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ID
35532
Beschreibung
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
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- 07.03.19 07.03.19 -
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GSK group of companies
Hochgeladen am
7. März 2019
DOI
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Creative Commons BY-NC 3.0
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Candidate Formulations of Pneumococcal Vaccines in Elderly Subjects - 111652
Diary Cards (visit 4 to visit 5)
- StudyEvent: ODM
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Diary Cards (visit 4 to visit 5)
- StudyEvent: ODM
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Subject Number
Item
Subject Number
integer
CL Item
Vaccination 1 (1)
Protocol Number
Item
Protocol Number
integer
Item Group
Local Symptoms - Redness (at injection site)
CL Item
Day 0 (1)
CL Item
Day 1 (evening) (2)
CL Item
Day 2 (evening) (3)
CL Item
Day 3 (evening) (4)
Size
Item
Size
integer
Ongoing after Day 3?
Item
Ongoing after Day 3?
boolean
If Yes, record date of last day of symptoms
Item
If Yes, record date of last day of symptoms
date
Medical attended visit?
Item
Medical attended visit?
boolean
Item Group
Local Symptoms - Swelling (at injection site)
CL Item
Day 0 (1)
CL Item
Day 1 (evening) (2)
CL Item
Day 2 (evening) (3)
CL Item
Day 3 (evening) (4)
Size
Item
Size
integer
Ongoing after Day 3?
Item
Ongoing after Day 3?
boolean
If Yes, record date of last day of symptoms
Item
If Yes, record date of last day of symptoms
date
Medical attended visit?
Item
Medical attended visit?
boolean
CL Item
Day 0 (1)
CL Item
Day 1 (evening) (2)
CL Item
Day 2 (evening) (3)
CL Item
Day 3 (evening) (4)
CL Item
Absent (1)
CL Item
Minor reaction to touch (2)
CL Item
Cries/protests on touch (3)
CL Item
Cries when limb is moved/spontaneously painful (4)
Ongoing after day 3?
Item
Ongoing after day 3?
boolean
If Yes, record date of last day of symptoms
Item
If Yes, record date of last day of symptoms
date
Medically attended visit?
Item
Medically attended visit?
boolean
Description
Item
Description
text
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Start date
Item
Start date
date
End date
Item
End date
date
Ongoing?
Item
Ongoing?
boolean
Medically attended visit?
Item
Medically attended visit?
boolean
Trade/Generic name
Item
Trade/Generic name
text
Reason
Item
Reason
text
Total Daily Dose
Item
Total Daily Dose
text
Start date
Item
Start date
date
End date
Item
End date
date
Ongoing
Item
check box if continuing
boolean
General Symptoms
Item
Please fill in below and assess the occurrence of any of the following signs or symptoms
text
Temperature
Item
Temperature
boolean
t°
Item
t°
float
CL Item
Rectal (1)
CL Item
Oral (2)
CL Item
Axillary (3)
Ongoing after day 6?
Item
Ongoing after day 6?
boolean
Date of last day of symptoms
Item
Date of last day of symptoms
date
Causality?
Item
Causality?
boolean
Medically attended visit
Item
Medically attended visit
boolean
Type of Medical involvement
Item
Medically attended visit
boolean
Fatigue
Item
Fatigue
boolean
CL Item
Day 0 (1)
CL Item
Day 1 (2)
CL Item
Day 2 (3)
CL Item
Day 3 (4)
CL Item
Day 4 (5)
CL Item
Day 5 (6)
CL Item
Day 6 (7)
CL Item
Normal (1)
CL Item
Fatigue that is easily tolerated (2)
CL Item
Fatigue that interferes with normal activity (3)
CL Item
Fatigue that prevents normal activity (4)
Ongoing after day 6?
Item
Ongoing after day 6?
boolean
Date of last day of symptoms
Item
Date of last day of symptoms
date
Causality?
