ID
41478
Description
Study ID: 111476 Clinical Study ID: 111476 Study Title: An open, single-arm trial to assess the clinical activity of recMAGE-A3 + AS15 in patients with unresectable MAGE-A3-positive metastatic cutaneous melanoma Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00942162 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Antigen-Specific Cancer Immunotherapeutic Study Indication: Melanoma
Keywords
Versions (2)
- 10/24/20 10/24/20 -
- 11/3/20 11/3/20 -
Copyright Holder
GlaxoSmithKline
Uploaded on
October 24, 2020
DOI
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License
Creative Commons BY 4.0
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Clinical activity of recMAGE-A3 + AS15 in patients with metastatic cutaneous melanoma NCT00942162
Laboratory Reference Ranges, Use of Human Samples by GSK, Investigator's Signature
Description
Laboratory Reference Ranges
Alias
- UMLS CUI-1
- C0883335
Description
Laboratory Name
Data type
text
Alias
- UMLS CUI [1]
- C3258037
Description
Lab Code
Data type
text
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C0805701
Description
Date these reference ranges became effective
Data type
date
Alias
- UMLS CUI [1,1]
- C0883335
- UMLS CUI [1,2]
- C0011008
Description
Age range low
Data type
float
Alias
- UMLS CUI [1,1]
- C0001779
- UMLS CUI [1,2]
- C1514721
- UMLS CUI [1,3]
- C0205251
Description
Age range high
Data type
float
Alias
- UMLS CUI [1,1]
- C0001779
- UMLS CUI [1,2]
- C1514721
- UMLS CUI [1,3]
- C0205250
Description
Age units
Data type
integer
Alias
- UMLS CUI [1,1]
- C0001779
- UMLS CUI [1,2]
- C1519795
Description
Sex
Data type
text
Alias
- UMLS CUI [1]
- C0079399
Description
Laboratory Reference Ranges - Haematology
Alias
- UMLS CUI-1
- C0883335
- UMLS CUI-2
- C0018941
Description
Haematology - Test
Data type
integer
Alias
- UMLS CUI [1]
- C0018941
Description
Haematology - Unit
Data type
text
Alias
- UMLS CUI [1,1]
- C0018941
- UMLS CUI [1,2]
- C1519795
Description
Haematology - Low Reference Value
Data type
float
Alias
- UMLS CUI [1]
- C0018941
- UMLS CUI [2]
- C1272773
Description
Haematology - High Reference Value
Data type
float
Alias
- UMLS CUI [1]
- C0018941
- UMLS CUI [2]
- C1299400
Description
Laboratory Reference Ranges - Biochemistry
Alias
- UMLS CUI-1
- C0883335
- UMLS CUI-2
- C0005477
Description
Biochemistry - Test
Data type
integer
Alias
- UMLS CUI [1]
- C1655775
Description
Biochemistry - Unit
Data type
text
Alias
- UMLS CUI [1]
- C0005477
- UMLS CUI [2]
- C1519795
Description
Biochemistry - Low Reference Value
Data type
float
Alias
- UMLS CUI [1]
- C0005477
- UMLS CUI [2]
- C1272773
Description
Biochemistry - High Reference Value
Data type
float
Alias
- UMLS CUI [1]
- C0005477
- UMLS CUI [2]
- C1299400
Description
Laboratory Reference Ranges - Hepatic Function
Alias
- UMLS CUI-1
- C0883335
- UMLS CUI-2
- C0232741
Description
Hepatic function - Test
Data type
integer
Alias
- UMLS CUI [1]
- C0232741
- UMLS CUI [2]
- C0022885
Description
Hepatic function - Unit
Data type
text
Alias
- UMLS CUI [1]
- C0232741
- UMLS CUI [2]
- C1519795
Description
Hepatic function - Low Reference Value
Data type
float
Alias
- UMLS CUI [1]
- C0232741
- UMLS CUI [2]
- C1272773
Description
Hepatic function - High Reference Value
Data type
float
Alias
- UMLS CUI [1]
- C0232741
- UMLS CUI [2]
- C1299400
Description
Laboratory Reference Ranges - Renal Function
Alias
- UMLS CUI-1
- C0883335
- UMLS CUI-2
- C0232804
Description
Renal function - Test
Data type
integer
Alias
- UMLS CUI [1]
- C0232804
- UMLS CUI [2]
- C0022885
Description
Renal function - Unit
Data type
text
Alias
- UMLS CUI [1]
- C0232804
- UMLS CUI [2]
- C1519795
Description
Renal function - Low Reference Value
Data type
float
Alias
- UMLS CUI [1]
- C0232804
- UMLS CUI [2]
- C1272773
Description
Renal function - High Reference Value
Data type
float
Alias
- UMLS CUI [1]
- C0232804
- UMLS CUI [2]
- C1299400
Description
Use of human samples by GSK
Alias
- UMLS CUI-1
- C2347026
- UMLS CUI-2
- C0086418
- UMLS CUI-3
- C0457083
Description
Use of human samples by GSK
Data type
text
Alias
- UMLS CUI [1,1]
- C2347026
- UMLS CUI [1,2]
- C0086418
- UMLS CUI [1,3]
- C0457083
Description
Please tick below box if a 15 years GSK storage period is covered by the subject’s Informed Consent form of your center.
Data type
integer
Alias
- UMLS CUI [1]
- C1698986
- UMLS CUI [2]
- C0449238
- UMLS CUI [3]
- C0021430
Description
Specify other storage period
Data type
text
Alias
- UMLS CUI [1]
- C1698986
- UMLS CUI [2]
- C0449238
- UMLS CUI [3]
- C0205394
Description
Complete and submit a new form for each change during the study.
Data type
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0009797
Description
Investigator's Signature
Alias
- UMLS CUI-1
- C2346576
Description
Investigator's Signature
Data type
text
Alias
- UMLS CUI [1]
- C2346576
Description
Printed Investigator's name
Data type
text
Alias
- UMLS CUI [1]
- C2826892
Description
Investigator's signature date
Data type
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
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