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])
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])
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])
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])
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])
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])
Code List
Non-Serious Adverse Event Maximum Intensity:
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])
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)
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])
Code List
Was an autopsy performed?
Item
Primary cause of death:
text
C0007465 (UMLS CUI [1])
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
Did the subject become pregnant during the study?
text
C3828490 (UMLS CUI [1])
Code List
Did the subject become pregnant during the study?
CL Item
Not applicable (not of childbearing potential or male) (NA)
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])
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])
Code List
Who made the decision
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])
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])