ID
35182
Description
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
Keywords
Versions (3)
- 2/12/19 2/12/19 -
- 2/16/19 2/16/19 -
- 2/22/19 2/22/19 -
Copyright Holder
GlaxoSmithKline
Uploaded on
February 22, 2019
DOI
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License
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
Diary Card
- StudyEvent: ODM
Description
Solicited Adverse Events Record - Local Symptoms
Alias
- UMLS CUI-1
- C1457887
- UMLS CUI-2
- C0205276
- UMLS CUI-3
- C0042196
Description
for each symptom, every item hereafter should be ticked accordingly.
Data type
text
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C0205276
Description
Fill out for each day
Data type
integer
Alias
- UMLS CUI [1]
- C2826182
Description
Intensity: Pain (at injection site): 0:Absent. 1:Painful on touch. 2:Painful when limb is moved. 3:Spontaneously painful / prevents normal activity.
Data type
integer
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C0030193
Description
Please measure the greatest diameter (in mm), for redness, swelling or ecchymosis
Data type
integer
Measurement units
- mm
Alias
- UMLS CUI [1]
- C0449453
Description
Ongoing Symptom
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C3174772
Description
if ongoing after Day 6
Data type
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C1517741
- UMLS CUI [1,3]
- C1457887
Description
Other Local Symptoms (Day 0 to Day 29)
Alias
- UMLS CUI-1
- C1457887
- UMLS CUI-2
- C0205276
- UMLS CUI-3
- C0042196
Description
please specify side(s) and site(s
Data type
text
Alias
- UMLS CUI [1]
- C0678257
Description
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).
Data type
integer
Alias
- UMLS CUI [1]
- C0518690
Description
Start Date
Data type
date
Alias
- UMLS CUI [1]
- C0808070
Description
if symptom ended during the study period
Data type
date
Alias
- UMLS CUI [1]
- C0806020
Description
tick if symptom has not ended during the study period
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C3174772
Description
Medication
Alias
- UMLS CUI-1
- C2347852
Description
Trade/Generic Name
Data type
text
Alias
- UMLS CUI [1]
- C2360065
Description
Reason
Data type
text
Alias
- UMLS CUI [1]
- C0392360
Description
Total Daily Dose
Data type
text
Alias
- UMLS CUI [1]
- C2348070
Description
Start Date
Data type
date
Alias
- UMLS CUI [1]
- C0808070
Description
tick if medication has ended during the study period
Data type
date
Alias
- UMLS CUI [1]
- C0806020
Description
tick if medication has not ended during the study period
Data type
boolean
Alias
- UMLS CUI [1]
- C2826666
Description
Solicited Adverse Events Record - General Symptoms
Alias
- UMLS CUI-1
- C0159028
- UMLS CUI-2
- C0042196
- UMLS CUI-3
- C0877248
Description
arthralgia = joint pain for each symptom, every item hereafter should be ticked accordingly.
Data type
text
Alias
- UMLS CUI [1,1]
- C0042196
- UMLS CUI [1,2]
- C0159028
- UMLS CUI [1,3]
- C1556354
Description
Fill out for each day
Data type
integer
Alias
- UMLS CUI [1]
- C2826182
Description
Fatigue, Headache, Muscle Ache, Shivering, Arthralgia/Joint Pain 0: Normal 1: Easily tolerated 2: Interferes with normal activity 3: That prevents normal activity
Data type
integer
Alias
- UMLS CUI [1]
- C0518690
Description
Ongoing Symptom
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C3174772
Description
Date of Last Day of Symptoms
Data type
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C1517741
- UMLS CUI [1,3]
- C1457887
Description
Solicited Adverse Events - Temperature
Alias
- UMLS CUI-1
- C0159028
- UMLS CUI-2
- C0042196
- UMLS CUI-3
- C0877248
- UMLS CUI-4
- C0039476
Description
oral is preferred
Data type
text
Alias
- UMLS CUI [1]
- C0886414
Description
Fill out for each day
Data type
integer
Alias
- UMLS CUI [1]
- C2826182
Description
Body Temperature
Data type
float
Measurement units
- °C
Alias
- UMLS CUI [1]
- C0005903
Description
Ongoing Symptom
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C3174772
Description
Date of Last Day of Symptoms
Data type
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C1517741
- UMLS CUI [1,3]
- C1457887
Description
Other General Symptoms (Day 0 to Day 29)
Alias
- UMLS CUI-1
- C0029625
Description
please specify side(s) and site(s
Data type
text
Alias
- UMLS CUI [1]
- C0678257
Description
Other general 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).
Data type
integer
Alias
- UMLS CUI [1]
- C0518690
Description
Start Date
Data type
date
Alias
- UMLS CUI [1]
- C0808070
Description
tick if symptom has ended during the study period
Data type
date
Alias
- UMLS CUI [1]
- C0806020
Description
tick if symptom has not ended during the study period
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C3174772
Similar models
Diary Card
- StudyEvent: ODM
C0042196 (UMLS CUI [1,2])
C0205276 (UMLS CUI-2)
C0042196 (UMLS CUI-3)
C3174772 (UMLS CUI [1,2])
C1517741 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205276 (UMLS CUI-2)
C0042196 (UMLS CUI-3)
C3174772 (UMLS CUI [1,2])
C0042196 (UMLS CUI-2)
C0877248 (UMLS CUI-3)
C0159028 (UMLS CUI [1,2])
C1556354 (UMLS CUI [1,3])
C3174772 (UMLS CUI [1,2])
C1517741 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0042196 (UMLS CUI-2)
C0877248 (UMLS CUI-3)
C0039476 (UMLS CUI-4)
C3174772 (UMLS CUI [1,2])
C1517741 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C3174772 (UMLS CUI [1,2])