ID

32906

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 non-serious adverse events, occuring during the study. It should be filled in in case of drop-out due to non-serious AE.

Link

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

Keywords

Versions (3)
  1. 11/1/18 11/1/18 -
  2. 11/17/18 11/17/18 -
  3. 11/19/18 11/19/18 - Sarah Riepenhausen
Copyright Holder

GlaxoSmithKline

Uploaded on

November 19, 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

Non-serious AE

1 forms  
  1. StudyEvent: ODM
    1. Non-serious AE
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject number
Description

Subject number

Data type

integer

Alias
UMLS CUI [1]
C2348585
Non-serious Adverse Events
Description

Non-serious Adverse Events

Alias
UMLS CUI-1
C1518404
Has any non-serious adverse event (leading to drop-outs) occurred since Visit 1 until Visit 5?
Description

if yes, please complete the following table.

Data type

boolean

Alias
UMLS CUI [1]
C1518404
Non-serious Adverse Events Leading to Drop Out
Description

Non-serious Adverse Events Leading to Drop Out

Alias
UMLS CUI-1
C1518404
Non-serious Adverse Event Number
Description

Non-serious Adverse Event Number

Data type

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0237753
Non-serious Adverse Event Description
Description

Non-serious Adverse Event Description

Data type

text

Alias
UMLS CUI [1,1]
C0678257
UMLS CUI [1,2]
C1518404
Date Non-serious Adverse Event Started
Description

Date Non-serious Adverse Event Started

Data type

date

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0011008
Adverse Event Started During Immediate Postvaccination Period
Description

Adverse Event Started During Immediate Postvaccination Period

Data type

boolean

Alias
UMLS CUI [1,1]
C0231291
UMLS CUI [1,2]
C1518404
Date Adverse Event Stopped
Description

Date Adverse Event Stopped

Data type

date

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

Maximum Intensity

Data type

integer

Alias
UMLS CUI [1,1]
C1710056
UMLS CUI [1,2]
C1518404
Is there a reasonable possibility that the AE may have been caused by the investigational product?
Description

Relationship to investigational products

Data type

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0013230
UMLS CUI [1,3]
C0439849
Outcome
Description

Outcome

Data type

integer

Alias
UMLS CUI [1,1]
C1705586
UMLS CUI [1,2]
C1518404
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Similar models

Non-serious AE

1 forms
  1. StudyEvent: ODM
    1. Non-serious AE
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Item Group
Non-serious Adverse Events
C1518404 (UMLS CUI-1)
Non-Serious Adverse event occurred
Item
Has any non-serious adverse event (leading to drop-outs) occurred since Visit 1 until Visit 5?
boolean
C1518404 (UMLS CUI [1])
Item Group
Non-serious Adverse Events Leading to Drop Out
C1518404 (UMLS CUI-1)
Item
Non-serious Adverse Event Number
integer
C1518404 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Adverse Event Number
Code List
Non-serious Adverse Event Number
CL Item
AE1 (1)
CL Item
AE2 (2)
CL Item
AE3 (3)
CL Item
AE4 (4)
Non-serious Adverse Event Description
Item
Non-serious Adverse Event Description
text
C0678257 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Date Non-serious Adverse Event Started
Item
Date Non-serious Adverse Event Started
date
C1518404 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Adverse Event Started During Immediate Postvaccination Period
Item
Adverse Event Started During Immediate Postvaccination Period
boolean
C0231291 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Date Adverse Event Stopped
Item
Date Adverse Event Stopped
date
C0806020 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Item
Maximum Intensity
integer
C1710056 (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
Is there a reasonable possibility that the AE may have been caused by the investigational product?
text
C1518404 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
Relationship to investigational products
Code List
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
integer
C1705586 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
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)
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