NCT03782064 · ADVERSE EVENTS

Adverse events

Dendritic Cell (DC)/Myeloma Fusions in Combination With Nivolumab in Patients With Relapsed Multiple Myeloma · Source last updated 2023-06-22

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame: Adverse events were collected from the first dose of treatment through 30 days after the last dose of treatment up to 6 months. All-Cause Mortality monitored/assessed up to 2 years
Other-event reporting threshold: 0%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Nivolumab+DC/Myeloma Fusions/GM-CSF * Nivolumab will be given every two weeks * The DC/myeloma fusion vaccine/GM-CSF is administered 4 days per cycle Nivolumab: Nivolumab is a monoclonal antibody. Antibodies are part of your immune system; they are a type of protein that protects your body against foreign invaders, called antigens, by grabbing hold of antigens to stop them from invading your system. Nivolumab has been shown to react against cancer cells, including MM cells. DC/myeloma fusions/GM-CSF: The DC/MM vaccine is an investigational agent that tries to help the immune system recognize and fight against cancer cells, utilizing unique markers.	1 / 2	2 / 2	2 / 2

Group identifiers: EG000: Nivolumab+DC/Myeloma Fusions/GM-CSF

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
stats
group Id
EG000
num Affected
1
num At Risk
2
num Events
1
term
Rash, maculopapular

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
1
num At Risk
2
num Events
1
term
Alkaline Phosphatase Increase
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
1
num At Risk
2
num Events
1
term
GGT increased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
2
num At Risk
2
num Events
2
term
Injection Site Reaction
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
1
num At Risk
2
num Events
1
term
Anemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
stats
group Id
EG000
num Affected
1
num At Risk
2
num Events
1
term
Muscle Weakness (lower limb)
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
stats
group Id
EG000
num Affected
1
num At Risk
2
num Events
1
term
Pain, hip

Complete source fields

event Groups

deaths Num Affected
2
deaths Num At Risk
2
description
* Nivolumab will be given every two weeks * The DC/myeloma fusion vaccine/GM-CSF is administered 4 days per cycle Nivolumab: Nivolumab is a monoclonal antibody. Antibodies are part of your immune system; they are a type of protein that protects your body against foreign invaders, called antigens, by grabbing hold of antigens to stop them from invading your system. Nivolumab has been shown to react against cancer cells, including MM cells. DC/myeloma fusions/GM-CSF: The DC/MM vaccine is an investigational agent that tries to help the immune system recognize and fight against cancer cells, utilizing unique markers.
id
EG000
other Num Affected
2
other Num At Risk
2
serious Num Affected
1
serious Num At Risk
2
title
Nivolumab+DC/Myeloma Fusions/GM-CSF

frequency Threshold

other Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
1
num At Risk
2
num Events
1
term
Alkaline Phosphatase Increase
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
1
num At Risk
2
num Events
1
term
GGT increased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
2
num At Risk
2
num Events
2
term
Injection Site Reaction
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
1
num At Risk
2
num Events
1
term
Anemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
stats
group Id
EG000
num Affected
1
num At Risk
2
num Events
1
term
Muscle Weakness (lower limb)
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
stats
group Id
EG000
num Affected
1
num At Risk
2
num Events
1
term
Pain, hip

serious Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
stats
group Id
EG000
num Affected
1
num At Risk
2
num Events
1
term
Rash, maculopapular

time Frame

Adverse events were collected from the first dose of treatment through 30 days after the last dose of treatment up to 6 months. All-Cause Mortality monitored/assessed up to 2 years

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Preserved source evidence · Not medical advice