ID

34246

Beschrijving

Study ID:103812 & 104727 Clinical Study ID:103812 & 104727 Study Title: Study to assess safety and reactogenicity of booster dose of either an investigational vaccination regimen or DTPw-HBV/Hib when administered at 15 to 18 months of age and of a dose of Mencevax ACWY vaccine. Sponsor: GlaxoSmithKline 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

Trefwoorden

Houder van rechten

GlaxoSmithKline

Geüploaded op

15 januari 2019

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY-NC 3.0

Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Terug naar het model Commentaren

Itemgroep Commentaren voor :

Item Commentaren voor :

U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

Safety and reactogenicity of booster dose of either an investigational vaccination regimen or DTPw HBVHib 103812 & 104727

model
Details

Visit 1 - General Medical History/ Physical Examination; Vaccine Administration; Unsolicited adverse events; Solicited Adverse Events - Local Symptoms; Soliced adverse events - General Symptoms

1 Formulieren

StudyEvent: ODM
1. Visit 1 - General Medical History/ Physical Examination; Vaccine Administration; Unsolicited adverse events; Solicited Adverse Events - Local Symptoms; Soliced adverse events - General Symptoms

Name

Type

Description | Question | Decode (Coded Value)

Datatype

Alias

General medical history/ Physical examination

Item Group

General medical history/ Physical examination

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

Pre- existing conditions or signs and/ or symptoms present in the subject

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

C0521987 (UMLS CUI [1,1])
C0332152 (UMLS CUI [1,2])
C2347804 (UMLS CUI [1,3])
C0037088 (UMLS CUI [2,1])
C2347662 (UMLS CUI [2,2])
C0332152 (UMLS CUI [2,3])
C2347804 (UMLS CUI [2,4])

Diagnosis

Item Group

Diagnosis

C0011900 (UMLS CUI-1)

Medical condition

Item

Medical condition

integer

C0012634 (UMLS CUI [1])

Location/ System

Code List

Medical condition

CL Item

Cutaneous (10)

CL Item

Eyes (5)

CL Item

Ears- Nose- Throat (6)

CL Item

Cardiovascular (2)

CL Item

Respiratory (3)

CL Item

GAstrointestinal (1)

CL Item

Muskuloskeletal (7)

CL Item

Neurological (8)

CL Item

Genitourinary (12)

CL Item

Haematology (11)

CL Item

Allergies (4)

CL Item

Endocrine (9)

CL Item

Persistent crying (crying continuous [i.e. not episodic, not interrupted within the time period of 3 hours by e.g. naps] and unaltered >= 3 hours.) (13)

Diagnosis

Item

Diagnosis

text

C0011900 (UMLS CUI [1])

Medical Condition Status

Item

Medical Condition Status

integer

C0012634 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])

Medical Condition Status

Code List

Medical Condition Status

CL Item

Past (1)

CL Item

Current (2)

Baseline Measurement of mid left thigh circumference

Item Group

Baseline Measurement of mid left thigh circumference

C0230426 (UMLS CUI-1)
C0444598 (UMLS CUI-2)
C0424682 (UMLS CUI-3)

Circumference of mid left thigh

Item

Circumference of mid left thigh

integer

C0230426 (UMLS CUI [1,1])
C0444598 (UMLS CUI [1,2])
C0424682 (UMLS CUI [1,3])

Vaccine administration

Item Group

Vaccine administration

C2368628 (UMLS CUI-1)

Date of vaccination

Item

Date of vaccination

date

C0011008 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])

Pre- Vaccination temperature

Item

Pre- Vaccination temperature

float

C0005903 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])

Vaccine administration

Item

Vaccine administration

text

C2368628 (UMLS CUI [1])

Vaccine administration

Code List

Vaccine administration

CL Item

DTPw- HBV/Hib Vaccine (S)

CL Item

DTPw- HBV/Hib Vaccine (S)

CL Item

Replacement vial (R)

CL Item

Wrong vial number (W)

CL Item

Not administered (N)

Why not administered?

Item

Why not administered?

text

C2368628 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])

Why not administered?

