ID

32440

Beskrivning

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 asks for the general medical history of the patient and the results of a physical examination. It should be checked at first visit.

Länk

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

Nyckelord

Versioner (1)
  1. 2018-11-01 2018-11-01 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

1 november 2018

DOI

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Licens

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

Engelsk

Medical History and Physical Examination

1 Formulär  
Administrative Data
Beskrivning

Administrative Data

Alias
UMLS CUI-1
C1320722
Date of visit
Beskrivning

Date of visit

Datatyp

date

Alias
UMLS CUI [1]
C1320303
Subject number
Beskrivning

Subject number

Datatyp

integer

Alias
UMLS CUI [1]
C2348585
General Medical History, Phyiscal Examination
Beskrivning

General Medical History, Phyiscal Examination

Alias
UMLS CUI-1
C0262926
UMLS CUI-2
C0031809
Are you aware of any pre-existing conditions, signs or symptoms present prior to the start of the study?
Beskrivning

Pre-existing conditions, signs or symptoms

Datatyp

boolean

Alias
UMLS CUI [1]
C0521987
UMLS CUI [2]
C0037088
MedDRA SYSTEM ORGAN CLASS
Beskrivning

MedDRA System Organ Class

Datatyp

integer

Alias
UMLS CUI [1]
C2347091
Diagnosis
Beskrivning

Diagnosis

Datatyp

text

Alias
UMLS CUI [1]
C0011900
Past diagnosis
Beskrivning

Past

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1444637
UMLS CUI [1,2]
C0011900
Current diagnosis
Beskrivning

Current

Datatyp

boolean

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

Medical History and Physical Examination

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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])
Item Group
General Medical History, Phyiscal Examination
C0262926 (UMLS CUI-1)
C0031809 (UMLS CUI-2)
Pre-existing conditions, signs or symptoms
Item
Are you aware of any pre-existing conditions, signs or symptoms present prior to the start of the study?
boolean
C0521987 (UMLS CUI [1])
C0037088 (UMLS CUI [2])
Item
MedDRA SYSTEM ORGAN CLASS
integer
C2347091 (UMLS CUI [1])
MedDRA System Organ Class
Code List
MedDRA SYSTEM ORGAN CLASS
CL Item
Skin and subcutaneous tissue (1)
CL Item
Musculoskeletal and (2)
CL Item
connective tissue (3)
CL Item
Cardiac (4)
CL Item
Vascular (5)
CL Item
Respiratory, thoracic and (6)
CL Item
mediastinal (7)
CL Item
Gastrointestinal (8)
CL Item
Hepatobiliary (9)
CL Item
Renal and urinary (10)
CL Item
Nervous system (11)
CL Item
Eye (12)
CL Item
Ear and labyrinth (13)
CL Item
Endocrine (14)
CL Item
Metabolism and nutrition (15)
CL Item
Blood and lymphatic system (16)
CL Item
Immune system (17)
CL Item
Infections and infestations (18)
CL Item
Neoplasms benign, malignant (19)
CL Item
and unspecified (20)
CL Item
Surgical and medical (21)
CL Item
procedures (22)
CL Item
Other (23)
Diagnosis
Item
Diagnosis
text
C0011900 (UMLS CUI [1])
Past
Item
Past diagnosis
boolean
C1444637 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Current
Item
Current diagnosis
boolean
C0521116 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Tillbaka till toppen 

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