ID
41531
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)
- 23.09.20 23.09.20 -
- 02.11.20 02.11.20 -
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
2. November 2020
DOI
Für eine Beantragung loggen Sie sich ein.
Lizenz
Creative Commons BY 4.0
Modell Kommentare :
Hier können Sie das Modell kommentieren. Über die Sprechblasen an den Itemgruppen und Items können Sie diese spezifisch kommentieren.
Itemgroup Kommentare für :
Item Kommentare für :
Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.
Clinical activity of recMAGE-A3 + AS15 in patients with metastatic cutaneous melanoma NCT00942162
Non-Serious Adverse Events; Study Conclusion (Report Final and Annex Report 2 Final)
Beschreibung
Non-Serious Adverse Event
Alias
- UMLS CUI-1
- C1518404
Beschreibung
Non-Serious Adverse Event
Alias
- UMLS CUI-1
- C1518404
Beschreibung
AE No.
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0237753
Beschreibung
Non-Serious Adverse Event Description
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0678257
- UMLS CUI [1,2]
- C1518404
Beschreibung
Non-Serious Adverse Event site
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C1515974
Beschreibung
Please check in case of new onsets of autoimmune diseases or immune-mediated inflammatory disorders
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0004364
- UMLS CUI [1,2]
- C0746890
- UMLS CUI [2,1]
- C0012634
- UMLS CUI [2,2]
- C4330477
Beschreibung
Non-Serious Adverse Event Start Date
Datentyp
date
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0808070
Beschreibung
Non-Serious Adverse Event Start Date during immediate post-administration period (30 minutes)
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0808070
- UMLS CUI [2,1]
- C3469597
- UMLS CUI [2,2]
- C0687676
- UMLS CUI [2,3]
- C0347984
Beschreibung
Non-Serious Adverse Event Date stopped
Datentyp
date
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0806020
Beschreibung
(CTC AE GRADING)
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0518690
- UMLS CUI [1,3]
- C0806909
Beschreibung
Relationship to investigational products
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0013230
- UMLS CUI [1,3]
- C0439849
Beschreibung
Non-Serious Adverse Event Outcome:
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C1705586
Beschreibung
Death Form
Alias
- UMLS CUI-1
- C0011065
- UMLS CUI-2
- C1516308
Beschreibung
Did the patient die during the study?
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0011065
- UMLS CUI [1,2]
- C0347984
- UMLS CUI [1,3]
- C0008976
Beschreibung
Date of death
Datentyp
date
Alias
- UMLS CUI [1]
- C1148348
Beschreibung
Was an autopsy performed?
Datentyp
text
Alias
- UMLS CUI [1]
- C0004398
Beschreibung
(tick only one box)
Datentyp
text
Alias
- UMLS CUI [1]
- C0007465
Beschreibung
Specify comorbidity
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0009488
- UMLS CUI [1,2]
- C2348235
Beschreibung
Other cause of death, specify
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0007465
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2348235
Beschreibung
Study Conclusion - Pregnancy Information
Alias
- UMLS CUI-1
- C1707478
- UMLS CUI-2
- C0008972
- UMLS CUI-3
- C0032961
- UMLS CUI-4
- C1533716
Beschreibung
Study Conclusion
Alias
- UMLS CUI-1
- C1707478
- UMLS CUI-2
- C0008972
Beschreibung
Was the patient withdrawn from the study?
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0422727
Beschreibung
(tick one box only)
Datentyp
text
Alias
- UMLS CUI [1,1]
- C2349954
- UMLS CUI [1,2]
- C0392360
Beschreibung
Specify SAE No.
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0237753
Beschreibung
Specify AE No.
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0237753
Beschreibung
Specify protocol viaolation
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1709750
- UMLS CUI [1,2]
- C2348235
Beschreibung
Specify other reason for withdrawal
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C0392360
- UMLS CUI [2]
- C2348235
Beschreibung
Who made the decision
Datentyp
text
Alias
- UMLS CUI [1]
- C0679006
Beschreibung
Date of last contact:
Datentyp
date
Alias
- UMLS CUI [1]
- C0805839
Beschreibung
No → Please give details in Adverse Events section
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1142435
- UMLS CUI [1,2]
- C0681850
Beschreibung
Study Conclusion - Investigator's Siganture
Alias
- UMLS CUI-1
- C1707478
- UMLS CUI-2
- C0008972
- UMLS CUI-3
- C2346576
- UMLS CUI-4
- C0011008
Beschreibung
I confirm that I have reviewed the data in this Case Report Form for this patient. All information entered by myself or my colleagues is, to the best of my knowledge, complete and accurate, as of the date below.
Datentyp
text
Alias
- UMLS CUI [1]
- C2346576
Beschreibung
Investigator's Siganture Date
Datentyp
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Beschreibung
Printed Investigator's name:
Datentyp
text
Alias
- UMLS CUI [1]
- C2826892
Ähnliche Modelle
Non-Serious Adverse Events; Study Conclusion (Report Final and Annex Report 2 Final)
C2348563 (UMLS CUI [2])
C0237753 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,2])
C1515974 (UMLS CUI [1,2])
C0746890 (UMLS CUI [1,2])
C0012634 (UMLS CUI [2,1])
C4330477 (UMLS CUI [2,2])
C0808070 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
C3469597 (UMLS CUI [2,1])
C0687676 (UMLS CUI [2,2])
C0347984 (UMLS CUI [2,3])
C0806020 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
C0013230 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
C1705586 (UMLS CUI [1,2])
C0347984 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0008972 (UMLS CUI-2)
C0032961 (UMLS CUI-3)
C1533716 (UMLS CUI-4)
C0392360 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,2])
C2348235 (UMLS CUI [2])
C0681850 (UMLS CUI [1,2])
C0008972 (UMLS CUI-2)
C2346576 (UMLS CUI-3)
C0011008 (UMLS CUI-4)
C0011008 (UMLS CUI [1,2])