ID

35745

Beschreibung

Study ID: 110028 Clinical Study ID: 110028 Study Title: Study to Evaluate the Safety and Immune Response of Two-Doses of Candidate Influenza Vaccine GSK 1557484A in Adults Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00510874 https://clinicaltrials.gov/ct2/show/NCT00510874 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Candidate Influenza Vaccine Trade Name: Pumarix, Pandemrix Study Indication: Influenza This study consists of 6 Visits and one Telephone Contact: -Visit 1: Visit „Day 0“ -Visit 2: Visit „Day 7“, Contact Window: Day 6-8, Minimum Number of Days between Successive Visits: 6 -Visit 3: Visit „Day 21“: Contact Window: Day 19-23, Minimum Number of Days between Successive Visits: 12 -Visit 4: Visit „Day 28“: Contact Window: Day 26-30, Minimum Number of Days between Successive Visits: 6 -Visit 5: Visit „Day 42“: Contact Window: Day 38-46, Minimum Number of Days between Successive Visits: 12 -Telephone Contact „Day 84“: Contact Window: Day 80-88 -Visit 6: Visit „Day 182“: Contact Window: Day 167-197 The screening can take place up to 21 days prior to Visit 1. This document contains the Lymph node examination form. It has to be filled in for screening and for all Visits (Visit 1-6).

Link

https://clinicaltrials.gov/ct2/show/NCT00510874

Stichworte

Versionen (1)
  1. 20/3/19 20/3/19 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

20 de marzo de 2019

DOI

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Creative Commons BY-NC 3.0
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Safety and Immune Response of Two-Doses of Candidate Influenza Vaccine in Adults, NCT00510874

Englisch

Lymph node examination

1 Formulare  
  1. StudyEvent: ODM
    1. Lymph node examination
Administrative data
Beschreibung

Administrative data

Alias
UMLS CUI-1
C1320722
Subject Number
Beschreibung

Subject Number

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Date of Visit
Beschreibung

day month year

Datentyp

date

Alias
UMLS CUI [1]
C0011008
Visit type
Beschreibung

Visit type

Datentyp

integer

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0332307
Lymph node examination (for axillary and supraclavicular)
Beschreibung

Lymph node examination (for axillary and supraclavicular)

Alias
UMLS CUI-1
C0031809
UMLS CUI-2
C0729594
UMLS CUI-3
C0229730
Was the required examination of the axillary and supraclavicular lymph nodes bilaterally performed?
Beschreibung

Axillary and supraclavicular lymph nodes

Datentyp

text

Alias
UMLS CUI [1]
C0729594
UMLS CUI [2]
C0229730
If examination of axillary and supraclavicular lymph nodes was performed, was any non-zero grade of axillary or supraclavicular lymphadenopathy found?
Beschreibung

Axillary or supraclavicular lymphadenopathy

Datentyp

text

Alias
UMLS CUI [1]
C0578735
UMLS CUI [2,1]
C0229730
UMLS CUI [2,2]
C0497156
If any non-zero grade of axillary or supraclavicular lymphadenopathy was found, please tick the relevant anatomic structure.
Beschreibung

Lymphadenopathy results, anatomic structure

Datentyp

integer

Alias
UMLS CUI [1,1]
C0497156
UMLS CUI [1,2]
C0700276
If any non-zero grade of axillary or supraclavicular lymphadenopathy was found, please tick the relevant anatomic side.
Beschreibung

Lymphadenopathy results, anatomic Side

Datentyp

integer

Alias
UMLS CUI [1,1]
C0497156
UMLS CUI [1,2]
C1515974
If any non-zero grade of axillary or supraclavicular lymphadenopathy was found, please tick the grade.
Beschreibung

Grade definition: Grade 0 (none): No palpable nodes, or all nodes < 1 cm (pea-sized), mobile, and non-tender Grade 1 (mild): At least one node > 1 cm (pea-sized) but less than 2.5 cm (cherry-sized), but mobile and non-tender or tender only with firm pressure Grade 2 (moderate): At least one node >= 2.5 cm (cherry-sized) or tender to light touch or spontaneously reported as painful, but not causing significant limitation of normal everyday activities Grade 3 (severe): At least one node that is tender to light touch or spontaneously reported as painful AND causing significant limitation of normal everyday activities. Any one of palpable fluctuance or heat, fixation to underlying tissues, or visible erythema. If ulceration or drainage is present, must also report as SAE.

