NCT02612779 · ADVERSE EVENTS

Adverse events

A Study of Elotuzumab in Combination With Pomalidomide and Low Dose Dexamethasone and Elotuzumab in Combination With Nivolumab in Patients With Multiple Myeloma Relapsed or Refractory to Prior Treatment With Lenalidomide. · Source last updated 2021-07-02

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: From first dose to 100 days after last dose
Other-event reporting threshold: 5%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
EPd Cohort Participants received treatment with Elotuzumab in combination with Pomalidomide and low-dose Dexamethasone in a 28 day cycle.	39 / 68	66 / 68	32 / 68
EN Cohort Participants received Elotuzumab in combination with Nivolumab in a 28-day cycle.	3 / 6	4 / 6	2 / 6

Group identifiers: EG000: EPd Cohort · EG001: EN Cohort

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
source Vocabulary
23.0
stats
group Id
EG000
num Affected
3
num At Risk
68
group Id
EG001
num Affected
0
num At Risk
6
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
23.0
stats
group Id
EG000
num Affected
1
num At Risk
68
group Id
EG001
num Affected
0
num At Risk
6
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
23.0
stats
group Id
EG000
num Affected
2
num At Risk
68
group Id
EG001
num Affected
0
num At Risk
6
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
23.0
stats
group Id
EG000
num Affected
2
num At Risk
68
group Id
EG001
num Affected
0
num At Risk
6
term
Cardiac arrest
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
23.0
stats
group Id
EG000
num Affected
1
num At Risk
68
group Id
EG001
num Affected
0
num At Risk
6
term
Cardiac failure congestive
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
23.0
stats
group Id
EG000
num Affected
1
num At Risk
68
group Id
EG001
num Affected
0
num At Risk
6
term
Amaurosis fugax
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
23.0
stats
group Id
EG000
num Affected
1
num At Risk
68
group Id
EG001
num Affected
0
num At Risk
6
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
23.0
stats
group Id
EG000
num Affected
1
num At Risk
68
group Id
EG001
num Affected
0
num At Risk
6
term
Rectal haemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
23.0
stats
group Id
EG000
num Affected
1
num At Risk
68
group Id
EG001
num Affected
0
num At Risk
6
term
Disease progression
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
23.0
stats
group Id
EG000
num Affected
1
num At Risk
68
group Id
EG001
num Affected
0
num At Risk
6
term
Sudden death
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
23.0
stats
group Id
EG000
num Affected
0
num At Risk
68
group Id
EG001
num Affected
1
num At Risk
6
term
Systemic inflammatory response syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
23.0
stats
group Id
EG000
num Affected
1
num At Risk
68
group Id
EG001
num Affected
0
num At Risk
6
term
Appendicitis perforated

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
Blood and lymphatic system disorders
source Vocabulary
23.0
stats
group Id
EG000
num Affected
15
num At Risk
68
group Id
EG001
num Affected
2
num At Risk
6
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
23.0
stats
group Id
EG000
num Affected
13
num At Risk
68
group Id
EG001
num Affected
0
num At Risk
6
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
23.0
stats
group Id
EG000
num Affected
11
num At Risk
68
group Id
EG001
num Affected
1
num At Risk
6
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
23.0
stats
group Id
EG000
num Affected
24
num At Risk
68
group Id
EG001
num Affected
0
num At Risk
6
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
23.0
stats
group Id
EG000
num Affected
8
num At Risk
68
group Id
EG001
num Affected
1
num At Risk
6
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
23.0
stats
group Id
EG000
num Affected
5
num At Risk
68
group Id
EG001
num Affected
0
num At Risk
6
term
Cataract
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
23.0
stats
group Id
EG000
num Affected
0
num At Risk
68
group Id
EG001
num Affected
1
num At Risk
6
term
Conjunctival hyperaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
23.0
stats
group Id
EG000
num Affected
5
num At Risk
68
group Id
EG001
num Affected
0
num At Risk
6
term
Vision blurred
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
23.0
stats
group Id
EG000
num Affected
2
num At Risk
68
group Id
EG001
num Affected
1
num At Risk
6
term
Abdominal distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
23.0
stats
group Id
EG000
num Affected
17
num At Risk
68
group Id
EG001
num Affected
1
num At Risk
6
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
23.0
stats
group Id
EG000
num Affected
24
num At Risk
68
group Id
EG001
num Affected
0
num At Risk
6
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
23.0
stats
group Id
EG000
num Affected
4
num At Risk
68
group Id
EG001
num Affected
1
num At Risk
6
term
Dyspepsia

