Information:
Fel:
ID
24986
Beskrivning
Study ID: 100478 Clinical Study ID: 100478 Study Title: Study to show non-inferiority of Tritanrix™-HepB/Hib-MenAC (+/- hepatitis B vaccine at birth) versus Tritanrix™-HepB/Hiberix™ without hepatitis B vacc. at birth for antibody response to all vaccine antigens given in healthy infants Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00290303 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 This form contains the VISIT 4 form
Nyckelord
Versioner (1)
- 2017-08-23 2017-08-23 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
23 augusti 2017
DOI
För en begäran logga in.
Licens
Creative Commons BY-NC 3.0
Modellkommentarer :
Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.
Itemgroup-kommentar för :
Item-kommentar för :
Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.
GSK non-inferiority of Tritanrix Hepatitis B VISIT 4 NCT00290303
GSK non-inferiority of Tritanrix Hepatitis B VISIT 4 NCT00290303
- StudyEvent: ODM
Similar models
GSK non-inferiority of Tritanrix Hepatitis B VISIT 4 NCT00290303
- StudyEvent: ODM
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
CHECK FOR STUDY CONTINUATION
C0805733 (UMLS CUI-1)
C0008976 (UMLS CUI-2)
C0042210 (UMLS CUI-3)
C0008976 (UMLS CUI-2)
C0042210 (UMLS CUI-3)
Did the subject return for visit 4 ?
Item
Did the subject return for visit 4 ?
boolean
C0545082 (UMLS CUI [1])
Item
If no return because:
integer
C0545082 (UMLS CUI [1,1])
C1548100 (UMLS CUI [1,2])
C1548100 (UMLS CUI [1,2])
CL Item
Serious adverse event (1)
CL Item
Non-Serious adverse event (2)
CL Item
Other, please specify (3)
no return other
Item
If no return because:
text
C0545082 (UMLS CUI [1,1])
C1548100 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
C1548100 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
Serious adverse event
Item
Please specify SAE No.
integer
C1519255 (UMLS CUI [1])
Non-Serious adverse event
Item
Please specify AE No
text
C1518404 (UMLS CUI [1])
CL Item
Investigator (1)
CL Item
Parents/Guardians (2)
Item Group
ELIMINATION CRITERIA DURING THE STUDY
C0013893 (UMLS CUI-1)
investigational or non-registered product
Item
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) during the study period.
boolean
C0013227 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,2])
immunosuppressants
Item
Chronic administration (defined as more than 14 days) of immunosuppressants or other immunemodifying drugs during the study period. (For corticosteroids, this will mean prednisone, or equivalent, ³ 0.5 mg/kg/day. Inhaled and topical steroids are allowed).
boolean
C0021081 (UMLS CUI [1])
vaccine
Item
Administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before vaccination and ending 30 days after.
boolean
C0042210 (UMLS CUI [1,1])
C1444655 (UMLS CUI [1,2])
C1444655 (UMLS CUI [1,2])
meningococcal vaccine
Item
Administration of a meningococcal vaccine not foreseen in the protocol throughout the study period.
boolean
C0700144 (UMLS CUI [1,1])
C1444655 (UMLS CUI [1,2])
C1444655 (UMLS CUI [1,2])
immunoglobulins blood products
Item
Administration of immunoglobulins and/or any blood products during the study period.
boolean
C0021027 (UMLS CUI [1,1])
C0371802 (UMLS CUI [1,2])
C0371802 (UMLS CUI [1,2])
hypersensitivity
Item
Known hypersensitivity to any component of the vaccine.
boolean
C0020517 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,2])
Item Group
CONTRAINDICATIONS TO SUBSEQUENT VACCINATION
C0683526 (UMLS CUI-1)
Anaphylactic reaction
Item
Anaphylactic reaction following the administration of vaccine.
boolean
C0002792 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
C0042196 (UMLS CUI [1,2])
hypersensitivity vaccine
Item
Known hypersensitivity to any component of the vaccine.
boolean
C0020517 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,2])
Acute disease
Item
Acute disease at the time of vaccination. (Acute disease is defined as the presence of a moderate or severe illness with or without fever. All vaccines can be administered to persons with a minor illness such as diarrhoea, mild upper respiratory infection with or without low-grade febrile illness, i.e. Axillary temperature < 37.5°C).
