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Informações:
Falhas:
ID
41372
Descrição
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
Palavras-chave
Versões (2)
- 14/09/2020 14/09/2020 -
- 30/10/2020 30/10/2020 -
Titular dos direitos
GlaxoSmithKline
Transferido a
14 de setembro de 2020
DOI
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Licença
Creative Commons BY 4.0
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Clinical activity of recMAGE-A3 + AS15 in patients with metastatic cutaneous melanoma NCT00942162
Radiotherapy; Local Surgery
- StudyEvent: ODM
Similar models
Radiotherapy; Local Surgery
- StudyEvent: ODM
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Patient Number
Item
Patient Number
text
C2348585 (UMLS CUI [1])
Has the patient received low-dose radiotherapy during the study treatment period?
Item
Has the patient received low-dose radiotherapy during the study treatment period?
boolean
C1522449 (UMLS CUI [1,1])
C1708745 (UMLS CUI [1,2])
C0347984 (UMLS CUI [2,1])
C0008976 (UMLS CUI [2,2])
C1708745 (UMLS CUI [1,2])
C0347984 (UMLS CUI [2,1])
C0008976 (UMLS CUI [2,2])
Item
Radiotherapy Site
integer
C1522449 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
C1515974 (UMLS CUI [1,2])
CL Item
Primary tumor/recurrence (1)
CL Item
Lymphnode regional (2)
CL Item
Lymphnode distant (3)
CL Item
Cutaneous/subcutaneous regional (4)
CL Item
Cutaneous/subcutaneous distant (5)
CL Item
Confluent skin lesions regional (6)
CL Item
Confluent skin lesions distant (7)
CL Item
Lung (9)
CL Item
Brain (10)
CL Item
Other site (99)
Other site, specify
Item
Other site, specify
text
C1515974 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Cumulative dose
Item
Cumulative dose
float
C2986497 (UMLS CUI [1])
CL Item
Grays (Gy)
CL Item
Centigrays (cGy)
CL Item
x100 Rads (rd)
Date of first administration
Item
Date of first administration
date
C3173309 (UMLS CUI [1])
Date of last administration
Item
Date of last administration
date
C1762893 (UMLS CUI [1,1])
C1533734 (UMLS CUI [1,2])
C1533734 (UMLS CUI [1,2])
Item
Status of the lesion before radiotherapy
text
C0449438 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
C1522449 (UMLS CUI [2,1])
C0332152 (UMLS CUI [2,2])
C0221198 (UMLS CUI [1,2])
C1522449 (UMLS CUI [2,1])
C0332152 (UMLS CUI [2,2])
CL Item
Progressive lesion (PD)
CL Item
Stable lesion (SD)
CL Item
Regressive lesion (Reg)
CL Item
New lesion (New)
Item
Type of lesion (Radiotherapy)
text
C0221198 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C1522449 (UMLS CUI [2])
C0332307 (UMLS CUI [1,2])
C1522449 (UMLS CUI [2])
CL Item
Target lesion (TG)
CL Item
Non-Target lesion (NT)
If target lesion, specify number (Radiotherapy)
Item
If target lesion, specify number (Radiotherapy)
integer
C1521840 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
C2348235 (UMLS CUI [2])
C0237753 (UMLS CUI [3])
C1522449 (UMLS CUI [4])
C0221198 (UMLS CUI [1,2])
C2348235 (UMLS CUI [2])
C0237753 (UMLS CUI [3])
C1522449 (UMLS CUI [4])
Have some lesions been resected during the study treatment period?
Item
Have some lesions been resected during the study treatment period?
boolean
C0221198 (UMLS CUI [1,1])
C0728940 (UMLS CUI [1,2])
C0347984 (UMLS CUI [2,1])
C0008976 (UMLS CUI [2,2])
C0728940 (UMLS CUI [1,2])
C0347984 (UMLS CUI [2,1])
C0008976 (UMLS CUI [2,2])
CL Item
Primary tumor/recurrence (1)
CL Item
Lymphnode regional (2)
CL Item
Lymphnode distant (3)
CL Item
Cutaneous/subcutaneous regional (4)
CL Item
Cutaneous/subcutaneous distant (5)
CL Item
Confluent skin lesions regional (6)
CL Item
Confluent skin lesions distant (7)
CL Item
Lung (9)
CL Item
Brain (10)
CL Item
Other site (99)
Date of surgery
Item
Date of surgery
date
C3258210 (UMLS CUI [1])
Item
Status of the lesion before surgery
text
C0449438 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
C0543467 (UMLS CUI [2,1])
C0332152 (UMLS CUI [2,2])
C0221198 (UMLS CUI [1,2])
C0543467 (UMLS CUI [2,1])
C0332152 (UMLS CUI [2,2])
CL Item
Progressive lesion (PD)
CL Item
Stable lesion (SD)
CL Item
Regressive lesion (Reg)
CL Item
New lesion (New)
Item
Type of lesion (Surgery)
text
C0221198 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C0543467 (UMLS CUI [2])
C0332307 (UMLS CUI [1,2])
C0543467 (UMLS CUI [2])
CL Item
Target lesion (TG)
CL Item
Non-Target lesion (NT)
If target lesion, specify number (Surgery)
Item
If target lesion, specify number (Surgery)
integer
C0221198 (UMLS CUI [1,1])
C1521840 (UMLS CUI [1,2])
C0237753 (UMLS CUI [2,1])
C2348235 (UMLS CUI [2,2])
C0543467 (UMLS CUI [3])
C1521840 (UMLS CUI [1,2])
C0237753 (UMLS CUI [2,1])
C2348235 (UMLS CUI [2,2])
C0543467 (UMLS CUI [3])