Item
Causality?
boolean
Medically attended visit
Item
Medically attended visit?
boolean
CL Item
Hospitalization (1)
CL Item
Emergency Room (2)
CL Item
Medical Personnel (3)
Headache
Item
Headache
boolean
CL Item
Day 0 (1)
CL Item
Day 1 (2)
CL Item
Day 2 (3)
CL Item
Day 3 (4)
CL Item
Day 4 (5)
CL Item
Day 5 (6)
CL Item
Day 6 (7)
CL Item
Normal (1)
CL Item
Headache that is easily tolerated (2)
CL Item
Headache that interferes with normal activity (3)
CL Item
Headache that prevents normal activity (4)
Ongoing after day 6?
Item
Ongoing after day 6?
boolean
Date of last day of symptoms
Item
Date of last day of symptoms
date
Causality?
Item
Causality?
boolean
Medically attended visit
Item
Medically attended visit
boolean
CL Item
Hospitalization (1)
CL Item
Emergency Room (2)
CL Item
Medical Personnel (3)
Gastrointestinal symptoms
Item
Gastrointestinal symptoms
boolean
CL Item
Day 0 (1)
CL Item
Day 1 (2)
CL Item
Day 2 (3)
CL Item
Day 3 (4)
CL Item
Day 4 (5)
CL Item
Day 5 (6)
CL Item
Day 6 (7)
CL Item
Normal (1)
CL Item
Gastrointestinal symptoms that are easily tolerated (2)
CL Item
Gastrointestinal symptoms that interfere with normal activity (3)
CL Item
Gastrointestinal symptoms that prevent normal activity (4)
Ongoing after day 6?
Item
Ongoing after day 6?
boolean
Date of last day of symptoms
Item
Date of last day of symptoms
date
Causality?
Item
Causality?
boolean
Medically attended visit
Item
Medically attended visit
boolean
CL Item
Hospitalization (1)
CL Item
Emergency Room (2)
CL Item
Medical Personnel (3)
Malaise
Item
Malaise
boolean
CL Item
Day 0 (1)
CL Item
Day 1 (2)
CL Item
Day 2 (3)
CL Item
Day 3 (4)
CL Item
Day 4 (5)
CL Item
Day 5 (6)
CL Item
Day 6 (7)
CL Item
Normal (1)
CL Item
Malaise that is easily tolerated (2)
CL Item
Malaise that interferes with normal activity (3)
CL Item
Malaise that prevents normal activity (4)
Ongoing after day 6?
Item
Ongoing after day 6?
boolean
Date of last day of symptoms
Item
Date of last day of symptoms
date
Medically attended visit
Item
Medically attended visit
boolean
CL Item
Hospitalization (1)
CL Item
Emergency Room (2)
CL Item
Medical Personnel (3)
Myalgia
Item
Myalgia
boolean
CL Item
Day 0 (1)
CL Item
Day 1 (2)
CL Item
Day 2 (3)
CL Item
Day 3 (4)
CL Item
Day 4 (5)
CL Item
Day 5 (6)
CL Item
Day 6 (7)
CL Item
Normal (1)
CL Item
Myalgia that is easily tolerated (2)
CL Item
Myalgia that interferes with normal activity (3)
CL Item
Myalgia that prevents normal activity (4)
Ongoing after day 6?
Item
Ongoing after day 6?
boolean
Date of last day of symptoms
Item
Date of last day of symptoms
date
Causality
Item
Causality
boolean
Medically attended visit
Item
Medically attended visit
boolean
CL Item
Hospitalization (1)
CL Item
Emergency Room (2)
CL Item
Medical Personnel (3)
Description
Item
Description
text
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Start Date
Item
Start Date
date
End Date
Item
End Date
date
Ongoing?
Item
Ongoing?
boolean
Medically attended visit?
Item
Medically attended visit?
boolean
Trade Name/Generic Name
Item
Trade Name/Generic Name
text
Reason
Item
Reason
text
Total Daily Dose?
Item
Total Daily Dose?
text
Start Date
Item
Start Date
date
End Date
Item
End Date
date
Ongoing?
Item
Ongoing?
boolean