ID

29178

Descripción

Open, phase IV clinical trial to compare the immunogenicity and reactogenicity of GSK Biologicals’ Infanrix™ (DTPa) vaccine administered as a booster dose at 4 years of age in preterm vs. full-term children previously primed and boosted with Infanrix™ hexa.

Palabras clave

Versiones (1)
  1. 4/3/18 4/3/18 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

4 de marzo de 2018

DOI

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Licencia

Creative Commons BY-NC 3.0
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Infanrix Vaccine - 102038

Inglés

Solicited Adverse Events

1 formularios  
Solicited Adverse Events Local Symptoms
Descripción

Solicited Adverse Events Local Symptoms

Alias
UMLS CUI-1
C1457887
UMLS CUI-2
C0205276
UMLS CUI-3
C0877248
Has the subject experienced any of the following local (at administration site) solicited signs/symptoms during the solicited period?
Descripción

If Yes, please check a No/Yes box for each symptom. If Yes is checked, please complete all items

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0205276
UMLS CUI [1,3]
C0877248
Local Symptoms
Descripción

Local Symptoms

Alias
UMLS CUI-1
C1457887
UMLS CUI-2
C0205276
Local Symptoms
Descripción

Local Symptom

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0205276
Symptom present?
Descripción

Symptom present

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1457887
Ongoing after day 3?
Descripción

symptoms ongoing

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0549178
Date of last day of symptoms
Descripción

last day of symptoms

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1457887
UMLS CUI [1,3]
C0806020
Daily Record of Symptom Severeness
Descripción

Daily Record of Symptom Severeness

Alias
UMLS CUI-1
C1457887
UMLS CUI-2
C0332173
Day after Injection
Descripción

Day after Injection

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0021485
Redness Size
Descripción

Redness Size

Tipo de datos

float

Unidades de medida
  • mm
Alias
UMLS CUI [1,1]
C0332575
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C2700396
mm
Swelling Size
Descripción

Swelling Size

Tipo de datos

float

Unidades de medida
  • mm
Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C2700396
mm
Pain intensity
Descripción

Pain

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0030193
UMLS CUI [1,2]
C0522510
UMLS CUI [1,3]
C2700396
Solicited Adverse Events - General Symptoms
Descripción

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 general solicited signs/symptoms during the solicited period?
Descripción

If Yes, please check a No/Yes box for each symptom. If Yes is checked, please complete all items

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0159028
UMLS CUI [1,2]
C0042196
UMLS CUI [1,3]
C0877248
Route
Descripción

Route body temperature

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C1515974
General Symptoms
Descripción

General Symptoms

Alias
UMLS CUI-1
C0159028
General Symptoms
Descripción

Fever: Axillary ≥ 37.5°C Tympanic (rectal conversion) ≥ 38°C Rectal ≥ 38°C

Tipo de datos

text

Alias
UMLS CUI [1]
C0159028
Symptom present?
Descripción

Symptom present

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1457887
Ongoing after day 3?
Descripción

symptoms ongoing

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0549178
Date of last day of symptoms
Descripción

last day of symptoms

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1457887
UMLS CUI [1,3]
C0806020
Causality?
Descripción

Causality

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1547657
Daily Record of Symptom Severeness
Descripción

Daily Record of Symptom Severeness

Day after Injection
Descripción

Day after Injection

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0021485
Fever temperature
Descripción

Fever temperature

Tipo de datos

float

Unidades de medida
  • °C
Alias
UMLS CUI [1]
C0039476
°C
Irritability/Fussiness Intensity
Descripción

Irritability/Fussiness Intensity

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0022107
UMLS CUI [1,2]
C0522510
Drowsiness Intensity
Descripción

Drowsiness Intensity

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0013144
UMLS CUI [1,2]
C0522510
Loss of appetite Intensity
Descripción

Loss of appetite Intensity

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1971624
UMLS CUI [1,2]
C0522510
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Similar models