Code List

Why not administered?

CL Item

Serious adverse event (complete the Serious Adverse Event form) (SAE)

CL Item

Non- serious adverse event (complete the Non- serious Adverse Event section) (AEX)

CL Item

Other, please specify (e.g.: consent withdrawal, protocol violation,...) (OTH)

Replacement vial

Item

Replacement vial

text

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

Wrong vial number

Item

Wrong vial number

text

C0184301 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
C3827420 (UMLS CUI [1,3])

Has the study vaccine been administered according to the Protocol

Item

Has the study vaccine been administered according to the Protocol?

boolean

C2368628 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])

If study vaccine has not been administered according to the Protocol, check all that apply.

Item

If study vaccine has not been administered according to the Protocol, check all that apply.

text

C2368628 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])

If study vaccine has not been administered according to the Protocol, check all that apply.

Code List

If study vaccine has not been administered according to the Protocol, check all that apply.

CL Item

Left side (L)

CL Item

Right side (R)

CL Item

Deltoid (1)

CL Item

Thigh (3)

CL Item

Buttock (6)

CL Item

I.M. (IM)

CL Item

S.C. (SC)

Comments

Item

Comments

text

C0947611 (UMLS CUI [1])

If other reason for vaccine not administered, please specify.

Item

If other reason for vaccine not administered, please specify.

text

C2368628 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])

If vaccine not administered, please tick who took the decision

Item

If vaccine not administered, please tick who took the decision

text

C2368628 (UMLS CUI [1,1])
C1272696 (UMLS CUI [1,2])
C0679006 (UMLS CUI [1,3])

If vaccine not administered, please tick who took the decision

Code List

If vaccine not administered, please tick who took the decision

CL Item

Investigator (I)

CL Item

Parents/ Guardians (P)

Unsolicited Adverse events

Item Group

Unsolicited Adverse events

C0877248 (UMLS CUI-1)

Has the subject experienced any serious or non- serious unsolicited adverse events

Item

Has the subject experienced any serious or non- serious unsolicited adverse events within one month (minimum 30 days) post- vaccination?

text

C1518404 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
C0687676 (UMLS CUI [1,3])
C1519255 (UMLS CUI [2,1])
C2368628 (UMLS CUI [2,2])
C0687676 (UMLS CUI [2,3])

Has the subject experienced any serious or non- serious unsolicited adverse events

Code List

Has the subject experienced any serious or non- serious unsolicited adverse events within one month (minimum 30 days) post- vaccination?

CL Item

Information not available (U)

CL Item

No Vaccine administered (NA)

CL Item

No (N)

CL Item

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

Solicited Adverse Events - Local Symptoms

Item Group

Solicited Adverse Events - Local Symptoms

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

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

Item

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

text

C0037088 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
C0013153 (UMLS CUI [1,3])
C0042210 (UMLS CUI [1,4])

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

Code List

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

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])

Size of redness Day 0

Item

If redness, enter size at Day 0

integer

C0332575 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])

Size of redness Day 1

Item

If redness, enter size at Day 1

integer

C0332575 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])

Size of redness Day 2

Item

If redness, enter size at Day 2

integer

C0332575 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])

Size of redness Day 3

Item

If redness, enter size at Day 3

integer

C0332575 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])

Redness ongoing after day 3?

Item

Redness ongoing after day 3?

boolean

C0332575 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])

Date of last day of redness

Item

Date of last day of redness

date

C0332575 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])

Redness - medically attended visit?

Item

Redness - medically attended visit?

boolean

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

Redness - specify medically attended visit

Item

Redness - specify medically attended visit

text

C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C0332575 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])

Redness - specify medically attended visit

Code List

Redness - specify medically attended visit

CL Item

Hospitalization (HO)

CL Item

Emergency Room (ER)

CL Item

Medical Personnel (MD)

Swelling

Item

Swelling

boolean

C0038999 (UMLS CUI [1])

Size of swelling Day 0

Item

If swelling, enter size at Day 0

integer

C0456389 (UMLS CUI [1,1])
C0038999 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])

Size of swelling Day 1

Item

If swelling, enter size at Day 1

integer

C0456389 (UMLS CUI [1,1])
C0038999 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])

Size of swelling Day 2

Item

If swelling, enter size at Day 2

integer

C0456389 (UMLS CUI [1,1])
C0038999 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])

Size of swelling Day 3

Item

If swelling, enter size at Day 3

integer

C0456389 (UMLS CUI [1,1])
C0038999 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])

Swelling ongoing after day 3?

