ID

26168

Description

Study ID: 101223 Clinical Study ID: 101223 Study Title: Study to assess the lot-to-lot consistency of the production method of GSK Biologicals' DTPw-HBV/ Hib Kft. vaccine and to compare to GSK Biologicals' Tritanrix™-HepB/Hiberix™ vaccine, when administered as a primary vaccination course. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Haemophilus influenzae Type b Vaccine (KFT) Trade Name:Zilbrix/Hib Study Indication: Diphtheria; Haemophilus influenzae type b; Hepatitis B; Tetanus; Whole Cell Pertussis Documentation part: Visit 1, Day 0, Dose 1

Mots-clés

10/10/2017 10/10/2017 -

Détendeur de droits

GlaxoSmithKline

Téléchargé le

10 octobre 2017

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY-NC 3.0

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GSK Biologicals' DTPw-HBV/ Hib Kft. vaccine compared to GSK Biologicals' Tritanrix-HepB/Hiberix vaccine Visit 1 101223

model
Détails

Visit 1 GSK Biologicals' DTPw-HBV/ Hib Kft. vaccine compared to GSK Biologicals' Tritanrix-HepB/Hiberix vaccine 101223

1 Formulaires

StudyEvent: ODM
1. Visit 1 GSK Biologicals' DTPw-HBV/ Hib Kft. vaccine compared to GSK Biologicals' Tritanrix-HepB/Hiberix vaccine 101223

Name

Type

Description | Question | Decode (Coded Value)

Type de données

Alias

Informed Consent

Item Group

Informed Consent

C0021430 (UMLS CUI-1)
C1955348 (UMLS CUI-2)

Informed Consent Date

Item

Informed Consent Date

date

C0021430 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])

Demographics

Item Group

Demographics

C1704791 (UMLS CUI-1)
C1955348 (UMLS CUI-2)

Center number

Item

Center number

text

C1301943 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])

Date of birth

Item

Date of birth

date

C0421451 (UMLS CUI [1])

Gender

Item

Gender

text

C0079399 (UMLS CUI [1])

Gender

Code List

Gender

CL Item

Male (M)

CL Item

Female (F)

Race

Item

Race

integer

C0034510 (UMLS CUI [1])

Race

Code List

Race

CL Item

Black (1)

CL Item

Arabic/North African (4)

CL Item

White/Caucasian (2)

CL Item

East & South East Asian (5)

CL Item

South Asian (6)

CL Item

Other (9)

CL Item

American Hispanic (7)

CL Item

Japanese (8)

Race

Item

Other Race, please specify

text

C0034510 (UMLS CUI [1])

Height

Item

Height

integer

C0005890 (UMLS CUI [1])

Weight

Item

Weight

float

C0005910 (UMLS CUI [1])

Eligibility Question

Item Group

Eligibility Question

C1516637 (UMLS CUI-1)
C0042210 (UMLS CUI-2)

Did the subject meet all the entry criteria?

Item

Did the subject meet all the entry criteria?

boolean

C1516637 (UMLS CUI [1])

Inclusion Criteria

Item

Inclusion Criteria

integer

C1512693 (UMLS CUI [1])

Inclusion Criteria

Code List

Inclusion Criteria

CL Item

Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits) should be enrolled in the study. (1)

CL Item

A male or female between, and including, 6 and 10 weeks of age at the time of the first vaccination. (2)

CL Item

Written informed consent obtained from the parent or guardian of the subject. (3)

CL Item

Free of obvious health problems as established by medical history and clinical examination before entering into the study. (4)

CL Item

Born after a normal gestation period (between 36 and 42 weeks (5)

CL Item

For Venezuela and Argentina: born to a mother proven seronegative for HBsAg (6)

CL Item

For Venezuela and Argentina: results of maternal blood sample assayed for the presence of (7)

CL Item

HBsAg must be available before the infant can be enrolled in the study. (8)

CL Item

For Venezuela and Argentina: written Informed consent will be obtained from the mothers in (8)

CL Item

case the prenatal screening is done at the study site. (10)

Exclusion Criteria

Item

Exclusion Criteria

integer

C0680251 (UMLS CUI [1])

Exclusion Criteria

Code List

Exclusion Criteria

CL Item

Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the vaccination, or planned use during the study period. (9)

CL Item

Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth, (10)

CL Item

Any chronic drug therapy to be continued during the study. (11)

CL Item

Planned administration/ administration of a vaccine not foreseen by the study protocol during the period from 30 days before each dose of vaccine and ending 30 days after each dose. (12)

CL Item

Bacille Calmette-Guérin (BCG) vaccine given after the first 2 weeks of life. (13)

CL Item

Previous vaccination against diphtheria, tetanus, pertussis, hepatitis B, H. influenzae or poliomyelitis. (14)

