ID

41530

Beschreibung

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

Stichworte

Versionen (2)
  1. 21.09.20 21.09.20 -
  2. 02.11.20 02.11.20 -
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GlaxoSmithKline

Hochgeladen am

2. November 2020

DOI

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Creative Commons BY 4.0
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Clinical activity of recMAGE-A3 + AS15 in patients with metastatic cutaneous melanoma NCT00942162

Englisch

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

1 Formulare  
Administrative
Beschreibung

Administrative

Alias
UMLS CUI-1
C1320722
Patient number
Beschreibung

Patient number

Datentyp

text

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

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?
Beschreibung

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

Datentyp

boolean

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

Chronic and concomitant medication

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

Trade/ Generic Name

Datentyp

text

Alias
UMLS CUI [1]
C0013227
Medical Indication
Beschreibung

Medical Indication

Datentyp

text

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

Medications/ Treatments status

Datentyp

integer

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

Total daily dose

Datentyp

text

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

Administration route

Datentyp

text

Alias
UMLS CUI [1]
C0013153
Medication Start date
Beschreibung

Medication Start date

Datentyp

date

Alias
UMLS CUI [1]
C2826734
Medication end date
Beschreibung

Medication end date

Datentyp

date

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

Medication continuing at end of study

Datentyp

boolean

Alias
UMLS CUI [1]
C1553904
Concomitant Vaccination
Beschreibung

Concomitant Vaccination

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

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

Datentyp

boolean

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

Concomitant Vaccination

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

Trade / (Generic) Name

Datentyp

text

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

Vaccine administration route

Datentyp

text

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

Vaccine administration date

Datentyp

date

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C0011008
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Ähnliche Modelle

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

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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