ID

34653

Description

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

Keywords

Versions (3)
  1. 1/15/19 1/15/19 -
  2. 1/18/19 1/18/19 -
  3. 1/22/19 1/22/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

January 22, 2019

DOI

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License

Creative Commons BY-NC 3.0
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Safety and reactogenicity of booster dose of either an investigational vaccination regimen or DTPw HBVHib 103812 & 104727

English

Visit 1 103812 (DTPW-HBV=HIB-MENAC-TT-014 BST:013&004 (15-18/24M)) - General Medical History/ Physical Examination; Vaccine Administration; Unsolicited adverse events; Solicited Adverse Events - Local Symptoms; Soliced adverse events - General Symptoms

1 forms  
General medical history/ Physical examination
Description

General medical history/ Physical examination

Alias
UMLS CUI-1
C0262926
UMLS CUI-2
C0031809
Are you aware of any pre- existing conditions or signs and/ or symptoms present in the subject prior to the start of the study?
Description

If yes, tick appropriate box(es) and give diagnosis.

Data type

boolean

Alias
UMLS CUI [1,1]
C0521987
UMLS CUI [1,2]
C0332152
UMLS CUI [1,3]
C2347804
UMLS CUI [2,1]
C0037088
UMLS CUI [2,2]
C2347662
UMLS CUI [2,3]
C0332152
UMLS CUI [2,4]
C2347804
Diagnosis
Description

Diagnosis

Alias
UMLS CUI-1
C0011900
Medical condition
Description

Medical condition

Data type

integer

Alias
UMLS CUI [1]
C0012634
Diagnosis
Description

Diagnosis

Data type

text

Alias
UMLS CUI [1]
C0011900
Medical Condition Status
Description

Medical Condition Status

Data type

integer

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0449438
Baseline Measurement of mid left thigh circumference
Description

Baseline Measurement of mid left thigh circumference

Alias
UMLS CUI-1
C0230426
UMLS CUI-2
C0444598
UMLS CUI-3
C0424682
Circumference of mid left thigh
Description

Circumference of mid left thigh

Data type

integer

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C0230426
UMLS CUI [1,2]
C0444598
UMLS CUI [1,3]
C0424682
mm
Vaccine administration
Description

Vaccine administration

Alias
UMLS CUI-1
C2368628
Date of vaccination
Description

Fill in only if different from visit date.

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0042196
Pre- Vaccination temperature
Description

Route: Axillary

Data type

float

Measurement units
  • °C
Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C0042196
UMLS CUI [1,3]
C0332152
°C
Vaccine administration
Description

Only one box must be ticked by vaccine.

Data type

text

Alias
UMLS CUI [1]
C2368628
Why not administered?
Description

Please tick the ONE most appropriate category for non administration.

Data type

text

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C0392360
UMLS CUI [1,3]
C1272696
Replacement vial
Description

Replacement vial

Data type

text

Alias
UMLS CUI [1,1]
C0184301
UMLS CUI [1,2]
C0559956
Wrong vial number
Description

Wrong vial number

Data type

text

Alias
UMLS CUI [1,1]
C0184301
UMLS CUI [1,2]
C0600091
UMLS CUI [1,3]
C3827420
Has the study vaccine been administered according to the Protocol?
Description

Protocol: Left anterolateral thigh i.m.

Data type

boolean

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C2348563
If study vaccine has not been administered according to the Protocol, check all that apply.
Description

Protocol: Left anterolateral thigh i.m.

Data type

text

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C2348563
UMLS CUI [1,3]
C0205394
Comments
Description

Comments

Data type

text

Alias
UMLS CUI [1]
C0947611
If other reason for vaccine not administered, please specify.
Description

If other reason for vaccine not administered, please specify.

