ID

32087

Description

Study ID: 103992 Clinical Study ID: 103992 Study Title: Evaluate immunogenicity, reactogenicity & safety of 2 doses of GSK Biologicals’ oral live attenuated HRV vaccine (RIX4414 at 106.5 CCID50) when given concomitantly with OPV versus given alone (HRV vaccine dose given 15 days after the OPV dose) in healthy infants in Bangladesh Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00139334 https://clinicaltrials.gov/ct2/show/NCT00139334 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Rotavirus Vaccine Trade Name: Rotarix Study Indication: Haemophilus influenzae type b; Neisseria Meningitidis This form is for documentation of non-serious adverse events occuring during the study, excluding solicited adverse events (to be documented in the "unsolicited and solicited adverse events" form at visits 3 and 5).

Link

https://clinicaltrials.gov/ct2/show/NCT00139334

Keywords

Versions (1)
  1. 10/17/18 10/17/18 - Sarah Riepenhausen
Copyright Holder

GlaxoSmithKline

Uploaded on

October 17, 2018

DOI

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License

Creative Commons BY-NC 3.0
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GSK Biologicals' oral HRV vaccine given with OPV in infants NCT00139334

English

Non-Serious Adverse Events

1 forms  
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
Have any non-serious adverse events leading to drop out occurred since visit 1 until visit 3 or has any non-serious adverse events occurred since visit 3 until visit 6, excluding those recorded on the Solicited Adverse Events pages?
Description

(Please report all serious adverse events only on the Serious Adverse Event (SAE) form). If yes, please complete the following itemgroup

Data type

boolean

Alias
UMLS CUI [1]
C1518404
Characteristics of non-serious adverse events
Description

Characteristics of non-serious adverse events

Alias
UMLS CUI-1
C1518404
UMLS CUI-2
C2348235
AE number
Description

AE number

Data type

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0237753
Description
Description

Description

Data type

text

Alias
UMLS CUI [1,1]
C0678257
UMLS CUI [1,2]
C1518404
Date started
Description

Date started

Data type

date

Alias
UMLS CUI [1]
C0808070
Start during immediate post-vaccination period (30 minutes)
Description

Start immediately post vaccination

Data type

boolean

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0687676
UMLS CUI [1,3]
C1301880
UMLS CUI [1,4]
C1518404
Date stopped
Description

Date stopped

Data type

date

Alias
UMLS CUI [1]
C0806020
Intensity
Description

Intensity

Data type

integer

Alias
UMLS CUI [1,1]
C0518690
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]
C1705586
For GSK
Description

For GSK

Data type

text

Alias
UMLS CUI [1,1]
C0008961
UMLS CUI [1,2]
C0947611
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Similar models

Non-Serious Adverse Events

1 forms
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
Item
Have any non-serious adverse events leading to drop out occurred since visit 1 until visit 3 or has any non-serious adverse events occurred since visit 3 until visit 6, excluding those recorded on the Solicited Adverse Events pages?
boolean
C1518404 (UMLS CUI [1])
Item Group
Characteristics of non-serious adverse events
C1518404 (UMLS CUI-1)
C2348235 (UMLS CUI-2)
AE number
Item
AE number
integer
C1518404 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Description
Item
Description
text
C0678257 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Date started
Item
Date started
date
C0808070 (UMLS CUI [1])
Start immediately post vaccination
Item
Start during immediate post-vaccination period (30 minutes)
boolean
C0042196 (UMLS CUI [1,1])
C0687676 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,3])
C1518404 (UMLS CUI [1,4])
Date stopped
Item
Date stopped
date
C0806020 (UMLS CUI [1])
Item
Intensity
integer
C0518690 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Intensity
Code List
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
No (N)
CL Item
yes (Y)
Item
Outcome
integer
C1705586 (UMLS CUI [1])
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)
For GSK
Item
For GSK
text
C0008961 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
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