ID
35094
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 his form is to document if the subject has had any adverse events in the course of the study. It should be filled out at the date of vaccination. SERIOUS ADVERSE EVENT A serious adverse event is any untoward medical occurrence that: · results in death · is life threatening · results in persistent or significant disability / incapacity · requires in-patient hospitalization · prolongation of existing hospitalization · is a congenital anomaly / birth defect in the offspring of a study subject · In addition, important medical events that may jeopardize the subject or may require intervention to prevent one of the other outcomes listed above should be considered serious. (Examples of such events are invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm; blood dyscrasias or convulsions that do not result in hospitalization.) For each serious adverse event the investigator becomes aware of, please fill in a Serious Adverse Event(SAE) report and fax it to GSK Biologicals Study Contact for SAE reporting within 24 hours. 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 (6)
- 2/4/19 2/4/19 -
- 2/7/19 2/7/19 -
- 2/10/19 2/10/19 -
- 2/12/19 2/12/19 -
- 2/16/19 2/16/19 -
- 2/20/19 2/20/19 - Sarah Riepenhausen
Copyright Holder
GlaxoSmithKline
Uploaded on
February 16, 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
Solicited Adverse Events
- StudyEvent: ODM
Description
Solicited Adverse Events
Alias
- UMLS CUI-1
- C1457887
- UMLS CUI-2
- C0042196
- UMLS CUI-3
- C0877248
Description
If any of these adverse events meets the protocol definition of serious, please complete a Serious Adverse Event report and fax to GSK Biologicals Study Contact for SAE reporting within 24 hours. If "yes" is ticked, please tick No/Yes for each symptom. If Yes is ticked, please complete all items.
Data type
text
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C0042196
- UMLS CUI [1,3]
- C0877248
Description
Solicited Adverse Events Record - Local Symptoms
Alias
- UMLS CUI-1
- C1457887
- UMLS CUI-2
- C0205276
- UMLS CUI-3
- C0042196
Description
Applies to every single local symptom and should be filled out for each one. If a symptom is ticked, all items hereafter shold be filled out
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C2745955
Description
Local Symptom
Data type
text
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C0205276
Description
To be filled out for each day
Data type
integer
Alias
- UMLS CUI [1]
- C2826182
Description
Intensity: 0 / 1 / 2 / 3, if pain is ticked if pain occurred INTENSITY FOR NON-SOLICITED 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 event 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
Size in mm, if redness, swelling or ecchymosis occurred
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
Solicited Adverse Events - General Symptoms
Alias
- UMLS CUI-1
- C0159028
- UMLS CUI-2
- C0042196
- UMLS CUI-3
- C0877248
Description
Solicited Adverse Events Record - General Symptoms
Alias
- UMLS CUI-1
- C0159028
- UMLS CUI-2
- C0042196
- UMLS CUI-3
- C0877248
Description
Applies to every single local symptom and should be filled out for each one. If a symptom is ticked, all items hereafter shold be filled out
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C2745955
Description
arthralgia = joint pain
Data type
text
Alias
- UMLS CUI [1,1]
- C0042196
- UMLS CUI [1,2]
- C0159028
- UMLS CUI [1,3]
- C1556354
Description
To be filled out for each day
Data type
integer
Alias
- UMLS CUI [1]
- C2826182
Description
Intensity: 0 / 1 / 2 / 3 INTENSITY FOR NON-SOLICITED 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 event would, for example, prevent attendance at work/school and would necessitate the administration of corrective therapy).
Data type
integer
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
Causality
Data type
boolean
Alias
- UMLS CUI [1]
- C0015127
Description
Solicited Adverse Events - Fever
Description
Fever: Axillary > 37.5°C Oral > 37.5°C Rectal > 38° C
Data type
boolean
Alias
- UMLS CUI [1]
- C0015967
Description
If fever occurred oral is preferred
Data type
text
Alias
- UMLS CUI [1,1]
- C0449687
- UMLS CUI [1,2]
- C0015967
Description
To be filled 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
Temperature not Taken
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0039476
- UMLS CUI [1,2]
- C0437722
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
Causality
Data type
boolean
Alias
- UMLS CUI [1]
- C0015127
Description
Unsolicited Adverse Events
Alias
- UMLS CUI-1
- C0877248
- UMLS CUI-2
- C0042196
Similar models
Solicited Adverse Events
- StudyEvent: ODM
C0042196 (UMLS CUI-2)
C0877248 (UMLS CUI-3)
C0042196 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,3])
C0205276 (UMLS CUI-2)
C0042196 (UMLS CUI-3)
C2745955 (UMLS CUI [1,2])
C3174772 (UMLS CUI [1,2])
C1517741 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0042196 (UMLS CUI-2)
C0877248 (UMLS CUI-3)
C0042196 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,3])
C0042196 (UMLS CUI-2)
C0877248 (UMLS CUI-3)
C2745955 (UMLS CUI [1,2])
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])
C0015967 (UMLS CUI [1,2])
C0437722 (UMLS CUI [1,2])
C3174772 (UMLS CUI [1,2])
C1517741 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0042196 (UMLS CUI-2)
C0042196 (UMLS CUI [1,2])