CL Item

History of diphtheria, tetanus, pertussis, hepatitis B, polio or Hib disease (15)

CL Item

Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection. (16)

CL Item

A family history of congenital or hereditary immunodeficiency. (17)

CL Item

History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s). (18)

CL Item

Major congenital defects or serious chronic illness (19)

CL Item

History of any neurologic disorders or seizures. (20)

CL Item

Acute disease at the time of enrolment. (Acute disease is defined as the presence of a moderate or severe illness with or without fever. All vaccines can be administered to persons with a minor illness such as diarrhea, mild upper respiratory infection with or without low-grade febrile illness, i.e. rectal temperature <38°C/ axillary temperature ≥ 37.5°C). (21)

CL Item

Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period. (22)

CL Item

Other conditions which in the opinion of the investigator may potentially interfere with interpretation of study outcomes (23)

Record treatment number

Item

Record treatment number

text

C1522541 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])

General Medical History / Physical Examination

Item Group

General Medical History / Physical Examination

C0262926 (UMLS CUI-1)
C0031809 (UMLS CUI-2)
C0042210 (UMLS CUI-3)

pre-existing conditions or signs and/or symptoms

Item

Are you aware of any pre-existing conditions or signs and/or symptoms present in the subject prior to the start of the study?

boolean

C0262926 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])

Cutaneous disease

Item

Cutaneous: Diagnosis

text

C0037274 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])

Cutaneous disease

Item

Cutaneous disease

integer

C0037274 (UMLS CUI [1])

Cutaneous disease

Code List

Cutaneous disease

CL Item

Past (1)

CL Item

Current (2)

Disorder of eye

Item

Eyes: Diagnosis

text

C0015397 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])

Disorder of eye

Item

Disorder of eye

integer

C0015397 (UMLS CUI [1])

Cutaneous disease

Code List

Disorder of eye

CL Item

Past (1)

CL Item

Current (2)

Ears-nose-throat disorder

Item

Ears-nose-throat: Diagnosis

text

C0395797 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])

Ears-nose-throat disorder

Item

Ears-nose-throat disorder

integer

C0395797 (UMLS CUI [1])

Cutaneous disease

Code List

Ears-nose-throat disorder

CL Item

Past (1)

CL Item

Current (2)

Cardiovascular disorder

Item

Cardiovascular: Diagnosis

text

C0007222 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])

Cardiovascular disorder

Item

Cardiovascular disorder

integer

C0007222 (UMLS CUI [1])

Cutaneous disease

Code List

Cardiovascular disorder

CL Item

Past (1)

CL Item

Current (2)

Respiratory disorder

Item

Respiratory: Diagnosis

text

C0035204 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])

Respiratory disorder

Item

Respiratory disorder

integer

C0035204 (UMLS CUI [1])

Cutaneous disease

Code List

Respiratory disorder

CL Item

Past (1)

CL Item

Current (2)

Gastrointestinal disorder

Item

Gastrointestinal: Diagnosis

text

C0017178 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])

Gastrointestinal disorder

Item

Gastrointestinal disorder

integer

C0017178 (UMLS CUI [1])

Cutaneous disease

Code List

Gastrointestinal disorder

CL Item

Past (1)

CL Item

Current (2)

Musculoskeletal disorder

Item

Muskuloskeletal: Diagnosis

text

C0026857 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])

Musculoskeletal disorder

Item

Musculoskeletal disorder

integer

C0026857 (UMLS CUI [1])

Cutaneous disease

Code List

Musculoskeletal disorder

CL Item

Past (1)

CL Item

Current (2)

Neurological disorder

Item

Neurological: Diagnosis

text

C0027765 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])

Neurological disorder

Item

Neurological disorder

integer

C0027765 (UMLS CUI [1])

Cutaneous disease

Code List

Neurological disorder

CL Item

Past (1)

CL Item

Current (2)

Genitourinary disorder

Item

Genitourinary: Diagnosis

text

C0080276 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])

Genitourinary disorder

Item

Genitourinary disorder

integer

C0080276 (UMLS CUI [1])

Cutaneous disease

Code List

Genitourinary disorder

CL Item

Past (1)

CL Item

Current (2)

Hematology disorder

Item

Haematology: Diagnosis

text

C0018939 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])

Hematology disorder

Item

Hematology disorder

integer

C0018939 (UMLS CUI [1])

Cutaneous disease

Code List

Hematology disorder

CL Item

Past (1)

CL Item

Current (2)

Allergies

Item

Allergies: Diagnosis

text

C0020517 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])

Allergies

Item

Allergies

integer

C0020517 (UMLS CUI [1])

Cutaneous disease

Code List

Allergies

CL Item

Past (1)

CL Item

Current (2)

Endocrine disorder

Item

Endocrine: Diagnosis

text

C0014130 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])