Item

Swelling ongoing after day 3?

boolean

C0038999 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])

Date of last day of swelling

Item

Date of last day of swelling

date

C0038999 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])

Swelling - medically attended visit?

Item

Swelling - medically attended visit?

boolean

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

Sewlling - specify medically attended visit

Item

Swelling - specify medically attended visit

text

C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C0038999 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])

Sewlling - specify medically attended visit

Code List

Swelling - specify medically attended visit

CL Item

Hospitalization (HO)

CL Item

Emergency Room (ER)

CL Item

Medical Personnel (MD)

Pain

Item

Pain

boolean

C0030193 (UMLS CUI [1])

Intensity of pain Day 0

Item

If pain, enter Intensity at Day 0

integer

C1320357 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])

Intensity of pain Day 0

Code List

If pain, enter Intensity at Day 0

CL Item

None (0)

CL Item

Mild (1)

CL Item

Moderate (2)

CL Item

Severe (3)

Intensity of pain Day 1

Item

If pain, enter Intensity at Day 1

integer

C1320357 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])

Intensity of pain Day 1

Code List

If pain, enter Intensity at Day 1

CL Item

None (0)

CL Item

Mild (1)

CL Item

Moderate (2)

CL Item

Severe (3)

Intensity of pain Day 2

Item

If pain, enter Intensity at Day 2

integer

C1320357 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])

Intensity of pain Day 2

Code List

If pain, enter Intensity at Day 2

CL Item

None (0)

CL Item

Mild (1)

CL Item

Moderate (2)

CL Item

Severe (3)

Intensity of pain Day 3

Item

If pain, enter Intensity at Day 3

integer

C1320357 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])

Intensity of pain Day 3

Code List

If pain, enter Intensity at 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])
C0549178 (UMLS CUI [1,2])

Date of last day of pain

Item

Date of last day of pain

date

C0030193 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])

Pain - medically attended visit?

Item

Pain - medically attended visit?

boolean

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

Pain - specify medically attended visit

Item

Pain - specify medically attended visit

text

C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C0030193 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])

Pain - specify medically attended visit

Code List

Pain - specify medically attended visit

CL Item

Hospitalization (HO)

CL Item

Emergency Room (ER)

CL Item

Medical Personnel (MD)

Soliced Adverse Events - General Symptoms

Item Group

Soliced Adverse Events - General Symptoms

C0877248 (UMLS CUI-1)
C0159028 (UMLS CUI-2)

Signs/symptoms during the solicited period

Item

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

text

C0037088 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
C0013153 (UMLS CUI [1,3])
C0042210 (UMLS CUI [1,4])

Signs/symptoms during the solicited period

Code List

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

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)

General Symptoms

Item

General Symptoms

text

C0159028 (UMLS CUI [1])

General Symptoms

Code List

General Symptoms

CL Item

Fever (FE)

CL Item

Irritability/ Fussiness (IR)

CL Item

Drowsiness (DR)

CL Item

Loss of appetite (LO)

Fever - Body temperature Day 0

Item

Fever - Body temperature Day 0

float

C0039476 (UMLS CUI [1,1])
C0015967 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])

Fever - Body temperature Day 0 not taken

Item

Fever - Body temperature Day 0 not taken

integer

C0437722 (UMLS CUI [1,1])
C0015967 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])

Fever - Body temperature Day 0 not taken

Code List

Fever - Body temperature Day 0 not taken

CL Item

not taken (1)

Fever - Body temperature Day 1

Item

Fever - Body temperature Day 1

float

C0039476 (UMLS CUI [1,1])
C0015967 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])

