ID

41325

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)
  1. 8/21/20 8/21/20 -
  2. 8/21/20 8/21/20 -
Copyright Holder

GlaxoSmithKline

Uploaded on

August 21, 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

English

Screening - Physical Examination

1 forms  
Administrative
Description

Administrative

Alias
UMLS CUI-1
C1320722
Patient Number
Description

Physical Examination

Data type

text

Alias
UMLS CUI [1]
C2348585
Physical Examination
Description

Physical Examination

Alias
UMLS CUI-1
C0031809
Has a complete physical examination been performed?
Description

Has a complete physical examination been performed?

Data type

boolean

Alias
UMLS CUI [1]
C0031809
Physical Examination Result
Description

Tick all that apply. At least one box must be ticked.

Data type

integer

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0456984
Other Physical Examination Result
Description

Other Physical Examination Result

Data type

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0456984
UMLS CUI [2]
C0205394
General Medical History/ Physical Examination
Description

General Medical History/ Physical Examination

Alias
UMLS CUI-1
C0262926
UMLS CUI-2
C0031809
Are you aware of any relevant pre-existing conditions, signs or diseases (excluding study disease) prior to the start of the study?
Description

Are you aware of any relevant pre-existing conditions, signs or diseases (excluding study disease) prior to the start of the study?

Data type

boolean

Alias
UMLS CUI [1]
C0521987
UMLS CUI [2]
C0037088
UMLS CUI [3]
C0012634
Conditions, signs, diseases
Description

Conditions, signs, diseases

Alias
UMLS CUI-1
C0521987
UMLS CUI-2
C0037088
UMLS CUI-3
C0012634
MeDRA System Organ Class
Description

MeDRA System Organ Class

Data type

integer

Alias
UMLS CUI [1]
C2347091
Diagnosis
Description

Diagnosis

Data type

text

Alias
UMLS CUI [1]
C0011900
Condition, sign or disease status
Description

Condition, sign or disease status

Data type

integer

Alias
UMLS CUI [1,1]
C0521987
UMLS CUI [1,2]
C0449438
UMLS CUI [2,1]
C0037088
UMLS CUI [2,2]
C0449438
UMLS CUI [3,1]
C0012634
UMLS CUI [3,2]
C0449438
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Similar models

Screening - Physical Examination

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Physical Examination
Item
Patient Number
text
C2348585 (UMLS CUI [1])
Item Group
Physical Examination
C0031809 (UMLS CUI-1)
Has a complete physical examination been performed?
Item
Has a complete physical examination been performed?
boolean
C0031809 (UMLS CUI [1])
Item
Physical Examination Result
integer
C0031809 (UMLS CUI [1,1])
C0456984 (UMLS CUI [1,2])
Physical Examination Result
Code List
Physical Examination Result
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
SAE (Record in SAE section) (3)
CL Item
Pre-existing medical condition (Complete General Medical History page) (4)
CL Item
Other, specify (5)
Other Physical Examination Result
Item
Other Physical Examination Result
text
C0031809 (UMLS CUI [1,1])
C0456984 (UMLS CUI [1,2])
C0205394 (UMLS CUI [2])
Item Group
General Medical History/ Physical Examination
C0262926 (UMLS CUI-1)
C0031809 (UMLS CUI-2)
Are you aware of any relevant pre-existing conditions, signs or diseases (excluding study disease) prior to the start of the study?
Item
Are you aware of any relevant pre-existing conditions, signs or diseases (excluding study disease) prior to the start of the study?
boolean
C0521987 (UMLS CUI [1])
C0037088 (UMLS CUI [2])
C0012634 (UMLS CUI [3])
Item Group
Conditions, signs, diseases
C0521987 (UMLS CUI-1)
C0037088 (UMLS CUI-2)
C0012634 (UMLS CUI-3)
Item
MeDRA System Organ Class
integer
C2347091 (UMLS CUI [1])
MeDRA System Organ Class
Code List
MeDRA System Organ Class
CL Item
Skin and subcutaneous tissue (1)
CL Item
Musculoskeletal and connective tissue (2)
CL Item
Cardiac (3)
CL Item
Vascular (4)
CL Item
Respiratory, thoracic and mediastinal (5)
CL Item
Gastrointestinal (6)
CL Item
Hepatobiliary (7)
CL Item
Renal and urinary (8)
CL Item
Nervous system (9)
CL Item
Eye (10)
CL Item
Ear and labyrinth (11)
CL Item
Endocrine (12)
CL Item
Metabolism and nutrition (13)
CL Item
Blood and lymphatic system (14)
CL Item
Immune system (Incl. allergies, autoimmune disorders) (15)
CL Item
Infections and infestations (16)
CL Item
Neoplasms benign, malignant and unspecified (incl. cysts, polyps) (17)
CL Item
Surgical and medical procedures (18)
CL Item
Psychiatric (20)
CL Item
Other (99)
Diagnosis
Item
Diagnosis
text
C0011900 (UMLS CUI [1])
Item
Condition, sign or disease status
integer
C0521987 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
C0037088 (UMLS CUI [2,1])
C0449438 (UMLS CUI [2,2])
C0012634 (UMLS CUI [3,1])
C0449438 (UMLS CUI [3,2])
Condition, sign or disease status
Code List
Condition, sign or disease status
CL Item
Past (1)
CL Item
Current (2)
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