ID

30029

Beschrijving

Study ID: 100480, 759346/004 & 100791 Clinical Study ID: 100480, 759346/004 & 100791 Study Title: A phase III, partially double blind, randomized, controlled primary vaccination study to assess the reactogenicity and safety of GlaxoSmithKline (GSK) Biologicals’ Tritanrix-HepB/Hib-MenAC vaccine as compared to Tritanrix-HepB/Hib2.5 + Meningitec™ when administered to healthy infants at 6, 10, 14 weeks of age, who have received a birth dose of hepatitis B vaccine. 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 Trade Name: Tritanrix HepB/Hiberix Study Indication: Diphtheria; Haemophilus influenzae type b; Hepatitis B; Tetanus; Whole Cell Pertussis Documentation part: Visit 2, Month 1,5, 42-56 days after Visit 1, Dose 1

Trefwoorden

Haemophilus influenzae type b

A36.9

Tetanus

D014611

10-07-17 10-07-17 -
04-05-18 04-05-18 - Sarah Riepenhausen

Houder van rechten

GlaxoSmithKline

Geüploaded op

4 mei 2018

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY-NC 3.0

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Tritanrix-HepB/Hib-MenAC vaccine compared to Tritanrix-HepB/Hiberix and Meningitec Visit 2 759346/004

model
Details

Visit 2 Tritanrix-HepB/Hib-MenAC vaccine compared to Tritanrix-HepB/Hiberix and Meningitec 759346/004

1 Formulieren

StudyEvent: ODM
1. Visit 2 Tritanrix-HepB/Hib-MenAC vaccine compared to Tritanrix-HepB/Hiberix and Meningitec 759346/004

Name

Type

Description | Question | Decode (Coded Value)

Datatype

Alias

Check for Study Continuation

Item Group

Check for Study Continuation

C0805733 (UMLS CUI-1)
C0008976 (UMLS CUI-2)
C0042210 (UMLS CUI-3)

subject return for visit 2

Item

Did the subject come at visit 2 ?

integer

C0545082 (UMLS CUI [1,1])
C0805733 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])

subject return for visit 2

Code List

Did the subject come at visit 2 ?

CL Item

Yes, please complete the next pages. (1)

CL Item

No, please specify (2)

reason for study discontinuation

Item

Please tick the ONE most appropriate reason and skip the following pages of this visit.

integer

C0392360 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])

reason for study discontinuation

Code List

Please tick the ONE most appropriate reason and skip the following pages of this visit.

CL Item

Serious adverse Event (1)

CL Item

Non-Serious adverse Event (2)

CL Item

Other (3)

SAE Number

Item

SAE Number

integer

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

AE Number

Item

AE Number or Code

integer

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

Other reason for Study Discontinuation

Item

Other reason for Study Discontinuation

text

C0392360 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])

reason for study discontinuation

Item

reason for study discontinuation

integer

C0392360 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])

non administration

Code List

reason for study discontinuation

CL Item

Investigator (1)

CL Item

Parents/Guardians (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])

Gender

Code List

Gastrointestinal: Diagnosis

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

integer

C2721683 (UMLS CUI [1])

Persistent Crying

Code List

Persistent Crying

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])

Cutaneous disease

Code List

Other disorder

CL Item

Past (1)

CL Item

Current (2)

Height

Item

Height

integer

C0005890 (UMLS CUI [1])

Weight

Item

Weight

float

C0005910 (UMLS CUI [1])

Pre-Vaccination Assessment

Item Group

Pre-Vaccination Assessment

C0220825 (UMLS CUI-1)
C0005903 (UMLS CUI-2)
C0042196 (UMLS CUI-3)

Temperature

Item

Temperature

float

C0005903 (UMLS CUI [1])

Vaccine Administration

Item Group

Vaccine Administration, Dose 1, Tritanrix-HepB/Hib-MenAC Vaccine

C2368628 (UMLS CUI-1)
C0042196 (UMLS CUI-2)
C0700144 (UMLS CUI-3)
C2240392 (UMLS CUI-4)

Date of Vaccine Administration

Item

Date of Vaccine Administration

date

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

Vaccine Administration

Item

Vaccine Administration

integer

C2368628 (UMLS CUI [1])

Vaccine Administration

Code List

Vaccine Administration

CL Item

Tritanrix-HepB/Hib-MenAC Vaccine (lot 1 or 2 or 3) (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])

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])

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)

