ID
35532
Description
Study ID: 111652 Clinical Study ID: 111652 Study Title: A Study to Evaluate GSK Biologicals' Candidate Formulations of Pneumococcal Vaccines (GSK2189241A) in Elderly Subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00756067 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Pneumococcal vaccine GSK2189241A Trade Name: Pneumo 23™ Study Indication: Infections, Streptococcal
Keywords
Versions (1)
- 3/7/19 3/7/19 -
Copyright Holder
GSK group of companies
Uploaded on
March 7, 2019
DOI
To request one please log in.
License
Creative Commons BY-NC 3.0
Model comments :
You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.
Itemgroup comments for :
Item comments for :
In order to download data models you must be logged in. Please log in or register for free.
Candidate Formulations of Pneumococcal Vaccines in Elderly Subjects - 111652
Diary Cards (visit 4 to visit 5)
- StudyEvent: ODM
Description
Local Symptoms - Redness (at injection site)
Description
Day
Data type
integer
Description
please measure the greatest diameter
Data type
integer
Measurement units
- mm
Description
Ongoing after Day 3?
Data type
boolean
Description
If Yes, record date of last day of symptoms
Data type
date
Description
Medical attended visit?
Data type
boolean
Description
Local Symptoms - Swelling (at injection site)
Description
Day
Data type
integer
Description
please measure the greatest diameter
Data type
integer
Measurement units
- mm
Description
Ongoing after Day 3?
Data type
boolean
Description
If Yes, record date of last day of symptoms
Data type
date
Description
Medical attended visit?
Data type
boolean
Description
Local Symptoms - Pain (at injection site)
Description
Day
Data type
integer
Description
Intensity
Data type
integer
Description
Ongoing after day 3?
Data type
boolean
Description
If Yes, record date of last day of symptoms
Data type
date
Description
Medically attended visit?
Data type
boolean
Description
Other Local Symptoms
Description
please specify side(s) and site(s)
Data type
text
Description
Intensity
Data type
text
Description
Start date
Data type
date
Description
End date
Data type
date
Description
Ongoing?
Data type
boolean
Description
Medically attended visit?
Data type
boolean
Description
MEDICATION
Description
Trade/Generic name
Data type
text
Description
Reason
Data type
text
Description
Total Daily Dose
Data type
text
Description
Start date
Data type
date
Description
End date
Data type
date
Description
Ongoing
Data type
boolean
Description
GENERAL SYMPTOMS
Description
Temperature
Description
Tick Yes from following limits Axillary, Oral > 37.5 °C Rectal > 38 °C
Data type
boolean
Description
t°
Data type
float
Measurement units
- °C
Description
Route
Data type
text
Description
Ongoing after day 6?
Data type
boolean
Description
Date of last day of symptoms
Data type
date
Description
Causality?
Data type
boolean
Description
Medically attended visit
Data type
boolean
Description
Type of Medical involvement
Data type
boolean
Description
Fatigue
Description
Fatigue
Data type
boolean
Description
Day
Data type
integer
Description
fatigue intensity
Data type
text
Description
Ongoing after day 6?
Data type
boolean
Description
Date of last day of symptoms
Data type
date
Description
Causality?
Data type
boolean
Description
Medically attended visit
Data type
boolean
Description
Type of Medical Attention
Data type
text
Description
Headache
Description
Headache
Data type
boolean
Description
Day
Data type
text
Description
Intensity
Data type
text
Description
Ongoing after day 6?
Data type
boolean
Description
Date of last day of symptoms
Data type
date
Description
Causality?
Data type
boolean
Description
Medically attended visit
Data type
boolean
Description
Type of Medical Attention
Data type
text
Description
Gastrointestinal symptoms
Description
Gastrointestinal symptoms
Data type
boolean
Description
Day
Data type
integer
Description
Intensity
Data type
text
Description
Ongoing after day 6?
Data type
boolean
Description
Date of last day of symptoms
Data type
date
Description
Causality?
Data type
boolean
Description
Medically attended visit
Data type
boolean
Description
Type of Medical Attention
Data type
text
Description
Malaise
Description
Malaise
Data type
boolean
Description
Day
Data type
text
Description
Intensity
Data type
text
Description
Ongoing after day 6?
Data type
boolean
Description
Date of last day of symptoms
Data type
date
Description
Medically attended visit
Data type
boolean
Description
Type of Medical Attention
Data type
text
Description
Myalgia
Description
Myalgia
Data type
boolean
Description
Day
Data type
text
Description
intensity
Data type
text
Description
Ongoing after day 6?
Data type
boolean
Description
Date of last day of symptoms
Data type
date
Description
Causality
Data type
boolean
Description
Medically attended visit
Data type
boolean
Description
Type of Medical Attention
Data type
text
Description
Other Symptoms
Description
Description
Data type
text
Description
Mild (an adverse event which is easily tolerated by the subject, causing minimal discomfort and not interfering with everyday activities); Moderate (An adverse event which is sufficiently discomforting to interfere with normal everyday activities); Severe (An adverse event which prevents normal, everyday activities: e.g attendance at school/kindergarten/a day-care centre and would cause parents/guardians to seek medical advice)
Data type
text
Description
Start Date
Data type
date
Description
End Date
Data type
date
Description
Ongoing?
Data type
boolean
Description
Medically attended visit?
Data type
boolean
Description
Medication
Description
Trade Name/Generic Name
Data type
text
Description
Reason
Data type
text
Description
Total Daily Dose?
Data type
text
Description
Start Date
Data type
date
Description
End Date
Data type
date
Description
Ongoing?
Data type
boolean
Similar models
Diary Cards (visit 4 to visit 5)
- StudyEvent: ODM