Fever - Body temperature Day 1 not taken

Item

Fever - Body temperature Day 1 not taken

integer

C0437722 (UMLS CUI [1,1])
C0015967 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])

Fever - Body temperature Day 1 not taken

Code List

Fever - Body temperature Day 1 not taken

CL Item

not taken (1)

Fever - Body temperature Day 2

Item

Fever - Body temperature Day 2

float

C0039476 (UMLS CUI [1,1])
C0015967 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])

Fever - Body temperature Day 2 not taken

Item

Fever - Body temperature Day 2 not taken

integer

C0437722 (UMLS CUI [1,1])
C0015967 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])

Fever - Body temperature Day 2 not taken

Code List

Fever - Body temperature Day 2 not taken

CL Item

not taken (1)

Fever - Body temperature Day 3

Item

Fever - Body temperature Day 3

float

C0039476 (UMLS CUI [1,1])
C0015967 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])

Fever - Body temperature Day 3 not taken

Item

Fever - Body temperature Day 3 not taken

integer

C0437722 (UMLS CUI [1,1])
C0015967 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])

Fever - Body temperature Day 3 not taken

Code List

Fever - Body temperature Day 3 not taken

CL Item

not taken (1)

Is fever ongoing after day 3?

Item

Is fever ongoing after day 3?

boolean

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

Date of last day of fever.

Item

Date of last day of fever.

date

C0015967 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])

Fever - Causality?

Item

Fever - Causality?

boolean

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

Fever - medically attended visit?

Item

Fever - medically attended visit?

boolean

C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C0015967 (UMLS CUI [1,3])

Fever - specify medically attended visit

Item

Fever - specify medically attended visit.

text

C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C0015967 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])

Fever - specify medically attended visit

Code List

Fever - specify medically attended visit.

CL Item

Hospitalization (HO)

CL Item

Emergency Room (ER)

CL Item

Medical Personnel (MD)

Irritability/ Fussiness - Intensity Day 0

Item

Irritability/ Fussiness - Intensity Day 0

integer

C0022107 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])

Irritability/ Fussiness - Intensity Day 0

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])
C0518690 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])

Irritability/ Fussiness - Intensity Day 1

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])
C0518690 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])

Irritability/ Fussiness - Intensity Day 2

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])
C0518690 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])

Irritability/ Fussiness - Intensity Day 3

Code List

Irritability/ Fussiness - Intensity Day 3

CL Item

None (0)

CL Item

Mild (1)

CL Item

Moderate (2)

CL Item

Severe (3)

Is irritability/ fussiness ongoing after day 3?

Item

Is irritability/ fussiness ongoing after day 3?

boolean

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

Date of last day of irritability/ fussiness.

Item

Date of last day of irritability/ fussiness.

date

C0022107 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])

Irritability/ Fussiness- Causality?

Item

Irritability/ Fussiness- Causality?

boolean

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

Irritability/ Fussiness- medically attended visit?

Item

Irritability/Fussiness - medically attended visit?

boolean

C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C0022107 (UMLS CUI [1,3])

Irritability/ Fussiness - specify medically attended visit

Item

Irritability/ Fussiness- specify medically attended visit.

text

C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C0022107 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])

Irritability/ Fussiness - specify medically attended visit

Code List

Irritability/ Fussiness- specify medically attended visit.

CL Item

Hospitalization (HO)

CL Item

Emergency Room (ER)

CL Item

Medical Personnel (MD)

Drowsiness - Intensity Day 0

Item

Drowsiness - Intensity Day 0

integer

C0013144 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])

Drowsiness - Intensity Day 0

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])
C0518690 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])

Drowsiness - Intensity Day 1

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])
C0518690 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])

Drowsiness - Intensity Day 2

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])
C0518690 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])

Drowsiness - Intensity Day 3

Code List

Drowsiness - Intensity Day 3

CL Item

None (0)

CL Item

Mild (1)

CL Item

Moderate (2)

CL Item

Severe (3)

Is drowsiness ongoing after day 3?