Endocrine disorder

Item

Endocrine disorder

integer

C0014130 (UMLS CUI [1])

Cutaneous disease

Code List

Endocrine disorder

CL Item

Past (1)

CL Item

Current (2)

Persistent Crying

Item

Persistent Crying (crying continuous and unaltered for over 3 hours): Diagnosis

text

C2721683 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])

Persistent Crying

Item

Persistent Crying (crying continuous and unaltered for over 3 hours)

integer

C2721683 (UMLS CUI [1])

Cutaneous disease

Code List

Persistent Crying (crying continuous and unaltered for over 3 hours)

CL Item

Past (1)

CL Item

Current (2)

Other disorder

Item

Other disorder, please specify

text

C0012634 (UMLS CUI [1])

Other disorder

Item

Other disorder

integer

C0012634 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])

Cutaneous disease

Code List

Other disorder

CL Item

Past (1)

CL Item

Current (2)

Laboratory tests

Item Group

Laboratory tests

C0022885 (UMLS CUI-1)

Subject number

Item

Subject number

integer

C2348585 (UMLS CUI [1])

Blood sample

Item

Has a blood sample been taken?

boolean

C0005834 (UMLS CUI [1])

Collection Date

Item

Date blood sample was taken

date

C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])

Vaccine Administration, Tritanrix-Hep B/Hiberix group

Item Group

Vaccine Administration, Tritanrix-Hep B/Hiberix group

C2368628 (UMLS CUI-1)
C2240392 (UMLS CUI-2)

Date of Vaccine Administration

Item

Date of Vaccine Administration

date

C2368628 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])

Pre-Vaccination temperature

Item

Pre-Vaccination temperature:

float

C0005903 (UMLS CUI [1])

Pre-Vaccination temperature Route

Item

Pre-Vaccination temperature Route:

integer

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

Vaccine Administration

Code List

Pre-Vaccination temperature Route:

CL Item

None (0)

CL Item

Mild (1)

CL Item

Moderate (2)

CL Item

Severe (3)

Vaccine Administration

Item

Vaccine Administration

integer

C2368628 (UMLS CUI [1])

Vaccine Administration

Code List

Vaccine Administration

CL Item

DTPw-HBV/Hib Kft. Vaccine (1)

CL Item

Replacement vial (2)

CL Item

Wrong vial number (3)

CL Item

Not administered (4)

Wrong vial number

Item

Wrong vial number

integer

C0184301 (UMLS CUI [1])

Replacement vial

Item

Replacement vial

integer

C0184301 (UMLS CUI [1,1])
C0559956 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,3])

reason for non administration

Item

Please tick the major reason for non administration

integer

C1533734 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])

reason for non administration

Code List

Please tick the major reason for non administration

CL Item

Serious adverse event (1)

CL Item

Non-Serious adverse event (2)

CL Item

Other (3)

Serious adverse event Number

Item

Serious adverse event Number

integer

C1519255 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])

Non-serious adverse event Number

Item

Non-serious adverse event Number

integer

C1518404 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])

reason for non administration

Item

reason for non administration, if other please specify

text

C1533734 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])

non administration

Item

Please tick who made the decision

integer

C1533734 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])

non administration

Code List

Please tick who made the decision

CL Item

Investigator (1)

CL Item

Parents/Guardians (2)

Administration Side

Item

Administration Side

text

C0441987 (UMLS CUI [1,1])
C0013153 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])

Administration Site

Item

Administration Site

text

C1515974 (UMLS CUI [1,1])
C0013153 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])

Administration Route

Item

Administration Route

text

C0013153 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])

Study vaccine Administration

Item

Has the study vaccine been administered according to the Protocol ?

boolean

C2368628 (UMLS CUI [1])

Study vaccine Administration Side

Item

Study vaccine Administration: Side

integer

C0441987 (UMLS CUI [1,1])
C0013153 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])

Study vaccine Administration

Code List

Study vaccine Administration: Side

CL Item

Left (1)

CL Item

Right (2)

Study vaccine Administration Site

Item

Study vaccine Administration: Site

integer

C1515974 (UMLS CUI [1,1])
C0013153 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])

Study vaccine Administration Site

Code List

Study vaccine Administration: Site

CL Item

Deltoid (1)

CL Item

Thigh (2)

CL Item

Buttock (3)

Study vaccine Administration Route

Item

Study vaccine Administration: Route

integer

C0013153 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])

Study vaccine Administration Route

Code List

Study vaccine Administration: Route

CL Item

I.M. (1)

CL Item

S.C. (2)

Vaccine administration

Item

Vaccine administration

integer

C2368628 (UMLS CUI [1])

Vaccine administration

Code List

Vaccine administration

CL Item

OPV Vaccine (1)

CL Item

Not administered (2)

Administration Route

Item

Administration Route

integer

C0013153 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])

