ID

35048

Descripción

Study ID: 107022 Clinical Study ID: 107022 Study Title: A phase IIb, controlled, randomised, multicenter, single blind study to demonstrate the Non-Inferiority of the low dose influenza vaccine with or without adjuvant AS03 compared with Fluarix (GlaxoSmithKline Biologicals) administered intramuscularly in elderly >= 60 years Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00321373 Study Link: https://clinicaltrials.gov/ct2/show/NCT00321373 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Candidate Influenza Vaccine GSK1247446A - 2 different formulations Trade Name: FluarixTM Study Indication: Influenza The purpose of this document is to serve as a diary card for the subject. It should be filled out all through the study. Visit 1: Day 0, Pre vaccination Visit 2: Day 21, Post vaccination 1 Phone contact: Day 30, post vaccination 1 Visit 3: Day 180, post vaccination 1

Link

https://clinicaltrials.gov/ct2/show/NCT00321373

Palabras clave

Versiones (3)
  1. 12/2/19 12/2/19 -
  2. 16/2/19 16/2/19 -
  3. 22/2/19 22/2/19 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

12 de febrero de 2019

DOI

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Licencia

Creative Commons BY-NC 3.0
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Demonstration of the Non-Inferiority of the Low Dose Influenza Vaccine Compared with Fluarix NCT00321373

Inglés

Diary Card

1 formularios  
  1. StudyEvent: ODM
    1. Diary Card
Administrative Data
Descripción

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Number
Descripción

Subject Number

Tipo de datos

integer

Alias
UMLS CUI [1]
C2348585
Day of Vaccination
Descripción

Day 0

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0042196
Solicited Adverse Events Record - Local Symptoms
Descripción

Solicited Adverse Events Record - Local Symptoms

Alias
UMLS CUI-1
C1457887
UMLS CUI-2
C0205276
UMLS CUI-3
C0042196
Local Symptom
Descripción

Local Symptom

Tipo de datos

text

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

Symptom Occurrence

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C2745955
Study Day
Descripción

Study Day

Tipo de datos

integer

Alias
UMLS CUI [1]
C2826182
Intensity
Descripción

Intensity: Pain (at injection site): 0:Absent. 1:Painful on touch. 2:Painful when limb is moved. 3:Spontaneously painful / prevents normal activity.

Tipo de datos

integer

Size
Descripción

Please measure the greatest diameter (in mm), if redness, swelling or ecchymosis is ticked

Tipo de datos

integer

Unidades de medida
  • mm
mm
Ongoing after Day 6?
Descripción

Ongoing Symptom

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C3174772
Date of Last Day of Symptoms
Descripción

if ongoing after Day 6

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1517741
UMLS CUI [1,3]
C1457887
Other Local Symptoms (Day 0 to Day 29)
Descripción

Other Local Symptoms (Day 0 to Day 29)

Alias
UMLS CUI-1
C1457887
UMLS CUI-2
C0205276
UMLS CUI-3
C0042196
Description
Descripción

please specify side(s) and site(s

Tipo de datos

text

Alias
UMLS CUI [1]
C0678257
Intensity
Descripción

Other local symptoms: 1: Mild: An adverse event which is easily tolerated by the subject, causing minimal discomfort and not interfering with everyday activities. 2: Moderate: An adverse event which is sufficiently discomforting to interfere with normal everyday activities. 3: Severe: An adverse event which prevents normal, everyday activities. (In adults/ adolescents, such an adverse would, for example, prevent attendance at work/ school and would necessitate the administration of corrective therapy).

Tipo de datos

integer

Start Date
Descripción

Start Date

Tipo de datos

date

Alias
UMLS CUI [1]
C0808070
End Date
Descripción

End Date

Tipo de datos

date

Alias
UMLS CUI [1]
C0806020
Ongoing Symptom
Descripción

tick box if continuing

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C3174772
Medication
Descripción

Medication

Alias
UMLS CUI-1
C2347852
Trade/Generic Name
Descripción

Trade/Generic Name

Tipo de datos

text

Alias
UMLS CUI [1]
C2360065
Reason
Descripción

Reason

Tipo de datos

text

Alias
UMLS CUI [1]
C0392360
Total Daily Dose
Descripción

Total Daily Dose

Tipo de datos

text

Alias
UMLS CUI [1]
C2348070
Start Date
Descripción

Start Date

Tipo de datos

date

Alias
UMLS CUI [1]
C0808070
End Date
Descripción

End Date

Tipo de datos

date

Alias
UMLS CUI [1]
C0806020
Ongoing Symptom
Descripción

tick box if continuing

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C3174772
Solicited Adverse Events Record - General Symptoms
Descripción

