ID

36177

Beskrivning

Study ID: 109616 (Y7), 109624 Clinical Study ID: 109616 (Y7) Study Title: A blinded long-term follow-up study of the efficacy of candidate HPV-16/18 L1 VLP AS04 vaccine in young adult women in Brazil vaccinated in the phase IIb, double-blind, multi- center primary study HPV-001 and having participated in the follow-up study HPV-007 Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00518336 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: HPV Vaccine Trade Name: Cervarix Study Indication: Infections, Papillomavirus

Nyckelord

  1. 2019-04-22 2019-04-22 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

22 april 2019

DOI

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Licens

Creative Commons BY-NC 3.0

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Candidate HPV-16/18 L1 VLP A04 Vaccine in Young Adult Women Vaccinated in Phase IIb, NCT00518336

Non-Serious Adverse Events

Administrative Data
Beskrivning

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Number
Beskrivning

Clinical Trial Subject Unique Identifier

Datatyp

integer

Alias
UMLS CUI [1]
C2348585
Non-Serious Adverse Events
Beskrivning

Non-Serious Adverse Events

Alias
UMLS CUI-1
C1518404
Has any of the following non-serious adverse events been occurred during the study period? - New onset of chronic diseases - Conditions prompting emergency room visits not related to common diseases - Conditions prompting physician visits not related to common diseases
Beskrivning

Non-serious Adverse Event

Datatyp

boolean

Alias
UMLS CUI [1]
C1518404
AE No.
Beskrivning

Non-serious Adverse Event, Numbers

Datatyp

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0237753
Description
Beskrivning

Non-serious Adverse Event, Description

Datatyp

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0678257
Please check box in case of new onset of chronic diseases
Beskrivning

Non-serious Adverse Event, Chronic disease, New Onset

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0008679
UMLS CUI [1,3]
C0449244
Date Started
Beskrivning

Non-serious Adverse Event, Start Date

Datatyp

date

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0808070
Date Stopped
Beskrivning

Non-serious Adverse Event, End Date

Datatyp

date

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0806020
Maximum Intensity
Beskrivning

Non-serious Adverse Event, Severity of Adverse Event

Datatyp

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C1710066
Relationship to investigational products: Is there a reasonable possibility that the AE may have been caused by the investigational product?
Beskrivning

Non-serious Adverse Event, Relationship, Experimental drug

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0439849
UMLS CUI [1,3]
C0304229
Outcome
Beskrivning

Non-serious Adverse Event, Adverse Event Outcome

Datatyp

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C1705586
Medically attended visit
Beskrivning

Non-serious Adverse Event, Visit, Advice, Medical

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0545082
UMLS CUI [1,3]
C1386497
If yes please specify type: HO: Hospitalisation ER: Emergency Room MD: Medical Personnel
Beskrivning

Non-serious Adverse Event, Visit, Advice, Medical, Type

Datatyp

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0545082
UMLS CUI [1,3]
C1386497
UMLS CUI [1,4]
C0332307

Similar models

Non-Serious Adverse Events

Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Clinical Trial Subject Unique Identifier
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Item Group
Non-Serious Adverse Events
C1518404 (UMLS CUI-1)
Non-serious Adverse Event
Item
Has any of the following non-serious adverse events been occurred during the study period? - New onset of chronic diseases - Conditions prompting emergency room visits not related to common diseases - Conditions prompting physician visits not related to common diseases
boolean
C1518404 (UMLS CUI [1])
Item
AE No.
text
C1518404 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
Non-serious Adverse Event, Description
Item
Description
text
C1518404 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
Non-serious Adverse Event, Chronic disease, New Onset
Item
Please check box in case of new onset of chronic diseases
boolean
C1518404 (UMLS CUI [1,1])
C0008679 (UMLS CUI [1,2])
C0449244 (UMLS CUI [1,3])
Non-serious Adverse Event, Start Date
Item
Date Started
date
C1518404 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Non-serious Adverse Event, End Date
Item
Date Stopped
date
C1518404 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Item
Maximum Intensity
text
C1518404 (UMLS CUI [1,1])
C1710066 (UMLS CUI [1,2])
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Non-serious Adverse Event, Relationship, Experimental drug
Item
Relationship to investigational products: Is there a reasonable possibility that the AE may have been caused by the investigational product?
boolean
C1518404 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
Item
Outcome
text
C1518404 (UMLS CUI [1,1])
C1705586 (UMLS CUI [1,2])
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)
Non-serious Adverse Event, Visit, Advice, Medical
Item
Medically attended visit
boolean
C1518404 (UMLS CUI [1,1])
C0545082 (UMLS CUI [1,2])
C1386497 (UMLS CUI [1,3])
Non-serious Adverse Event, Visit, Advice, Medical, Type
Item
If yes please specify type: HO: Hospitalisation ER: Emergency Room MD: Medical Personnel
text
C1518404 (UMLS CUI [1,1])
C0545082 (UMLS CUI [1,2])
C1386497 (UMLS CUI [1,3])
C0332307 (UMLS CUI [1,4])

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