

Mild (1)

CL Item

Moderate (2)

CL Item

Severe (3)

Nausea on Day 1

Item

Nausea on Day 1

integer

C0027497 (UMLS CUI [1])

Code List

Nausea on Day 1

CL Item

None (0)

CL Item

Mild (1)

CL Item

Moderate (2)

CL Item

Severe (3)

Nausea on Day 2

Item

Nausea on Day 2

integer

C0027497 (UMLS CUI [1])

Code List

Nausea on Day 2

CL Item

None (0)

CL Item

Mild (1)

CL Item

Moderate (2)

CL Item

Severe (3)

Nausea on Day 3

Item

Nausea on Day 3

integer

C0027497 (UMLS CUI [1])

Code List

Nausea on Day 3

CL Item

None (0)

CL Item

Mild (1)

CL Item

Moderate (2)

CL Item

Severe (3)

Nausea ongoing after day 3

Item

Nausea ongoing after day 3?

boolean

C0027497 (UMLS CUI [1])

Date of last day of symptoms

Item

Date of last day of symptoms

date

C0011008 (UMLS CUI [1,1])
C0027497 (UMLS CUI [1,2])

Causality

Item

Causality?

boolean

C0015127 (UMLS CUI [1])
C0027497 (UMLS CUI [2])

Medical advice

Item

Medical advice

boolean

C1386497 (UMLS CUI [1])
C0027497 (UMLS CUI [2])

Medical advice Type

Item

Medical advice Type

text

C0332307 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C0027497 (UMLS CUI [2])

Medical advice Type

Code List

Medical advice Type

CL Item

Hospitalization (HO)

CL Item

Emergency room (ER)

CL Item

Medical doctor (MD)

General feeling of being ill

Item

General feeling of being ill

boolean

C0231218 (UMLS CUI [1])

General feeling of being ill

Item

General feeling of being ill, Intensity

integer

C0522510 (UMLS CUI [1,1])
C0231218 (UMLS CUI [1,2])

Code List

General feeling of being ill, Intensity

CL Item

None (0)

CL Item

Mild (1)

CL Item

Moderate (2)

CL Item

Severe (3)

General feeling of being ill on Day 0

Item

General feeling of being ill on Day 0

integer

C0231218 (UMLS CUI [1])

Code List

General feeling of being ill on Day 0

CL Item

None (0)

CL Item

Mild (1)

CL Item

Moderate (2)

CL Item

Severe (3)

General feeling of being ill on Day 1

Item

General feeling of being ill on Day 1

integer

C0231218 (UMLS CUI [1])

Code List

General feeling of being ill on Day 1

CL Item

None (0)

CL Item

Mild (1)

CL Item

Moderate (2)

CL Item

Severe (3)

General feeling of being ill on Day 2

Item

General feeling of being ill on Day 2

integer

C0231218 (UMLS CUI [1])

Code List

General feeling of being ill on Day 2

CL Item

None (0)

CL Item

Mild (1)

CL Item

Moderate (2)

CL Item

Severe (3)

General feeling of being ill on Day 3

Item

General feeling of being ill on Day 3

integer

C0231218 (UMLS CUI [1])

Code List

General feeling of being ill on Day 3

CL Item

None (0)

CL Item

Mild (1)

CL Item

Moderate (2)

CL Item

Severe (3)

General feeling of being ill ongoing after day 3

Item

General feeling of being ill ongoing after day 3?

boolean

C0231218 (UMLS CUI [1])

Date of last day of symptoms

Item

Date of last day of symptoms

date

C0011008 (UMLS CUI [1,1])
C0231218 (UMLS CUI [1,2])

Causality

Item

Causality?

boolean

C0015127 (UMLS CUI [1])
C0231218 (UMLS CUI [2])

Medical advice

Item

Medical advice

boolean

C1386497 (UMLS CUI [1])
C0231218 (UMLS CUI [2])

Medical advice Type

Item

Medical advice Type

text

C0332307 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C0231218 (UMLS CUI [2])

Medical advice Type

Code List

Medical advice Type

CL Item

Hospitalization (HO)

CL Item

Emergency room (ER)

CL Item

Medical doctor (MD)

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