Solicited Adverse Events Record - General Symptoms

Alias
UMLS CUI-1
C0159028
UMLS CUI-2
C0042196
UMLS CUI-3
C0877248
General Symptom
Descripción

arthralgia = joint pain

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0159028
UMLS CUI [1,3]
C1556354
Symptom Occurrence
Descripción

Symptom Occurrence

Tipo de datos

boolean

Study Day
Descripción

Study Day

Tipo de datos

integer

Alias
UMLS CUI [1]
C2826182
Intensity
Descripción

Fatigue, Headache, Muscle Ache, Shivering, Arthralgia/Joint Pain 0: Normal 1: Easily tolerated 2: Interferes with normal activity 3: That prevents normal activity

Tipo de datos

integer

Ongoing after Day 6?
Descripción

Ongoing Symptom

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C3174772
Date of Last Day of Symptoms
Descripción

Date of Last Day of Symptoms

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1517741
UMLS CUI [1,3]
C1457887
Solicited Adverse Events - Fever
Descripción

Solicited Adverse Events - Fever

Fever
Descripción

Fever: Axillary > 37.5°C Oral > 37.5°C Rectal > 38° C Temperature: Please record the temperature every day in the evening. Should additional temperature measurements be performed at other times of the day, the highest temperature is to be recorded.

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0015967
Fever Measurement Route
Descripción

If fever is ticked oral is preferred

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0449687
UMLS CUI [1,2]
C0015967
Study Day
Descripción

Study Day

Tipo de datos

integer

Alias
UMLS CUI [1]
C2826182
Body Temperature
Descripción

Body Temperature

Tipo de datos

float

Unidades de medida
  • °C
Alias
UMLS CUI [1]
C0005903
°C
Ongoing after Day 6?
Descripción

Ongoing Symptom

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C3174772
Date of Last Day of Symptoms
Descripción

Date of Last Day of Symptoms

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1517741
UMLS CUI [1,3]
C1457887
Other General Symptoms (Day 0 to Day 29)
Descripción

Other General Symptoms (Day 0 to Day 29)

Alias
UMLS CUI-1
C0029625
Description
Descripción

please specify side(s) and site(s

Tipo de datos

text

Alias
UMLS CUI [1]
C0678257
Intensity
Descripción

Other local symptoms: 1: Mild: An adverse event which is easily tolerated by the subject, causing minimal discomfort and not interfering with everyday activities. 2: Moderate: An adverse event which is sufficiently discomforting to interfere with normal everyday activities. 3: Severe: An adverse event which prevents normal, everyday activities. (In adults/ adolescents, such an adverse would, for example, prevent attendance at work/ school and would necessitate the administration of corrective therapy).

Tipo de datos

integer

Start Date
Descripción

Start Date

Tipo de datos

date

Alias
UMLS CUI [1]
C0808070
End Date
Descripción

End Date

Tipo de datos

date

Alias
UMLS CUI [1]
C0806020
Ongoing Symptom
Descripción

tick box if continuing

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C3174772
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Similar models

