ID

41385

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

Keywords

Versions (2)
  1. 9/23/20 9/23/20 -
  2. 11/2/20 11/2/20 -
Copyright Holder

GlaxoSmithKline

Uploaded on

September 23, 2020

DOI

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License

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

English

Non-Serious Adverse Events; Study Conclusion

1 forms  
Administrative
Description

Administrative

Alias
UMLS CUI-1
C1320722
Patient Number
Description

Patient Number

Data type

text

Alias
UMLS CUI [1]
C2348585
Non-Serious Adverse Event
Description

Non-Serious Adverse Event

Alias
UMLS CUI-1
C1518404
Has any non-serious adverse events been reported during the timeframe as specified in the protocol?
Description

Has any non-serious adverse events been reported during the timeframe as specified in the protocol?

Data type

boolean

Alias
UMLS CUI [1]
C1518404
UMLS CUI [2]
C2348563
Non-Serious Adverse Event
Description

Non-Serious Adverse Event

Alias
UMLS CUI-1
C1518404
AE No.
Description

AE No.

Data type

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0237753
Non-Serious Adverse Event Description
Description

Non-Serious Adverse Event Description

Data type

text

Alias
UMLS CUI [1,1]
C0678257
UMLS CUI [1,2]
C1518404
Non-Serious Adverse Event site
Description

Non-Serious Adverse Event site

Data type

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C1515974
Please check in case of new onsets of autoimmune diseases or immune-mediated inflammatory disorders (please complete the IMD report)
Description

Please check in case of new onsets of autoimmune diseases or immune-mediated inflammatory disorders

Data type

integer

Alias
UMLS CUI [1,1]
C0004364
UMLS CUI [1,2]
C0746890
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C4330477
Non-Serious Adverse Event Start Date
Description

Non-Serious Adverse Event Start Date

Data type

date

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0808070
Non-Serious Adverse Event Start Date during immediate post-administration period (30 minutes)
Description

Non-Serious Adverse Event Start Date during immediate post-administration period (30 minutes)

Data type

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0808070
Non-Serious Adverse Event Start Date during immediate post-administration period (30 minutes)
Description

Non-Serious Adverse Event Start Date during immediate post-administration period (30 minutes)

Data type

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
Non-Serious Adverse Event Date stopped
Description

Non-Serious Adverse Event Date stopped

Data type

date

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0806020
Non-Serious Adverse Event Maximum Intensity:
Description

(CTC AE GRADING)

Data type

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0518690
UMLS CUI [1,3]
C0806909
Relationship to investigational products: Is there a reasonable possibility that the AE may have been caused by the investigational product?
Description

Relationship to investigational products

Data type

boolean

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0013230
UMLS CUI [1,3]
C0439849
Non-Serious Adverse Event Outcome:
Description

Non-Serious Adverse Event Outcome:

Data type

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C1705586
Death Form
Description

Death Form

Alias
UMLS CUI-1
C0011065
UMLS CUI-2
C1516308
Did the patient die during the study?
Description

Did the patient die during the study?

Data type

boolean

Alias
UMLS CUI [1,1]
C0011065
UMLS CUI [1,2]
C0347984
UMLS CUI [1,3]
C0008976
Date of death
Description

Date of death

Data type

date

Alias
UMLS CUI [1]
C1148348
Was an autopsy performed?
Description

Was an autopsy performed?

Data type

text

Alias
UMLS CUI [1]
C0004398
Primary cause of death:
Description

(tick only one box)

Data type

text

Alias
UMLS CUI [1]
C0007465
Specify comorbidity
Description

Specify comorbidity

Data type

text

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C2348235
Other cause of death, specify
Description

Other cause of death, specify

Data type

text

Alias
UMLS CUI [1,1]
C0007465
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C2348235
Study Conclusion - Pregnancy Information
Description

Study Conclusion - Pregnancy Information

Alias
UMLS CUI-1
C1707478
UMLS CUI-2
C0008972
UMLS CUI-3
C0032961
UMLS CUI-4
C1533716
Did the subject become pregnant during the study?
Description

Yes → Complete the Pregnancy notification form.

Data type

text

Alias
UMLS CUI [1]
C3828490
Study Conclusion
Description

Study Conclusion

Alias
UMLS CUI-1
C1707478
UMLS CUI-2
C0008972
Was the patient withdrawn from the study?
Description

Was the patient withdrawn from the study?

