ID

29752

Beschreibung

https://clinicaltrials.gov/show/NCT00197028 Visit 2, Vaccination 1, 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

Link

https://clinicaltrials.gov/show/NCT00197028

Stichworte

Versionen (1)
  1. 18.04.18 18.04.18 -
Rechteinhaber

GlaxoSmithKline (GSK)

Hochgeladen am

18. April 2018

DOI

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Lizenz

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

Englisch

Visit 2, Vaccination 1, Adverse Events

1 Formulare  
Vaccine administration
Beschreibung

Vaccine administration

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

Date of vaccination

Datentyp

date

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

Route: [A] Axillary

Datentyp

float

Maßeinheiten
  • °C
Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C0042196
UMLS CUI [1,3]
C0332152
°C
Vaccine name
Beschreibung

Vaccine name

Datentyp

integer

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

Side / Site Route

Datentyp

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?
Beschreibung

Vaccine administration protocol

Datentyp

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
Beschreibung

Vaccine administration side

Datentyp

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
Beschreibung

Vaccine administration site

Datentyp

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
Beschreibung

Vaccine administration route

Datentyp

integer

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

Comments on vaccination

Datentyp

text

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

Please tick the ONE most appropriate category for non administration:

Datentyp

text

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

Decision maker

Datentyp

integer

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

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?
Beschreibung

Unsolicited adverse events

Datentyp

integer

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

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?
Beschreibung

Adverse events

Datentyp

integer

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

Swelling day

Datentyp

integer

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

Swelling size

Datentyp

integer

Maßeinheiten
  • mm
Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C2700396
mm
Ongoing after Day 6?
Beschreibung

Swelling ongoing

Datentyp

boolean

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

Date of last Day of Symptoms

Datentyp

date

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

Pain day

Datentyp

integer

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

Pain intensity

Datentyp

integer

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

Pain ongoing

Datentyp

boolean

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

Date of last Day of Symptoms

Datentyp

date

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

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?
Beschreibung

Adverse event

Datentyp

integer

Alias
UMLS CUI [1]
C0877248
Fever day
Beschreibung

Fever day

Datentyp

integer

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

Fever not taken

Datentyp

boolean

Alias
UMLS CUI [1]
C0015967
Fever temperature
Beschreibung

[A]> Axillary

Datentyp

float

Maßeinheiten
  • °C
Alias
UMLS CUI [1,1]
C0039476
UMLS CUI [1,2]
C0015967
°C
Ongoing after Day 6?
Beschreibung

Ongoing fever

Datentyp

boolean

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

Date of last Day of Symptoms

Datentyp

date

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

Causality

Datentyp

boolean

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

Irritability/ Fussiness day

Datentyp

boolean

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

Irritability/ Fussiness intensity

Datentyp

integer

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

Irritability/ Fussiness ongoing

Datentyp

boolean

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

Date of last Day of Symptoms

Datentyp

date

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

Causality

Datentyp

boolean

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

Drowsiness day

Datentyp

integer

Alias
UMLS CUI [1]
C0013144
Drowsiness intensity
Beschreibung

Drowsiness intensity

Datentyp

integer

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

Drowsiness ongoing

Datentyp

boolean

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

Date of last Day of Symptoms

Datentyp

date

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

Causality

Datentyp

boolean

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

Loss of appetite day

Datentyp

integer

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

Loss of appetite intensity

Datentyp

integer

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

Loss of appetite ongoing

Datentyp

boolean

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

Date of last Day of Symptoms

Datentyp

date

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

Causality

Datentyp

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:
Beschreibung

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

Datentyp

text

Alias
UMLS CUI [1]
C0005903
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Ähnliche Modelle

Visit 2, Vaccination 1, Adverse Events

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
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])
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