ID

29757

Descrizione

https://clinicaltrials.gov/show/NCT00197028 Visit 7, Day 60, Vaccination 5, Adverse Events Study ID: 103967 Clinical Study ID: 103967 Study Title: A Phase I/IIb randomized, double-blind, controlled study of the safety, immunogenicity and proof-of-concept of RTS,S/AS02D, a candidate malaria vaccine in infants living in a malaria-endemic region Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00197028 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: SB257049 Trade Name: BIO MALARIA; SB257049 Study Indication: Malaria

collegamento

https://clinicaltrials.gov/show/NCT00197028

Keywords

versioni (1)
  1. 18/04/18 18/04/18 -
Titolare del copyright

GlaxoSmithKline (GSK)

Caricato su

18 aprile 2018

DOI

Per favore, per richiedere un accesso.

Licenza

Creative Commons BY-NC 3.0
Commenti del modello :

Puoi commentare il modello dati qui. Tramite i fumetti nei gruppi di articoli e articoli è possibile aggiungere commenti a quelli in modo specifico.

Torna ai commenti del modello
Commenti del gruppo di articoli per :

Commenti dell'articolo per :

Per scaricare i modelli di dati devi essere registrato. Per favore accesso o registrati GRATIS.

RTS,S/AS02D, a candidate malaria vaccine in infants living in a malaria-endemic region, Study ID: 103967, NCT00197028

Inglese

Visit 7, Day 60, Vaccination 5, Adverse Events

1 moduli  
Check for study continuation
Descrizione

Check for study continuation

Alias
UMLS CUI-1
C0805733
UMLS CUI-2
C0008976
UMLS CUI-3
C0042210
Did the subject return for visit 7?
Descrizione

Visit 7 participation

Tipo di dati

integer

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0805733
UMLS CUI [1,3]
C0008976
Withdrawal reason: Please tick the ONE most appropriate reason and skip the following pages of this visit.
Descrizione

Withdrawal reason

Tipo di dati

integer

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C0392360
UMLS CUI [1,3]
C0008976
Please tick who took the decision:
Descrizione

Withdrawal decision maker

Tipo di dati

integer

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0679006
Please tick who took the decision:
Descrizione

Withdrawal decision maker

Tipo di dati

integer

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0679006
Please tick who took the decision:
Descrizione

Withdrawal decision maker

Tipo di dati

integer

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0679006
Clearance of Malaria parasitemia
Descrizione

Clearance of Malaria parasitemia

Alias
UMLS CUI-1
C2239174
UMLS CUI-2
C0024530
Was amodiaquine for clearance of parasitemia administered according to protocol?
Descrizione

Amodiaquine administration

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0002641
If not given at Visit 7, please specify the date:
Descrizione

Amodiaquine administration

Tipo di dati

date

Alias
UMLS CUI [1]
C0002641
Was SP for clearance of parasitemia administered according to protocol?
Descrizione

Sulfadoxine-Pyrimethamine (SP) administration

Tipo di dati

float

Alias
UMLS CUI [1,1]
C0038679
UMLS CUI [1,2]
C0034283
If not given at Visit 7, please specify the date:
Descrizione

Sulfadoxine-Pyrimethamine (SP) administration

Tipo di dati

date

Alias
UMLS CUI [1,1]
C0038679
UMLS CUI [1,2]
C0034283
Vaccine administration
Descrizione

Vaccine administration

Alias
UMLS CUI-1
C2368628
Date (fill in only if different from visit date):
Descrizione

Date of vaccination

Tipo di dati

date

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

Route: [A] Axillary

Tipo di dati

float

Unità di misura
  • °C
Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C0042196
UMLS CUI [1,3]
C0332152
°C
Vaccine name
Descrizione

Vaccine name

Tipo di dati

integer

Alias
UMLS CUI [1]
C0042210
Side / Site Route
Descrizione

Side / Site Route

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C1515974
UMLS CUI [1,3]
C0013153
UMLS CUI [1,4]
C0441987
Has the study vaccine been administered according to the Protocol?
Descrizione