Solicited Adverse Events

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Solicited Adverse Events Local Symptoms
C1457887 (UMLS CUI-1)
C0205276 (UMLS CUI-2)
C0877248 (UMLS CUI-3)
Item
Has the subject experienced any of the following local (at administration site) solicited signs/symptoms during the solicited period?
text
C1457887 (UMLS CUI [1,1])
C0205276 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,3])
local symptoms of adverse event
Code List
Has the subject experienced any of the following local (at administration site) solicited signs/symptoms during the solicited period?
CL Item
No (N)
CL Item
Yes (Y)
CL Item
Information not retrievable (U)
CL Item
No vaccine administered (NA)
Item Group
Local Symptoms
C1457887 (UMLS CUI-1)
C0205276 (UMLS CUI-2)
Item
Local Symptoms
text
C1457887 (UMLS CUI [1,1])
C0205276 (UMLS CUI [1,2])
Local Symptom
Code List
Local Symptoms
CL Item
Redness (R)
CL Item
Swelling (S)
CL Item
Pain (P)
Symptom present
Item
Symptom present?
boolean
C1457887 (UMLS CUI [1])
symptoms ongoing
Item
Ongoing after day 3?
boolean
C1457887 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
last day of symptoms
Item
Date of last day of symptoms
date
C0011008 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,3])
Item Group
Daily Record of Symptom Severeness
C1457887 (UMLS CUI-1)
C0332173 (UMLS CUI-2)
Item
Day after Injection
integer
C0011008 (UMLS CUI [1,1])
C0021485 (UMLS CUI [1,2])
Day after Injection
Code List
Day after Injection
CL Item
Day 0 (0)
CL Item
Day 1 (1)
CL Item
Day 2 (2)
CL Item
Day 3 (3)
Redness Size
Item
Redness Size
float
C0332575 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Swelling Size
Item
Swelling Size
float
C0038999 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
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
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (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 general solicited signs/symptoms during the solicited period?
text
C0159028 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,3])
local symptoms of adverse event
Code List
Has the subject experienced any of the following general solicited signs/symptoms during the solicited period?
CL Item
No (N)
CL Item
Yes (Y)
CL Item
Information not retrievable (U)
CL Item
No vaccine administered (NA)
Item
Route
text
C0005903 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
Route body temperature
Code List
Route
CL Item
Axillary (A)
CL Item
Rectal (R)
CL Item
Tympanic (T)
Item Group
General Symptoms
C0159028 (UMLS CUI-1)
Item
General Symptoms
text
C0159028 (UMLS CUI [1])
Local Symptom
Code List
General Symptoms
CL Item
Fever (F)
CL Item
Irritability/Fussiness (I)
CL Item
Drowsiness (D)
CL Item
Loss of appetite (L)
Symptom present
Item
Symptom present?
boolean
C1457887 (UMLS CUI [1])
symptoms ongoing
Item
Ongoing after day 3?
boolean
C1457887 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
last day of symptoms
Item
Date of last day of symptoms
date
C0011008 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,3])
Causality
Item
Causality?
boolean
C1547657 (UMLS CUI [1])
Item Group
Daily Record of Symptom Severeness
Item
Day after Injection
integer
C0011008 (UMLS CUI [1,1])
C0021485 (UMLS CUI [1,2])
Day after Injection
Code List
Day after Injection
CL Item
Day 0 (0)
CL Item
Day 1 (1)
CL Item
Day 2 (2)
CL Item
Day 3 (3)
Fever temperature
Item
Fever temperature
float
C0039476 (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
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Drowsiness Intensity
integer
C0013144 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
Irritability/Fussiness Intensity
Code List
Drowsiness Intensity
CL Item
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Loss of appetite Intensity
integer
C1971624 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
Irritability/Fussiness Intensity
Code List
Loss of appetite Intensity
CL Item
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
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