ID

35890

Beskrivning

Study ID: 102370 (primary study) Clinical Study ID: 102370 Study Title: A multicentre when given according to the 2-4-6 month schedule to healthy infants with booster dose at 12 to 15 months Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00134719 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Haemophilus influenzae Type b, Meningococcal C and Y-Tetanus Toxoid Conjugate Vaccine Trade Name: BIO HIB-MENCY-TT; MenHibrix Study Indication: Haemophilus influenzae type b; Neisseria Meningitidis

Nyckelord

Versioner (1)
  1. 2019-04-02 2019-04-02 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

2 april 2019

DOI

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Creative Commons BY-NC 3.0
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GSK Biologicals' Hib-MenCY-TT Conjugate Vaccine vs ActHIB® & MenC Conjugate Licensed Vaccine (NCT00134719)

Engelsk

Parotid / Salivary Gland Swelling Events

1 Formulär  
Administrative Data
Beskrivning

Administrative Data

Subject Number
Beskrivning

Clinical Trial Subject Unique Identifier

Datatyp

integer

Alias
UMLS CUI [1]
C2348585
Parotid / Salivary Gland Swelling Events
Beskrivning

Parotid / Salivary Gland Swelling Events

Alias
UMLS CUI-1
C0240925
UMLS CUI-2
C0240668
PS No.
Beskrivning

Swelling of salivary gland, Numbers; parotid gland swelling, Numbers

Datatyp

text

Alias
UMLS CUI [1,1]
C0240925
UMLS CUI [1,2]
C0237753
UMLS CUI [2,1]
C0240668
UMLS CUI [2,2]
C0237753
Description
Beskrivning

Swelling of salivary gland, Description; parotid gland swelling, Description

Datatyp

text

Alias
UMLS CUI [1,1]
C0240925
UMLS CUI [1,2]
C0678257
UMLS CUI [2,1]
C0240668
UMLS CUI [2,2]
C0678257
Date started
Beskrivning

Swelling of salivary gland, Start Date; parotid gland swelling, Start Date

Datatyp

date

Alias
UMLS CUI [1,1]
C0240925
UMLS CUI [1,2]
C0808070
UMLS CUI [2,1]
C0240668
UMLS CUI [2,2]
C0808070
Date stopped
Beskrivning

Swelling of salivary gland, End Date; parotid gland swelling, End Date

Datatyp

date

Alias
UMLS CUI [1,1]
C0240925
UMLS CUI [1,2]
C0806020
UMLS CUI [2,1]
C0240668
UMLS CUI [2,2]
C0806020
Intensity
Beskrivning

Swelling of salivary gland, Intensity; parotid gland swelling, Intensity

Datatyp

text

Alias
UMLS CUI [1,1]
C0240925
UMLS CUI [1,2]
C0518690
UMLS CUI [2,1]
C0240668
UMLS CUI [2,2]
C0518690
Relationship to investigational products: Is there a reasonable possibility that the AE may have been caused by the investigational product?
Beskrivning

Swelling of salivary gland, Relationship, Experimental drug; parotid gland swelling, Relationship, Experimental drug

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0240925
UMLS CUI [1,2]
C0439849
UMLS CUI [1,3]
C0304229
UMLS CUI [2,1]
C0240668
UMLS CUI [2,2]
C0439849
UMLS CUI [2,3]
C0304229
Outcome
Beskrivning

Swelling of salivary gland, Outcome; parotid gland swelling, Outcome

Datatyp

text

Alias
UMLS CUI [1,1]
C0240925
UMLS CUI [1,2]
C1547647
UMLS CUI [2,1]
C0240668
UMLS CUI [2,2]
C1547647
Medically attended visit (Refer to protocol for full definition.) If yes please specify type: HO: Hospitalisation ER: Emergency Room MD: MedicalPersonnel
Beskrivning

Swelling of salivary gland, Visit, advice, medical; parotid gland swelling, Visit, advice, medical