boolean
C0001314 (UMLS CUI [1])
Axillary temperature
Item
Axillary temperature > 37.5°C at the time of vaccination.
boolean
C1531924 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
C0042196 (UMLS CUI [1,2])
blood sample
Item
Has a blood sample been taken?
boolean
C0005834 (UMLS CUI [1,1])
C1277698 (UMLS CUI [1,2])
C1277698 (UMLS CUI [1,2])
blood sample date
Item
blood sample date
date
C0011008 (UMLS CUI [1,1])
C0005834 (UMLS CUI [1,2])
C0005834 (UMLS CUI [1,2])
Item Group
VACCINE ADMINISTRATION
C2368628 (UMLS CUI-1)
C4310469 (UMLS CUI-2)
C4310469 (UMLS CUI-2)
Vaccination Date
Item
Date of vaccination
date
C1115436 (UMLS CUI [1,1])
C4310469 (UMLS CUI [1,2])
C4310469 (UMLS CUI [1,2])
Pre-Vaccination temperature
Item
Pre-Vaccination temperature
integer
C0005903 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
C0042196 (UMLS CUI [1,2])
Item
Pre-Vaccination temperature Route
integer
C0005903 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
C0449687 (UMLS CUI [1,3])
C0042196 (UMLS CUI [1,2])
C0449687 (UMLS CUI [1,3])
CL Item
Axillary (1)
CL Item
Oral (2)
CL Item
Rectal (3)
Item
Vaccine administration
integer
C2368628 (UMLS CUI [1,1])
C4310469 (UMLS CUI [1,2])
C4310469 (UMLS CUI [1,2])
CL Item
Mencevax ACWY (1/5 th dose) (1)
CL Item
Vaccine (2)
CL Item
Replacement vial (3)
CL Item
Wrong vial number (4)
CL Item
Not administered (5)
Side / Site Route
Item
Side / Site Route: Left Upper arm I.M.
boolean
C0441987 (UMLS CUI [1,1])
C0678813 (UMLS CUI [1,2])
C0678813 (UMLS CUI [1,2])
Has the study vaccine been administered according to the Protocol?
Item
Has the study vaccine been administered according to the Protocol?
boolean
C0042196 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
C2368628 (UMLS CUI [1,2])
Item
Has the study vaccine been administered according to the Protocol? Side
integer
C0042196 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
C0441987 (UMLS CUI [1,3])
C2368628 (UMLS CUI [1,2])
C0441987 (UMLS CUI [1,3])
Code List
Has the study vaccine been administered according to the Protocol? Side
CL Item
Left (1)
CL Item
Right (2)
Item
Has the study vaccine been administered according to the Protocol? Site
integer
C0042196 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
C0205145 (UMLS CUI [1,3])
C2368628 (UMLS CUI [1,2])
C0205145 (UMLS CUI [1,3])
Code List
Has the study vaccine been administered according to the Protocol? Site
CL Item
Deltoid (1)
CL Item
Tigh (2)
CL Item
Buttock (3)
CL Item
Upper arm (4)
CL Item
Lower arm (5)
Item
Has the study vaccine been administered according to the Protocol? Route
integer
C0042196 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
C0013153 (UMLS CUI [1,3])
C2368628 (UMLS CUI [1,2])
C0013153 (UMLS CUI [1,3])
Code List
Has the study vaccine been administered according to the Protocol? Route
CL Item
i.m. (1)
CL Item
s.c. (2)
Item
Why not administered?
integer
C0042196 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
C2368628 (UMLS CUI [1,2])
Code List
Why not administered?
CL Item
Serious adverse event (1)
CL Item
Non-Serious adverse event (2)
CL Item
Other, please specify (3)
Why not administered? Other
Item
Why not administered? Other, please specify
text
C0042196 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
C2368628 (UMLS CUI [1,2])
Item Group
SOLICITED ADVERSE EVENTS – LOCAL SYMPTOMS
C0877248 (UMLS CUI-1)
Item
Has the subject experienced any of the following signs/symptoms at the administration site during the solicited period?
integer
C1457887 (UMLS CUI [1])
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 (1)
CL Item
No vaccine administered (2)
CL Item
No (3)
CL Item
Yes, please tick No/Yes for each symptom. If Yes is ticked, please complete all items. (4)
Redness
Item
Redness
boolean
C0332575 (UMLS CUI [1,1])
C2700396 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,2])
Redness
Item
Redness, size
integer
C0332575 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Item
Redness intensity day 0
integer
C0332575 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,2])
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Item
Redness intensity day 1
integer
C0332575 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,2])
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Item
Redness intensity day 2
integer
C0332575 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,2])
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Item
Redness intensity day 3
integer
C0332575 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,2])
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Ongoing after day 3?