Item

Is drowsiness ongoing after day 3?

boolean

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

Date of last day of drowsiness.

Item

Date of last day of drowsiness.

date

C0013144 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])

Drowsiness - Causality?

Item

Drowsiness - Causality?

boolean

C0013144 (UMLS CUI [1,1])
C0015127 (UMLS CUI [1,2])

Drowsiness - medically attended visit?

Item

Drowsiness - medically attended visit?

boolean

C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C0013144 (UMLS CUI [1,3])

Drowsiness - specify medically attended visit

Item

Drowsiness - specify medically attended visit.

text

C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C0013144 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])

Drowsiness - specify medically attended visit

Code List

Drowsiness - specify medically attended visit.

CL Item

Hospitalization (HO)

CL Item

Emergency Room (ER)

CL Item

Medical Personnel (MD)

Loss of appetite - Intensity Day 0

Item

Loss of appetite - Intensity Day 0

integer

C1971624 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])

Loss of appetite - Intensity Day 0

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])
C0518690 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])

Loss of appetite - Intensity Day 1

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])
C0518690 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])

Loss of appetite - Intensity Day 2

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])
C0518690 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])

Loss of appetite - Intensity Day 3

Code List

Loss of appetite - Intensity Day 3

CL Item

None (0)

CL Item

Mild (1)

CL Item

Moderate (2)

CL Item

Severe (3)

Is loss of appetite ongoing after day 3?

Item

Is loss of appetite ongoing after day 3?

boolean

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

If loss of appetite is ongoing after day 3, record date of last day of symptoms.

Item

Date of last day of loss of appetite.

date

C1971624 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])

Loss of appetite - Causality?

Item

Loss of appetite - Causality?

boolean

C1971624 (UMLS CUI [1,1])
C0015127 (UMLS CUI [1,2])

Loss of appetite - medically attended visit?

Item

Loss of appetite - medically attended visit?

boolean

C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C1971624 (UMLS CUI [1,3])

Loss of appetite - specify medically attended visit

Item

Loss of appetite - specify medically attended visit.

text

C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C1971624 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])

Loss of appetite - specify medically attended visit

Code List

Loss of appetite - specify medically attended visit.

CL Item

Hospitalization (HO)

CL Item

Emergency Room (ER)

CL Item

Medical Personnel (MD)

In case of intensity 3: Was the crying continuous

Item

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

boolean

C0518690 (UMLS CUI [1])
C2721683 (UMLS CUI [2])

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

Item

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

boolean

C0518690 (UMLS CUI [1,1])
C0438697 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,3])

Terug naar het begin van de pagina

ID

Beschrijving

Trefwoorden

Versies (3)

Houder van rechten

Geüploaded op

DOI

Licentie

Model Commentaren :

Itemgroep Commentaren voor :

Item Commentaren voor :

Safety and reactogenicity of booster dose of either an investigational vaccination regimen or DTPw HBVHib 103812 & 104727

Visit 1 - General Medical History/ Physical Examination; Vaccine Administration; Unsolicited adverse events; Solicited Adverse Events - Local Symptoms; Soliced adverse events - General Symptoms

Beschrijving

Alias

Beschrijving

Datatype

Alias

Beschrijving

Alias

Beschrijving

Datatype

Alias

Beschrijving

Datatype

Alias

Beschrijving

Datatype

Alias

Beschrijving

Alias

Beschrijving

Datatype

Maateenheden

Alias

Beschrijving

Alias

Beschrijving

Datatype

Alias

Beschrijving

Datatype

Maateenheden

Alias

Beschrijving

Datatype

Alias

Beschrijving

Datatype

Alias

Beschrijving

Datatype

Alias

Beschrijving

Datatype

Alias

Beschrijving

Datatype

Alias

Beschrijving

Datatype

Alias

Beschrijving

Datatype

Alias

Beschrijving

Datatype

Alias

Beschrijving

Datatype

Alias

Beschrijving

Alias

Beschrijving

Datatype

Alias

Beschrijving

Alias

Beschrijving

Datatype