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0240925
UMLS CUI [1,2]
C0545082
UMLS CUI [1,3]
C1386497
UMLS CUI [2,1]
C0240668
UMLS CUI [2,2]
C0545082
UMLS CUI [2,3]
C1386497
Type HO: Hospitalisation ER: Emergency Room MD: MedicalPersonnel
Beskrivning

Swelling of salivary gland, Visit, advice, medical, Type; parotid gland swelling, Visit, advice, medical Type

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0240925
UMLS CUI [1,2]
C0545082
UMLS CUI [1,3]
C1386497
UMLS CUI [1,4]
C0332307
UMLS CUI [2,1]
C0240668
UMLS CUI [2,2]
C0545082
UMLS CUI [2,3]
C1386497
UMLS CUI [2,4]
C0332307
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Similar models

Parotid / Salivary Gland Swelling Events

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Administrative Data
Clinical Trial Subject Unique Identifier
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Item Group
Parotid / Salivary Gland Swelling Events
C0240925 (UMLS CUI-1)
C0240668 (UMLS CUI-2)
Item
PS No.
text
C0240925 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C0240668 (UMLS CUI [2,1])
C0237753 (UMLS CUI [2,2])
Exanthema, Numbers
Code List
PS No.
CL Item
PS.1 (1)
CL Item
PS.2 (2)
Swelling of salivary gland, Description; parotid gland swelling, Description
Item
Description
text
C0240925 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
C0240668 (UMLS CUI [2,1])
C0678257 (UMLS CUI [2,2])
Swelling of salivary gland, Start Date; parotid gland swelling, Start Date
Item
Date started
date
C0240925 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C0240668 (UMLS CUI [2,1])
C0808070 (UMLS CUI [2,2])
Swelling of salivary gland, End Date; parotid gland swelling, End Date
Item
Date stopped
date
C0240925 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C0240668 (UMLS CUI [2,1])
C0806020 (UMLS CUI [2,2])
Item
Intensity
text
C0240925 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0240668 (UMLS CUI [2,1])
C0518690 (UMLS CUI [2,2])
Exanthema, Intensity
Code List
Intensity
CL Item
Swelling without difficulties to move the jaw. (1)
CL Item
Swelling with difficulties to move the jaw. (2)
CL Item
Swelling and additional general symptoms. (3)
Swelling of salivary gland, Relationship, Experimental drug; parotid gland swelling, 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
C0240925 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
C0240668 (UMLS CUI [2,1])
C0439849 (UMLS CUI [2,2])
C0304229 (UMLS CUI [2,3])
Item
Outcome
text
C0240925 (UMLS CUI [1,1])
C1547647 (UMLS CUI [1,2])
C0240668 (UMLS CUI [2,1])
C1547647 (UMLS CUI [2,2])
Exanthema, 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)
Swelling of salivary gland, Visit, advice, medical; parotid gland swelling, Visit, advice, medical
Item
Medically attended visit (Refer to protocol for full definition.) If yes please specify type: HO: Hospitalisation ER: Emergency Room MD: MedicalPersonnel
boolean
C0240925 (UMLS CUI [1,1])
C0545082 (UMLS CUI [1,2])
C1386497 (UMLS CUI [1,3])
C0240668 (UMLS CUI [2,1])
C0545082 (UMLS CUI [2,2])
C1386497 (UMLS CUI [2,3])
Swelling of salivary gland, Visit, advice, medical, Type; parotid gland swelling, Visit, advice, medical Type
Item
Type HO: Hospitalisation ER: Emergency Room MD: MedicalPersonnel
boolean
C0240925 (UMLS CUI [1,1])
C0545082 (UMLS CUI [1,2])
C1386497 (UMLS CUI [1,3])
C0332307 (UMLS CUI [1,4])
C0240668 (UMLS CUI [2,1])
C0545082 (UMLS CUI [2,2])
C1386497 (UMLS CUI [2,3])
C0332307 (UMLS CUI [2,4])
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