Datentyp

integer

Alias
UMLS CUI [1,1]
C0497156
UMLS CUI [1,2]
C1274040
Lymph node examination (for other lymph nodes localisation)
Beschreibung

Lymph node examination (for other lymph nodes localisation)

Alias
UMLS CUI-1
C0031809
UMLS CUI-2
C0205394
UMLS CUI-3
C0024204
UMLS CUI-4
C0475264
Was an examination of lymph nodes at any other site performed based on investigator judgement?
Beschreibung

Other lymph nodes

Datentyp

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C0024204
If examination of other lymph nodes was performed, was any non-zero grade of lymphadenopathy in another anatomic site found?
Beschreibung

Other lymphadenopathy

Datentyp

text

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C0497156
If any non-zero grade of lymphadenopathy in another anatomic site was found, please tick the relevant anatomic structure.
Beschreibung

Other Lymphadenopathy results, anatomic structure

Datentyp

integer

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C0497156
UMLS CUI [1,3]
C0700276
If other anatomic structure, please specify
Beschreibung

Other anatomic structure

Datentyp

text

Alias
UMLS CUI [1,1]
C0700276
UMLS CUI [1,2]
C0205394
If any non-zero grade of lymphadenopathy in another anatomic site was found, please tick the relevant anatomic site.
Beschreibung

Other Lymphadenopathy results, anatomic Site

Datentyp

integer

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C0497156
UMLS CUI [1,3]
C1515974
If any non-zero grade of axillary or supraclavicular lymphadenopathy found, please tick the grade.
Beschreibung

Grade definition: Grade 0 (none): No palpable nodes, or all nodes < 1 cm (pea-sized), mobile, and non-tender Grade 1 (mild): At least one node > 1 cm (pea-sized) but less than 2.5 cm (cherry-sized), but mobile and non-tender or tender only with firm pressure Grade 2 (moderate): At least one node >= 2.5 cm (cherry-sized) or tender to light touch or spontaneously reported as painful, but not causing significant limitation of normal everyday activities Grade 3 (severe): At least one node that is tender to light touch or spontaneously reported as painful AND causing significant limitation of normal everyday activities. Any one of palpable fluctuance or heat, fixation to underlying tissues, or visible erythema. If ulceration or drainage is present, must also report as SAE.

Datentyp

integer

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C0497156
UMLS CUI [1,3]
C1274040
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Ähnliche Modelle

