Information:
Fel:
ID
35527
Beskrivning
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
Nyckelord
Versioner (1)
- 2019-03-07 2019-03-07 -
Rättsinnehavare
GSK group of companies
Uppladdad den
7 mars 2019
DOI
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Licens
Creative Commons BY-NC 3.0
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Candidate Formulations of Pneumococcal Vaccines in Elderly Subjects - 111652
Concomitant Medication, Adverse Events Forms
- StudyEvent: ODM
Similar models
Concomitant Medication, Adverse Events Forms
- StudyEvent: ODM
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Subject Number
Item
Subject Number
integer
Concomitant Vaccination Question
Item
Have any other than the study vaccine(s) been administered during the timeframe as specified in the Protocol?
boolean
Trade/Generic Name
Item
Trade/Generic Name
text
CL Item
Intradermal (1)
CL Item
Inhalation (2)
CL Item
Intramuscular (3)
CL Item
Intravenous (4)
CL Item
Intranasal (5)
CL Item
Parenteral (6)
CL Item
Oral (7)
CL Item
Subcutaneous (8)
CL Item
Sublingual (9)
CL Item
Transdermal (10)
CL Item
Unknown (11)
CL Item
Other (12)
Administration Date
Item
Administration Date
date
concomitant medications / treatments
Item
Have any medications/treatments been administered during the time frame as specified in the Protocol?
boolean
Trade/Genereic Name
Item
Trade/Genereic Name
text
Prophylactic Administration
Item
Was the administration prophylactic?
boolean
Medical Indication
Item
Medical Indication
text
Total daily dose
Item
Total daily dose
text
CL Item
Intradermal (1)
CL Item
Inhalation (2)
CL Item
Intramuscular (3)
CL Item
Intravenous (4)
CL Item
Intranasal (5)
CL Item
Parenteral (6)
CL Item
Oral (7)
CL Item
Subcutaneous (8)
CL Item
Sublingual (9)
CL Item
Transdermal (10)
CL Item
Vaginal (11)
CL Item
Unknown (12)
CL Item
Other (13)
Specify Other
Item
If Other, please specify
text
Start Date
Item
Start Date
date
End Date
Item
End Date
date
Ongoing?
Item
Is the event continuing?
boolean
Non-Serious AE
Item
Has any non-serious adverse events occurred within minimum 30 days post-vaccination, excluding those recorded on the Solicited Adverse Events forms?
boolean
Episode Number
Item
Episode Number
integer
Description
Item
Description
text
CL Item
administrationsite (1)
CL Item
non-administration site (2)
CL Item
Hib-MenC vaccine (1)
CL Item
Priorix vaccine (2)
Date started
Item
Date started
date
Date stopped
Item
Date stopped
date
CL Item
mild (1)
CL Item
moderate (2)
CL Item
severe (3)
Relationship To Investigational Products
Item
Is there a reasonable possibility that the AE may have been caused by the investigational product?
boolean
CL Item
Recovered/Resolved (1)
CL Item
Recovering/Resolving (2)
CL Item
Not recovered/Not resolved (3)
CL Item
Recovered with sequelae/Resolved with sequelae (4)
Medically attended visit
Item
Medically attended visit
boolean
CL Item
Hospitalization (1)
CL Item
Emergency Room (2)
CL Item
Medical Personnel (3)
Potential Follow-up Study Participation
Item
If a booster study or a follow-up study is offered in the future, would the subject be willing to be contacted and learn more about it?
boolean
CL Item
Adverse Events, or Serious Adverse Events (1)
CL Item
Other (2)
Comment
Item
Comment
text
Occurrence of SAE
Item
Did the subject experience any Serious Adverse Event during the study?
boolean
Specify Number of SAE
Item
If Yes, Specify total number of SAE's:
integer
Status of the Treatment Blind
Item
Was the treatment blind broken during the study?
boolean
Treatment Blind Broken
Item
If Yes, complete date and tick one reason below.
date
CL Item
Medical emergency requiring identification of investigational product for further treatments. (1)
CL Item
Other (2)
Specify Other
Item
if Other, please specify
text
Elimination Criteria
Item
Did any elimination criteria become applicable during the study?
boolean
Specify Elimination Criteria
Item
If Yes, please specify
text
Subject Withdrawn
Item
Was the subject withdrawn from the study?
boolean
CL Item
Serious adverse event (1)
CL Item
Non-Serious adverse event (2)
CL Item
Protocol violation (3)
CL Item
Consent withdrawal, not due to an adverse event (4)
CL Item
Migrated / moved from the study area (5)
CL Item
Lost to follow-up (6)
CL Item
Other (7)
Specify Number of SAE
Item
Specify Number of SAE
integer
Specify Number of AE
Item
Specify Number of AE
integer
Protocol Violation Specify
Item
Please specify the typo of protocol violation
text
Specify Other
Item
If Other, please specify below
text
CL Item
Investigator (1)
CL Item
Subject (2)
Date of last contact
Item
Date of last contact:
date
Subject Status
Item
Was the subject in good condition at date of last contact?
boolean
Investigator's Confirmation
Item
I confirm that I have reviewed the data in this Case Report Form for this subject. All information entered by myself or my colleagues is, to the best of my knowledge, complete and accurate, as of the date below.
date
Investigator's signature
Item
Investigator's signature:
text
Printed Investigator's name
Item
Printed Investigator's name:
text