ID

35062

Beschreibung

Study ID: 104951 Clinical Study ID: 104951 Study Title: A Phase III, double-blind, randomized, controlled study to evaluate the immunogenicity and safety of GlaxoSmithKline (GSK) Biologicals' HPV-16/18 L1 VLP AS04 vaccine administered intramuscularly according to a 0_ 1_ 6 month schedule in healthy female subjects aged 10 - 14 years. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00290277 https://clinicaltrials.gov/ct2/show/NCT00290277 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: HPV-16/18 L1/AS04 Vaccine Trade Name: N/A Study Indication: Infections, Papillomavirus This form contains information about study continuation and should be filled in at visit 2, 3 and 4.

Link

https://clinicaltrials.gov/ct2/show/NCT00290277

Stichworte

Versionen (1)
  1. 13.02.19 13.02.19 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

13. Februar 2019

DOI

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Lizenz

Creative Commons BY-NC 3.0
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Evaluation of immunogenicity and safety of GSK Biologicals' HPV-16/18 L1 VLP AS04 vaccine in healthy females NCT00290277

Englisch

Check for study continuation

1 Formulare  
Administrative data
Beschreibung

Administrative data

Alias
UMLS CUI-1
C1320722
Subject number
Beschreibung

Subject number

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Protocol number
Beschreibung

Protocol number

Datentyp

text

Alias
UMLS CUI [1,1]
C0008971
UMLS CUI [1,2]
C0600091
Visit number
Beschreibung

Visit number

Datentyp

text

Alias
UMLS CUI [1]
C1549755
Date of visit
Beschreibung

Date of visit

Datentyp

date

Alias
UMLS CUI [1]
C1320303
Check for study continuation
Beschreibung

Check for study continuation

Alias
UMLS CUI-1
C0805733
UMLS CUI-2
C0008976
Did the subject return for this visit?
Beschreibung

If YES, please complete the study forms for this visit. If NO, please specify the reason below and skip the other forms for this visit.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0805733
UMLS CUI [1,3]
C0008976
Please tick the ONE most appropriate reason:
Beschreibung

If you ticked 'SAE', please complete and submit SAE report and specify SAE number below. If you ticked 'AEX', please complete Non-serious adverse event section and specify AE number or solicited AE code below. If you ticked 'OTH', please specify below. If you complete this form at visit 3 or 4, choosing 'same reason and decision as previous visit' is also possible.

Datentyp

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0457454
UMLS CUI [1,3]
C0008976
SAE number
Beschreibung

Please complete if the subject did not return for study continuation because of SAE.

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0237753
AE number
Beschreibung

Please complete if the subject did not return for study continuation because of Non-SAE. You have to complete this AE number OR the following solicited AE code.

Datentyp

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0237753
Solicited adverse event code
Beschreibung

Please complete if the subject did not return for study continuation because of Non-SAE. You have to complete this solicited AE code OR the preciously asked AE number.

Datentyp

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C1517001
UMLS CUI [1,3]
C0805701
UMLS CUI [1,4]
C1521902
Please specify 'other' reason for discontinuation:
Beschreibung

If you ticked 'Other' reason for discontinuation, please specify. (E.g. consent withdrawal, protocol violation, ...)

Datentyp

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0457454
UMLS CUI [1,3]
C0008976
UMLS CUI [1,4]
C3840932
UMLS CUI [1,5]
C1521902
Please tick, who made the decision for discontinuation:
Beschreibung

If the subject did not return for study continuation, please specify, who made the decision for discontinuation.

Datentyp

text

Alias
UMLS CUI [1,1]
C0457454
UMLS CUI [1,2]
C0008976
UMLS CUI [1,3]
C0679006
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Ähnliche Modelle

Check for study continuation

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Subject number
Item
Subject number
text
C2348585 (UMLS CUI [1])
Protocol number
Item
Protocol number
text
C0008971 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Item
Visit number
text
C1549755 (UMLS CUI [1])
Visit number
Code List
Visit number
CL Item
Visit 2 (Month 1) (Visit 2)
CL Item
Visit 3 (Month 6) (Visit 3)
CL Item
Visit 4 (Month 7) (Visit 4)
Date of visit
Item
Date of visit
date
C1320303 (UMLS CUI [1])
Item Group
Check for study continuation
C0805733 (UMLS CUI-1)
C0008976 (UMLS CUI-2)
Return of subject
Item
Did the subject return for this visit?
boolean
C0545082 (UMLS CUI [1,1])
C0805733 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Item
Please tick the ONE most appropriate reason:
text
C0392360 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Reason for discontinuation
Code List
Please tick the ONE most appropriate reason:
CL Item
Serious adverse event (SAE)
(Comment:en)
CL Item
Non-Serious adverse event (AEX)
(Comment:en)
CL Item
Other (OTH)
(Comment:en)
CL Item
same reason and decision as previous visit (Same reason and decision as previous visit)
SAE number
Item
SAE number
text
C1519255 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
AE number
Item
AE number
text
C1518404 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Solicited adverse event code
Item
Solicited adverse event code
text
C0877248 (UMLS CUI [1,1])
C1517001 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,3])
C1521902 (UMLS CUI [1,4])
Other reason for discontinuation
Item
Please specify 'other' reason for discontinuation:
text
C0392360 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C3840932 (UMLS CUI [1,4])
C1521902 (UMLS CUI [1,5])
Item
Please tick, who made the decision for discontinuation:
text
C0457454 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C0679006 (UMLS CUI [1,3])
Decision for discontinuation
Code List
Please tick, who made the decision for discontinuation:
CL Item
Investigator (I)
(Comment:en)
CL Item
Subject or Parents / Legally Acceptable Representative(s) (S)
(Comment:en)
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