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NCT01335399 · ADVERSE EVENTS

Adverse events

Phase III Study of Lenalidomide and Dexamethasone With or Without Elotuzumab to Treat Newly Diagnosed, Previously Untreated Multiple Myeloma · Source last updated 2022-09-30

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
All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
Other-event reporting threshold
5%

The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
E-Ld Cohort

Participants receiving a combination of Elotuzumab (E) Lenalidomide (L) Dexamethasone (d) in a 28 day cycle

293 / 371364 / 371240 / 374
Ld Cohort

Participants receiving a combination of Lenalidomide (L) Dexamethasone (d) in a 28 day cycle

279 / 371365 / 371232 / 374

Group identifiers: EG000: E-Ld Cohort · EG001: Ld Cohort

Serious adverse events

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

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      371
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      371
    term
    Agranulocytosis
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      371
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      371
    term
    Anaemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      371
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      371
    term
    Febrile neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      371
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      371
    term
    Haemolysis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      371
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      371
    term
    Haemolytic anaemia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      371
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      371
    term
    Neutropenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      371
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      371
    term
    Pancytopenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      371
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      371
    term
    Plasmacytosis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      371
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      371
    term
    Thrombocytopenia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      371
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      371
    term
    Acute coronary syndrome
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      371
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      371
    term
    Acute myocardial infarction
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      371
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      371
    term
    Angina pectoris

Other reported adverse events

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

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      153
      num At Risk
      371
    2. group Id
      EG001
      num Affected
      160
      num At Risk
      371
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      371
    2. group Id
      EG001
      num Affected
      37
      num At Risk
      371
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      93
      num At Risk
      371
    2. group Id
      EG001
      num Affected
      117
      num At Risk
      371
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      66
      num At Risk
      371
    2. group Id
      EG001
      num Affected
      69
      num At Risk
      371
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      371
    2. group Id
      EG001
      num Affected
      25
      num At Risk
      371
    term
    Atrial fibrillation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      61
      num At Risk
      371
    2. group Id
      EG001
      num Affected
      56
      num At Risk
      371
    term
    Cataract
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      371
    2. group Id
      EG001
      num Affected
      28
      num At Risk
      371
    term
    Vision blurred
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      50
      num At Risk
      371
    2. group Id
      EG001
      num Affected
      51
      num At Risk
      371
    term
    Abdominal pain
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      33
      num At Risk
      371
    2. group Id
      EG001
      num Affected
      29
      num At Risk
      371
    term
    Abdominal pain upper
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      142
      num At Risk
      371
    2. group Id
      EG001
      num Affected
      144
      num At Risk
      371
    term
    Constipation
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      192
      num At Risk
      371
    2. group Id
      EG001
      num Affected
      180
      num At Risk
      371
    term
    Diarrhoea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      371
    2. group Id
      EG001
      num Affected
      26
      num At Risk
      371
    term
    Dry mouth
Complete source fields
description
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication"
event Groups
  1. deaths Num Affected
    240
    deaths Num At Risk
    374
    description
    Participants receiving a combination of Elotuzumab (E) Lenalidomide (L) Dexamethasone (d) in a 28 day cycle
    id
    EG000
    other Num Affected
    364
    other Num At Risk
    371
    serious Num Affected
    293
    serious Num At Risk
    371
    title
    E-Ld Cohort
  2. deaths Num Affected
    232
    deaths Num At Risk
    374
    description
    Participants receiving a combination of Lenalidomide (L) Dexamethasone (d) in a 28 day cycle
    id
    EG001
    other Num Affected
    365
    other Num At Risk
    371
    serious Num Affected
    279
    serious Num At Risk
    371
    title
    Ld Cohort
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      153
      num At Risk
      371
    2. group Id
      EG001
      num Affected
      160
      num At Risk
      371
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      371
    2. group Id
      EG001
      num Affected
      37
      num At Risk
      371
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      93
      num At Risk
      371
    2. group Id
      EG001
      num Affected
      117
      num At Risk
      371
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      66
      num At Risk
      371
    2. group Id
      EG001
      num Affected
      69
      num At Risk
      371
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      371
    2. group Id
      EG001
      num Affected
      25
      num At Risk
      371
    term
    Atrial fibrillation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      61
      num At Risk
      371
    2. group Id
      EG001
      num Affected
      56
      num At Risk
      371
    term
    Cataract
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      371
    2. group Id
      EG001
      num Affected
      28
      num At Risk
      371
    term
    Vision blurred
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      50
      num At Risk
      371
    2. group Id
      EG001
      num Affected
      51
      num At Risk
      371
    term
    Abdominal pain
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      33
      num At Risk
      371
    2. group Id
      EG001
      num Affected
      29
      num At Risk
      371
    term
    Abdominal pain upper
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      142
      num At Risk
      371
    2. group Id
      EG001
      num Affected
      144
      num At Risk
      371
    term
    Constipation
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      192
      num At Risk
      371
    2. group Id
      EG001
      num Affected
      180
      num At Risk
      371
    term
    Diarrhoea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      371
    2. group Id
      EG001
      num Affected
      26
      num At Risk
      371
    term
    Dry mouth
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      371
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      371
    term
    Agranulocytosis
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      371
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      371
    term
    Anaemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      371
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      371
    term
    Febrile neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      371
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      371
    term
    Haemolysis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      371
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      371
    term
    Haemolytic anaemia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      371
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      371
    term
    Neutropenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      371
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      371
    term
    Pancytopenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      371
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      371
    term
    Plasmacytosis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      371
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      371
    term
    Thrombocytopenia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      371
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      371
    term
    Acute coronary syndrome
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      371
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      371
    term
    Acute myocardial infarction
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      371
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      371
    term
    Angina pectoris
time Frame
All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)

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