Administration Route

Code List

Administration Route

CL Item

Oral (1)

Study vaccine Administration

Item

Has the study vaccine been administered according to the Protocol ? (OPV Vaccine)

boolean

C2368628 (UMLS CUI [1])

Vaccine Administration, Triple Antigen + Hiberix group

Item Group

Vaccine Administration, Triple Antigen + Hiberix group

C2368628 (UMLS CUI-1)
C0042196 (UMLS CUI-2)
C2240392 (UMLS CUI-3)

Date of Vaccine Administration

Item

Date of Vaccine Administration

date

C2368628 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])

Pre-Vaccination temperature

Item

Pre-Vaccination temperature:

float

C0005903 (UMLS CUI [1])

Pre-Vaccination temperature Route

Item

Pre-Vaccination temperature Route:

integer

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

Vaccine Administration

Code List

Pre-Vaccination temperature Route:

CL Item

None (0)

CL Item

Mild (1)

CL Item

Moderate (2)

CL Item

Severe (3)

Vaccine Administration

Item

Vaccine Administration

integer

C2368628 (UMLS CUI [1])

Vaccine Administration

Code List

Vaccine Administration

CL Item

Triple Antigen Vaccine (1)

CL Item

Replacement vial (2)

CL Item

Wrong vial number (3)

CL Item

Not administered (4)

Wrong vial number

Item

Wrong vial number

integer

C0184301 (UMLS CUI [1])

Replacement vial

Item

Replacement vial

integer

C0184301 (UMLS CUI [1,1])
C0559956 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,3])

reason for non administration

Item

Please tick the major reason for non administration

integer

C1533734 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])

reason for non administration

Code List

Please tick the major reason for non administration

CL Item

Serious adverse event (1)

CL Item

Non-Serious adverse event (2)

CL Item

Other (3)

Serious adverse event Number

Item

Serious adverse event Number

integer

C1519255 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])

Non-serious adverse event Number

Item

Non-serious adverse event Number

integer

C1518404 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])

reason for non administration

Item

reason for non administration, if other please specify

text

C1533734 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])

non administration

Item

Please tick who made the decision

integer

C1533734 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])

non administration

Code List

Please tick who made the decision

CL Item

Investigator (1)

CL Item

Parents/Guardians (2)

Administration Side

Item

Administration Side

text

C0441987 (UMLS CUI [1,1])
C0013153 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])

Administration Site

Item

Administration Site

text

C1515974 (UMLS CUI [1,1])
C0013153 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])

Administration Route

Item

Administration Route

text

C0013153 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])

Study vaccine Administration

Item

Has the study vaccine been administered according to the Protocol ?

boolean

C2368628 (UMLS CUI [1])

Study vaccine Administration Side

Item

Study vaccine Administration: Side

integer

C0441987 (UMLS CUI [1,1])
C0013153 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])

Study vaccine Administration

Code List

Study vaccine Administration: Side

CL Item

Left (1)

CL Item

Right (2)

Study vaccine Administration Site

Item

Study vaccine Administration: Site

integer

C1515974 (UMLS CUI [1,1])
C0013153 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])

Study vaccine Administration Site

Code List

Study vaccine Administration: Site

CL Item

Deltoid (1)

CL Item

Thigh (2)

CL Item

Buttock (3)

Study vaccine Administration Route

Item

Study vaccine Administration: Route

integer

C0013153 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])

Study vaccine Administration Route

Code List

Study vaccine Administration: Route

CL Item

I.M. (1)

CL Item

S.C. (2)

Vaccine administration

Item

Vaccine administration

integer

C2368628 (UMLS CUI [1])

Vaccine administration

Code List

Vaccine administration

CL Item

OPV Vaccine (1)

CL Item

Not administered (2)

Administration Route

Item

Administration Route

integer

C0013153 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])

Administration Route

Code List

Administration Route

CL Item

Oral (1)

Study vaccine Administration

Item

Has the study vaccine been administered according to the Protocol ? (OPV Vaccine)

boolean

C2368628 (UMLS CUI [1])

Vaccine Administration, Triple Antigen + Hiberix group

Item Group

Vaccine Administration, Triple Antigen + Hiberix group

C2368628 (UMLS CUI-1)
C0042196 (UMLS CUI-2)
C2240392 (UMLS CUI-3)

Vaccine Administration

Item

Vaccine Administration

integer

C2368628 (UMLS CUI [1])

Vaccine Administration

Code List

Vaccine Administration

CL Item

Hiberix Vaccine (1)

CL Item

Replacement vial (2)

CL Item

Wrong vial number (3)

CL Item

Not administered (4)

Wrong vial number

Item

Wrong vial number

integer

C0184301 (UMLS CUI [1])