Vaccine administration protocol

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C2348563
If you answered the previous question with No → Please tick all items that apply: Side
Descrizione

Vaccine administration side

Tipo di dati

integer

Alias
UMLS CUI [1,1]
C0441987
UMLS CUI [1,2]
C0013153
UMLS CUI [1,3]
C0042210
If you answered the previous question with No → Please tick all items that apply: Site
Descrizione

Vaccine administration site

Tipo di dati

text

Alias
UMLS CUI [1,1]
C1515974
UMLS CUI [1,2]
C0013153
UMLS CUI [1,3]
C0042210
If you answered the previous question with No Please tick all items that apply: Route
Descrizione

Vaccine administration route

Tipo di dati

integer

Alias
UMLS CUI [1,1]
C0013153
UMLS CUI [1,2]
C0042210
Comments:
Descrizione

Comments on vaccination

Tipo di dati

text

Alias
UMLS CUI [1]
C0947611
If the vaccine was not administered (*) Why not administered?
Descrizione

Please tick the ONE most appropriate category for non administration:

Tipo di dati

text

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C0566251
Please tick who took the decision:
Descrizione

Decision maker

Tipo di dati

integer

Alias
UMLS CUI [1]
C0679006
UMLS CUI [2]
C1709536
Unsolicited adverse events
Descrizione

Unsolicited adverse events

Alias
UMLS CUI-1
C0877248
UMLS CUI-2
C0042196
Has the subject experienced any serious or non-serious unsolicited adverse events within two weeks postvaccination?
Descrizione

Unsolicited adverse events

Tipo di dati

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0042196
Solicited adverse events - Local symptoms
Descrizione

Solicited adverse events - Local symptoms

Alias
UMLS CUI-1
C1457887
UMLS CUI-2
C0205276
UMLS CUI-3
C0042196
Has the subject experienced any of the following signs/symptoms at the administration site during the solicited period?
Descrizione

Adverse events

Tipo di dati

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0042196
Swelling day
Descrizione

Swelling day

Tipo di dati

integer

Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C2700396
Swelling size
Descrizione

Swelling size

Tipo di dati

integer

Unità di misura
  • mm
Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C2700396
mm
Ongoing after Day 6?
Descrizione

Swelling ongoing

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0549178
UMLS CUI [1,3]
C2700396
Date of last Day of Symptoms
Descrizione

Date of last Day of Symptoms

Tipo di dati

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0038999
UMLS CUI [1,3]
C2700396
Pain day
Descrizione

Pain day

Tipo di dati

integer

Alias
UMLS CUI [1,1]
C0030193
UMLS CUI [1,2]
C2700396
Pain intensity
Descrizione

Pain intensity

Tipo di dati

integer

Alias
UMLS CUI [1,1]
C0030193
UMLS CUI [1,2]
C0522510
UMLS CUI [1,3]
C2700396
Ongoing after Day 6?
Descrizione

Pain ongoing

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0030193
UMLS CUI [1,2]
C0549178
UMLS CUI [1,3]
C2700396
Date of last Day of Symptoms
Descrizione

Date of last Day of Symptoms

Tipo di dati

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0030193
UMLS CUI [1,3]
C2700396
Solicited adverse events - General symptoms
Descrizione

Solicited adverse events - General symptoms

Alias
UMLS CUI-1
C0159028
UMLS CUI-2
C0042196
UMLS CUI-3
C0877248
Has the subject experienced any of the following signs/symptoms during the solicited period?
Descrizione

Adverse event

Tipo di dati

integer

Alias
UMLS CUI [1]
C0877248
Fever day
Descrizione

Fever day

Tipo di dati

integer

Alias
UMLS CUI [1]
C0015967
Fever not taken?
Descrizione

Fever not taken

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0015967
Fever temperature
Descrizione

[A]> Axillary

Tipo di dati

float

Unità di misura
  • °C
Alias
UMLS CUI [1,1]
C0039476
UMLS CUI [1,2]
C0015967
°C
Ongoing after Day 6?
Descrizione

