ID

32063

Descripción

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 medical history and results of the physical examination. To be assessed at visit 1. Timing: Day 0 Age: 6 weeks +/- 1 week

Link

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

Palabras clave

  1. 16/10/18 16/10/18 - Sarah Riepenhausen
  2. 16/10/18 16/10/18 - Sarah Riepenhausen
Titular de derechos de autor

GlaxoSmithKline

Subido en

16 de octubre de 2018

DOI

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Licencia

Creative Commons BY-NC 3.0

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GSK Biologicals' oral HRV vaccine given with OPV in infants NCT00139334

Medical history and Physical examination

General medical history and physical examination
Descripción

General medical history and physical examination

Alias
UMLS CUI-1
C0262926
UMLS CUI-2
C0031809
Are you aware of any pre-existing conditions or signs and/or symptoms present in the subject prior to the start of the study?
Descripción

If yes: please tick appropriate boxe(s) below and give diagnosis. Please report medication(s) as specified in the protocol and fill in the Medication section

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0262926
UMLS CUI [2,1]
C1457887
UMLS CUI [2,2]
C0262926
Organ system
Descripción

Organ system

Tipo de datos

integer

Alias
UMLS CUI [1]
C0678852
If other Organ system, specify
Descripción

Other Organ system

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0678852
UMLS CUI [1,2]
C0205394
Diagnoses
Descripción

Diagnoses

Tipo de datos

text

Alias
UMLS CUI [1]
C0011900
Was the diagnosis in the past?
Descripción

past diagnosis

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0011900
UMLS CUI [1,2]
C0679831
Is the diagnosis current?
Descripción

Current diagnosis

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0011900
UMLS CUI [1,2]
C0521116

Similar models

Medical history and Physical examination

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
General medical history and physical examination
C0262926 (UMLS CUI-1)
C0031809 (UMLS CUI-2)
Medical history
Item
Are you aware of any pre-existing conditions or signs and/or symptoms present in the subject prior to the start of the study?
boolean
C0012634 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C1457887 (UMLS CUI [2,1])
C0262926 (UMLS CUI [2,2])
Item
Organ system
integer
C0678852 (UMLS CUI [1])
Code List
Organ system
CL Item
cutaneous (10)
CL Item
eyes (5)
CL Item
ears-nose-throat (6)
CL Item
cardiovascular (2)
CL Item
respiratory (3)
CL Item
gastrointestinal (1)
CL Item
muskuloskeletal (7)
CL Item
neurological (8)
CL Item
genitourinary (12)
CL Item
haematology (11)
CL Item
allergies (4)
CL Item
endocrine (9)
CL Item
other (99)
Other Organ system
Item
If other Organ system, specify
text
C0678852 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Diagnoses
Item
Diagnoses
text
C0011900 (UMLS CUI [1])
past diagnosis
Item
Was the diagnosis in the past?
boolean
C0011900 (UMLS CUI [1,1])
C0679831 (UMLS CUI [1,2])
Current diagnosis
Item
Is the diagnosis current?
boolean
C0011900 (UMLS CUI [1,1])
C0521116 (UMLS CUI [1,2])

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