Data type

text

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C0392360
UMLS CUI [1,3]
C1272696
UMLS CUI [1,4]
C2348235
If vaccine not administered, please tick who took the decision
Description

If vaccine not administered, please tick who took the decision

Data type

text

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C1272696
UMLS CUI [1,3]
C0679006
Unsolicited Adverse events
Description

Unsolicited Adverse events

Alias
UMLS CUI-1
C0877248
Has the subject experienced any serious or non- serious unsolicited adverse events within one month (minimum 30 days) post- vaccination?
Description

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

Data type

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C2368628
UMLS CUI [1,3]
C0687676
UMLS CUI [2,1]
C1519255
UMLS CUI [2,2]
C2368628
UMLS CUI [2,3]
C0687676
Solicited Adverse Events - Local Symptoms
Description

Solicited Adverse Events - Local Symptoms

Alias
UMLS CUI-1
C0877248
UMLS CUI-2
C1457887
UMLS CUI-3
C0205276
Has the subject experienced any of the following signs/ symptoms at the administration site during the solicited period?
Description

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

Data type

text

Alias
UMLS CUI [1,1]
C0037088
UMLS CUI [1,2]
C1515974
UMLS CUI [1,3]
C0013153
UMLS CUI [1,4]
C0042210
Redness
Description

Redness

Data type

boolean

Alias
UMLS CUI [1]
C0332575
If redness, enter size at Day 0
Description

Size of redness Day 0

Data type

integer

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C0332575
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C0011008
mm
If redness, enter size at Day 1
Description

Size of redness Day 1

Data type

integer

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C0332575
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C0011008
mm
If redness, enter size at Day 2
Description

Size of redness Day 2

Data type

integer

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C0332575
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C0011008
mm
If redness, enter size at Day 3
Description

Size of redness Day 3

Data type

integer

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C0332575
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C0011008
mm
Redness ongoing after day 3?
Description

Redness ongoing after day 3?

Data type

boolean

Alias
UMLS CUI [1,1]
C0332575
UMLS CUI [1,2]
C0549178
Date of last day of redness
Description

Date of last day of redness

Data type

date

Alias
UMLS CUI [1,1]
C0332575
UMLS CUI [1,2]
C0806020
Redness - medically attended visit?
Description

Redness - medically attended visit?

Data type

boolean

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1386497
UMLS CUI [1,3]
C0332575
Redness - specify medically attended visit
Description

Redness - specify medically attended visit

Data type

text

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1386497
UMLS CUI [1,3]
C0332575
UMLS CUI [1,4]
C2348235
Swelling
Description

In case of large swelling reaction at the administration site, please fill in ALSO the Large Swelling Reaction report.

Data type

boolean

Alias
UMLS CUI [1]
C0038999
If swelling, enter size at Day 0
Description

Size of swelling Day 0

Data type

integer

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C0456389
UMLS CUI [1,2]
C0038999
UMLS CUI [1,3]
C0011008
mm
If swelling, enter size at Day 1
Description

Size of swelling Day 1

Data type

integer

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C0456389
UMLS CUI [1,2]
C0038999
UMLS CUI [1,3]
C0011008
mm
If swelling, enter size at Day 2
Description

Size of swelling Day 2

Data type

integer

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C0456389
UMLS CUI [1,2]
C0038999
UMLS CUI [1,3]
C0011008
mm
If swelling, enter size at Day 3
Description

Size of swelling Day 3

Data type

integer

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C0456389
UMLS CUI [1,2]
C0038999
UMLS CUI [1,3]
C0011008
mm
Swelling ongoing after day 3?
Description

Swelling ongoing after day 3?

Data type

boolean

Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0549178
Date of last day of swelling
Description

Date of last day of swelling

Data type

date

Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0806020
Swelling - medically attended visit?
Description

Swelling - medically attended visit?

Data type

boolean

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1386497
UMLS CUI [1,3]
C0038999
Swelling - specify medically attended visit
Description

Sewlling - specify medically attended visit

Data type

text

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1386497
UMLS CUI [1,3]
C0038999
UMLS CUI [1,4]
C2348235
Pain
Description

Pain

Data type

boolean

Alias
UMLS CUI [1]
C0030193
If pain, enter Intensity at Day 0
Description

Intensity of pain Day 0

Data type

integer

Alias
UMLS CUI [1,1]
C1320357
UMLS CUI [1,2]
C0011008
If pain, enter Intensity at Day 1
Description

Intensity of pain Day 1

Data type

integer

Alias
UMLS CUI [1,1]
C1320357
UMLS CUI [1,2]
C0011008
If pain, enter Intensity at Day 2
Description

Intensity of pain Day 2

Data type

integer

Alias
UMLS CUI [1,1]
C1320357
UMLS CUI [1,2]
C0011008
If pain, enter Intensity at Day 3
Description

Intensity of pain Day 3

Data type

integer

Alias
UMLS CUI [1,1]
C1320357
UMLS CUI [1,2]
C0011008
Pain ongoing after day 3?
Description

Pain ongoing after day 3?