Item
Ongoing after day 3?
boolean
C0332575 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,3])
C0518690 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,3])
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])
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 [1,3])
C1386497 (UMLS CUI [1,2])
C0332575 (UMLS CUI [1,3])
Item
Medically attended visit
integer
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])
CL Item
HO (1)
CL Item
ER (2)
CL Item
MD (3)
Swelling
Item
Swelling
boolean
C0038999 (UMLS CUI [1,1])
C2700396 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,2])
Size Swelling
Item
Size Swelling
integer
C0456389 (UMLS CUI [1,1])
C0038999 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0038999 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Item
Swelling intensity day 0
integer
C0038999 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,2])
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Item
Swelling intensity day 1
integer
C0038999 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,2])
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Item
Swelling intensity day 2
integer
C0038999 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,2])
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Item
Swelling intensity day 3
integer
C0038999 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,2])
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Ongoing after day 3?
Item
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 symptoms
Item
Date of last day of symptoms
date
C0011008 (UMLS CUI [1,1])
C0038999 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
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])
C1518404 (UMLS CUI [1,3])
C1386497 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
Item
Medically attended visit
integer
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
C1386497 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
CL Item
HO (1)
CL Item
ER (2)
CL Item
MD (3)
Pain
Item
Pain
boolean
C0030193 (UMLS CUI [1,1])
C2700396 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,2])
Pain intensity
Item
Pain intensity
integer
C3840282 (UMLS CUI [1,1])
C2700396 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,2])
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Ongoing after day 3?
Item
Ongoing after day 3?
boolean
C0549178 (UMLS CUI [1,1])
C0030193 (UMLS CUI [1,2])
C0030193 (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])
C0030193 (UMLS CUI [1,2])
Medically attended visit
Item
Medically attended visit
boolean
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
C1386497 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
Item
Medically attended visit
integer
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
C1386497 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
CL Item
HO (1)
CL Item
ER (2)
CL Item
MD (3)
Item Group
SOLICITED ADVERSE EVENTS - GENERAL SYMPTOMS
C1457887 (UMLS CUI-1)
C0042196 (UMLS CUI-2)
C0877248 (UMLS CUI-3)
C0042196 (UMLS CUI-2)
C0877248 (UMLS CUI-3)
Item
Has the subject experienced any of the following signs/symptoms during the solicited period?
integer
C1457887 (UMLS CUI [1])
Code List
Has the subject experienced any of the following signs/symptoms during the solicited period?
CL Item
Information not available (1)
CL Item
No Vaccine administered (2)
CL Item
No (3)
CL Item
Yes (4)
Fever
Item
Fever
boolean
C0015967 (UMLS CUI [1])
Fever C
Item
Fever C°
integer
C0015967 (UMLS CUI [1,1])
Item
Fever intensity day 0
integer
C0015967 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C0522510 (UMLS CUI [1,2])
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
CL Item
Not taken (5)
Item
Fever intensity day 1
integer
C0015967 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C0522510 (UMLS CUI [1,2])
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
CL Item
Not taken (5)
Item
Fever intensity day 2
integer
C0015967 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C0522510 (UMLS CUI [1,2])
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
CL Item
Not taken (5)
Item
Fever intensity day 3
integer
C0015967 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C0522510 (UMLS CUI [1,2])
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
CL Item
Not taken (5)
Ongoing after day 3?
Item
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 symptoms
Item
Date of last day of symptoms
date
C0011008 (UMLS CUI [1,1])
C0015967 (UMLS CUI [1,2])
C0015967 (UMLS CUI [1,2])
Causality?