Replacement vial

Item

Replacement vial

integer

C0184301 (UMLS CUI [1,1])
C0559956 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,3])

reason for non administration

Item

Please tick the major reason for non administration

integer

C1533734 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])

reason for non administration

Code List

Please tick the major reason for non administration

CL Item

Serious adverse event (1)

CL Item

Non-Serious adverse event (2)

CL Item

Other (3)

Serious adverse event Number

Item

Serious adverse event Number

integer

C1519255 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])

Non-serious adverse event Number

Item

Non-serious adverse event Number

integer

C1518404 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])

reason for non administration

Item

reason for non administration, if other please specify

text

C1533734 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])

non administration

Item

Please tick who made the decision

integer

C1533734 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])

non administration

Code List

Please tick who made the decision

CL Item

Investigator (1)

CL Item

Parents/Guardians (2)

Administration Side

Item

Administration Side

text

C0441987 (UMLS CUI [1,1])
C0013153 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])

Administration Site

Item

Administration Site

text

C1515974 (UMLS CUI [1,1])
C0013153 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])

Administration Route

Item

Administration Route

text

C0013153 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])

Study vaccine Administration

Item

Has the study vaccine been administered according to the Protocol ?

boolean

C2368628 (UMLS CUI [1])

Study vaccine Administration Side

Item

Study vaccine Administration: Side

integer

C0441987 (UMLS CUI [1,1])
C0013153 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])

Study vaccine Administration

Code List

Study vaccine Administration: Side

CL Item

Left (1)

CL Item

Right (2)

Study vaccine Administration Site

Item

Study vaccine Administration: Site

integer

C1515974 (UMLS CUI [1,1])
C0013153 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])

Study vaccine Administration Site

Code List

Study vaccine Administration: Site

CL Item

Deltoid (1)

CL Item

Thigh (2)

CL Item

Buttock (3)

Study vaccine Administration Route

Item

Study vaccine Administration: Route

integer

C0013153 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])

Study vaccine Administration Route

Code List

Study vaccine Administration: Route

CL Item

I.M. (1)

CL Item

S.C. (2)

Adverse Events, Post-Vaccination Observation

Item Group

Adverse Events, Post-Vaccination Observation

C0042196 (UMLS CUI-1)
C0700325 (UMLS CUI-2)
C0877248 (UMLS CUI-3)
C2240392 (UMLS CUI-4)

serious or non-serious unsolicited adverse events

Item

Has the subject experienced any serious or non-serious unsolicited adverse events within one month postvaccination?

integer

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

serious or non-serious unsolicited adverse events

Code List

Has the subject experienced any serious or non-serious unsolicited adverse events within one month postvaccination?

CL Item

Information not retrievable (1)

CL Item

No (2)

CL Item

Yes, fill in the Non-Serious Adverse Event pages or Serious Adverse Event form. (3)

CL Item

No Vaccine administered (4)

Solicited Adverse Events - Local Symptoms - DTPw-HBV/Hib Kft. groups +Tritanrix-Hep B/Hiberix group

Item Group

Solicited Adverse Events - Local Symptoms - DTPw-HBV/Hib Kft. groups +Tritanrix-Hep B/Hiberix group

C0877248 (UMLS CUI-1)
C1457887 (UMLS CUI-2)
C2240392 (UMLS CUI-3)

symptoms

Item

For each vaccine, has the subject experienced any of the following signs/symptoms at the administration site during the solicited period?

integer

C1457887 (UMLS CUI [1,1])
C2240392 (UMLS CUI [1,2])

symptoms

Code List

For each vaccine, has the subject experienced any of the following signs/symptoms at the administration site during the solicited period?

CL Item

Yes, please tick No/Yes for each symptom. If Yes is ticked, please complete all items. (1)

CL Item

No (2)

CL Item

No vaccine administered (3)

CL Item

Information not available (4)

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])

Medically attended visit

Item

Medically attended visit

boolean

C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C0332575 (UMLS CUI [2])

Medically attended visit Type

Item

Medically attended visit Type

text

C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C1386497 (UMLS CUI [1,3])
C0332575 (UMLS CUI [2])

Medical advice Type

Code List

Medically attended visit 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])

Medically attended visit

Item

Medically attended visit

boolean

C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C0038999 (UMLS CUI [2])

Medically attended visit Type

Item

Medically attended visit Type

text

C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C1386497 (UMLS CUI [1,3])
C0038999 (UMLS CUI [2])

Medical advice Type

Code List

Medically attended visit 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])

Pain

Item

Pain, intensity

integer

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

Pain

Code List

Pain, intensity

CL Item

None (0)

CL Item

Mild (1)

CL Item

Moderate (2)

CL Item

Severe (3)

Pain on Day 0

Item

Pain on Day 0

integer

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

Pain

Code List

Pain on Day 0

CL Item

None (0)

CL Item

Mild (1)

CL Item

Moderate (2)

CL Item

Severe (3)