Data type

boolean

Alias
UMLS CUI [1,1]
C0030193
UMLS CUI [1,2]
C0549178
Date of last day of pain
Description

Date of last day of pain

Data type

date

Alias
UMLS CUI [1,1]
C0030193
UMLS CUI [1,2]
C0806020
Pain - medically attended visit?
Description

Pain - medically attended visit?

Data type

boolean

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1386497
UMLS CUI [1,3]
C0030193
Pain - specify medically attended visit
Description

Pain - specify medically attended visit

Data type

text

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1386497
UMLS CUI [1,3]
C0030193
UMLS CUI [1,4]
C2348235
Soliced Adverse Events - General Symptoms
Description

Soliced Adverse Events - General Symptoms

Alias
UMLS CUI-1
C0877248
UMLS CUI-2
C0159028
Has the subject experienced any of the following signs/symptoms during the solicited period?
Description

Signs/symptoms during the solicited period

Data type

text

Alias
UMLS CUI [1,1]
C0037088
UMLS CUI [1,2]
C1515974
UMLS CUI [1,3]
C0013153
UMLS CUI [1,4]
C0042210
General Symptoms
Description

General Symptoms

Data type

text

Alias
UMLS CUI [1]
C0159028
Fever - Body temperature Day 0
Description

Fever - Body temperature Day 0

Data type

float

Measurement units
  • °C
Alias
UMLS CUI [1,1]
C0039476
UMLS CUI [1,2]
C0015967
UMLS CUI [1,3]
C0011008
°C
Fever - Body temperature Day 0 not taken
Description

Fever - Body temperature Day 0 not taken

Data type

integer

Alias
UMLS CUI [1,1]
C0437722
UMLS CUI [1,2]
C0015967
UMLS CUI [1,3]
C0011008
Fever - Body temperature Day 1
Description

Fever - Body temperature Day 1

Data type

float

Measurement units
  • °C
Alias
UMLS CUI [1,1]
C0039476
UMLS CUI [1,2]
C0015967
UMLS CUI [1,3]
C0011008
°C
Fever - Body temperature Day 1 not taken
Description

Fever - Body temperature Day 1 not taken

Data type

integer

Alias
UMLS CUI [1,1]
C0437722
UMLS CUI [1,2]
C0015967
UMLS CUI [1,3]
C0011008
Fever - Body temperature Day 2
Description

Fever - Body temperature Day 2

Data type

float

Measurement units
  • °C
Alias
UMLS CUI [1,1]
C0039476
UMLS CUI [1,2]
C0015967
UMLS CUI [1,3]
C0011008
°C
Fever - Body temperature Day 2 not taken
Description

Fever - Body temperature Day 2 not taken

Data type

integer

Alias
UMLS CUI [1,1]
C0437722
UMLS CUI [1,2]
C0015967
UMLS CUI [1,3]
C0011008
Fever - Body temperature Day 3
Description

Fever - Body temperature Day 3

Data type

float

Measurement units
  • °C
Alias
UMLS CUI [1,1]
C0039476
UMLS CUI [1,2]
C0015967
UMLS CUI [1,3]
C0011008
°C
Fever - Body temperature Day 3 not taken
Description

Fever - Body temperature Day 3 not taken

Data type

integer

Alias
UMLS CUI [1,1]
C0437722
UMLS CUI [1,2]
C0015967
UMLS CUI [1,3]
C0011008
Is fever ongoing after day 3?
Description

Is fever ongoing after day 3?

Data type

boolean

Alias
UMLS CUI [1,1]
C0015967
UMLS CUI [1,2]
C0549178
Date of last day of fever.
Description

Date of last day of fever.

