ID

32340

Beschreibung

Study ID: 109563 Clinical Study ID: 109563 Study Title: COMPAS:A phase III study to demonstrate efficacy of GSK Biologicals' 10-valent pneumococcal vaccine (GSK1024850A) against Community Acquired Pneumonia and Acute Otitis Media Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier https://clinicaltrials.gov/ct2/show/NCT00466947 Clinicaltrials.gov Identifier: NCT00466947 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Pneumococcal Polysaccharide Conjugate Vaccine (Adsorbed) Trade Name: BIO 10PN-PD-DIT; Synflorix Study Indication: Infections, Streptococcal The Study consists of three workbooks. Workbook 1: Argentina, all subjects + immuno & reacto subset Workbook 2: Panama, all subjects + immuno & reacto subset + carriage subset + additional immuno subset Workbook 3: Colombia, all subjects The protocol number for all workbooks: 109563 (10Pn-PD-DiT-028) There are ten visits in workbook 1 and 2, eight for workbook 3 (there are no visits 4 and 7): Visit 1: month 0, dose 1, 6-16 weeks of age Visit 2: month 2, dose 2, +/- 4 months of age, 49-83 days after visit 1 Visit 3: month 4, dose 3, +/- 6 months of age, 49-83 days after visit 2 Visit 4: month 5, +/- 7 months of age, 28-42 days after visit 3. Only for immuno & reacto subset + carriage subset. Visit 5: month 10-13, 12-15 months of age Visit 6: month 13-16, booster dose, 15-18 months of age, ≥ 28 days after visit 5 Visit 7: month 14-17, 16-19 months of age, 28-42 days after visit 6. Only for immuno & reacto subset, additional immuno subset + carriage subset. Visit 8: month 16-19, 18-21 months of age, ≥ 28 days after visit 6 Visit 9: month 22-25, 24-27 months of age Visit 10: Contact This document contains the non-serious adverse events form. It has to be filled in if non-serious adverse event occurs during study. It's for all workbooks.

Link

https://clinicaltrials.gov/ct2/show/NCT00466947

Stichworte

Versionen (3)
  1. 26.10.18 26.10.18 -
  2. 27.10.18 27.10.18 -
  3. 27.10.18 27.10.18 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

27. Oktober 2018

DOI

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Creative Commons BY-NC 3.0
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Vaccination against pneumonia and otitis media, NCT00466947

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
Workbook number
Beschreibung

Workbook number

Datentyp

integer

Alias
UMLS CUI [1]
C2986015
Date of non-serious adverse event
Beschreibung

Date of non-serious adverse event

Datentyp

date

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0011008
Case number
Beschreibung

Case number

Datentyp

integer

Alias
UMLS CUI [1,1]
C1698493
UMLS CUI [1,2]
C0600091
NON-SERIOUS ADVERSE EVENTS
Beschreibung

NON-SERIOUS ADVERSE EVENTS

Alias
UMLS CUI-1
C1518404
Has any non-serious adverse event leading to a non-administration of the vaccine or a visit/contact not done or a withdrawn?
Beschreibung

If you tick yes, please complete the following items.

Datentyp

boolean

Alias
UMLS CUI [1]
C1518404
UMLS CUI [2,1]
C1533734
UMLS CUI [2,2]
C0392360
UMLS CUI [2,3]
C1272696
UMLS CUI [2,4]
C0042210
UMLS CUI [3,1]
C0545082
UMLS CUI [3,2]
C1272696
AE Number
Beschreibung

AE Number

Alias
UMLS CUI-1
C1518404
UMLS CUI-2
C0237753
AE Number
Beschreibung

AE Number

Datentyp

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0237753
Description of AE
Beschreibung

Description of AE

Datentyp

text

Alias
UMLS CUI [1,1]
C0678257
UMLS CUI [1,2]
C1518404
Administration sites
Beschreibung