Ongoing fever

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0015967
UMLS CUI [1,2]
C0549178
Date of last Day of Symptoms
Descrizione

Date of last Day of Symptoms

Tipo di dati

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0015967
Causality?
Descrizione

Causality

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0015127
UMLS CUI [1,2]
C0015967
Irritability/ Fussiness day
Descrizione

Irritability/ Fussiness day

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0022107
Irritability/ Fussiness intensity
Descrizione

Irritability/ Fussiness intensity

Tipo di dati

integer

Alias
UMLS CUI [1,1]
C0022107
UMLS CUI [1,2]
C0522510
Ongoing after day 6?
Descrizione

Irritability/ Fussiness ongoing

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0022107
UMLS CUI [1,2]
C0549178
Date of last Day of Symptoms
Descrizione

Date of last Day of Symptoms

Tipo di dati

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0022107
Causality?
Descrizione

Causality

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0015127
UMLS CUI [1,2]
C0022107
Drowsiness day
Descrizione

Drowsiness day

Tipo di dati

integer

Alias
UMLS CUI [1]
C0013144
Drowsiness intensity
Descrizione

Drowsiness intensity

Tipo di dati

integer

Alias
UMLS CUI [1,1]
C0013144
UMLS CUI [1,2]
C0522510
Ongoing after day 6?
Descrizione

Drowsiness ongoing

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0013144
UMLS CUI [1,2]
C0549178
Date of last Day of Symptoms
Descrizione

Date of last Day of Symptoms

Tipo di dati

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0013144
Causality?
Descrizione

Causality

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0015127
UMLS CUI [1,2]
C0013144
Loss of appetite day
Descrizione

Loss of appetite day

Tipo di dati

integer

Alias
UMLS CUI [1]
C1971624
Loss of appetite intensity
Descrizione

Loss of appetite intensity

Tipo di dati

integer

Alias
UMLS CUI [1,1]
C1971624
UMLS CUI [1,2]
C0522510
Ongoing after Day 6?
Descrizione

Loss of appetite ongoing

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C1971624
UMLS CUI [1,2]
C0549178
Date of last Day of Symptoms
Descrizione

Date of last Day of Symptoms

Tipo di dati

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1971624
Causality?
Descrizione

Causality

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0015127
UMLS CUI [1,2]
C1971624
For any Grade 3 temperature not related to vaccination (temperature > 39°C) (Causality “NO”), please describe alternative reason:
Descrizione

Grade 3 temperature not related to vaccination (temperature > 39°C) (Causality “NO”)

