NCT01239797 · ADVERSE EVENTS

Adverse events

Phase III Study of Lenalidomide and Dexamethasone With or Without Elotuzumab to Treat Relapsed or Refractory Multiple Myeloma · Source last updated 2022-06-01

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 up to 60 days post last dose of study therapy (Up to approximately 9 years)
Other-event reporting threshold: 5%

Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Lenalidomide + Dexamethasone + Elotuzumab Lenalidomide: Capsules, Oral, 25 mg, once daily, on Days 1-21 Repeat every 28 days until participants met criteria for discontinuation of study drug Dexamethasone (Oral): On weeks without Elotuzumab dosing: Tablets, Oral, 40mg Repeat every 28 days until participants met criteria for discontinuation of study drug On weeks with Elotuzumab dosing: Tablets, Oral, 28 mg Repeat every 28 days until participants met criteria for discontinuation of study drug Dexamethasone (IV): On weeks without Elotuzumab dosing: Not Applicable (N/A) On weeks with Elotuzumab dosing: Solution, Intravenous (IV), 8 mg, weekly Repeat every 28 days until participants met criteria for discontinuation of study drug Elotuzumab (BMS-901608; HuLuc63): Solution, IV, 10 mg/kg, weekly, on Days 1, 8, 15, 22 (cycles 1\&2); Days 1 and 15 (cycles 3 and beyond) Repeat every 28 days until participants met criteria for discontinuation of study drug	238 / 318	314 / 318	226 / 321
Lenalidomide + Dexamethasone Lenalidomide: Capsules, Oral, 25 mg, once daily, on Days 1-21 Regimen repeated every 28 days until participants met criteria for discontinuation of study drug Dexamethasone: Tablets, Oral, 40 mg, weekly, on Days 1, 8, 15, 22 Regimen repeated every 28 days until participants met criteria for discontinuation of study drug	194 / 317	309 / 317	249 / 325

Group identifiers: EG000: Lenalidomide + Dexamethasone + Elotuzumab · EG001: Lenalidomide + Dexamethasone

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
24.0
stats
group Id
EG000
num Affected
11
num At Risk
318
group Id
EG001
num Affected
8
num At Risk
317
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
1
num At Risk
318
group Id
EG001
num Affected
0
num At Risk
317
term
Bone marrow failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
1
num At Risk
318
group Id
EG001
num Affected
0
num At Risk
317
term
Eosinophilia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
5
num At Risk
318
group Id
EG001
num Affected
4
num At Risk
317
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
1
num At Risk
318
group Id
EG001
num Affected
0
num At Risk
317
term
Microangiopathic haemolytic anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
1
num At Risk
318
group Id
EG001
num Affected
4
num At Risk
317
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
2
num At Risk
318
group Id
EG001
num Affected
0
num At Risk
317
term
Pancytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
0
num At Risk
318
group Id
EG001
num Affected
1
num At Risk
317
term
Splenic infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
5
num At Risk
318
group Id
EG001
num Affected
2
num At Risk
317
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
1
num At Risk
318
group Id
EG001
num Affected
2
num At Risk
317
term
Acute coronary syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
1
num At Risk
318
group Id
EG001
num Affected
0
num At Risk
317
term
Acute left ventricular failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
1
num At Risk
318
group Id
EG001
num Affected
2
num At Risk
317
term
Acute myocardial infarction

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
24.0
stats
group Id
EG000
num Affected
135
num At Risk
318
group Id
EG001
num Affected
118
num At Risk
317
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
26
num At Risk
318
group Id
EG001
num Affected
26
num At Risk
317
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
41
num At Risk
318
group Id
EG001
num Affected
23
num At Risk
317
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
114
num At Risk
318
group Id
EG001
num Affected
137
num At Risk
317
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
91
num At Risk
318
group Id
EG001
num Affected
72
num At Risk
317
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
58
num At Risk
318
group Id
EG001
num Affected
36
num At Risk
317
term
Cataract
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
31
num At Risk
318
group Id
EG001
num Affected
18
num At Risk
317
term
Vision blurred
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
44
num At Risk
318
group Id
EG001
num Affected
31
num At Risk
317
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
30
num At Risk
318
group Id
EG001
num Affected
20
num At Risk
317
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
115
num At Risk
318
group Id
EG001
num Affected
89
num At Risk
317
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
159
num At Risk
318
group Id
EG001
num Affected
122
num At Risk
317
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
16
num At Risk
318
group Id
EG001
num Affected
10
num At Risk
317
term
Dry mouth