Pain on Day 1

Item

Pain on Day 1

integer

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

Pain

Code List

Pain on Day 1

CL Item

None (0)

CL Item

Mild (1)

CL Item

Moderate (2)

CL Item

Severe (3)

Pain on Day 2

Item

Pain on Day 2

integer

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

Pain

Code List

Pain on Day 2

CL Item

None (0)

CL Item

Mild (1)

CL Item

Moderate (2)

CL Item

Severe (3)

Pain on Day 3

Item

Pain on Day 3

integer

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

Pain

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])

Medically attended visit

Item

Medically attended visit

boolean

C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C0030193 (UMLS CUI [2])

Medically attended visit Type

Item

Medically attended visit Type

text

C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C1386497 (UMLS CUI [1,3])
C0030193 (UMLS CUI [2])

Medical advice Type

Code List

Medically attended visit Type

CL Item

Hospitalization (HO)

CL Item

Emergency room (ER)

CL Item

Medical doctor (MD)

Solicited Adverse Events - Local Symptoms - Triple Antigen vaccine

Item Group

Solicited Adverse Events - Local Symptoms - Triple Antigen vaccine

C1457887 (UMLS CUI-1)
C0205276 (UMLS CUI-2)
C0877248 (UMLS CUI-3)

symptoms

Item

For each vaccine, has the subject experienced any of the following signs/symptoms at the administration site during the solicited period?

integer

C1457887 (UMLS CUI [1,1])
C2240392 (UMLS CUI [1,2])

symptoms

Code List

For each vaccine, has the subject experienced any of the following signs/symptoms at the administration site during the solicited period?

CL Item

Yes, please tick No/Yes for each symptom. If Yes is ticked, please complete all items. (1)

CL Item

No (2)

CL Item

No vaccine administered (3)

CL Item

Information not available (4)

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])

Medically attended visit

Item

Medically attended visit

boolean

C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C0332575 (UMLS CUI [2])

Medically attended visit Type

Item

Medically attended visit Type

text

C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C1386497 (UMLS CUI [1,3])
C0332575 (UMLS CUI [2])

Medical advice Type

Code List

Medically attended visit 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])

Medically attended visit

Item

Medically attended visit

boolean

C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C0038999 (UMLS CUI [2])

Medically attended visit Type

Item

Medically attended visit Type

text

C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C1386497 (UMLS CUI [1,3])
C0038999 (UMLS CUI [2])

Medical advice Type

Code List

Medically attended visit 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])

Pain

Item

Pain, intensity

integer

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

Pain

Code List

Pain, intensity

CL Item

None (0)

CL Item

Mild (1)

CL Item

Moderate (2)

CL Item

Severe (3)

Pain on Day 0

Item

Pain on Day 0

integer

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

Pain

Code List

Pain on Day 0

CL Item

None (0)

CL Item

Mild (1)

CL Item

Moderate (2)

CL Item

Severe (3)

Pain on Day 1

Item

Pain on Day 1

integer

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

Pain

Code List

Pain on Day 1

CL Item

None (0)

CL Item

Mild (1)

CL Item

Moderate (2)

CL Item

Severe (3)

Pain on Day 2

Item

Pain on Day 2

integer

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

Pain

Code List

Pain on Day 2

CL Item

None (0)

CL Item

Mild (1)

CL Item

Moderate (2)

CL Item

Severe (3)

Pain on Day 3

Item

Pain on Day 3

integer

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

Pain

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])

Medically attended visit

Item

Medically attended visit

boolean

C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C0030193 (UMLS CUI [2])

Medically attended visit Type

Item

Medically attended visit Type

text

C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C1386497 (UMLS CUI [1,3])
C0030193 (UMLS CUI [2])

Medical advice Type

Code List

Medically attended visit Type

CL Item

Hospitalization (HO)

CL Item

Emergency room (ER)

CL Item

Medical doctor (MD)

Solicited Adverse Events - Local Symptoms - Hiberix vaccine

Item Group

Solicited Adverse Events - Local Symptoms - Hiberix vaccine

C1457887 (UMLS CUI-1)
C0205276 (UMLS CUI-2)
C2240392 (UMLS CUI-3)
C0877248 (UMLS CUI-4)

symptoms

Item

For each vaccine, has the subject experienced any of the following signs/symptoms at the administration site during the solicited period?

integer

C1457887 (UMLS CUI [1,1])
C2240392 (UMLS CUI [1,2])

symptoms

Code List

For each vaccine, has the subject experienced any of the following signs/symptoms at the administration site during the solicited period?