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 Side

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 Group

Vaccine Administration - Dose 1 - Tritanrix-HepB/Hib Vaccine OR MenC Vaccine

C2368628 (UMLS CUI-1)
C0042196 (UMLS CUI-2)
C0700144 (UMLS CUI-3)
C2240392 (UMLS CUI-4)

Date of Vaccine Administration

Item

Date of Vaccine Administration

date

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

Vaccine Administration

Item

Vaccine Administration

integer

C2368628 (UMLS CUI [1])

Vaccine Administration

Code List

Vaccine Administration

CL Item

Tritanrix™-HepB/Hib Vaccine (1)

CL Item

MenC Vaccine (2)

CL Item

Replacement vial (3)

CL Item

Wrong vial number (4)

CL Item

Not administered (5)

Wrong vial number

Item

Wrong vial number

integer

C0184301 (UMLS CUI [1])

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])

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)

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 Side

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)

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 - Tritanrix-HepB/Hib-MenAC vaccine

Item Group

Solicited Adverse Events - Local Symptoms - Tritanrix-HepB/Hib-MenAC vaccine

C1457887 (UMLS CUI-1)
C0205276 (UMLS CUI-2)
C0042196 (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? Tritanrix-HepB/Hib-MenAC vaccine

text

C1457887 (UMLS CUI [1,1])
C0042196 (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? Tritanrix-HepB/Hib-MenAC vaccine

CL Item

Information not available (U)

CL Item

No vaccine administered (NA)

CL Item

No (N)

CL Item

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

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 - Tritanrix-HepB/Hib vaccine

Item Group

Solicited Adverse Events - Local Symptoms - Tritanrix-HepB/Hib 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? Tritanrix-HepB/Hib vaccine

boolean

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

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 - MenC vaccine

Item Group

Solicited Adverse Events - Local Symptoms - MenC vaccine

C1457887 (UMLS CUI-1)
C0205276 (UMLS CUI-2)
C0700144 (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? MenC vaccine

boolean

C1457887 (UMLS CUI [1,1])
C0700144 (UMLS CUI [1,2])

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

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)

Fever on Day 0

Item

Fever on Day 0

integer

C0015967 (UMLS CUI [1])

Fever on Day 0

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])

Fever on Day 1

Item

Fever on Day 1

integer

C0015967 (UMLS CUI [1])

Fever on Day 0

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])

Fever on Day 2

Item

Fever on Day 2

integer

C0015967 (UMLS CUI [1])

Fever on Day 0

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])

Fever on Day 3

Item

Fever on Day 3

integer

C0015967 (UMLS CUI [1])

Fever on Day 0

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])

Medically attended visit

Item

Medically attended visit

boolean

C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C0015967 (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])
C0015967 (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)

Irritability/Fussiness

Item

Irritability/Fussiness

boolean

C0022107 (UMLS CUI [1])

Irritability/Fussiness

Item

Irritability/Fussiness, Intensity

integer

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

Pain

Code List

Irritability/Fussiness, Intensity

CL Item

None (0)

CL Item

Mild (1)

CL Item

Moderate (2)

CL Item

Severe (3)

crying continuous

Item

In case of intensity 3: was the crying continuous ( i.e. not episodic, not interrupted within the time period of 3 hours by e.g. naps) ?

boolean

C0438697 (UMLS CUI [1])

crying unaltered

Item

In case of intensity 3: was the crying unaltered for > 3 hours ?

boolean

C0438697 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])

Irritability/Fussiness on Day 0

Item

Irritability/Fussiness on Day 0

integer

C0022107 (UMLS CUI [1])

Pain

Code List

Irritability/Fussiness on Day 0

CL Item

None (0)

CL Item

Mild (1)

CL Item

Moderate (2)

CL Item

Severe (3)

Irritability/Fussiness on Day 1

Item

Irritability/Fussiness on Day 1

integer

C0022107 (UMLS CUI [1])

Pain

Code List

Irritability/Fussiness on Day 1

CL Item

None (0)

CL Item

Mild (1)

CL Item

Moderate (2)

CL Item

Severe (3)

Irritability/Fussiness on Day 2

Item

Irritability/Fussiness on Day 2

integer

C0022107 (UMLS CUI [1])

Pain

Code List

Irritability/Fussiness on Day 2

CL Item

None (0)

CL Item

Mild (1)

CL Item

Moderate (2)

CL Item

Severe (3)

Irritability/Fussiness on Day 3

Item

Irritability/Fussiness on Day 3

integer

C0022107 (UMLS CUI [1])

