ID

35061

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 non serious adverse events and should be filled in if any non-serious adverse event occured. This section must be checked for final assessment at the end of the study. Investigators had to follow-up subjects in the case of other non-serious AEs, until they completed the study or they were lost to follow-up.

Link

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

Stichworte

Versionen (3)
  1. 13.02.19 13.02.19 -
  2. 13.02.19 13.02.19 -
  3. 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

Non-Serious Adverse Events

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
Number of non-serious adverse event
Beschreibung

This form has to be filled in once for each non-serious adverse event that occurred during the study period.

Datentyp

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0449788
Has any non-serious adverse events occurred during the study period, (as per protocol)?
Beschreibung

If YES, please complete the following items. A serious adverse event (SAE) was any untoward medical occurrence that: resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization (NOTE: Complications that occurred during hospitalization were AEs. If a complication prolonged hospitalization or fulfilled any other serious criteria, the eventwas serious), resulted in disability/incapacity (NOTE: The term disability meant a substantial disruption of a personís ability to conductnormal life functions. This definition was not intended to include experiences of relatively minor medical significance such as uncomplicated headache, nausea, vomiting,diarrhoea, influenza, and accidental trauma (e.g. sprained ankle) which might have interfered or prevented everyday life functions but did not constitute a substantial disruptio), was a congenital anomaly/birth defect in the offspring of a study subject. Medical or scientific judgement had to be exercised in deciding whether reportingwas appropriate in other situations, such as important medical events that might nothave been immediately life-threatening or resulted in death or hospitalization butmight have jeopardized the subject or might have required medical or surgicalintervention to prevent one of the other outcomes listed in the above definition.These were also considered serious. Examples of such events were invasive ormalignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that did not result in hospitalization. If the event met the definition of serious, a serious adverse event report has to be completed and faxed to Study Contact within 24 hours.

Datentyp

boolean

Alias
UMLS CUI [1]
C1518404
Non-Serious Adverse Events
Beschreibung

Non-Serious Adverse Events

Alias
UMLS CUI-1
C1518404
Description of Non-SAE
Beschreibung

Description of Non-SAE

Datentyp

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0678257
New onset of chronic diseases?
Beschreibung

Please check YES in case of new onset of chronic diseases.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0008679
UMLS CUI [1,2]
C0746890
Site of symptoms
Beschreibung

Site of symptoms

Datentyp

text

Alias
UMLS CUI [1,1]
C2700396
UMLS CUI [1,2]
C0037088
Date started:
Beschreibung

Start date

Datentyp

date

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C1518404
Start during immediate post-vaccination period (30 minutes)?
Beschreibung

Start during immediate post-vaccination period (30 minutes)

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0439659
UMLS CUI [1,2]
C1518404
UMLS CUI [1,3]
C0042196
UMLS CUI [1,4]
C0687676
UMLS CUI [1,5]
C0205253
Date stopped:
Beschreibung

End date

Datentyp

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C1518404
Maximum intensity
Beschreibung

Mild: An adverse event which is easily tolerated by the subject, causing minimal discomfort and notinterfering 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. (In adults / adolescents, such an adverse event would, for example, prevent attendance at work / school and would necessitate the administration of corrective therapy).

Datentyp

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0518690
Is there a reasonable possibility that the AE may have been caused by the investigational product?
Beschreibung

Relationship to investigational products

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0013230
UMLS CUI [1,3]
C0439849
Outcome
Beschreibung

Outcome

Datentyp

integer

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

If YES, specify medically attended visit below.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1386497
UMLS CUI [1,3]
C1518404
Specify type of medically attended visit
Beschreibung

'Medical personnel' means a visit to or from medical personnel (medical doctor).

Datentyp

text

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

Non-Serious Adverse Events

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 1 (Month 0) (Visit 1)
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])
Number of non-serious adverse event
Item
Number of non-serious adverse event
integer
C1518404 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
Occurrence of non-serious adverse event
Item
Has any non-serious adverse events occurred during the study period, (as per protocol)?
boolean
C1518404 (UMLS CUI [1])
Item Group
Non-Serious Adverse Events
C1518404 (UMLS CUI-1)
Description of Non-SAE
Item
Description of Non-SAE
text
C1518404 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
New onset of chronic diseases
Item
New onset of chronic diseases?
boolean
C0008679 (UMLS CUI [1,1])
C0746890 (UMLS CUI [1,2])
Item
Site of symptoms
text
C2700396 (UMLS CUI [1,1])
C0037088 (UMLS CUI [1,2])
Site of symptoms
Code List
Site of symptoms
CL Item
Administration site (a)
CL Item
Non-administration site (b)
Start date
Item
Date started:
date
C0808070 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Start during immediate post-vaccination period (30 minutes)
Item
Start during immediate post-vaccination period (30 minutes)?
boolean
C0439659 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
C0042196 (UMLS CUI [1,3])
C0687676 (UMLS CUI [1,4])
C0205253 (UMLS CUI [1,5])
End date
Item
Date stopped:
date
C0806020 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Item
Maximum intensity
integer
C1518404 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
Maximum intensity
Code List
Maximum intensity
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
C1518404 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
Item
Outcome
integer
C1518404 (UMLS CUI [1,1])
C1705586 (UMLS CUI [1,2])
Outcome
Code List
Outcome
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
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
Item
Specify type of medically attended visit
text
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
C0332307 (UMLS CUI [1,4])
Specify type of medically attended visit
Code List
Specify type of medically attended visit
CL Item
Hospitalization (HO)
CL Item
Emergency Room (ER)
CL Item
Medical Personnel (MD)
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