ID

32452

Description

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

Keywords

Versions (1)
  1. 11/1/18 11/1/18 -
Copyright Holder

GlaxoSmithKline

Uploaded on

November 1, 2018

DOI

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License

Creative Commons BY-NC 3.0
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Efficacy, Safety and Immunogenicity of Oral HRV Vaccine NCT00241644

English

Gastroenteritis Episode Form

1 forms  
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Date of visit
Description

Date of visit

Data type

date

Alias
UMLS CUI [1]
C1320303
Subject number
Description

Subject number

Data type

integer

Alias
UMLS CUI [1]
C2348585
GE Episode Number
Description

Gastroenteritis Episode Number

Data type

integer

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

Gastroenteritis Episodes

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

Visit 6 is only part of amendment 1

Data type

boolean

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

Treatment

Data type

boolean

Alias
UMLS CUI [1]
C0087111
Oral rehydration therapy
Description

If the subject has been treated

Data type

boolean

Alias
UMLS CUI [1]
C0086904
IV rehydration therapy
Description

If the subject has been treated

Data type

boolean

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

If the subject has been treated

Data type

boolean

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

If the subject has been treated

Data type

text

Alias
UMLS CUI [1]
C0418967
Dehydration?
Description

Dehydration

Data type

boolean

Alias
UMLS CUI [1]
C0011175
Degree of dehydration
Description

If subject was dehydrated

Data type

integer

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

Hospitalization

Data type

boolean

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

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.

Data type

datetime

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

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.

Data type

datetime

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

Documentation of Gastroenteritis Episode

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

Day of Gastroenteritis

Data type

date

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

Number of looser stools per day

Data type

integer

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

Number of vomiting per day

Data type

integer

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

Temperature

Data type

float

Measurement units
  • °C
Alias
UMLS CUI [1]
C0005903
°C
Temperature Route of Measurement
Description

Temperature Route of Measurement

Data type

text

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

Item only applicable in amendment 1

Data type

boolean

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

Item only applicable in amendment 1

Data type

boolean

Alias
UMLS CUI [1]
C0023380
Listless
Description

Item only applicable in amendment 1

Data type

boolean

Alias
UMLS CUI [1]
C3899149
Seizure
Description

Item only applicable in amendment 1

Data type

boolean

Alias
UMLS CUI [1]
C0036572
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Similar models

Gastroenteritis Episode Form

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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])
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