Tipo di dati

text

Alias
UMLS CUI [1]
C0005903
Ritorna all'inizio della pagina

Similar models

Visit 7, Day 60, Vaccination 5, Adverse Events

1 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
Check for study continuation
C0805733 (UMLS CUI-1)
C0008976 (UMLS CUI-2)
C0042210 (UMLS CUI-3)
Item
Did the subject return for visit 7?
integer
C0545082 (UMLS CUI [1,1])
C0805733 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Visit 3 participation
Code List
Did the subject return for visit 7?
CL Item
Yes → Please complete the next pages. (1)
CL Item
No → Please complete below. (2)
Item
Withdrawal reason: Please tick the ONE most appropriate reason and skip the following pages of this visit.
integer
C2349954 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Withdrawal reason
Code List
Withdrawal reason: Please tick the ONE most appropriate reason and skip the following pages of this visit.
CL Item
Same reason and decision as previous visit. (1)
CL Item
[SAE] Serious adverse event (complete the Serious Adverse Event form) Please specify SAE N°: |__|__| (2)
CL Item
[AEX] Non-Serious adverse event (complete the Non-serious Adverse Event section) Please specify unsolicited AE N°: |__|__| or solicited AE code: |__|__| (3)
CL Item
[OTH] Other, please specify: ____________________________________________________ (e.g.: consent withdrawal, Protocol violation, …) (4)
Item
Please tick who took the decision:
integer
C0422727 (UMLS CUI [1,1])
C0679006 (UMLS CUI [1,2])
Withdrawal decision maker
Code List
Please tick who took the decision:
CL Item
[I] Investigator (1)
CL Item
[P] Parents/Guardians (2)
Item
Please tick who took the decision:
integer
C0422727 (UMLS CUI [1,1])
C0679006 (UMLS CUI [1,2])
Withdrawal decision maker
Code List
Please tick who took the decision:
CL Item
[I] Investigator (1)
CL Item
[P] Parents/Guardians (2)
Item
Please tick who took the decision:
integer
C0422727 (UMLS CUI [1,1])
C0679006 (UMLS CUI [1,2])
Withdrawal decision maker
Code List
Please tick who took the decision:
CL Item
[I] Investigator (1)
CL Item
[P] Parents/Guardians (2)
Item Group
Clearance of Malaria parasitemia
C2239174 (UMLS CUI-1)
C0024530 (UMLS CUI-2)
Amodiaquine administration
Item
Was amodiaquine for clearance of parasitemia administered according to protocol?
boolean
C0002641 (UMLS CUI [1])
Amodiaquine administration
Item
If not given at Visit 7, please specify the date:
date
C0002641 (UMLS CUI [1])
Sulfadoxine-Pyrimethamine (SP) administration
Item
Was SP for clearance of parasitemia administered according to protocol?
float
C0038679 (UMLS CUI [1,1])
C0034283 (UMLS CUI [1,2])
Sulfadoxine-Pyrimethamine (SP) administration
Item
If not given at Visit 7, please specify the date:
date
C0038679 (UMLS CUI [1,1])
C0034283 (UMLS CUI [1,2])
Item Group
Vaccine administration
C2368628 (UMLS CUI-1)
Date of vaccination
Item
Date (fill in only if different from visit date):
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 name
integer
C0042210 (UMLS CUI [1])
Vaccine name
Code List
Vaccine name
CL Item
[S] TETRActHib Vaccine (1)
CL Item
[R] Replacement vial →|__|__|__|__|__| (2)
CL Item
[W] Wrong vial number→|__|__|__|__|__| (3)
CL Item
[N] Not administered → Please complete below (*) (4)
Side / Site Route
Item
Side / Site Route
boolean
C2368628 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
C0013153 (UMLS CUI [1,3])
C0441987 (UMLS CUI [1,4])
Vaccine administration 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 you answered the previous question with No → Please tick all items that apply: Side
integer
C0441987 (UMLS CUI [1,1])
C0013153 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
Vaccine administration
Code List
If you answered the previous question with No → Please tick all items that apply: Side
CL Item
[L] Left (1)
CL Item
[R] Right (2)
Item
If you answered the previous question with No → Please tick all items that apply: Site
text
C1515974 (UMLS CUI [1,1])
C0013153 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
Vaccine administration site
Code List
If you answered the previous question with No → Please tick all items that apply: Site