Data type

boolean

Alias
UMLS CUI [1]
C0422727
Major reason for withdrawal
Description

(tick one box only)

Data type

text

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C0392360
Specify SAE No.
Description

Specify SAE No.

Data type

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0237753
Specify AE No.
Description

Specify AE No.

Data type

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0237753
Specify protocol violation
Description

Specify protocol viaolation

Data type

text

Alias
UMLS CUI [1,1]
C1709750
UMLS CUI [1,2]
C2348235
Specify other reason for withdrawal
Description

Specify other reason for withdrawal

Data type

text

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0392360
UMLS CUI [2]
C2348235
Who made the decision
Description

Who made the decision

Data type

text

Alias
UMLS CUI [1]
C0679006
Date of last contact:
Description

Date of last contact:

Data type

date

Alias
UMLS CUI [1]
C0805839
Was the patient in good condition at date of last contact (except if patient is dead)?
Description

No → Please give details in Adverse Events section

Data type

boolean

Alias
UMLS CUI [1,1]
C1142435
UMLS CUI [1,2]
C0681850
Study Conclusion - Investigator's Siganture
Description

Study Conclusion - Investigator's Siganture

Alias
UMLS CUI-1
C1707478
UMLS CUI-2
C0008972
UMLS CUI-3
C2346576
UMLS CUI-4
C0011008
Investigator's Siganture
Description

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.

Data type

text

Alias
UMLS CUI [1]
C2346576
Investigator's Siganture Date
Description

Investigator's Siganture Date

Data type

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
Printed Investigator's name:
Description

Printed Investigator's name:

Data type

text

Alias
UMLS CUI [1]
C2826892
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Similar models

