ID

41372

Descripción

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

Palabras clave

Versiones (2)
  1. 14/9/20 14/9/20 -
  2. 30/10/20 30/10/20 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

14 de septiembre de 2020

DOI

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Licencia

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

Inglés

Radiotherapy; Local Surgery

1 formularios  
Administrative
Descripción

Administrative

Alias
UMLS CUI-1
C1320722
Patient Number
Descripción

Patient Number

Tipo de datos

text

Alias
UMLS CUI [1]
C2348585
Radiotherapy
Descripción

Radiotherapy

Alias
UMLS CUI-1
C1522449
Has the patient received low-dose radiotherapy during the study treatment period?
Descripción

If yes → Please record radiotherapy details below.

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C1708745
UMLS CUI [2,1]
C0347984
UMLS CUI [2,2]
C0008976
Radiotherapy
Descripción

Radiotherapy

Alias
UMLS CUI-1
C1522449
Radiotherapy Site
Descripción

Radiotherapy Site

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C1515974
Other site, specify
Descripción

Other site, specify

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1515974
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C2348235
Cumulative dose
Descripción

Cumulative dose

Tipo de datos

float

Alias
UMLS CUI [1]
C2986497
Units
Descripción

Units

Tipo de datos

text

Alias
UMLS CUI [1]
C1519795
Date of first administration
Descripción

Date of first administration

Tipo de datos

date

Alias
UMLS CUI [1]
C3173309
Date of last administration
Descripción

Date of last administration

Tipo de datos

date

Alias
UMLS CUI [1,1]
C1762893
UMLS CUI [1,2]
C1533734
Status of the lesion before radiotherapy
Descripción

Status of the lesion before radiotherapy

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0449438
UMLS CUI [1,2]
C0221198
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C0332152
Type of lesion (Radiotherapy)
Descripción

Type of lesion (Radiotherapy)

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C0332307
UMLS CUI [2]
C1522449
If target lesion, specify number (Radiotherapy)
Descripción

If target lesion, specify number (Radiotherapy)

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1521840
UMLS CUI [1,2]
C0221198
UMLS CUI [2]
C2348235
UMLS CUI [3]
C0237753
UMLS CUI [4]
C1522449
Local Surgery
Descripción

Local Surgery

Alias
UMLS CUI-1
C0543467
UMLS CUI-2
C0205276
Have some lesions been resected during the study treatment period?
Descripción

If Yes, please record surgery details below

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C0728940
UMLS CUI [2,1]
C0347984
UMLS CUI [2,2]
C0008976
Local Surgery
Descripción

Local Surgery

Alias
UMLS CUI-1
C0543467
UMLS CUI-2
C0205276
Surgery Site
Descripción

Surgery Site

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1515974
UMLS CUI [1,2]
C0543467
Date of surgery
Descripción

Date of surgery

Tipo de datos

date

Alias
UMLS CUI [1]
C3258210
Status of the lesion before surgery
Descripción

Status of the lesion before surgery

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0449438
UMLS CUI [1,2]
C0221198
UMLS CUI [2,1]
C0543467
UMLS CUI [2,2]
C0332152
Type of lesion (Surgery)
Descripción

Type of lesion (Surgery)

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C0332307
UMLS CUI [2]
C0543467
If target lesion, specify number (Surgery)
Descripción

If target lesion, specify number (Surgery)

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C1521840
UMLS CUI [2,1]
C0237753
UMLS CUI [2,2]
C2348235
UMLS CUI [3]
C0543467
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Similar models

Radiotherapy; Local Surgery

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Patient Number
Item
Patient Number
text
C2348585 (UMLS CUI [1])
Item Group
Radiotherapy
C1522449 (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])
Item Group
Radiotherapy
C1522449 (UMLS CUI-1)
Item
Radiotherapy Site
integer
C1522449 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
Site
Code List
Radiotherapy Site
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])
Cumulative dose
Item
Cumulative dose
float
C2986497 (UMLS CUI [1])
Item
Units
text
C1519795 (UMLS CUI [1])
Units
Code List
Units
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])
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])
Status of the lesion before radiotherapy
Code List
Status of the lesion before radiotherapy
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])
Type of lesion
Code List
Type of lesion (Radiotherapy)
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])
Item Group
Local Surgery
C0543467 (UMLS CUI-1)
C0205276 (UMLS CUI-2)
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])
Item Group
Local Surgery
C0543467 (UMLS CUI-1)
C0205276 (UMLS CUI-2)
Item
Surgery Site
integer
C1515974 (UMLS CUI [1,1])
C0543467 (UMLS CUI [1,2])
Surgery Site
Code List
Surgery Site
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])
Status of the lesion before surgery
Code List
Status of the lesion before surgery
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])
Type of lesion
Code List
Type of lesion (Surgery)
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])
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