CL Item
Deltoid (1)
CL Item
Thigh (2)
CL Item
Buttock (6)
Item
If you answered the previous question with No Please tick all items that apply: Route
integer
C0013153 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
Vaccine administration route
Code List
If you answered the previous question with No Please tick all items that apply: Route
CL Item
[IM] I.M. (1)
CL Item
[SC] S.C. (2)
Comments on vaccination
Item
Comments:
text
C0947611 (UMLS CUI [1])
Item
If the vaccine was not administered (*) Why not administered?
text
C2368628 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
No vaccination
Code List
If the vaccine was not administered (*) Why not administered?
CL Item
SAE] Serious adverse event (complete the Serious Adverse Event form) Please specify SAE N°: |__|__| (SAE] Serious adverse event (complete the Serious Adverse Event form) Please specify SAE N°: |__|__|)
CL Item
[AEX] Non-Serious adverse event (complete the Non-serious Adverse Event section) Please specify unsolicited AE N°: |__|__| or solicited AE code: |__|__| ([AEX] Non-Serious adverse event (complete the Non-serious Adverse Event section) Please specify unsolicited AE N°: |__|__| or solicited AE code: |__|__|)
CL Item
[OTH] Other, please specify: ___________________________________________________ (e.g.: consent withdrawal, protocol violation, …) ([OTH] Other, please specify: ___________________________________________________ (e.g.: consent withdrawal, protocol violation, …))
Item
Please tick who took the decision:
integer
C0679006 (UMLS CUI [1])
C1709536 (UMLS CUI [2])
Decision maker
Code List
Please tick who took the decision:
CL Item
[I] Investigator (1)
CL Item
[P] Parents/Guardians (2)
Item Group
Unsolicited adverse events
C0877248 (UMLS CUI-1)
C0042196 (UMLS CUI-2)
Item
Has the subject experienced any serious or non-serious unsolicited adverse events within two weeks postvaccination?
integer
C0877248 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
Unsolicited adverse events
Code List
Has the subject experienced any serious or non-serious unsolicited adverse events within two weeks postvaccination?
CL Item
[U] Information not available (1)
CL Item
[NA] No Vaccine administered (2)
CL Item
[N] No (3)
CL Item
[Y] Yes, fill in the Non-Serious Adverse Event pages or Serious Adverse Event form. (4)
Item Group
Solicited adverse events - Local symptoms
C1457887 (UMLS CUI-1)
C0205276 (UMLS CUI-2)
C0042196 (UMLS CUI-3)
Item
Has the subject experienced any of the following signs/symptoms at the administration site during the solicited period?
integer
C0877248 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
Adverse events
Code List
Has the subject experienced any of the following signs/symptoms at the administration site during the solicited period?
CL Item
[U] Information not available (1)
CL Item
[NA] No Vaccine administered (2)
CL Item
[N] No (3)
CL Item
[Y] Yes, please tick No/Yes for each symptom. If Yes is ticked, please complete all items. (4)
Item
Swelling day
integer
C0038999 (UMLS CUI [1,1])
C2700396 (UMLS CUI [1,2])
Swelling day
Code List
Swelling day
CL Item
Day 0 (1)
CL Item
Day 1 (2)
CL Item
Day 2 (3)
CL Item
Day 3 (4)
CL Item
Day 4 (5)
CL Item
Day 5 (6)
CL Item
Day 6 (7)
Swelling size
Item
Swelling size
integer
C0038999 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Swelling ongoing
Item
Ongoing after Day 6?
boolean
C0038999 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
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])
Item
Pain day
integer
C0030193 (UMLS CUI [1,1])
C2700396 (UMLS CUI [1,2])
Pain day
Code List
Pain day
CL Item
Day 0 (1)
CL Item
Day 1 (2)
CL Item
Day 2 (3)
CL Item
Day 3 (4)
CL Item
Day 4 (5)
CL Item
Day 5 (6)
CL Item
Day 6 (7)
Item
Pain intensity
integer
C0030193 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Pain intensity
Code List
Pain intensity
CL Item
0: None (1)
CL Item
1: Mild (2)
CL Item
2: Moderate (3)
CL Item
3: Severe (4)
Pain ongoing
Item
Ongoing after Day 6?
boolean
C0030193 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Date of last Day of Symptoms
