Informações:
Falhas:
ID
25104
Descrição
Visit 6 Booster Dose General Symptoms form Study ID: 208127/125 Clinical Study ID: 208127/125 (Ext-HAB-038 Month 90) Study Title: A double-blind, randomized study to evaluate the immunogenicity and reactogenicity of two different lots of GlaxoSmithKline Biologicals' combined hepatitis A / hepatitis B vaccine in healthy children between 6 and 15 years of age. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor:GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Hepatitis A (Inactivated), Hepatitis B (Recombinant) Vaccine Trade Name: Twinrix Study Indication: Hepatitis A; Hepatitis B
Palavras-chave
Versões (1)
- 25/08/2017 25/08/2017 -
Titular dos direitos
GlaxoSmithKline
Transferido a
25 de agosto de 2017
DOI
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Licença
Creative Commons BY-NC 3.0
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Visit 6 Booster Dose General Symptoms Biologicals HepA/HepB vaccine 208127/125
Visit 6 Booster Dose General Symptoms Biologicals HepA/HepB vaccine 208127/125
Similar models
Visit 6 Booster Dose General Symptoms Biologicals HepA/HepB vaccine 208127/125
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Protocol
Item
Protocol
text
C1507394 (UMLS CUI [1])
Activity
Item
Activity
text
C1512346 (UMLS CUI [1])
Subject number
Item
Subject number
text
C2348585 (UMLS CUI [1])
Item Group
SOLICITED ADVERSE EXPERIENCES - GENERAL SYMPTOMS
C0877248 (UMLS CUI-1)
C0159028 (UMLS CUI-2)
C0159028 (UMLS CUI-2)
Signs or symptoms since vaccine administration
Item
IV. Has the subject experienced any general solicited signs or symptoms since vaccine administration ?
boolean
C0159028 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
C2368628 (UMLS CUI [1,2])
General Symptoms
Item
GENERAL SYMPTOMS
boolean
C0159028 (UMLS CUI [1])
Axillary temperature
Item
Axillary ≥ 37,5°C
boolean
C1531924 (UMLS CUI [1])
Oral temperature
Item
Oral ≥ 37,5°C
boolean
C0005903 (UMLS CUI [1,1])
C0442027 (UMLS CUI [1,2])
C0442027 (UMLS CUI [1,2])
Rectal temperature
Item
Rectal ≥ 38°C
boolean
C0489749 (UMLS CUI [1])
Temperature Day 0
Item
Temperature Day 0
float
C0005903 (UMLS CUI [1,1])
C2826301 (UMLS CUI [1,2])
C2826301 (UMLS CUI [1,2])
Temperature Day 0 not taken
Item
Not taken
boolean
C2826301 (UMLS CUI [1,1])
C0437722 (UMLS CUI [1,2])
C0437722 (UMLS CUI [1,2])
Temperature Day 1
Item
Temperature Day 1
float
C0005903 (UMLS CUI [1,1])
C1442449 (UMLS CUI [1,2])
C1442449 (UMLS CUI [1,2])
Temperature Day 1 not taken
Item
Not taken
boolean
C1442449 (UMLS CUI [1,1])
C0437722 (UMLS CUI [1,2])
C0437722 (UMLS CUI [1,2])
Temperature Day 2
Item
Temperature Day 2
float
C0005903 (UMLS CUI [1,1])
C3842676 (UMLS CUI [1,2])
C3842676 (UMLS CUI [1,2])
Temperature Day 2 not taken
Item
Not taken
boolean
C3842676 (UMLS CUI [1,1])
C0437722 (UMLS CUI [1,2])
C0437722 (UMLS CUI [1,2])
Temperature Day 3
Item
Temperature Day 3
float
C0005903 (UMLS CUI [1,1])
C3842675 (UMLS CUI [1,2])
C3842675 (UMLS CUI [1,2])
Temperature Day 3 not taken
Item
Not taken
boolean
C3842675 (UMLS CUI [1,1])
C0437722 (UMLS CUI [1,2])
C0437722 (UMLS CUI [1,2])
Corrective therapy
Item
Corrective therapy ?
