ID

41530

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. 9/21/20 9/21/20 -
  2. 11/2/20 11/2/20 -
Copyright Holder

GlaxoSmithKline

Uploaded on

November 2, 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

Chronic and concomitant medication; Concomitant vaccination (Report Final and Annex Report 2 Final)

1 forms  
Administrative
Description

Administrative

Alias
UMLS CUI-1
C1320722
Patient number
Description

Patient number

Data type

text

Alias
UMLS CUI [1]
C2348585
Chronic and concomitant medication
Description

Chronic and concomitant medication

Alias
UMLS CUI-1
C2347852
UMLS CUI-2
C0013227
UMLS CUI-3
C0205191
Have any chronic or concomitant medications/treatments (other than anti-cancer treatment) been administered?
Description

Have any chronic or concomitant medications/treatments (other than anti-cancer treatment) been administered?

Data type

boolean

Alias
UMLS CUI [1]
C2347852
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0205191
UMLS CUI [3]
C0920425
Chronic and concomitant medication
Description

Chronic and concomitant medication

Alias
UMLS CUI-1
C2347852
UMLS CUI-2
C0013227
UMLS CUI-3
C0205191
Medication
Description

Trade/ Generic Name

Data type

text

Alias
UMLS CUI [1]
C0013227
Medical Indication
Description

Medical Indication

Data type

text

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0013227
Medications/ Treatments status
Description

Medications/ Treatments status

Data type

integer

Alias
UMLS CUI [1]
C0013227
UMLS CUI [2]
C0087111
UMLS CUI [3]
C0449438
Total daily dose
Description

Total daily dose

Data type

text

Alias
UMLS CUI [1,1]
C2348070
UMLS CUI [1,2]
C0439810
Administration route
Description

Administration route

Data type

text

Alias
UMLS CUI [1]
C0013153
Medication Start date
Description

Medication Start date

Data type

date

Alias
UMLS CUI [1]
C2826734
Medication end date
Description

Medication end date

Data type

date

Alias
UMLS CUI [1]
C2826744
Medication continuing at end of study
Description

Medication continuing at end of study

Data type

boolean

Alias
UMLS CUI [1]
C1553904
Concomitant Vaccination
Description

Concomitant Vaccination

Alias
UMLS CUI-1
C0042196
UMLS CUI-2
C2347852
Has any vaccine been administered during the timeframe as specified in the Protocol?
Description

Has any vaccine been administered during the timeframe as specified in the Protocol?

Data type

boolean

Alias
UMLS CUI [1,1]
C0042210
UMLS CUI [1,2]
C2348563
Concomitant Vaccination
Description

Concomitant Vaccination

Alias
UMLS CUI-1
C0042196
UMLS CUI-2
C2347852
Trade / (Generic) Name
Description

Trade / (Generic) Name

Data type

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C2360065
Vaccine administration route
Description

Vaccine administration route

Data type

text

Alias
UMLS CUI [1,1]
C0013153
UMLS CUI [1,2]
C0042210
Vaccine administration date
Description

Vaccine administration date

Data type

date

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C0011008
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Similar models

Chronic and concomitant medication; Concomitant vaccination (Report Final and Annex Report 2 Final)

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Patient number
Item
Patient number
text
C2348585 (UMLS CUI [1])
Item Group
Chronic and concomitant medication
C2347852 (UMLS CUI-1)
C0013227 (UMLS CUI-2)
C0205191 (UMLS CUI-3)
Have any chronic or concomitant medications/treatments (other than anti-cancer treatment) been administered?
Item
Have any chronic or concomitant medications/treatments (other than anti-cancer treatment) been administered?
boolean
C2347852 (UMLS CUI [1])
C0013227 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
C0920425 (UMLS CUI [3])
Item Group
Chronic and concomitant medication
C2347852 (UMLS CUI-1)
C0013227 (UMLS CUI-2)
C0205191 (UMLS CUI-3)
Medication
Item
Medication
text
C0013227 (UMLS CUI [1])
Medical Indication
Item
Medical Indication
text
C3146298 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Item
Medications/ Treatments status
integer
C0013227 (UMLS CUI [1])
C0087111 (UMLS CUI [2])
C0449438 (UMLS CUI [3])
Medications/ Treatments status
Code List
Medications/ Treatments status
CL Item
Chronic (1)
CL Item
Concomitant (2)
Total daily dose
Item
Total daily dose
text
C2348070 (UMLS CUI [1,1])
C0439810 (UMLS CUI [1,2])
Administration route
Item
Administration route
text
C0013153 (UMLS CUI [1])
Medication Start date
Item
Medication Start date
date
C2826734 (UMLS CUI [1])
Medication end date
Item
Medication end date
date
C2826744 (UMLS CUI [1])
Medication continuing at end of study
Item
Medication continuing at end of study
boolean
C1553904 (UMLS CUI [1])
Item Group
Concomitant Vaccination
C0042196 (UMLS CUI-1)
C2347852 (UMLS CUI-2)
Has any vaccine been administered during the timeframe as specified in the Protocol?
Item
Has any vaccine been administered during the timeframe as specified in the Protocol?
boolean
C0042210 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
Item Group
Concomitant Vaccination
C0042196 (UMLS CUI-1)
C2347852 (UMLS CUI-2)
Trade / (Generic) Name
Item
Trade / (Generic) Name
text
C0013227 (UMLS CUI [1,1])
C2360065 (UMLS CUI [1,2])
Item
Vaccine administration route
text
C0013153 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
Vaccine administration route
Code List
Vaccine administration route
CL Item
Intradermal  (ID)
CL Item
Inhalation  (IH)
CL Item
Intramuscular  (IM)
CL Item
Intravenous  (IV)
CL Item
Intranasal  (IN)
CL Item
Other (OTH)
CL Item
Parenteral  (PE)
CL Item
Oral  (PO)
CL Item
Subcutaneous  (SC)
CL Item
Sublingual  (SL)
CL Item
Transdermal  (TD)
CL Item
Unknown (UNK)
Vaccine administration date
Item
Vaccine administration date
date
C2368628 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
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