NCT01207765 · ADVERSE EVENTS

Adverse events

Zevalin for Patients With Incomplete Response to Chemo Prior to Autologous Stem Cell Transplant for Multiple Myeloma · Source last updated 2017-03-20

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: Not reported
Other-event reporting threshold: 0%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Zevalin 1.5mg of 111In Zevalin (containing 5 mCi of 111In) will be used for radioimaging on study day +1. 90Y Zevalin will be administered seven to nine days after 111In Zevalin administration. The dose of 90Y Zevalin will be 0.4 mCi/kg, capped at a maximum dose of 32 mCi.	3 / 8	2 / 8	Not reported / Not reported

Group identifiers: EG000: Zevalin

Serious adverse events

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

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
1
num At Risk
8
num Events
1
term
Septic thrombophlebitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
stats
group Id
EG000
num Affected
1
num At Risk
8
num Events
1
term
Perianal absess
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
stats
group Id
EG000
num Affected
1
num At Risk
8
num Events
1
term
Myoclonus

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
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
stats
group Id
EG000
num Affected
1
num At Risk
8
num Events
1
term
MRSA bacteremia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
stats
group Id
EG000
num Affected
1
num At Risk
8
num Events
1
term
S. viridans bacteremia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
stats
group Id
EG000
num Affected
1
num At Risk
8
num Events
1
term
S. epidermitis

Complete source fields

event Groups

description
1.5mg of 111In Zevalin (containing 5 mCi of 111In) will be used for radioimaging on study day +1. 90Y Zevalin will be administered seven to nine days after 111In Zevalin administration. The dose of 90Y Zevalin will be 0.4 mCi/kg, capped at a maximum dose of 32 mCi.
id
EG000
other Num Affected
2
other Num At Risk
8
serious Num Affected
3
serious Num At Risk
8
title
Zevalin

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
stats
group Id
EG000
num Affected
1
num At Risk
8
num Events
1
term
MRSA bacteremia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
stats
group Id
EG000
num Affected
1
num At Risk
8
num Events
1
term
S. viridans bacteremia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
stats
group Id
EG000
num Affected
1
num At Risk
8
num Events
1
term
S. epidermitis

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
1
num At Risk
8
num Events
1
term
Septic thrombophlebitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
stats
group Id
EG000
num Affected
1
num At Risk
8
num Events
1
term
Perianal absess
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
stats
group Id
EG000
num Affected
1
num At Risk
8
num Events
1
term
Myoclonus

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Preserved source evidence · Not medical advice