boolean
C0877248 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,2])
Item
Relation
text
C0304229 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
C0085978 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
CL Item
Related (R)
CL Item
Possibly related (PR)
CL Item
Probably unrelated (PU)
CL Item
Unrelated (U)
CL Item
Recovered (1)
CL Item
Recovered with sequelae (2)
CL Item
Ongoing (3)
CL Item
Died (4)
CL Item
Unknown (5)
General symptoms
Item
GENERAL SYMPTOMS
boolean
C0159028 (UMLS CUI [1])
CL Item
Nihil (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Nihil (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Nihil (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Nihil (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Corrective therapy
Item
Corrective therapy ?
boolean
C0877248 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,2])
Item
Relation
text
C0304229 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
C0085978 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
CL Item
Related (R)
CL Item
Possibly related (PR)
CL Item
Probably unrelated (PU)
CL Item
Unrelated (U)
CL Item
Recovered (1)
CL Item
Recovered with sequelae (2)
CL Item
Ongoing (3)
CL Item
Died (4)
CL Item
Unknown (5)
General symptoms
Item
GENERAL SYMPTOMS
boolean
C0159028 (UMLS CUI [1])
CL Item
Nihil (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Nihil (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Nihil (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Nihil (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Corrective therapy
Item
Corrective therapy ?
boolean
C0877248 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,2])
Item
Relation
text
C0304229 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
C0085978 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
CL Item
Related (R)
CL Item
Possibly related (PR)
CL Item
Probably unrelated (PU)
CL Item
Unrelated (U)
CL Item
Recovered (1)
CL Item
Recovered with sequelae (2)
CL Item
Ongoing (3)
CL Item
Died (4)
CL Item
Unknown (5)
General symptoms
Item
GENERAL SYMPTOMS
boolean
C0159028 (UMLS CUI [1])
CL Item
Nihil (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Nihil (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Nihil (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Nihil (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Corrective therapy
Item
Corrective therapy ?
boolean
C0877248 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,2])
Item
Relation
text
C0304229 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
C0085978 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
CL Item
Related (R)
CL Item
Possibly related (PR)
CL Item
Probably unrelated (PU)
CL Item
Unrelated (U)
CL Item
Recovered (1)
CL Item
Recovered with sequelae (2)
CL Item
Ongoing (3)
CL Item
Died (4)
CL Item
Unknown (5)
General symptoms
Item
GENERAL SYMPTOMS
boolean
C0159028 (UMLS CUI [1])
CL Item
Nihil (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Nihil (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Nihil (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Nihil (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Corrective therapy
Item
Corrective therapy ?
boolean
C0877248 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,2])
Item
Relation
text
C0304229 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
C0085978 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
CL Item
Related (R)
CL Item
Possibly related (PR)
CL Item
Probably unrelated (PU)
CL Item
Unrelated (U)
CL Item
Recovered (1)
CL Item
Recovered with sequelae (2)
CL Item
Ongoing (3)
CL Item
Died (4)
CL Item
Unknown (5)
General symptoms
Item
GENERAL SYMPTOMS
boolean
C0159028 (UMLS CUI [1])
CL Item
Nihil (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Nihil (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Nihil (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Nihil (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Corrective therapy
Item
Corrective therapy ?
boolean
C0877248 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,2])
Item
Relation
text
C0304229 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
C0085978 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
CL Item
Related (R)
CL Item
Possibly related (PR)
CL Item
Probably unrelated (PU)
CL Item
Unrelated (U)
CL Item
Recovered (1)
CL Item
Recovered with sequelae (2)
CL Item
Ongoing (3)
CL Item
Died (4)
CL Item
Unknown (5)
Item Group
Seriousness of symptoms
C0871902 (UMLS CUI-1)
C1457887 (UMLS CUI-2)
C1457887 (UMLS CUI-2)
Seriousness of symptoms
Item
Do you consider any of these adverse experiences to be serious ?
boolean
C1710056 (UMLS CUI [1])
Complete Adverse Experience Section
Item
If any general symptom other than those listed above occurred, please complete the Adverse Experience Section.
text
C0029625 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C1521800 (UMLS CUI [1,3])
C0205197 (UMLS CUI [1,2])
C1521800 (UMLS CUI [1,3])
Date
Item
Date :
date
C0011008 (UMLS CUI [1])
Signature
Item
Investigator Signature :
text
C2346576 (UMLS CUI [1])