Pain

Code List

Irritability/Fussiness on Day 3

CL Item

None (0)

CL Item

Mild (1)

CL Item

Moderate (2)

CL Item

Severe (3)

Irritability/Fussiness ongoing after day 3

Item

Irritability/Fussiness ongoing after day 3?

boolean

C0022107 (UMLS CUI [1])

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])
C0022107 (UMLS CUI [2])

Medically attended visit

Item

Medically attended visit

boolean

C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C0022107 (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])
C0022107 (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)

Drowsiness

Item

Drowsiness

boolean

C0013144 (UMLS CUI [1])

Drowsiness

Item

Drowsiness, Intensity

integer

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

Pain

Code List

Drowsiness, Intensity

CL Item

None (0)

CL Item

Mild (1)

CL Item

Moderate (2)

CL Item

Severe (3)

Drowsiness on Day 0

Item

Drowsiness on Day 0

integer

C0013144 (UMLS CUI [1])

Pain

Code List

Drowsiness on Day 0

CL Item

None (0)

CL Item

Mild (1)

CL Item

Moderate (2)

CL Item

Severe (3)

Drowsiness on Day 1

Item

Drowsiness on Day 1

integer

C0013144 (UMLS CUI [1])

Pain

Code List

Drowsiness on Day 1

CL Item

None (0)

CL Item

Mild (1)

CL Item

Moderate (2)

CL Item

Severe (3)

Drowsiness on Day 2

Item

Drowsiness on Day 2

integer

C0013144 (UMLS CUI [1])

Pain

Code List

Drowsiness on Day 2

CL Item

None (0)

CL Item

Mild (1)

CL Item

Moderate (2)

CL Item

Severe (3)

Drowsiness on Day 3

Item

Drowsiness on Day 3

integer

C0013144 (UMLS CUI [1])

Pain

Code List

Drowsiness on Day 3

CL Item

None (0)

CL Item

Mild (1)

CL Item

Moderate (2)

CL Item

Severe (3)

Drowsiness ongoing after day 3

Item

Drowsiness ongoing after day 3?

boolean

C0013144 (UMLS CUI [1])

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])
C0013144 (UMLS CUI [2])

Medically attended visit

Item

Medically attended visit

boolean

C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C0013144 (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])
C0013144 (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)

Loss of appetite

Item

Loss of appetite

boolean

C1971624 (UMLS CUI [1])

Loss of appetite

Item

Loss of appetite, Intensity

integer

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

Pain

Code List

Loss of appetite, Intensity

CL Item

None (0)

CL Item

Mild (1)

CL Item

Moderate (2)

CL Item

Severe (3)

Loss of appetite on Day 0

Item

Loss of appetite on Day 0

integer

C1971624 (UMLS CUI [1])

Pain

Code List

Loss of appetite on Day 0

CL Item

None (0)

CL Item

Mild (1)

CL Item

Moderate (2)

CL Item

Severe (3)

Loss of appetite on Day 1

Item

Loss of appetite on Day 1

integer

C1971624 (UMLS CUI [1])

Pain

Code List

Loss of appetite on Day 1

CL Item

None (0)

CL Item

Mild (1)

CL Item

Moderate (2)

CL Item

Severe (3)

Loss of appetite on Day 2

Item

Loss of appetite on Day 2

integer

C1971624 (UMLS CUI [1])

Pain

Code List

Loss of appetite on Day 2

CL Item

None (0)

CL Item

Mild (1)

CL Item

Moderate (2)

CL Item

Severe (3)

Loss of appetite on Day 3

Item

Loss of appetite on Day 3

integer

C1971624 (UMLS CUI [1])

Pain

Code List

Loss of appetite on Day 3

CL Item

None (0)

CL Item

Mild (1)

CL Item

Moderate (2)

CL Item

Severe (3)

Loss of appetite ongoing after day 3

Item

Loss of appetite ongoing after day 3?

boolean

C1971624 (UMLS CUI [1])

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])
C1971624 (UMLS CUI [2])

Medically attended visit

Item

Medically attended visit

boolean

C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C1971624 (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])
C1971624 (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)

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Tritanrix-HepB/Hib-MenAC vaccine compared to Tritanrix-HepB/Hiberix and Meningitec Visit 2 759346/004

Visit 2 Tritanrix-HepB/Hib-MenAC vaccine compared to Tritanrix-HepB/Hiberix and Meningitec 759346/004

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