CL Item

Yes, please tick No/Yes for each symptom. If Yes is ticked, please complete all items. (1)

CL Item

No (2)

CL Item

No vaccine administered (3)

CL Item

Information not available (4)

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])

Medically attended visit

Item

Medically attended visit

boolean

C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C0332575 (UMLS CUI [2])

Medically attended visit Type

Item

Medically attended visit Type

text

C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C1386497 (UMLS CUI [1,3])
C0332575 (UMLS CUI [2])

Medical advice Type

Code List

Medically attended visit 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])

Medically attended visit

Item

Medically attended visit

boolean

C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C0038999 (UMLS CUI [2])

Medically attended visit Type

Item

Medically attended visit Type

text

C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C1386497 (UMLS CUI [1,3])
C0038999 (UMLS CUI [2])

Medical advice Type

Code List

Medically attended visit 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])

Pain

Item

Pain, intensity

integer

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

Pain

Code List

Pain, intensity

CL Item

None (0)

CL Item

Mild (1)

CL Item

Moderate (2)

CL Item

Severe (3)

Pain on Day 0

Item

Pain on Day 0

integer

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

Pain

Code List

Pain on Day 0

CL Item

None (0)

CL Item

Mild (1)

CL Item

Moderate (2)

CL Item

Severe (3)

Pain on Day 1

Item

Pain on Day 1

integer

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

Pain

Code List

Pain on Day 1

CL Item

None (0)

CL Item

Mild (1)

CL Item

Moderate (2)

CL Item

Severe (3)

Pain on Day 2

Item

Pain on Day 2

integer

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

Pain

Code List

Pain on Day 2

CL Item

None (0)

CL Item

Mild (1)

CL Item

Moderate (2)

CL Item

Severe (3)

Pain on Day 3

Item

Pain on Day 3

integer

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

Pain

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])

Medically attended visit

Item

Medically attended visit

boolean

C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C0030193 (UMLS CUI [2])

Medically attended visit Type

Item

Medically attended visit Type

text

C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C1386497 (UMLS CUI [1,3])
C0030193 (UMLS CUI [2])

Medical advice Type

Code List

Medically attended visit Type

CL Item

Hospitalization (HO)

CL Item

Emergency room (ER)

CL Item

Medical doctor (MD)

Solicited Adverse Events - General Symptoms

Item Group

Solicited Adverse Events - General Symptoms

C1457887 (UMLS CUI-1)
C2240392 (UMLS CUI-2)
C0877248 (UMLS CUI-3)

signs/symptoms

Item

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

integer

C1457887 (UMLS CUI [1])

Fever

Item

Fever

boolean

C0015967 (UMLS CUI [1])

Fever

Item

Fever

integer

C0015967 (UMLS CUI [1])

Fever

Code List

Fever

CL Item

taken (1)

CL Item

not taken (2)

Fever Site of measurement

Item

Site of measurement

integer

C1515974 (UMLS CUI [1,1])
C0015967 (UMLS CUI [1,2])

Site

Code List

Site of measurement

CL Item

Axillary (1)

CL Item

Oral (2)

CL Item

Rectal (3)

Fever day 0

Item

Fever day 0

float

C0015967 (UMLS CUI [1])

Fever day 1

Item

Fever day 1

float

C0015967 (UMLS CUI [1])

Fever day 2

Item

Fever day 2

float

C0015967 (UMLS CUI [1])

Fever day 3

Item

Fever day 3

float

C0015967 (UMLS CUI [1])

Ongoing after day 3?

Item

Ongoing after day 3?

boolean

C0015967 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])

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

Medically attended visit

Item

Medically attended visit

boolean

C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])

Medically attended visit

Item

Medically attended visit

text

C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])

Medical advice Type

Code List

Medically attended visit

CL Item

Hospitalization (HO)

CL Item

Emergency room (ER)

CL Item

Medical doctor (MD)

Irritability

Item

Irritability/ Fussiness

boolean

C0022107 (UMLS CUI [1])

Irritability intensity day 0

Item

Irritability / Fussiness intensity day 0

integer

C0022107 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])

Vaccine Administration

Code List

Irritability / Fussiness intensity day 0

CL Item

None (0)

CL Item

Mild (1)

CL Item

Moderate (2)

CL Item

Severe (3)

Irritability / Fussiness intensity day 1

Item

Irritability / Fussiness intensity day 1

integer

C0022107 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])

Vaccine Administration

Code List

Irritability / Fussiness intensity day 1

CL Item

None (0)

CL Item

Mild (1)

CL Item

Moderate (2)

CL Item

Severe (3)

Irritability / Fussiness intensity day 2

Item

Irritability / Fussiness intensity day 2

integer

C0022107 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])

Vaccine Administration

Code List

Irritability / Fussiness intensity day 2

CL Item

None (0)

CL Item

Mild (1)

CL Item

Moderate (2)

CL Item

Severe (3)

Irritability / Fussiness intensity day 3

Item

Irritability / Fussiness intensity day 3

integer

C0022107 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])

Vaccine Administration

Code List

Irritability / Fussiness intensity day 3

CL Item

None (0)

CL Item

Mild (1)

CL Item

Moderate (2)

CL Item

Severe (3)

Ongoing after day 3?