Administration sites

Datentyp

integer

Alias
UMLS CUI [1]
C2368628
Non-serious adverse event: For GSK
Beschreibung

Non-serious adverse event: For GSK

Alias
UMLS CUI-1
C1518404
AE Number
Beschreibung

AE Number

Datentyp

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0237753
Date Started
Beschreibung

Date Started

Datentyp

date

Alias
UMLS CUI [1]
C0808070
Date started: during immediate post-vaccination period (30 minutes)
Beschreibung

Date started: post-vaccination periode

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C0231291
Date Stopped
Beschreibung

Date Stopped

Datentyp

date

Alias
UMLS CUI [1]
C0806020
Maximum Intensity
Beschreibung

Maximum Intensity

Datentyp

integer

Alias
UMLS CUI [1]
C0518690
Relationship to investigational products: 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]
C0085978
UMLS CUI [1,3]
C0304229
Outcome of AE
Beschreibung

Outcome of AE

Datentyp

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C1624730
Medically attended visit
Beschreibung

If yes please specify type in following item.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1386497
Type of medically attended visit
Beschreibung

Type of medically attended visit

Datentyp

text

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1386497
UMLS CUI [1,3]
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])
Item
Workbook number
integer
C2986015 (UMLS CUI [1])
Workbook number
Code List
Workbook number
CL Item
workbook 1 (1)
CL Item
workbook 2 (2)
CL Item
workbook 3 (3)
Date of non-serious adverse event
Item
Date of non-serious adverse event
date
C1518404 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Case number
Item
Case number
integer
C1698493 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Item Group
NON-SERIOUS ADVERSE EVENTS
C1518404 (UMLS CUI-1)
Non-serious adverse event leading to non-administration of vaccine, visit/contact not done
Item
Has any non-serious adverse event leading to a non-administration of the vaccine or a visit/contact not done or a withdrawn?
boolean
C1518404 (UMLS CUI [1])
C1533734 (UMLS CUI [2,1])
C0392360 (UMLS CUI [2,2])
C1272696 (UMLS CUI [2,3])
C0042210 (UMLS CUI [2,4])
C0545082 (UMLS CUI [3,1])
C1272696 (UMLS CUI [3,2])
Item Group
AE Number
C1518404 (UMLS CUI-1)
C0237753 (UMLS CUI-2)
Item
AE Number
integer
C1518404 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
AE Number
Code List
AE Number
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
Description of AE
Item
Description of AE
text
C0678257 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Item
Administration sites
integer
C2368628 (UMLS CUI [1])
Administration sites
Code List
Administration sites
CL Item
10Pn-PD-DiT vaccine / HBV Vaccine (1)
CL Item
10Pn-PD-DiT vaccine / HAV Vaccine (2)
CL Item
DTPa-IPV/Hib vaccine / Infanrix Hexa (3)
CL Item
Non-administration (4)
Item Group
Non-serious adverse event: For GSK
C1518404 (UMLS CUI-1)
Item
AE Number
integer
C1518404 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
AE Number
Code List
AE Number
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
Date Started
Item
Date Started
date
C0808070 (UMLS CUI [1])
Date started: post-vaccination periode
Item
Date started: during immediate post-vaccination period (30 minutes)
boolean
C0808070 (UMLS CUI [1,1])
C0231291 (UMLS CUI [1,2])
Date Stopped
Item
date
C0806020 (UMLS CUI [1])
Item
Maximum Intensity
integer
C0518690 (UMLS CUI [1])
Maximum Intensity
Code List
Maximum Intensity
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Relationship to investigational products
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])
C0085978 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
Item
Outcome of AE
integer
C1518404 (UMLS CUI [1,1])
C1624730 (UMLS CUI [1,2])
Outcome of AE
Code List
Outcome of AE
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])
Item
Type of medically attended visit
text
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,3])
Tpe of medically attended visit
Code List
Type of medically attended visit
CL Item
Hospitalisation (HO)
CL Item
Emergency Room (ER)
CL Item
Medical Personnel (MD)
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