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ID
34246
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)
- 1/15/19 1/15/19 -
- 1/18/19 1/18/19 -
- 1/22/19 1/22/19 -
Copyright Holder
GlaxoSmithKline
Uploaded on
January 15, 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
Visit 1 - General Medical History/ Physical Examination; Vaccine Administration; Unsolicited adverse events; Solicited Adverse Events - Local Symptoms; Soliced adverse events - General Symptoms
Similar models
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)
Data type
Alias
Item Group
General medical history/ Physical examination
C0262926 (UMLS CUI-1)
C0031809 (UMLS CUI-2)
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])
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])
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])
C0449438 (UMLS CUI [1,2])
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)
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])
C0444598 (UMLS CUI [1,2])
C0424682 (UMLS CUI [1,3])
Date of vaccination
Item
Date of vaccination
date
C0011008 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
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])
C0042196 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
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])
C0392360 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
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])
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])
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])
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])
C2348563 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
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])
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])
C1272696 (UMLS CUI [1,2])
C0679006 (UMLS CUI [1,3])
Code List
If vaccine not administered, please tick who took the decision
CL Item
Investigator (I)
CL Item
Parents/ Guardians (P)
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])
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])
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)
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])
C1515974 (UMLS CUI [1,2])
C0013153 (UMLS CUI [1,3])
C0042210 (UMLS CUI [1,4])
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])
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])
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])
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])
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])
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])
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])
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])
C1386497 (UMLS CUI [1,2])
C0332575 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
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])
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])
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])
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])
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])
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])
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])
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])
C1386497 (UMLS CUI [1,2])
C0038999 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
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])
C0011008 (UMLS CUI [1,2])
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])
C0011008 (UMLS CUI [1,2])
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])
C0011008 (UMLS CUI [1,2])
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])
C0011008 (UMLS CUI [1,2])
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])
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])
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])
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])
C1386497 (UMLS CUI [1,2])
C0030193 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
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)
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])
C1515974 (UMLS CUI [1,2])
C0013153 (UMLS CUI [1,3])
C0042210 (UMLS CUI [1,4])
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)
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])
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])
C0015967 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
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])
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])
C0015967 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
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])
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])
C0015967 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
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])
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])
C0015967 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
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])
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])
C0806020 (UMLS CUI [1,2])
Fever - Causality?
Item
Fever - Causality?
boolean
C0015967 (UMLS CUI [1,1])
C0015127 (UMLS CUI [1,2])
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])
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])
C1386497 (UMLS CUI [1,2])
C0015967 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
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])
C0518690 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
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])
C0518690 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
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])
C0518690 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
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])
C0518690 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
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])
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])
C0806020 (UMLS CUI [1,2])
Irritability/ Fussiness- Causality?
Item
Irritability/ Fussiness- Causality?
boolean
C0022107 (UMLS CUI [1,1])
C0015127 (UMLS CUI [1,2])
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])
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])
C1386497 (UMLS CUI [1,2])
C0022107 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
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])
C0518690 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
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])
C0518690 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
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])
C0518690 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
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])
C0518690 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
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])
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])
C0806020 (UMLS CUI [1,2])
Drowsiness - Causality?
Item
Drowsiness - Causality?
boolean
C0013144 (UMLS CUI [1,1])
C0015127 (UMLS CUI [1,2])
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])
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])
C1386497 (UMLS CUI [1,2])
C0013144 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
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])
C0518690 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
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])
C0518690 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
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])
C0518690 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
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])
C0518690 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
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])
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])
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])
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])
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])
C1386497 (UMLS CUI [1,2])
C1971624 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
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])
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])
C0438697 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,3])