Item

Ongoing after day 3?

boolean

C0022107 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])

Date of last day of symptoms

Item

Date of last day of symptoms

date

C0022107 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])

Causality?

Item

Causality?

boolean

C0015127 (UMLS CUI [1,1])
C0022107 (UMLS CUI [1,2])

Medically attended visit

Item

Medically attended visit

boolean

C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])

Medically attended visit

Item

Medically attended visit

integer

C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])

Medical advice Type

Code List

Medically attended visit

CL Item

Hospitalization (HO)

CL Item

Emergency room (ER)

CL Item

Medical doctor (MD)

Drowsiness

Item

Drowsiness

boolean

C0013144 (UMLS CUI [1])

Drowsiness intensity day 0

Item

Drowsiness intensity day 0

integer

C0013144 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])

Vaccine Administration

Code List

Drowsiness intensity day 0

CL Item

None (0)

CL Item

Mild (1)

CL Item

Moderate (2)

CL Item

Severe (3)

Drowsiness intensity day 1

Item

Drowsiness intensity day 1

integer

C0013144 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])

Vaccine Administration

Code List

Drowsiness intensity day 1

CL Item

None (0)

CL Item

Mild (1)

CL Item

Moderate (2)

CL Item

Severe (3)

Drowsiness intensity day 2

Item

Drowsiness intensity day 2

integer

C0013144 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])

Vaccine Administration

Code List

Drowsiness intensity day 2

CL Item

None (0)

CL Item

Mild (1)

CL Item

Moderate (2)

CL Item

Severe (3)

Drowsiness intensity day 3

Item

Drowsiness intensity day 3

integer

C0013144 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])

Vaccine Administration

Code List

Drowsiness intensity day 3

CL Item

None (0)

CL Item

Mild (1)

CL Item

Moderate (2)

CL Item

Severe (3)

Ongoing after day 3?

Item

Ongoing after day 3?

boolean

C0013144 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])

Date of last day of symptoms

Item

Date of last day of symptoms

date

C0013144 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])

Causality?

Item

Causality?

boolean

C0015127 (UMLS CUI [1])

Medically attended visit

Item

Medically attended visit

boolean

C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])

Medically attended visit

Item

Medically attended visit

integer

C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])

Medical advice Type

Code List

Medically attended visit

CL Item

Hospitalization (HO)

CL Item

Emergency room (ER)

CL Item

Medical doctor (MD)

Loss of appetite

Item

Loss of appetite

boolean

C1971624 (UMLS CUI [1])

Loss of appetite intensity day 0

Item

Loss of appetite intensity day 0

integer

C1971624 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])

Vaccine Administration

Code List

Loss of appetite intensity day 0

CL Item

None (0)

CL Item

Mild (1)

CL Item

Moderate (2)

CL Item

Severe (3)

Loss of appetite intensity day 1

Item

Loss of appetite intensity day 1

integer

C1971624 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])

Vaccine Administration

Code List

Loss of appetite intensity day 1

CL Item

None (0)

CL Item

Mild (1)

CL Item

Moderate (2)

CL Item

Severe (3)

Loss of appetite intensity day 2

Item

Loss of appetite intensity day 2

integer

C1971624 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])

Vaccine Administration

Code List

Loss of appetite intensity day 2

CL Item

None (0)

CL Item

Mild (1)

CL Item

Moderate (2)

CL Item

Severe (3)

Loss of appetite intensity day 3

Item

Loss of appetite intensity day 3

integer

C1971624 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])

Vaccine Administration

Code List

Loss of appetite intensity day 3

CL Item

None (0)

CL Item

Mild (1)

CL Item

Moderate (2)

CL Item

Severe (3)

Ongoing after day 3?

Item

Ongoing after day 3?

boolean

C1971624 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])

Date of last day of symptoms

Item

Date of last day of symptoms

date

C1971624 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])

Causality?

Item

Causality?

boolean

C0015127 (UMLS CUI [1])

Medically attended visit

Item

Medically attended visit

boolean

C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])

Medically attended visit

Item

Medically attended visit

integer

C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])

Medical advice Type

Code List

Medically attended visit

CL Item

Hospitalization (HO)

CL Item

Emergency room (ER)

CL Item

Medical doctor (MD)

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Item commentaires pour :

GSK Biologicals' DTPw-HBV/ Hib Kft. vaccine compared to GSK Biologicals' Tritanrix-HepB/Hiberix vaccine Visit 1 101223

Visit 1 GSK Biologicals' DTPw-HBV/ Hib Kft. vaccine compared to GSK Biologicals' Tritanrix-HepB/Hiberix vaccine 101223

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