Complete source fields

event Groups

deaths Num Affected
32
deaths Num At Risk
68
description
Participants received treatment with Elotuzumab in combination with Pomalidomide and low-dose Dexamethasone in a 28 day cycle.
id
EG000
other Num Affected
66
other Num At Risk
68
serious Num Affected
39
serious Num At Risk
68
title
EPd Cohort
deaths Num Affected
2
deaths Num At Risk
6
description
Participants received Elotuzumab in combination with Nivolumab in a 28-day cycle.
id
EG001
other Num Affected
4
other Num At Risk
6
serious Num Affected
3
serious Num At Risk
6
title
EN Cohort

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
23.0
stats
group Id
EG000
num Affected
15
num At Risk
68
group Id
EG001
num Affected
2
num At Risk
6
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
23.0
stats
group Id
EG000
num Affected
13
num At Risk
68
group Id
EG001
num Affected
0
num At Risk
6
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
23.0
stats
group Id
EG000
num Affected
11
num At Risk
68
group Id
EG001
num Affected
1
num At Risk
6
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
23.0
stats
group Id
EG000
num Affected
24
num At Risk
68
group Id
EG001
num Affected
0
num At Risk
6
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
23.0
stats
group Id
EG000
num Affected
8
num At Risk
68
group Id
EG001
num Affected
1
num At Risk
6
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
23.0
stats
group Id
EG000
num Affected
5
num At Risk
68
group Id
EG001
num Affected
0
num At Risk
6
term
Cataract
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
23.0
stats
group Id
EG000
num Affected
0
num At Risk
68
group Id
EG001
num Affected
1
num At Risk
6
term
Conjunctival hyperaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
23.0
stats
group Id
EG000
num Affected
5
num At Risk
68
group Id
EG001
num Affected
0
num At Risk
6
term
Vision blurred
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
23.0
stats
group Id
EG000
num Affected
2
num At Risk
68
group Id
EG001
num Affected
1
num At Risk
6
term
Abdominal distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
23.0
stats
group Id
EG000
num Affected
17
num At Risk
68
group Id
EG001
num Affected
1
num At Risk
6
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
23.0
stats
group Id
EG000
num Affected
24
num At Risk
68
group Id
EG001
num Affected
0
num At Risk
6
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
23.0
stats
group Id
EG000
num Affected
4
num At Risk
68
group Id
EG001
num Affected
1
num At Risk
6
term
Dyspepsia

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
23.0
stats
group Id
EG000
num Affected
3
num At Risk
68
group Id
EG001
num Affected
0
num At Risk
6
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
23.0
stats
group Id
EG000
num Affected
1
num At Risk
68
group Id
EG001
num Affected
0
num At Risk
6
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
23.0
stats
group Id
EG000
num Affected
2
num At Risk
68
group Id
EG001
num Affected
0
num At Risk
6
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
23.0
stats
group Id
EG000
num Affected
2
num At Risk
68
group Id
EG001
num Affected
0
num At Risk
6
term
Cardiac arrest
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
23.0
stats
group Id
EG000
num Affected
1
num At Risk
68
group Id
EG001
num Affected
0
num At Risk
6
term
Cardiac failure congestive
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
23.0
stats
group Id
EG000
num Affected
1
num At Risk
68
group Id
EG001
num Affected
0
num At Risk
6
term
Amaurosis fugax
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
23.0
stats
group Id
EG000
num Affected
1
num At Risk
68
group Id
EG001
num Affected
0
num At Risk
6
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
23.0
stats
group Id
EG000
num Affected
1
num At Risk
68
group Id
EG001
num Affected
0
num At Risk
6
term
Rectal haemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
23.0
stats
group Id
EG000
num Affected
1
num At Risk
68
group Id
EG001
num Affected
0
num At Risk
6
term
Disease progression
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
23.0
stats
group Id
EG000
num Affected
1
num At Risk
68
group Id
EG001
num Affected
0
num At Risk
6
term
Sudden death
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
23.0
stats
group Id
EG000
num Affected
0
num At Risk
68
group Id
EG001
num Affected
1
num At Risk
6
term
Systemic inflammatory response syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
23.0
stats
group Id
EG000
num Affected
1
num At Risk
68
group Id
EG001
num Affected
0
num At Risk
6
term
Appendicitis perforated

time Frame

From first dose to 100 days after last dose

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Preserved source evidence · Not medical advice