Data type

date

Alias
UMLS CUI [1,1]
C0015967
UMLS CUI [1,2]
C0806020
Fever - Causality?
Description

Fever - Causality?

Data type

boolean

Alias
UMLS CUI [1,1]
C0015967
UMLS CUI [1,2]
C0015127
Fever - medically attended visit?
Description

Fever - medically attended visit?

Data type

boolean

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1386497
UMLS CUI [1,3]
C0015967
Fever - specify medically attended visit.
Description

Fever - specify medically attended visit

Data type

text

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1386497
UMLS CUI [1,3]
C0015967
UMLS CUI [1,4]
C2348235
Irritability/ Fussiness - Intensity Day 0
Description

Irritability/ Fussiness - Intensity Day 0

Data type

integer

Alias
UMLS CUI [1,1]
C0022107
UMLS CUI [1,2]
C0518690
UMLS CUI [1,3]
C0011008
Irritability/ Fussiness - Intensity Day 1
Description

Irritability/ Fussiness - Intensity Day 1

Data type

integer

Alias
UMLS CUI [1,1]
C0022107
UMLS CUI [1,2]
C0518690
UMLS CUI [1,3]
C0011008
Irritability/ Fussiness - Intensity Day 2
Description

Irritability/ Fussiness - Intensity Day 2

Data type

integer

Alias
UMLS CUI [1,1]
C0022107
UMLS CUI [1,2]
C0518690
UMLS CUI [1,3]
C0011008
Irritability/ Fussiness - Intensity Day 3
Description

Irritability/ Fussiness - Intensity Day 3

Data type

integer

Alias
UMLS CUI [1,1]
C0022107
UMLS CUI [1,2]
C0518690
UMLS CUI [1,3]
C0011008
Is irritability/ fussiness ongoing after day 3?
Description

Is irritability/ fussiness ongoing after day 3?

Data type

boolean

Alias
UMLS CUI [1,1]
C0022107
UMLS CUI [1,2]
C0549178
Date of last day of irritability/ fussiness.
Description

Date of last day of irritability/ fussiness.

Data type

date

Alias
UMLS CUI [1,1]
C0022107
UMLS CUI [1,2]
C0806020
Irritability/ Fussiness- Causality?
Description

Irritability/ Fussiness- Causality?

Data type

boolean

Alias
UMLS CUI [1,1]
C0022107
UMLS CUI [1,2]
C0015127
Irritability/Fussiness - medically attended visit?
Description

Irritability/ Fussiness- medically attended visit?

Data type

boolean

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1386497
UMLS CUI [1,3]
C0022107
Irritability/ Fussiness- specify medically attended visit.
Description

Irritability/ Fussiness - specify medically attended visit

Data type

text

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1386497
UMLS CUI [1,3]
C0022107
UMLS CUI [1,4]
C2348235
Drowsiness - Intensity Day 0
Description

Drowsiness - Intensity Day 0

Data type

integer

Alias
UMLS CUI [1,1]
C0013144
UMLS CUI [1,2]
C0518690
UMLS CUI [1,3]
C0011008
Drowsiness - Intensity Day 1
Description

Drowsiness - Intensity Day 1

Data type

integer

Alias
UMLS CUI [1,1]
C0013144
UMLS CUI [1,2]
C0518690
UMLS CUI [1,3]
C0011008
Drowsiness - Intensity Day 2
Description

Drowsiness - Intensity Day 2

Data type

integer

Alias
UMLS CUI [1,1]
C0013144
UMLS CUI [1,2]
C0518690
UMLS CUI [1,3]
C0011008
Drowsiness - Intensity Day 3
Description

Drowsiness - Intensity Day 3

Data type

integer

Alias
UMLS CUI [1,1]
C0013144
UMLS CUI [1,2]
C0518690
UMLS CUI [1,3]
C0011008
Is drowsiness ongoing after day 3?
Description

Is drowsiness ongoing after day 3?

Data type

boolean

Alias
UMLS CUI [1,1]
C0013144
UMLS CUI [1,2]
C0549178
Date of last day of drowsiness.
Description

Date of last day of drowsiness.