Non-Serious Adverse Events; Study Conclusion

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Patient Number
Item
Patient Number
text
C2348585 (UMLS CUI [1])
Item Group
Non-Serious Adverse Event
C1518404 (UMLS CUI-1)
Has any non-serious adverse events been reported during the timeframe as specified in the protocol?
Item
Has any non-serious adverse events been reported during the timeframe as specified in the protocol?
boolean
C1518404 (UMLS CUI [1])
C2348563 (UMLS CUI [2])
Item Group
Non-Serious Adverse Event
C1518404 (UMLS CUI-1)
AE No.
Item
AE No.
integer
C1518404 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Non-Serious Adverse Event Description
Item
Non-Serious Adverse Event Description
text
C0678257 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Item
Non-Serious Adverse Event site
text
C1518404 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
Non-Serious Adverse Event site
Code List
Non-Serious Adverse Event site
CL Item
Administration site  (L)
CL Item
Non-administration site (G)
Item
Please check in case of new onsets of autoimmune diseases or immune-mediated inflammatory disorders (please complete the IMD report)
integer
C0004364 (UMLS CUI [1,1])
C0746890 (UMLS CUI [1,2])
C0012634 (UMLS CUI [2,1])
C4330477 (UMLS CUI [2,2])
Please check in case of new onsets of autoimmune diseases or immune-mediated inflammatory disorders
Code List
Please check in case of new onsets of autoimmune diseases or immune-mediated inflammatory disorders (please complete the IMD report)
CL Item
New onsets of autoimmune diseases or immune-mediated inflammatory disorders (1)
Non-Serious Adverse Event Start Date
Item
Non-Serious Adverse Event Start Date
date
C1518404 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Non-Serious Adverse Event Start Date during immediate post-administration period (30 minutes)
Item
Non-Serious Adverse Event Start Date during immediate post-administration period (30 minutes)
text
C1518404 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Item
Non-Serious Adverse Event Start Date during immediate post-administration period (30 minutes)
integer
C1518404 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C3469597 (UMLS CUI [2,1])
C0687676 (UMLS CUI [2,2])
C0347984 (UMLS CUI [2,3])
Non-Serious Adverse Event Start Date during immediate post-administration period (30 minutes)
Code List
Non-Serious Adverse Event Start Date during immediate post-administration period (30 minutes)
CL Item
During immediate post-administration period (1)
Non-Serious Adverse Event Date stopped
Item
Non-Serious Adverse Event Date stopped
date
C1518404 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Item
Non-Serious Adverse Event Maximum Intensity:
integer
C1518404 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
Non-Serious Adverse Event Maximum Intensity:
Code List
Non-Serious Adverse Event Maximum Intensity:
CL Item
Grade 1 (1)
CL Item
Grade 2 (2)
CL Item
Grade 3 (3)
CL Item
Grade 4 (4)
Relationship to investigational products
Item
Relationship to investigational products: Is there a reasonable possibility that the AE may have been caused by the investigational product?
boolean
C1518404 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
Item
Non-Serious Adverse Event Outcome:
integer
C1518404 (UMLS CUI [1,1])
C1705586 (UMLS CUI [1,2])
Non-Serious Adverse Event Outcome:
Code List
Non-Serious Adverse Event Outcome:
CL Item
Recovered / resolved (1)
CL Item
Recovering / resolving (2)
CL Item
Not recovered / not resolved (3)
CL Item
Recovered with sequelae / resolved with sequelae (4)
Item Group
Death Form
C0011065 (UMLS CUI-1)
C1516308 (UMLS CUI-2)
Did the patient die during the study?
Item
Did the patient die during the study?
boolean
C0011065 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Date of death
Item
Date of death
date
C1148348 (UMLS CUI [1])
Item
Was an autopsy performed?
text
C0004398 (UMLS CUI [1])
Was an autopsy performed?
Code List
Was an autopsy performed?
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Unknown (U)
Item
Primary cause of death:
text
C0007465 (UMLS CUI [1])
Primary cause of death:
Code List
Primary cause of death:
CL Item
Disease under study (melanoma) (DI)
CL Item
Adverse event related to study medication (AE)
CL Item
Comorbidity, please specify (CO)
CL Item
Toxicity due to subsequent treatment (TO)
CL Item
Other, specify: (OT)
Specify comorbidity
Item
Specify comorbidity
text
C0009488 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Other cause of death, specify
Item
Other cause of death, specify
text
C0007465 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Item Group
Study Conclusion - Pregnancy Information
C1707478 (UMLS CUI-1)
C0008972 (UMLS CUI-2)
C0032961 (UMLS CUI-3)
C1533716 (UMLS CUI-4)
Item
Did the subject become pregnant during the study?
text
C3828490 (UMLS CUI [1])
Did the subject become pregnant during the study?
Code List
Did the subject become pregnant during the study?
CL Item
No (N)
CL Item
Yes (Y)
CL Item
Not applicable (not of childbearing potential or male) (NA)
Item Group
Study Conclusion
C1707478 (UMLS CUI-1)
C0008972 (UMLS CUI-2)
Was the patient withdrawn from the study?
Item
Was the patient withdrawn from the study?
boolean
C0422727 (UMLS CUI [1])
Item
Major reason for withdrawal
text
C2349954 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Major reason for withdrawal
Code List
Major reason for withdrawal
CL Item
Death (any cause) (Please complete Death Form section)  (DEA)
CL Item
Serious adverse event (Please complete and submit SAE report. Please specify SAE No.) (SAE)
CL Item
Non-Serious adverse event (Please complete Non-serious Adverse Event section. Please specify AE No.) (AEX)
CL Item
Protocol violation, please specify (PTV)
CL Item
Consent withdrawal, not due to an adverse event  (CWL)
CL Item
Migrated / moved from the study area  (MIG)
CL Item
Lost to follow-up.  (LFU)
CL Item
Other, please specify (OTH)
Specify SAE No.
Item
Specify SAE No.
integer
C1519255 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Specify AE No.
Item
Specify AE No.
integer
C1518404 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Specify protocol viaolation
Item
Specify protocol violation
text
C1709750 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Specify other reason for withdrawal
Item
Specify other reason for withdrawal
text
C0422727 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C2348235 (UMLS CUI [2])
Item
Who made the decision
text
C0679006 (UMLS CUI [1])
Who made the decision
Code List
Who made the decision
CL Item
Investigator (I)
CL Item
Patient (S)
CL Item
Both (B)
Date of last contact:
Item
Date of last contact:
date
C0805839 (UMLS CUI [1])
Was the patient in good condition at date of last contact (except if patient is dead)?
Item
Was the patient in good condition at date of last contact (except if patient is dead)?
boolean
C1142435 (UMLS CUI [1,1])
C0681850 (UMLS CUI [1,2])
Item Group
Study Conclusion - Investigator's Siganture
C1707478 (UMLS CUI-1)
C0008972 (UMLS CUI-2)
C2346576 (UMLS CUI-3)
C0011008 (UMLS CUI-4)
Investigator's Siganture
Item
Investigator's Siganture
text
C2346576 (UMLS CUI [1])
Investigator's Siganture Date
Item
Investigator's Siganture Date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Printed Investigator's name:
Item
Printed Investigator's name:
text
C2826892 (UMLS CUI [1])
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