Informações:
Falhas:
ID
29245
Descrição
Open, phase IV clinical trial to compare the immunogenicity and reactogenicity of GSK Biologicals’ Infanrix™ (DTPa) vaccine administered as a booster dose at 4 years of age in preterm vs. full-term children previously primed and boosted with Infanrix™ hexa.
Palavras-chave
Versões (1)
- 11/03/2018 11/03/2018 -
Titular dos direitos
GlaxoSmithKline
Transferido a
11 de março de 2018
DOI
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Licença
Creative Commons BY-NC 3.0
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Infanrix Vaccine - 102038
Similar models
Additional Forms
- StudyEvent: ODM
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
subject number
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Date of physical examination
Item
1. Date of physical examination
date
C0011008 (UMLS CUI [1,1])
C0031809 (UMLS CUI [1,2])
C0031809 (UMLS CUI [1,2])
Research Personnel; physical examination swelling
Item
Was the examination performed by a member of study personnel during the extensive swelling period :
boolean
C0035173 (UMLS CUI [1])
C0031809 (UMLS CUI [2,1])
C0038999 (UMLS CUI [2,2])
C0031809 (UMLS CUI [2,1])
C0038999 (UMLS CUI [2,2])
Date swelling
Item
2. Date when the swelling was first considered to be extensive:
date
C0011008 (UMLS CUI [1,1])
C0038999 (UMLS CUI [1,2])
C0038999 (UMLS CUI [1,2])
Swelling; Vaccination
Item
If occurring within 24 hours after vaccination, please specify how long after vaccination:
text
C0038999 (UMLS CUI [1])
C0042196 (UMLS CUI [2])
C0042196 (UMLS CUI [2])
Size
Item
3. Size of swelling:
float
C0456389 (UMLS CUI [1])
CL Item
Local swelling around injection site, not involving adjacent joint (Local swelling around injection site, not involving adjacent joint)
CL Item
Diffuse swelling, not involving adjacent joint (Diffuse swelling, not involving adjacent joint)
CL Item
Swelling, involving adjacent joint (Swelling, involving adjacent joint)
Circumference Swelling limb
Item
5. Circumference of swollen limb (at the site of maximum swelling):
float
C0424682 (UMLS CUI [1,1])
C0038999 (UMLS CUI [1,2])
C0015385 (UMLS CUI [1,3])
C0038999 (UMLS CUI [1,2])
C0015385 (UMLS CUI [1,3])
Circumference limb
Item
5. Circumference of the opposite limb (at the same level):
float
C0424682 (UMLS CUI [1,1])
C0015385 (UMLS CUI [1,2])
C1521805 (UMLS CUI [1,3])
C0015385 (UMLS CUI [1,2])
C1521805 (UMLS CUI [1,3])
Temperature
Item
6. Associated signs: Temperature
float
C0039476 (UMLS CUI [1])
CL Item
Axillary [ A ] (1)
C0004454 (UMLS CUI-1)
(Comment:en)
(Comment:en)
CL Item
Rectal [ R ] (2)
C0205052 (UMLS CUI-1)
(Comment:en)
(Comment:en)
Redness
Item
6. Associated signs: Redness
boolean
C0332575 (UMLS CUI [1])
diameter
Item
Largest diameter :
integer
C1301886 (UMLS CUI [1])
Induration
Item
6. Associated signs: Induration
boolean
C0332534 (UMLS CUI [1])
diameter
Item
Largest diameter :
integer
C1301886 (UMLS CUI [1])
Pain
Item
6. Associated signs: Pain (at administration site)
boolean
C0030193 (UMLS CUI [1])
CL Item
grade 1: Minor reaction to touch (1)
CL Item
grade 2: Cries / protests on touch (2)
CL Item
grade 3: Cries when limb is moved /spontaneously painful (3)
Functional impairment
Item
6. Associated signs: Functional impairment
boolean
C4062321 (UMLS CUI [1])
CL Item
grade 1: easily tolerated, causing minimal discomfort and not interfering with everyday activities (1)
CL Item
grade 2: sufficiently discomforting to interfere with normal everyday activities (2)
CL Item
grade 3: prevents normal everyday activities (3)
Swelling Description; diagnostic procedure; therapeutic interventions.
Item
7. Please give a clinical description of the observed extensive swelling, including a description of the joint involved and specific associated symptoms. Please mention also eventual diagnostic(s) procedures and therapeutic interventions.
text
C0038999 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
C0430022 (UMLS CUI [2])
C0808232 (UMLS CUI [3])
C0678257 (UMLS CUI [1,2])
C0430022 (UMLS CUI [2])
C0808232 (UMLS CUI [3])
Last date swelling
Item
8. Last date when the swelling was still considered to be extensive:
date
C3260033 (UMLS CUI [1,1])
C0038999 (UMLS CUI [1,2])
C0038999 (UMLS CUI [1,2])
Duration Swelling
Item
If lasting for less than 24 hours, please specify duration (hours):
integer
C0449238 (UMLS CUI [1,1])
C0038999 (UMLS CUI [1,2])
C0038999 (UMLS CUI [1,2])
Item
9. Outcome of the swelling:
integer
C1705586 (UMLS CUI [1,1])
C0038999 (UMLS CUI [1,2])
C0038999 (UMLS CUI [1,2])
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)
causality allergy infection trauma
Item
10. Is there an alternative explanation for the swelling? (e.g. : allergy, infection, trauma, underlying conditions)
boolean
C1314792 (UMLS CUI [1,1])
C0020517 (UMLS CUI [1,2])
C0009450 (UMLS CUI [1,3])
C3714660 (UMLS CUI [1,4])
C0020517 (UMLS CUI [1,2])
C0009450 (UMLS CUI [1,3])
C3714660 (UMLS CUI [1,4])
Specify
Item
If yes, please specify:
text
C1521902 (UMLS CUI [1])
Item Group
Concomitant Vaccination
C0042196 (UMLS CUI-1)
C2347852 (UMLS CUI-2)
C2347852 (UMLS CUI-2)
Item
Has any vaccine other than the study vaccine(s) been administered during the period starting 30 days prior to the vaccine dose and ending one month [minimum 30 days] after it?
