ID

32344

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 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]
C1298908
UMLS CUI [2,2]
C2368628
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
Site/Location of Adverse event
Beschreibung

Site/Location of Adverse event

Datentyp

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0450429
Date Started
Beschreibung

Date Started

Datentyp

date

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C1518404
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]
C1518404
UMLS CUI [1,3]
C0231291
Date Stopped
Beschreibung

Date Stopped

Datentyp

date

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

Maximum Intensity

Datentyp

integer

Alias
UMLS CUI [1,1]
C0518690
UMLS CUI [1,2]
C1518404
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

text

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

text

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
Comment for GSK
Beschreibung

Comment for GSK

Datentyp

text

Alias
UMLS CUI [1,1]
C0947611
UMLS CUI [1,2]
C0008961
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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])
C1298908 (UMLS CUI [2,1])
C2368628 (UMLS CUI [2,2])
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
Site/Location of Adverse event
integer
C0877248 (UMLS CUI [1,1])
C0450429 (UMLS CUI [1,2])
Administration sites
Code List
Site/Location of Adverse event
CL Item
10Pn-PD-DiT vaccine / HBV Vaccine administration site (1)
CL Item
10Pn-PD-DiT vaccine / HAV Vaccine administration site (2)
CL Item
DTPa-IPV/Hib vaccine / Infanrix Hexa administration site (3)
CL Item
Non-administration site (4)
Date Started
Item
Date Started
date
C0808070 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Date started: post-vaccination periode
Item
Date started: during immediate post-vaccination period (30 minutes)
boolean
C0808070 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
C0231291 (UMLS CUI [1,3])
Date Stopped
Item
Date Stopped
date
C0806020 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Item
Maximum Intensity
integer
C0518690 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Maximum Intensity
Code List
Maximum Intensity
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Relationship to investigational products: Is there a reasonable possibility that the AE may have been caused by the investigational product?
text
C1518404 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
Relationship to investigational products
Code List
Relationship to investigational products: Is there a reasonable possibility that the AE may have been caused by the investigational product?
CL Item
Yes (Y)
CL Item
No (N)
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)
Item
Medically attended visit
text
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
Medically attended visit
Code List
Medically attended visit
CL Item
Yes (Y)
CL Item
No (N)
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)
Comment for GSK
Item
Comment for GSK
text
C0947611 (UMLS CUI [1,1])
C0008961 (UMLS CUI [1,2])
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