ID

29758

Description

https://clinicaltrials.gov/show/NCT00197028 Visit 8, Day 74, Vaccination 6, 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

Lien

https://clinicaltrials.gov/show/NCT00197028

Mots-clés

18/04/2018 18/04/2018 -

Détendeur de droits

GlaxoSmithKline (GSK)

Téléchargé le

18 avril 2018

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY-NC 3.0

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

model
Détails

Visit 8, Day 74, Vaccination 6, Adverse Events

1 Formulaires

StudyEvent: ODM
1. Visit 8, Day 74, Vaccination 6, Adverse Events

Name

Type

Description | Question | Decode (Coded Value)

Type de données

Alias

Check for study continuation

Item Group

Check for study continuation

C0805733 (UMLS CUI-1)
C0008976 (UMLS CUI-2)
C0042210 (UMLS CUI-3)

Visit 8 participation

Item

Did the subject return for visit 8?

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 8?

CL Item

Yes → Please complete the next pages. (1)

CL Item

No → Please complete below. (2)

Withdrawal reason

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)

Withdrawal decision maker

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)

Laboratory tests, Blood film for parasitemia determination

Item Group

Laboratory tests, Blood film for parasitemia determination

C2239174 (UMLS CUI-1)
C0024530 (UMLS CUI-2)

Blood smear

Item

Has a smear been taken?

boolean

C2238079 (UMLS CUI [1])

Blood smear date

Item

Please complete only if different from visit date:

date

C2238079 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])

Blood smear results

Item

Results:

integer

C1167864 (UMLS CUI [1,1])
C1167865 (UMLS CUI [1,2])

Blood smear results

Code List

Results:

CL Item

Not available (1)

CL Item

Negative (2)

CL Item

Positive (*) (3)

Parasite genotyping

Item

Has a blood sample been taken for Parasite genotyping?

boolean

C1285573 (UMLS CUI [1,1])
C0030498 (UMLS CUI [1,2])

Parasite genotyping date

Item

Please complete only if different from visit date:

date

C1285573 (UMLS CUI [1,1])
C0030498 (UMLS CUI [1,2])

Vaccine Administration

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])

Vaccine name

Item

Vaccine name

integer

C0042210 (UMLS CUI [1])

Vaccine name

Code List

Vaccine name

CL Item

[S] RTS,S/AS02D Vaccine or Engerix-B Vaccine (1)

(Comment:en)

CL Item

[R] Replacement vial →|__|__|__|__|__| (2)

(Comment:en)

CL Item

[W] Wrong vial number→|__|__|__|__|__| (3)

(Comment:en)

CL Item

[N] Not administered → Please complete below (*) (4)

(Comment:en)

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])

Vaccine administration side

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)

Vaccine administration site

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)

Vaccine administration route

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])

No vaccination

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, …))

Decision maker

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)

Unsolicited adverse events

Item Group

Unsolicited adverse events

C0877248 (UMLS CUI-1)
C0042196 (UMLS CUI-2)

Unsolicited adverse events

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)

Solicited adverse events - Local symptoms

Item Group

Solicited adverse events - Local symptoms

C1457887 (UMLS CUI-1)
C0205276 (UMLS CUI-2)
C0042196 (UMLS CUI-3)

Adverse events

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)

Swelling day

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])

Pain day

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)

Pain intensity

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])

Solicited adverse events - General symptoms

Item Group

Solicited adverse events - General symptoms

C0159028 (UMLS CUI-1)
C0042196 (UMLS CUI-2)
C0877248 (UMLS CUI-3)

Adverse event

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)

Fever day

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])

Irritability/ Fussiness intensity

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])

Drowsiness day

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)

Drowsiness intensity

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])

Loss of appetite day

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)

Loss of appetite intensity

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])

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ID

Description

Lien

Mots-clés

Versions (1)

Détendeur de droits

Téléchargé le

DOI

Licence

Modèle Commentaires :

Groupe Item commentaires pour :

Item commentaires pour :

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

Visit 8, Day 74, Vaccination 6, Adverse Events

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