Complete source fields

description

Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.

event Groups

deaths Num Affected
226
deaths Num At Risk
321
description
Lenalidomide: Capsules, Oral, 25 mg, once daily, on Days 1-21 Repeat every 28 days until participants met criteria for discontinuation of study drug Dexamethasone (Oral): On weeks without Elotuzumab dosing: Tablets, Oral, 40mg Repeat every 28 days until participants met criteria for discontinuation of study drug On weeks with Elotuzumab dosing: Tablets, Oral, 28 mg Repeat every 28 days until participants met criteria for discontinuation of study drug Dexamethasone (IV): On weeks without Elotuzumab dosing: Not Applicable (N/A) On weeks with Elotuzumab dosing: Solution, Intravenous (IV), 8 mg, weekly Repeat every 28 days until participants met criteria for discontinuation of study drug Elotuzumab (BMS-901608; HuLuc63): Solution, IV, 10 mg/kg, weekly, on Days 1, 8, 15, 22 (cycles 1\&2); Days 1 and 15 (cycles 3 and beyond) Repeat every 28 days until participants met criteria for discontinuation of study drug
id
EG000
other Num Affected
314
other Num At Risk
318
serious Num Affected
238
serious Num At Risk
318
title
Lenalidomide + Dexamethasone + Elotuzumab
deaths Num Affected
249
deaths Num At Risk
325
description
Lenalidomide: Capsules, Oral, 25 mg, once daily, on Days 1-21 Regimen repeated every 28 days until participants met criteria for discontinuation of study drug Dexamethasone: Tablets, Oral, 40 mg, weekly, on Days 1, 8, 15, 22 Regimen repeated every 28 days until participants met criteria for discontinuation of study drug
id
EG001
other Num Affected
309
other Num At Risk
317
serious Num Affected
194
serious Num At Risk
317
title
Lenalidomide + Dexamethasone

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
135
num At Risk
318
group Id
EG001
num Affected
118
num At Risk
317
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
26
num At Risk
318
group Id
EG001
num Affected
26
num At Risk
317
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
41
num At Risk
318
group Id
EG001
num Affected
23
num At Risk
317
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
114
num At Risk
318
group Id
EG001
num Affected
137
num At Risk
317
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
91
num At Risk
318
group Id
EG001
num Affected
72
num At Risk
317
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
58
num At Risk
318
group Id
EG001
num Affected
36
num At Risk
317
term
Cataract
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
31
num At Risk
318
group Id
EG001
num Affected
18
num At Risk
317
term
Vision blurred
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
44
num At Risk
318
group Id
EG001
num Affected
31
num At Risk
317
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
30
num At Risk
318
group Id
EG001
num Affected
20
num At Risk
317
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
115
num At Risk
318
group Id
EG001
num Affected
89
num At Risk
317
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
159
num At Risk
318
group Id
EG001
num Affected
122
num At Risk
317
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
16
num At Risk
318
group Id
EG001
num Affected
10
num At Risk
317
term
Dry mouth

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
11
num At Risk
318
group Id
EG001
num Affected
8
num At Risk
317
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
1
num At Risk
318
group Id
EG001
num Affected
0
num At Risk
317
term
Bone marrow failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
1
num At Risk
318
group Id
EG001
num Affected
0
num At Risk
317
term
Eosinophilia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
5
num At Risk
318
group Id
EG001
num Affected
4
num At Risk
317
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
1
num At Risk
318
group Id
EG001
num Affected
0
num At Risk
317
term
Microangiopathic haemolytic anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
1
num At Risk
318
group Id
EG001
num Affected
4
num At Risk
317
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
2
num At Risk
318
group Id
EG001
num Affected
0
num At Risk
317
term
Pancytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
0
num At Risk
318
group Id
EG001
num Affected
1
num At Risk
317
term
Splenic infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
5
num At Risk
318
group Id
EG001
num Affected
2
num At Risk
317
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
1
num At Risk
318
group Id
EG001
num Affected
2
num At Risk
317
term
Acute coronary syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
1
num At Risk
318
group Id
EG001
num Affected
0
num At Risk
317
term
Acute left ventricular failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
1
num At Risk
318
group Id
EG001
num Affected
2
num At Risk
317
term
Acute myocardial infarction

time Frame

From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years)

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Preserved source evidence · Not medical advice