Lymph node examination

1 Formulare
  1. StudyEvent: ODM
    1. Lymph node examination
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Subject Number
Item
Subject Number
text
C2348585 (UMLS CUI [1])
Date of Visit
Item
Date of Visit
date
C0011008 (UMLS CUI [1])
Item
Visit type
integer
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Visit type
Code List
Visit type
CL Item
Screening (1)
CL Item
Visit 1 (2)
CL Item
Visit 2 (3)
CL Item
Visit 3 (4)
CL Item
Visit 4 (5)
CL Item
Visit 5 (6)
CL Item
Visit 6 (7)
Item Group
Lymph node examination (for axillary and supraclavicular)
C0031809 (UMLS CUI-1)
C0729594 (UMLS CUI-2)
C0229730 (UMLS CUI-3)
Item
Was the required examination of the axillary and supraclavicular lymph nodes bilaterally performed?
text
C0729594 (UMLS CUI [1])
C0229730 (UMLS CUI [2])
Axillary and supraclavicular lymph nodes
Code List
Was the required examination of the axillary and supraclavicular lymph nodes bilaterally performed?
CL Item
Yes (Y)
CL Item
No (N)
Item
If examination of axillary and supraclavicular lymph nodes was performed, was any non-zero grade of axillary or supraclavicular lymphadenopathy found?
text
C0578735 (UMLS CUI [1])
C0229730 (UMLS CUI [2,1])
C0497156 (UMLS CUI [2,2])
Axillary or supraclavicular lymphadenopathy
Code List
If examination of axillary and supraclavicular lymph nodes was performed, was any non-zero grade of axillary or supraclavicular lymphadenopathy found?
CL Item
Yes (Y)
CL Item
No (N)
Item
If any non-zero grade of axillary or supraclavicular lymphadenopathy was found, please tick the relevant anatomic structure.
integer
C0497156 (UMLS CUI [1,1])
C0700276 (UMLS CUI [1,2])
Lymphadenopathy results, anatomic structure
Code List
If any non-zero grade of axillary or supraclavicular lymphadenopathy was found, please tick the relevant anatomic structure.
CL Item
Axillary (1)
CL Item
Supraclavicular (2)
Item
If any non-zero grade of axillary or supraclavicular lymphadenopathy was found, please tick the relevant anatomic side.
integer
C0497156 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
Lymphadenopathy results, anatomic structure
Code List
If any non-zero grade of axillary or supraclavicular lymphadenopathy was found, please tick the relevant anatomic side.
CL Item
Left (1)
CL Item
Right (2)
Item
If any non-zero grade of axillary or supraclavicular lymphadenopathy was found, please tick the grade.
integer
C0497156 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Lymphadenopathy results, Grade
Code List
If any non-zero grade of axillary or supraclavicular lymphadenopathy was found, please tick the grade.
CL Item
Grade 0 (0)
CL Item
Grade 1 (1)
CL Item
Grade 2 (2)
CL Item
Grade 3 (3)
Item Group
Lymph node examination (for other lymph nodes localisation)
C0031809 (UMLS CUI-1)
C0205394 (UMLS CUI-2)
C0024204 (UMLS CUI-3)
C0475264 (UMLS CUI-4)
Item
Was an examination of lymph nodes at any other site performed based on investigator judgement?
text
C0031809 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0024204 (UMLS CUI [1,3])
Other lymph nodes
Code List
Was an examination of lymph nodes at any other site performed based on investigator judgement?
CL Item
Yes (Y)
CL Item
No (N)
Item
If examination of other lymph nodes was performed, was any non-zero grade of lymphadenopathy in another anatomic site found?
text
C0205394 (UMLS CUI [1,1])
C0497156 (UMLS CUI [1,2])
Axillary or supraclavicular lymphadenopathy
Code List
If examination of other lymph nodes was performed, was any non-zero grade of lymphadenopathy in another anatomic site found?
CL Item
Yes (Y)
CL Item
No (N)
Item
If any non-zero grade of lymphadenopathy in another anatomic site was found, please tick the relevant anatomic structure.
integer
C0205394 (UMLS CUI [1,1])
C0497156 (UMLS CUI [1,2])
C0700276 (UMLS CUI [1,3])
Lymphadenopathy results, anatomic structure
Code List
If any non-zero grade of lymphadenopathy in another anatomic site was found, please tick the relevant anatomic structure.
CL Item
Cervical (1)
CL Item
Inguinal (2)
CL Item
Occipital (3)
CL Item
Submandibular (4)
CL Item
Other  (5)
Other anatomic structure
Item
If other anatomic structure, please specify
text
C0700276 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Item
If any non-zero grade of lymphadenopathy in another anatomic site was found, please tick the relevant anatomic site.
integer
C0205394 (UMLS CUI [1,1])
C0497156 (UMLS CUI [1,2])
C1515974 (UMLS CUI [1,3])
Lymphadenopathy results, anatomic structure
Code List
If any non-zero grade of lymphadenopathy in another anatomic site was found, please tick the relevant anatomic site.
CL Item
Left (1)
CL Item
Right (2)
Item
If any non-zero grade of axillary or supraclavicular lymphadenopathy found, please tick the grade.
integer
C0205394 (UMLS CUI [1,1])
C0497156 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
Lymphadenopathy results, Grade
Code List
If any non-zero grade of axillary or supraclavicular lymphadenopathy found, please tick the grade.
CL Item
Grade 0 (0)
CL Item
Grade 1 (1)
CL Item
Grade 2 (2)
CL Item
Grade 3 (3)
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