Item
Date of last Day of Symptoms
date
C0011008 (UMLS CUI [1,1])
C0030193 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Item Group
Solicited adverse events - General symptoms
C0159028 (UMLS CUI-1)
C0042196 (UMLS CUI-2)
C0877248 (UMLS CUI-3)
Item
Has the subject experienced any of the following signs/symptoms during the solicited period?
integer
C0877248 (UMLS CUI [1])
Adverse event
Code List
Has the subject experienced any of the following signs/symptoms during the solicited period?
CL Item
[U] Information not available (1)
CL Item
[NA] No Vaccine administered (2)
CL Item
[N] No (3)
CL Item
[Y] Yes, please tick No/Yes for each symptom. If Yes is ticked, please complete all items. (4)
Item
Fever day
integer
C0015967 (UMLS CUI [1])
Fever day
Code List
Fever day
CL Item
Day 0 (1)
CL Item
Day 1 (2)
CL Item
Day 2 (3)
CL Item
Day 3 (4)
CL Item
Day 4 (5)
CL Item
Day 5 (6)
CL Item
Day 6 (7)
Fever not taken
Item
Fever not taken?
boolean
C0015967 (UMLS CUI [1])
Fever temperature
Item
Fever temperature
float
C0039476 (UMLS CUI [1,1])
C0015967 (UMLS CUI [1,2])
Ongoing fever
Item
Ongoing after Day 6?
boolean
C0015967 (UMLS CUI [1,1])
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])
Causality
Item
Causality?
boolean
C0015127 (UMLS CUI [1,1])
C0015967 (UMLS CUI [1,2])
Irritability/ Fussiness day
Item
Irritability/ Fussiness day
boolean
C0022107 (UMLS CUI [1])
Item
Irritability/ Fussiness intensity
integer
C0022107 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
Irritability/ Fussiness intensity
Code List
Irritability/ Fussiness intensity
CL Item
0: None (1)
CL Item
1: Mild (2)
CL Item
2: Moderate (3)
CL Item
3: Severe (*) (4)
Irritability/ Fussiness ongoing
Item
Ongoing after day 6?
boolean
C0022107 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Date of last Day of Symptoms
Item
Date of last Day of Symptoms
date
C0011008 (UMLS CUI [1,1])
C0022107 (UMLS CUI [1,2])
Causality
Item
Causality?
boolean
C0015127 (UMLS CUI [1,1])
C0022107 (UMLS CUI [1,2])
Item
Drowsiness day
integer
C0013144 (UMLS CUI [1])
Drowsiness day
Code List
Drowsiness day
CL Item
Day 0 (1)
CL Item
Day 1 (2)
CL Item
Day 2 (3)
CL Item
Day 3 (4)
CL Item
Day 4 (5)
CL Item
Day 5 (6)
CL Item
Day 6 (7)
Item
Drowsiness intensity
integer
C0013144 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
Drowsiness intensity
Code List
Drowsiness intensity
CL Item
0: None (1)
CL Item
1: Mild (2)
CL Item
2: Moderate (3)
CL Item
3: Severe (*) (4)
Drowsiness ongoing
Item
Ongoing after day 6?
boolean
C0013144 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Date of last Day of Symptoms
Item
Date of last Day of Symptoms
date
C0011008 (UMLS CUI [1,1])
C0013144 (UMLS CUI [1,2])
Causality
Item
Causality?
boolean
C0015127 (UMLS CUI [1,1])
C0013144 (UMLS CUI [1,2])
Item
Loss of appetite day
integer
C1971624 (UMLS CUI [1])
Loss of appetite day
Code List
Loss of appetite day
CL Item
Day 0 (1)
CL Item
Day 1 (2)
CL Item
Day 2 (3)
CL Item
Day 3 (4)
CL Item
Day 4 (5)
CL Item
Day 5 (6)
CL Item
Day 6 (7)
Item
Loss of appetite intensity
integer
C1971624 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
Loss of appetite intensity
Code List
Loss of appetite intensity
CL Item
0: None (1)
CL Item
1: Mild (2)
CL Item
2: Moderate (3)
CL Item
3: Severe (*) (4)
Loss of appetite ongoing
Item
Ongoing after Day 6?
boolean
C1971624 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Date of last Day of Symptoms
Item
Date of last Day of Symptoms
date
C0011008 (UMLS CUI [1,1])
C1971624 (UMLS CUI [1,2])
Causality
Item
Causality?
boolean
C0015127 (UMLS CUI [1,1])
C1971624 (UMLS CUI [1,2])
Temperature not related to vaccination
Item
For any Grade 3 temperature not related to vaccination (temperature > 39°C) (Causality “NO”), please describe alternative reason:
text
C0005903 (UMLS CUI [1])
Ritorna all'inizio della pagina 

Contatto

Si prega di utilizzare questo modulo per feedback, domande e suggerimenti per miglioramenti.

I campi contrassegnati da * sono obbligatori.

Aiuto

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial