ID

32452

Beschreibung

Study ID: 102248 Clinical Study ID: 102248 Study Title: Multi-Center Study to Assess the Efficacy, Safety and Immunogenicity of 2 or 3 Doses of GSK Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Vaccine Given Concomitantly With Routine EPI Vaccinations in Healthy Infants Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00241644 Study Link: https://clinicaltrials.gov/ct2/show/NCT00241644 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Rotavirus Vaccine Trade Name: Rotarix Study Indication: Infections, Rotavirus The visits are defined as follows: Visit 1: (Study/Participation) Day 0, Age: 5-10 weeks, Dose 1 Visit 2: (Study/Participation) Month 1, 30-48 days after Visit 1, Dose 2 Visit 3: (Study/Participation) Month 2, 30-48 days after Visit 2, Dose 3 Visit 4: (Study/Participation) Month 3, 30-48 days after Visit 3, Visit 5: (Study/Participation) 1 year of age, 343-391 days of age For amendment 5: Visit 5: (Study/Participation) 21-48 days after Visit 4 Visit 6: (Study/Participation) 1 year of age, 343-391 days of age This form contains information about gastroenteritis episodes and should be filled out if the subject has experienced an episode of GE between visits.

Link

https://clinicaltrials.gov/ct2/show/NCT00241644

Stichworte

Versionen (1)
  1. 01.11.18 01.11.18 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

1. November 2018

DOI

Für eine Beantragung loggen Sie sich ein.

Lizenz

Creative Commons BY-NC 3.0
Modell Kommentare :

Hier können Sie das Modell kommentieren. Über die Sprechblasen an den Itemgruppen und Items können Sie diese spezifisch kommentieren.

Zurück zu Modell Kommentaren
Itemgroup Kommentare für :

Item Kommentare für :

Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.

Efficacy, Safety and Immunogenicity of Oral HRV Vaccine NCT00241644

Englisch

Gastroenteritis Episode Form

1 Formulare  
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

Subject number

Datentyp

integer

Alias
UMLS CUI [1]
C2348585
GE Episode Number
Beschreibung

Gastroenteritis Episode Number

Datentyp

integer

Alias
UMLS CUI [1,1]
C0017160
UMLS CUI [1,2]
C4086638
Gastroenteritis Episodes
Beschreibung

Gastroenteritis Episodes

Alias
UMLS CUI-1
C0017160
Has any gastroenteritis occurred from Visit 1 until Visit 6?
Beschreibung

Visit 6 is only part of amendment 1

Datentyp

boolean

Alias
UMLS CUI [1]
C0017160
Has the subject been treated?
Beschreibung

Treatment

Datentyp

boolean

Alias
UMLS CUI [1]
C0087111
Oral rehydration therapy
Beschreibung

If the subject has been treated

Datentyp

boolean

Alias
UMLS CUI [1]
C0086904
IV rehydration therapy
Beschreibung

If the subject has been treated

Datentyp

boolean

Alias
UMLS CUI [1]
C0860129
Oral and IV rehydration therapy
Beschreibung

If the subject has been treated

Datentyp

boolean

Alias
UMLS CUI [1]
C0086904
UMLS CUI [2]
C0860129
Other therapy
Beschreibung

If the subject has been treated

Datentyp

text

Alias
UMLS CUI [1]
C0418967
Dehydration?
Beschreibung

Dehydration

Datentyp

boolean

Alias
UMLS CUI [1]
C0011175
Degree of dehydration
Beschreibung

If subject was dehydrated

Datentyp

integer

Alias
UMLS CUI [1,1]
C0011175
UMLS CUI [1,2]
C0521117
Hospitalization?
Beschreibung

Hospitalization

Datentyp

boolean

Alias
UMLS CUI [1]
C0019993
Stool collection date and time
Beschreibung

One single stool sample should be collected as soon as possible and not later than 7 days after the beginning (preferably) of the gastroenteritis. A second stool sample can be taken if the first one is insufficient.

Datentyp

datetime

Alias
UMLS CUI [1]
C0455051
Stool collection date and time:
Beschreibung

One single stool sample should be collected as soon as possible and not later than 7 days after the beginning (preferably) of the gastroenteritis. A second stool sample can be taken if the first one is insufficient.

Datentyp

datetime

Alias
UMLS CUI [1]
C0455051
Documentation of Gastroenteritis Episode
Beschreibung

Documentation of Gastroenteritis Episode

Alias
UMLS CUI-1
C0017160
UMLS CUI-2
C0332189
UMLS CUI-3
C0920316
Day of Gastroenteritis
Beschreibung

Day of Gastroenteritis

Datentyp

date

Alias
UMLS CUI [1,1]
C0017160
UMLS CUI [1,2]
C0011008
Number of looser stools per day
Beschreibung

Number of looser stools per day

Datentyp

integer

Alias
UMLS CUI [1,1]
C2129214
UMLS CUI [1,2]
C1265611
Number of vomiting per day
Beschreibung

Number of vomiting per day

Datentyp

integer

Alias
UMLS CUI [1,1]
C0042963
UMLS CUI [1,2]
C1265611
Temperature
Beschreibung

Temperature

Datentyp

float

Maßeinheiten
  • °C
Alias
UMLS CUI [1]
C0005903
°C
Temperature Route of Measurement
Beschreibung

Temperature Route of Measurement

Datentyp

text

Alias
UMLS CUI [1,1]
C0886414
UMLS CUI [1,2]
C0449444
Subject less playfull/irritability
Beschreibung

Item only applicable in amendment 1

Datentyp

boolean

Alias
UMLS CUI [1]
C0022107
UMLS CUI [2]
C2237128
Lethargic
Beschreibung

Item only applicable in amendment 1

Datentyp

boolean

Alias
UMLS CUI [1]
C0023380
Listless
Beschreibung

Item only applicable in amendment 1

Datentyp

boolean

Alias
UMLS CUI [1]
C3899149
Seizure
Beschreibung

Item only applicable in amendment 1

Datentyp

boolean

Alias
UMLS CUI [1]
C0036572
Zum Seitenanfang zurückkehren

Ähnliche Modelle

Gastroenteritis Episode Form

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1320722 (UMLS CUI-1)
Date of visit
Item
Date of visit
date
C1320303 (UMLS CUI [1])
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Gastroenteritis Episode Number
Item
GE Episode Number
integer
C0017160 (UMLS CUI [1,1])
C4086638 (UMLS CUI [1,2])
Item Group
Gastroenteritis Episodes
C0017160 (UMLS CUI-1)
Gastroenteritis occurred
Item
Has any gastroenteritis occurred from Visit 1 until Visit 6?
boolean
C0017160 (UMLS CUI [1])
Treatment
Item
Has the subject been treated?
boolean
C0087111 (UMLS CUI [1])
Oral rehydration therapy
Item
Oral rehydration therapy
boolean
C0086904 (UMLS CUI [1])
IV rehydration therapy
Item
IV rehydration therapy
boolean
C0860129 (UMLS CUI [1])
Oral and IV rehydration therapy
Item
Oral and IV rehydration therapy
boolean
C0086904 (UMLS CUI [1])
C0860129 (UMLS CUI [2])
Other therapy
Item
Other therapy
text
C0418967 (UMLS CUI [1])
Dehydration
Item
Dehydration?
boolean
C0011175 (UMLS CUI [1])
Item
Degree of dehydration
integer
C0011175 (UMLS CUI [1,1])
C0521117 (UMLS CUI [1,2])
Degree of Dehydration
Code List
Degree of dehydration
CL Item
1 - 5% (1)
CL Item
>= 6% (2)
Hospitalization
Item
Hospitalization?
boolean
C0019993 (UMLS CUI [1])
First Stool collection date and time
Item
Stool collection date and time
datetime
C0455051 (UMLS CUI [1])
Second stool collection
Item
Stool collection date and time:
datetime
C0455051 (UMLS CUI [1])
Item Group
Documentation of Gastroenteritis Episode
C0017160 (UMLS CUI-1)
C0332189 (UMLS CUI-2)
C0920316 (UMLS CUI-3)
Day of Gastroenteritis
Item
Day of Gastroenteritis
date
C0017160 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Number of looser stools per day
Item
Number of looser stools per day
integer
C2129214 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Number of vomiting per day
Item
Number of vomiting per day
integer
C0042963 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Temperature
Item
Temperature
float
C0005903 (UMLS CUI [1])
Item
Temperature Route of Measurement
text
C0886414 (UMLS CUI [1,1])
C0449444 (UMLS CUI [1,2])
Temperature Route of Measurement
Code List
Temperature Route of Measurement
CL Item
Axillary (recommended) (A)
CL Item
Oral (O)
CL Item
Rectal (R)
Less playfull/irritability
Item
Subject less playfull/irritability
boolean
C0022107 (UMLS CUI [1])
C2237128 (UMLS CUI [2])
Lethargic
Item
Lethargic
boolean
C0023380 (UMLS CUI [1])
Listless
Item
Listless
boolean
C3899149 (UMLS CUI [1])
Seizure
Item
Seizure
boolean
C0036572 (UMLS CUI [1])
Zum Seitenanfang zurückkehren 

Kontakt

Benutzen Sie dieses Formular für Rückmeldungen, Fragen und Verbesserungsvorschläge.

Mit * gekennzeichnete Felder sind notwendig.

Hilfe

Benötigen Sie Hilfe bei der Suche? Um mehr Details zu erfahren und die Suche effektiver nutzen zu können schauen Sie sich doch das entsprechende Video auf unserer Tutorial Seite an.

Zum Video