text
C0042196 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,2])
Code List
Has any vaccine other than the study vaccine(s) been administered during the period starting 30 days prior to the vaccine dose and ending one month [minimum 30 days] after it?
CL Item
No (1)
CL Item
Yes, please record concomitant vaccination with trade name and/or generic name, route and vaccine administration date (fill in items below). (2)
Item Group
Concomitant vaccination
C0042196 (UMLS CUI-1)
C2347852 (UMLS CUI-2)
C2347852 (UMLS CUI-2)
Trade name of vaccine
Item
Trade / (Generic) Name
text
C0592503 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
C0042196 (UMLS CUI [1,2])
Vaccine administration date
Item
Administration date
date
C1533734 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
Item
Have any medications/treatments been administered during study period?
integer
C0013227 (UMLS CUI [1])
C0087111 (UMLS CUI [2])
C0087111 (UMLS CUI [2])
CL Item
No (1)
CL Item
Yes, please complete the following table. (2)
Medication name
Item
Trade or generic name
text
C2360065 (UMLS CUI [1])
Indication
Item
Medical Indication
text
C3146298 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,2])
Prophylactic
Item
Medical Indication: Prophylactic?
boolean
C0199176 (UMLS CUI [1])
C3146298 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
C3146298 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
Total daily dose
Item
Total daily dose
text
C2348070 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,2])
CL Item
External (EXT)
CL Item
Intradermal (ID)
CL Item
Inhalation (IH)
CL Item
Intramuscular (IM)
CL Item
Intraarticular (IR)
CL Item
Intrathecal (IT)
CL Item
Intravenous (IV)
CL Item
Intranasal (NA)
CL Item
Other (OTH)
CL Item
Parenteral (PE)
CL Item
Oral (PO)
CL Item
Rectal (PR)
CL Item
Subcutaneous (SC)
CL Item
Sublingual (SL)
CL Item
Transdermal (TD)
CL Item
Topical (TO)
CL Item
Unknown (UNK)
CL Item
Vaginal (VA)
Medication Start Date
Item
Start Date
date
C0013227 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
Medication End Date
Item
End Date
date
C0013227 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
Medication Ongoing
Item
Medication Ongoing: tick box if continuing at end of study
boolean
C2826666 (UMLS CUI [1])
Item Group
Non-serious Adverse Events
C1518404 (UMLS CUI-1)
C0042210 (UMLS CUI-2)
C0042210 (UMLS CUI-2)
Item
Has any non-serious adverse events occurred within one month (Day 0 to Day 29) post-vaccination, excluding those recorded on the Solicited Adverse Events pages?
integer
C1518404 (UMLS CUI [1])
Code List
Has any non-serious adverse events occurred within one month (Day 0 to Day 29) post-vaccination, excluding those recorded on the Solicited Adverse Events pages?
CL Item
No (1)
CL Item
Yes, please complete the following table (2)
Adverse Event Number
Item
Adverse Event Number
integer
C1518404 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
Description
Item
Non-serious adverse events: Description
text
C0678257 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,2])
Item
Non-serious adverse events: Description
integer
C0678257 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,2])
CL Item
Administration sites (1)
CL Item
Non-administration site (2)
Start Date
Item
Start Date
date
C1518404 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
Start
Item
Start: during immediate post-vaccination period (protocol specific: 0 – 30 minutes)
boolean
C0439659 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,2])
End Date
Item
End Date
date
C1518404 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
Item
Maximum Intensity
integer
C1710056 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,2])
CL Item
Mild (1)
CL Item
Modearte (2)
CL Item
Severe (3)
Causality
Item
In your opinion, did the vaccine possibly contribute to this AE?
boolean
C0304229 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
C0085978 (UMLS CUI [1,3])
C1518404 (UMLS CUI [1,4])
C0042210 (UMLS CUI [1,2])
C0085978 (UMLS CUI [1,3])
C1518404 (UMLS CUI [1,4])
CL Item
Recovered (1)
CL Item
Recovered with sequelae (2)
CL Item
Ongoing at subject study conclusion (3)
CL Item
Died (4)
CL Item
Unknown (5)
Medical advice
Item
Did the subject seek medical advice?
boolean
C1386497 (UMLS CUI [1])
Item
Type - Medical advice
text
C0332307 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C1386497 (UMLS CUI [1,2])
CL Item
Hospitalization (HO)
CL Item
Emergency room (ER)
CL Item
Medical doctor (MD)