NCT03411031 · ADVERSE EVENTS

Adverse events

Elotuzumab Plus Lenalidomide (Elo/Rev) for Serologic Relapse/Progression While on Lenalidomide · Source last updated 2023-03-29

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 cycle 1, day 1, and only while the participants were on study treatment only for up to a total of 12 months.
Other-event reporting threshold: 0%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
A: Elotuzumab + Lenalidomide at 25 mg Elotuzumab 10 mg/kg intravenously (IV) weekly (days 1, 8, 15 and 22) for 2 cycles, then 20 mg/kg every 4 weeks. Dexamethasone will be administered as premedication for elotuzumab. Lenalidomide 25 mg by mouth (PO) daily days 1-21 out of a 28-day schedule. Elotuzumab: Elotuzumab according to dosing schedule outlined in treatment arms. Lenalidomide: Lenalidomide according to dosing schedule outlined in treatment arms. Dexamethasone: Dexamethasone is a commercially available drug. The description, how supplied, and storage instructions for dexamethasone product are found in the prescribing information. During the study, dexamethasone will be administered as premedication for elotuzumab as indicated in the package insert.	3 / 9	2 / 9	0 / 9
B: Elotuzumab + Lenalidomide at 10 mg Elotuzumab 10 mg/kg IV weekly (days 1, 8, 15 and 22) for 2 cycles, then 20 mg/kg every 4 weeks. Dexamethasone will be administered as premedication for elotuzumab. Lenalidomide 10 mg PO daily days 1-21 out of a 28-day schedule. Elotuzumab: Elotuzumab according to dosing schedule outlined in treatment arms. Lenalidomide: Lenalidomide according to dosing schedule outlined in treatment arms. Dexamethasone: Dexamethasone is a commercially available drug. The description, how supplied, and storage instructions for dexamethasone product are found in the prescribing information. During the study, dexamethasone will be administered as premedication for elotuzumab as indicated in the package insert.	0 / 9	1 / 9	0 / 9

Group identifiers: EG000: A: Elotuzumab + Lenalidomide at 25 mg · EG001: B: Elotuzumab + Lenalidomide at 10 mg

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
General disorders
source Vocabulary
CTCAE Version 5.0
stats
group Id
EG000
num Affected
1
num At Risk
9
num Events
1
group Id
EG001
num Affected
0
num At Risk
9
num Events
0
term
Fever
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE Version 5.0
stats
group Id
EG000
num Affected
1
num At Risk
9
num Events
1
group Id
EG001
num Affected
0
num At Risk
9
num Events
0
term
Non-cardiac chest pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE Version 5.0
stats
group Id
EG000
num Affected
1
num At Risk
9
num Events
1
group Id
EG001
num Affected
0
num At Risk
9
num Events
0
term
Lung Infection - Probable Pneumonia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE Version 5.0
stats
group Id
EG000
num Affected
1
num At Risk
9
num Events
1
group Id
EG001
num Affected
0
num At Risk
9
num Events
0
term
Lung Infection

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
General disorders
source Vocabulary
CTCAE Version 5.0
stats
group Id
EG000
num Affected
1
num At Risk
9
num Events
2
group Id
EG001
num Affected
0
num At Risk
9
num Events
0
term
Fatigue
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE Version 5.0
stats
group Id
EG000
num Affected
0
num At Risk
9
num Events
0
group Id
EG001
num Affected
1
num At Risk
9
num Events
1
term
Neutrophil count decreased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
CTCAE Version 5.0
stats
group Id
EG000
num Affected
1
num At Risk
9
num Events
1
group Id
EG001
num Affected
0
num At Risk
9
num Events
0
term
Syncope

Complete source fields

event Groups

deaths Num Affected
0
deaths Num At Risk
9
description
Elotuzumab 10 mg/kg intravenously (IV) weekly (days 1, 8, 15 and 22) for 2 cycles, then 20 mg/kg every 4 weeks. Dexamethasone will be administered as premedication for elotuzumab. Lenalidomide 25 mg by mouth (PO) daily days 1-21 out of a 28-day schedule. Elotuzumab: Elotuzumab according to dosing schedule outlined in treatment arms. Lenalidomide: Lenalidomide according to dosing schedule outlined in treatment arms. Dexamethasone: Dexamethasone is a commercially available drug. The description, how supplied, and storage instructions for dexamethasone product are found in the prescribing information. During the study, dexamethasone will be administered as premedication for elotuzumab as indicated in the package insert.
id
EG000
other Num Affected
2
other Num At Risk
9
serious Num Affected
3
serious Num At Risk
9
title
A: Elotuzumab + Lenalidomide at 25 mg
deaths Num Affected
0
deaths Num At Risk
9
description
Elotuzumab 10 mg/kg IV weekly (days 1, 8, 15 and 22) for 2 cycles, then 20 mg/kg every 4 weeks. Dexamethasone will be administered as premedication for elotuzumab. Lenalidomide 10 mg PO daily days 1-21 out of a 28-day schedule. Elotuzumab: Elotuzumab according to dosing schedule outlined in treatment arms. Lenalidomide: Lenalidomide according to dosing schedule outlined in treatment arms. Dexamethasone: Dexamethasone is a commercially available drug. The description, how supplied, and storage instructions for dexamethasone product are found in the prescribing information. During the study, dexamethasone will be administered as premedication for elotuzumab as indicated in the package insert.
id
EG001
other Num Affected
1
other Num At Risk
9
serious Num Affected
0
serious Num At Risk
9
title
B: Elotuzumab + Lenalidomide at 10 mg

frequency Threshold

other Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE Version 5.0
stats
group Id
EG000
num Affected
1
num At Risk
9
num Events
2
group Id
EG001
num Affected
0
num At Risk
9
num Events
0
term
Fatigue
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE Version 5.0
stats
group Id
EG000
num Affected
0
num At Risk
9
num Events
0
group Id
EG001
num Affected
1
num At Risk
9
num Events
1
term
Neutrophil count decreased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
CTCAE Version 5.0
stats
group Id
EG000
num Affected
1
num At Risk
9
num Events
1
group Id
EG001
num Affected
0
num At Risk
9
num Events
0
term
Syncope

serious Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE Version 5.0
stats
group Id
EG000
num Affected
1
num At Risk
9
num Events
1
group Id
EG001
num Affected
0
num At Risk
9
num Events
0
term
Fever
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE Version 5.0
stats
group Id
EG000
num Affected
1
num At Risk
9
num Events
1
group Id
EG001
num Affected
0
num At Risk
9
num Events
0
term
Non-cardiac chest pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE Version 5.0
stats
group Id
EG000
num Affected
1
num At Risk
9
num Events
1
group Id
EG001
num Affected
0
num At Risk
9
num Events
0
term
Lung Infection - Probable Pneumonia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE Version 5.0
stats
group Id
EG000
num Affected
1
num At Risk
9
num Events
1
group Id
EG001
num Affected
0
num At Risk
9
num Events
0
term
Lung Infection

time Frame

Adverse events were collected from cycle 1, day 1, and only while the participants were on study treatment only for up to a total of 12 months.

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice