ID

41514

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

Mots-clés

Versions (2)
  1. 18/09/2020 18/09/2020 -
  2. 30/10/2020 30/10/2020 -
Détendeur de droits

GlaxoSmithKline

Téléchargé le

30 octobre 2020

DOI

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Licence

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

Anglais

Yearly Follow-up contact; Anti Cancer Therapy (Report Final and Annex Report 2 Final)

1 Formulaires  
Adminstrative
Description

Adminstrative

Alias
UMLS CUI-1
C1320722
Patient Number
Description

Patient Number

Type de données

text

Alias
UMLS CUI [1]
C2348585
Yearly Follow-up - Check for Follow-up contact
Description

Yearly Follow-up - Check for Follow-up contact

Alias
UMLS CUI-1
C1522577
UMLS CUI-2
C0332158
Is the patient still alive?
Description

Yes → Date of contact No → Please complete the Death Form. Please complete the Study Conclusion Unknown → Please specify the reason

Type de données

text

Alias
UMLS CUI [1]
C2584946
If patient ist alive, enter date of contact
Description

If patient ist alive, enter date of contact

Type de données

date

Alias
UMLS CUI [1,1]
C2584946
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C1705415
If unknown if patient is still alive, please specify reason
Description

If unknown if patient is still alive, please specify reason

Type de données

text

Alias
UMLS CUI [1]
C2584946
UMLS CUI [2]
C0439673
UMLS CUI [3,1]
C0392360
UMLS CUI [3,2]
C2348235
If other reason, please specify
Description

If other reason, please specify

Type de données

text

Alias
UMLS CUI [1,1]
C3840932
UMLS CUI [1,2]
C2348235
End of yearly Follow-up contact
Description

End of yearly Follow-up contact

Alias
UMLS CUI-1
C1522577
UMLS CUI-2
C0332158
UMLS CUI-3
C0444930
Is it the last Yearly Follow-up contact for this patient?
Description

Yes → Please complete the Study Conclusion. No → Please schedule the next Yearly Follow-up contact.

Type de données

boolean

Alias
UMLS CUI [1,1]
C1522577
UMLS CUI [1,2]
C1517741
UMLS CUI [1,3]
C0332158
Anti-cancer therapy(ies) following last study treatment administration
Description

Anti-cancer therapy(ies) following last study treatment administration

Alias
UMLS CUI-1
C0920425
UMLS CUI-2
C3469597
UMLS CUI-3
C0304229
UMLS CUI-4
C1517741
Has the patient received any anti-cancer therapy(ies) following last study treatment administration?
Description

Yes → Please record any subsequent treatment the patient received

Type de données

boolean

Alias
UMLS CUI [1]
C0920425
UMLS CUI [2,1]
C3469597
UMLS CUI [2,2]
C0304229
UMLS CUI [3]
C1517741
Subsequent treatment
Description

Subsequent treatment

Alias
UMLS CUI-1
C0087111
UMLS CUI-2
C0332282
Type of therapy
Description

Type of therapy

Type de données

text

Alias
UMLS CUI [1,1]
C0332307
UMLS CUI [1,2]
C0087111
Specify
Description

Specify

Type de données

text

Alias
UMLS CUI [1]
C2348235
Date of First Treatment administration/ surgery
Description

Date of First Treatment administration/ surgery

Type de données

date

Alias
UMLS CUI [1,1]
C3469597
UMLS CUI [1,2]
C0304229
UMLS CUI [1,3]
C0205435
UMLS CUI [1,4]
C0011008
UMLS CUI [2,1]
C0543467
UMLS CUI [2,2]
C0205435
UMLS CUI [2,3]
C0011008
Date of last Treatment administration (Not applicable for surgery)
Description

Date of last Treatment administration (Not applicable for surgery)

Type de données

date

Alias
UMLS CUI [1,1]
C3469597
UMLS CUI [1,2]
C0304229
UMLS CUI [1,3]
C1517741
UMLS CUI [1,4]
C0011008
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Similar models

Yearly Follow-up contact; Anti Cancer Therapy (Report Final and Annex Report 2 Final)

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
Adminstrative
C1320722 (UMLS CUI-1)
Patient Number
Item
Patient Number
text
C2348585 (UMLS CUI [1])
Item Group
Yearly Follow-up - Check for Follow-up contact
C1522577 (UMLS CUI-1)
C0332158 (UMLS CUI-2)
Item
Is the patient still alive?
text
C2584946 (UMLS CUI [1])
Is the patient still alive?
Code List
Is the patient still alive?
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Unknown (U)
If patient ist alive, enter date of contact
Item
If patient ist alive, enter date of contact
date
C2584946 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C1705415 (UMLS CUI [1,3])
Item
If unknown if patient is still alive, please specify reason
text
C2584946 (UMLS CUI [1])
C0439673 (UMLS CUI [2])
C0392360 (UMLS CUI [3,1])
C2348235 (UMLS CUI [3,2])
If unknown if patient is still alive, please specify reason
Code List
If unknown if patient is still alive, please specify reason
CL Item
Lost to follow-up  (LFU)
CL Item
Consent withdrawal  (CWS)
CL Item
Other, please specify (OTH)
If other reason, please specify
Item
If other reason, please specify
text
C3840932 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Item Group
End of yearly Follow-up contact
C1522577 (UMLS CUI-1)
C0332158 (UMLS CUI-2)
C0444930 (UMLS CUI-3)
Is it the last Yearly Follow-up contact for this patient?
Item
Is it the last Yearly Follow-up contact for this patient?
boolean
C1522577 (UMLS CUI [1,1])
C1517741 (UMLS CUI [1,2])
C0332158 (UMLS CUI [1,3])
Item Group
Anti-cancer therapy(ies) following last study treatment administration
C0920425 (UMLS CUI-1)
C3469597 (UMLS CUI-2)
C0304229 (UMLS CUI-3)
C1517741 (UMLS CUI-4)
Has the patient received any anti-cancer therapy(ies) following last study treatment administration?
Item
Has the patient received any anti-cancer therapy(ies) following last study treatment administration?
boolean
C0920425 (UMLS CUI [1])
C3469597 (UMLS CUI [2,1])
C0304229 (UMLS CUI [2,2])
C1517741 (UMLS CUI [3])
Item Group
Subsequent treatment
C0087111 (UMLS CUI-1)
C0332282 (UMLS CUI-2)
Item
Type of therapy
text
C0332307 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
Type of therapy
Code List
Type of therapy
CL Item
Surgery  (S)
CL Item
Biological response modifier (B)
CL Item
Chemotherapy  (C)
CL Item
Hormonal therapy  (H)
CL Item
Radiation  (R)
CL Item
Other  (O)
CL Item
Immunotherapy (I)
Specify
Item
Specify
text
C2348235 (UMLS CUI [1])
Date of First Treatment administration/ surgery
Item
Date of First Treatment administration/ surgery
date
C3469597 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0205435 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
C0543467 (UMLS CUI [2,1])
C0205435 (UMLS CUI [2,2])
C0011008 (UMLS CUI [2,3])
Date of last Treatment administration (Not applicable for surgery)
Item
Date of last Treatment administration (Not applicable for surgery)
date
C3469597 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C1517741 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
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