ID

36273

Beschreibung

Study ID: 103792 Clinical Study ID: 103792 Study Title: A multicenter study of the immunogenicity & safety of 2 doses of GSK Biologicals’ oral live attenuated human rotavirus vaccine (RIX4414) as primary dosing of healthy infants in India aged approximately 8 wks at the time of the first dose Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00289172 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: Rotavirus Vaccine Trade Name: BIO ROTA; Rotarix Study Indication: Infections, Rotavirus

Stichworte

Versionen (1)
  1. 28.04.19 28.04.19 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

28. April 2019

DOI

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Creative Commons BY-NC 3.0
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GSK Biologicals' oral live attenuated human rotavirus vaccine (RIX4414) as primary dosing of healthy infants; NCT00289172

Englisch

Visit 3

1 Formulare  
  1. StudyEvent: ODM
    1. Visit 3
Administrative Data
Beschreibung

Administrative Data

Alias
UMLS CUI-1
C1320722
Date of visit
Beschreibung

Date of visit

Datentyp

date

Alias
UMLS CUI [1]
C1320303
Subject Number
Beschreibung

Clinical Trial Subject Unique Identifier

Datentyp

integer

Alias
UMLS CUI [1]
C2348585
Check for Study Continuation
Beschreibung

Check for Study Continuation

Alias
UMLS CUI-1
C0805733
UMLS CUI-2
C0008976
Did the subject come at visit 3?
Beschreibung

Yes -> Please complete the next pages. No -> Please complete below.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0805733
UMLS CUI [1,2]
C0008976
If No, Please tick the ONE most appropriate reason and skip the following pages of this visit.
Beschreibung

Continuation status, Clinical Trials, Reason

Datentyp

text

Alias
UMLS CUI [1,1]
C0805733
UMLS CUI [1,2]
C0008976
UMLS CUI [1,3]
C0566251
Specify
Beschreibung

Continuation status, Clinical Trials, Reason

Datentyp

text

Alias
UMLS CUI [1,1]
C0805733
UMLS CUI [1,2]
C0008976
UMLS CUI [1,3]
C0566251
Please tick who took the decision
Beschreibung

Continuation status, Clinical Trials, Decision

Datentyp

text

Alias
UMLS CUI [1,1]
C0805733
UMLS CUI [1,2]
C0008976
UMLS CUI [1,3]
C0679006
Laboratory Tests - Post-Vaccination Blood Sample
Beschreibung

Laboratory Tests - Post-Vaccination Blood Sample

Alias
UMLS CUI-1
C0005834
UMLS CUI-2
C1443955
Has a blood sample been taken?
Beschreibung

Collection of blood specimen for laboratory procedure, Post-vaccination precautions

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C1443955
Please complete only if different from visit date
Beschreibung

Collection of blood specimen for laboratory procedure, Post-vaccination precautions, Date in time

Datentyp

date

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C1443955
UMLS CUI [1,3]
C0011008
Gastroenteritis Episodes
Beschreibung

Gastroenteritis Episodes

Alias
UMLS CUI-1
C0017160
UMLS CUI-2
C0332189
Did the subject present Gastroenteritis anytime starting from day 8 after dose 2 until visit 3?
Beschreibung

If Yes, please fill the Gastroenteritis section If Yes, please collect a stool sample as soon as possible after Gastroenteritis begins and not later than 7 days after the start of the Gastroenteritis and report the stool collection date in the Gastroenteritis section.

Datentyp

boolean

Alias
UMLS CUI [1]
C0017160
Height / Weight
Beschreibung

Height / Weight

Alias
UMLS CUI-1
C0005890
UMLS CUI-2
C0005910
Height
Beschreibung

Body Height

Datentyp

integer

Maßeinheiten
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Weight
Beschreibung

Body Weight

Datentyp

float

Maßeinheiten
  • kg
Alias
UMLS CUI [1]
C0005910
kg
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Ähnliche Modelle

Visit 3

1 Formulare
  1. StudyEvent: ODM
    1. Visit 3
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Date of visit
Item
Date of visit
date
C1320303 (UMLS CUI [1])
Clinical Trial Subject Unique Identifier
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Item Group
Check for Study Continuation
C0805733 (UMLS CUI-1)
C0008976 (UMLS CUI-2)
Continuation status, Clinical Trials
Item
Did the subject come at visit 3?
boolean
C0805733 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
Item
If No, Please tick the ONE most appropriate reason and skip the following pages of this visit.
text
C0805733 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
Continuation status, Clinical Trials, Reason
Code List
If No, Please tick the ONE most appropriate reason and skip the following pages of this visit.
CL Item
Same reason and decision as previous visit. (1)
CL Item
Serious adverse event (Please specify SAE N°) (2)
CL Item
Non-Serious adverse event (Please specify unsolicited AE N° or solicited AE code) (3)
CL Item
Other, please specify (e.g. consent withdrawal, Protocol violation, ...) (4)
Item
Specify
text
C0805733 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
Continuation status, Clinical Trials, Reason
Code List
Specify
Item
Please tick who took the decision
text
C0805733 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C0679006 (UMLS CUI [1,3])
Continuation status, Clinical Trials, Decision
Code List
Please tick who took the decision
CL Item
Investigator  (1)
CL Item
Parents/Guardians (2)
Item Group
Laboratory Tests - Post-Vaccination Blood Sample
C0005834 (UMLS CUI-1)
C1443955 (UMLS CUI-2)
Collection of blood specimen for laboratory procedure, Post-vaccination precautions
Item
Has a blood sample been taken?
boolean
C0005834 (UMLS CUI [1,1])
C1443955 (UMLS CUI [1,2])
Collection of blood specimen for laboratory procedure, Post-vaccination precautions, Date in time
Item
Please complete only if different from visit date
date
C0005834 (UMLS CUI [1,1])
C1443955 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item Group
Gastroenteritis Episodes
C0017160 (UMLS CUI-1)
C0332189 (UMLS CUI-2)
Gastroenteritis
Item
Did the subject present Gastroenteritis anytime starting from day 8 after dose 2 until visit 3?
boolean
C0017160 (UMLS CUI [1])
Item Group
Height / Weight
C0005890 (UMLS CUI-1)
C0005910 (UMLS CUI-2)
Body Height
Item
Height
integer
C0005890 (UMLS CUI [1])
Body Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
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