Data type

date

Alias
UMLS CUI [1,1]
C0013144
UMLS CUI [1,2]
C0806020
Drowsiness - Causality?
Description

Drowsiness - Causality?

Data type

boolean

Alias
UMLS CUI [1,1]
C0013144
UMLS CUI [1,2]
C0015127
Drowsiness - medically attended visit?
Description

Drowsiness - medically attended visit?

Data type

boolean

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1386497
UMLS CUI [1,3]
C0013144
Drowsiness - specify medically attended visit.
Description

Drowsiness - specify medically attended visit

Data type

text

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1386497
UMLS CUI [1,3]
C0013144
UMLS CUI [1,4]
C2348235
Loss of appetite - Intensity Day 0
Description

Loss of appetite - Intensity Day 0

Data type

integer

Alias
UMLS CUI [1,1]
C1971624
UMLS CUI [1,2]
C0518690
UMLS CUI [1,3]
C0011008
Loss of appetite - Intensity Day 1
Description

Loss of appetite - Intensity Day 1

Data type

integer

Alias
UMLS CUI [1,1]
C1971624
UMLS CUI [1,2]
C0518690
UMLS CUI [1,3]
C0011008
Loss of appetite - Intensity Day 2
Description

Loss of appetite - Intensity Day 2

Data type

integer

Alias
UMLS CUI [1,1]
C1971624
UMLS CUI [1,2]
C0518690
UMLS CUI [1,3]
C0011008
Loss of appetite - Intensity Day 3
Description

Loss of appetite - Intensity Day 3

Data type

integer

Alias
UMLS CUI [1,1]
C1971624
UMLS CUI [1,2]
C0518690
UMLS CUI [1,3]
C0011008
Is loss of appetite ongoing after day 3?
Description

Is loss of appetite ongoing after day 3?

Data type

boolean

Alias
UMLS CUI [1,1]
C1971624
UMLS CUI [1,2]
C0549178
Date of last day of loss of appetite.
Description

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

Data type

date

Alias
UMLS CUI [1,1]
C1971624
UMLS CUI [1,2]
C0806020
Loss of appetite - Causality?
Description

Loss of appetite - Causality?

Data type

boolean

Alias
UMLS CUI [1,1]
C1971624
UMLS CUI [1,2]
C0015127
Loss of appetite - medically attended visit?
Description

Loss of appetite - medically attended visit?

Data type

boolean

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1386497
UMLS CUI [1,3]
C1971624
Loss of appetite - specify medically attended visit.
Description

Loss of appetite - specify medically attended visit

Data type

text

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1386497
UMLS CUI [1,3]
C1971624
UMLS CUI [1,4]
C2348235
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)?
Description

In case of intensity 3: Was the crying continuous

Data type

boolean

Alias
UMLS CUI [1]
C0518690
UMLS CUI [2]
C2721683
In case of intensity 3: was the crying unaltered >=3 hours?
Description

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

Data type

boolean

Alias
UMLS CUI [1,1]
C0518690
UMLS CUI [1,2]
C0438697
UMLS CUI [1,3]
C0449238
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Visit 1 103812 (DTPW-HBV=HIB-MENAC-TT-014 BST:013&004 (15-18/24M)) - General Medical History/ Physical Examination; Vaccine Administration; Unsolicited adverse events; Solicited Adverse Events - Local Symptoms; Soliced adverse events - General Symptoms

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
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])
Item Group
Diagnosis
C0011900 (UMLS CUI-1)
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])
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)
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])
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])
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)
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])
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])
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)
Item Group
Unsolicited Adverse events
C0877248 (UMLS CUI-1)
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)
Item Group
Solicited Adverse Events - Local Symptoms
C0877248 (UMLS CUI-1)
C1457887 (UMLS CUI-2)
C0205276 (UMLS CUI-3)
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])
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])
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])
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)
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)
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)
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])
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)
Item Group
Soliced Adverse Events - General Symptoms
C0877248 (UMLS CUI-1)
C0159028 (UMLS CUI-2)
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)
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])
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])
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])
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])
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])
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)
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)
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)
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)
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])
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)
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)
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)
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)
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])
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)
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)
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)
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)
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])
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])
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