Item
Causality?
boolean
C0015127 (UMLS CUI [1,1])
C0015967 (UMLS CUI [1,2])
C0015967 (UMLS CUI [1,2])
Medically attended visit
Item
Medically attended visit
boolean
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
C1386497 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
Item
Medically attended visit
integer
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
C1386497 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
CL Item
HO (1)
CL Item
ER (2)
CL Item
MD (3)
CL Item
Axillary (1)
CL Item
Oral (2)
CL Item
Rectal (3)
Irritability/ Fussiness
Item
Irritability/ Fussiness
boolean
C0022107 (UMLS CUI [1])
Item
Irritability / Fussiness intensity day 0
integer
C0022107 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C0522510 (UMLS CUI [1,2])
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Item
Irritability / Fussiness intensity day 1
integer
C0022107 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C0522510 (UMLS CUI [1,2])
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Item
Irritability / Fussiness intensity day 2
integer
C0022107 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C0522510 (UMLS CUI [1,2])
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Item
Irritability / Fussiness intensity day 3
integer
C0022107 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C0522510 (UMLS CUI [1,2])
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Ongoing after day 3?
Item
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 symptoms
Item
Date of last day of symptoms
date
C0022107 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Causality?
Item
Causality?
boolean
C0015127 (UMLS CUI [1,1])
C0022107 (UMLS CUI [1,2])
C0022107 (UMLS CUI [1,2])
Medically attended visit
Item
Medically attended visit
boolean
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
C1386497 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
Item
Medically attended visit
integer
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
C1386497 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
CL Item
HO (1)
CL Item
ER (2)
CL Item
MD (3)
Drowsiness
Item
Drowsiness
boolean
C0013144 (UMLS CUI [1])
Item
Drowsiness intensity day 0
integer
C0013144 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C0522510 (UMLS CUI [1,2])
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Item
Drowsiness intensity day 1
integer
C0013144 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C0522510 (UMLS CUI [1,2])
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Item
Drowsiness intensity day 2
integer
C0013144 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C0522510 (UMLS CUI [1,2])
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Item
Drowsiness intensity day 3
integer
C0013144 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C0522510 (UMLS CUI [1,2])
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Ongoing after day 3?
Item
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 symptoms
Item
Date of last day of symptoms
date
C0013144 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Causality?
Item
Causality?
boolean
C0015127 (UMLS CUI [1,1])
C0013144 (UMLS CUI [1,2])
C0013144 (UMLS CUI [1,2])
Medically attended visit
Item
Medically attended visit
boolean
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
C1386497 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
Item
Medically attended visit
integer
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
C1386497 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
CL Item
HO (1)
CL Item
ER (2)
CL Item
MD (3)
Loss of appetite
Item
Loss of appetite
boolean
C1971624 (UMLS CUI [1])
Item
Loss of appetite intensity day 0
integer
C1971624 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C0522510 (UMLS CUI [1,2])
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Item
Loss of appetite intensity day 1
integer
C1971624 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C0522510 (UMLS CUI [1,2])
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Item
Loss of appetite intensity day 2
integer
C1971624 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C0522510 (UMLS CUI [1,2])
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Item
Loss of appetite intensity day 3
integer
C1971624 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C0522510 (UMLS CUI [1,2])
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Ongoing after day 3?
Item
Ongoing after day 3?
boolean
C1971624 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,2])
Date of last day of symptoms
Item
Date of last day of symptoms
date
C1971624 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Causality?
Item
Causality?
boolean
C0015127 (UMLS CUI [1,1])
C1971624 (UMLS CUI [1,2])
C1971624 (UMLS CUI [1,2])
Medically attended visit
Item
Medically attended visit
boolean
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
C1386497 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
Item
Medically attended visit
integer
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
C1386497 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
CL Item
HO (1)
CL Item
ER (2)
CL Item
MD (3)
Item Group
UNSOLICITED ADVERSE EVENTS
C0877248 (UMLS CUI-1)
C0042196 (UMLS CUI-2)
C0042196 (UMLS CUI-2)
Item
Has the subject experienced any serious or non-serious unsolicited adverse events within one month post-vaccination?
text
Code List
Has the subject experienced any serious or non-serious unsolicited adverse events within one month post-vaccination?
CL Item
Information not available (1)
CL Item
No Vaccine administered (2)
CL Item
No (3)
CL Item
Yes, fill in the Non-Serious Adverse Event pages or Serious Adverse Event form. (4)