Diary Card

1 formularios
  1. StudyEvent: ODM
    1. Diary Card
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Subject Number
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Day of Vaccination
Item
Day of Vaccination
date
C0011008 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
Item Group
Solicited Adverse Events Record - Local Symptoms
C1457887 (UMLS CUI-1)
C0205276 (UMLS CUI-2)
C0042196 (UMLS CUI-3)
Item
Local Symptom
text
C1457887 (UMLS CUI [1,1])
C0205276 (UMLS CUI [1,2])
Local Symptom
Code List
Local Symptom
CL Item
Redness (RE)
CL Item
Swelling (SW)
CL Item
Ecchymosis (EC)
CL Item
Pain (PA)
Symptom Occurrence
Item
Symptom Occurrence
boolean
C1457887 (UMLS CUI [1,1])
C2745955 (UMLS CUI [1,2])
Item
Study Day
integer
C2826182 (UMLS CUI [1])
Study Day
Code List
Study Day
CL Item
Day 0 (0)
CL Item
Day 1 (1)
CL Item
Day 2 (2)
CL Item
Day 3 (3)
CL Item
Day 4 (4)
CL Item
Day 5 (5)
CL Item
Day 6 (6)
Item
Intensity
integer
Intensity
Code List
Intensity
CL Item
0 (0)
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
Size
Item
Size
integer
Ongoing Symptom
Item
Ongoing after Day 6?
boolean
C1457887 (UMLS CUI [1,1])
C3174772 (UMLS CUI [1,2])
Date of Last Day of Symptoms
Item
Date of Last Day of Symptoms
date
C0011008 (UMLS CUI [1,1])
C1517741 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
Item Group
Other Local Symptoms (Day 0 to Day 29)
C1457887 (UMLS CUI-1)
C0205276 (UMLS CUI-2)
C0042196 (UMLS CUI-3)
Description
Item
Description
text
C0678257 (UMLS CUI [1])
Item
Intensity
integer
Intensity
Code List
Intensity
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1])
End Date
Item
End Date
date
C0806020 (UMLS CUI [1])
Ongoing Symptom
Item
Ongoing Symptom
boolean
C1457887 (UMLS CUI [1,1])
C3174772 (UMLS CUI [1,2])
Item Group
Medication
C2347852 (UMLS CUI-1)
Trade/Generic Name
Item
Trade/Generic Name
text
C2360065 (UMLS CUI [1])
Reason
Item
Reason
text
C0392360 (UMLS CUI [1])
Total Daily Dose
Item
Total Daily Dose
text
C2348070 (UMLS CUI [1])
Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1])
End Date
Item
End Date
date
C0806020 (UMLS CUI [1])
Ongoing Symptom
Item
Ongoing Symptom
boolean
C1457887 (UMLS CUI [1,1])
C3174772 (UMLS CUI [1,2])
Item Group
Solicited Adverse Events Record - General Symptoms
C0159028 (UMLS CUI-1)
C0042196 (UMLS CUI-2)
C0877248 (UMLS CUI-3)
Item
General Symptom
text
C0042196 (UMLS CUI [1,1])
C0159028 (UMLS CUI [1,2])
C1556354 (UMLS CUI [1,3])
General Symptom
Code List
General Symptom
CL Item
Fatigue (FA)
CL Item
Headache (HE)
CL Item
Muscle Ache (MH)
CL Item
Shivering (SH)
CL Item
Arthralgia (AR)
Symptom Occurrence
Item
Symptom Occurrence
boolean
Item
Study Day
integer
C2826182 (UMLS CUI [1])
Study Day
Code List
Study Day
CL Item
Day 0 (0)
CL Item
Day 1 (1)
CL Item
Day 2 (2)
CL Item
Day 3 (3)
CL Item
Day 4 (4)
CL Item
Day 5 (5)
CL Item
Day 6 (6)
Item
Intensity
integer
Intensity
Code List
Intensity
CL Item
0 (0)
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
Ongoing Symptom
Item
Ongoing after Day 6?
boolean
C1457887 (UMLS CUI [1,1])
C3174772 (UMLS CUI [1,2])
Date of Last Day of Symptoms
Item
Date of Last Day of Symptoms
date
C0011008 (UMLS CUI [1,1])
C1517741 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
Item Group
Solicited Adverse Events - Fever
Fever
Item
Fever
boolean
C0015967 (UMLS CUI [1])
Item
Fever Measurement Route
text
C0449687 (UMLS CUI [1,1])
C0015967 (UMLS CUI [1,2])
Fever Measurement Route
Code List
Fever Measurement Route
CL Item
Axillary (A)
CL Item
Oral (O)
CL Item
Rectal (R)
Item
Study Day
integer
C2826182 (UMLS CUI [1])
Study Day
Code List
Study Day
CL Item
Day 0 (0)
CL Item
Day 1 (1)
CL Item
Day 2 (2)
CL Item
Day 3 (3)
CL Item
Day 4 (4)
CL Item
Day 5 (5)
CL Item
Day 6 (6)
Body Temperature
Item
Body Temperature
float
C0005903 (UMLS CUI [1])
Ongoing Symptom
Item
Ongoing after Day 6?
boolean
C1457887 (UMLS CUI [1,1])
C3174772 (UMLS CUI [1,2])
Date of Last Day of Symptoms
Item
Date of Last Day of Symptoms
date
C0011008 (UMLS CUI [1,1])
C1517741 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
Item Group
Other General Symptoms (Day 0 to Day 29)
C0029625 (UMLS CUI-1)
Description
Item
Description
text
C0678257 (UMLS CUI [1])
Item
Intensity
integer
Intensity
Code List
Intensity
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1])
End Date
Item
End Date
date
C0806020 (UMLS CUI [1])
Ongoing Symptom
Item
Ongoing Symptom
boolean
C1457887 (UMLS CUI [1,1])
C3174772 (UMLS CUI [1,2])
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