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NCT02279394 · ADVERSE EVENTS

Adverse events

E-PRISM: Phase II Trial of Elotuzumab Lenalidomide and Dexamethasone in High-Risk Smoldering Multiple Myeloma · Source last updated 2023-06-09

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 assessed/monitored from the day of consent up to the end of treatment for an average of 26 months All-Cause Mortality as well as Serious Adverse Events were collected up to +/- 60 months. These duration may vary individually based on possible dose delays as well as follow up study visit delays or some participants possibly coming off study early.
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Elo / Len / Dex

•Drug: Elotuzumab 10 mg/kg IV; Days 1, 8,15, 22 Cycles 1-2 10 mg/kg IV; Days 1 \& 15 Cycles 3-8 Other Name: HuLuc63 •Drug: Lenalidomide 25 mg Oral; Days 1-21 days Cycles 1-24 Other Name: REVLIMID •Drug: Dexamethasone 40 mg Oral; Days 1, 8, 15, 22 Cycles 1-2 40 mg Oral; Days 1, 8, 15 Cycles 3-8 Other Name: Decadron Elotuzumab: 10 mg/kg IV; Days 1, 8,15, 22 Cycles 1-2 10 mg/kg IV; Days 1 \& 15 Cycles 3-8 Lenalidomide: 25 mg Oral; Days 1-21 days Cycles 1-24 Dexamethasone: 40 mg Oral; Days 1, 8, 15, 22 Cycles 1-2 40 mg Oral; Days 1, 8, 15 Cycles 3-8

8 / 4040 / 402 / 40
Elo / Len

•Drug: Elotuzumab 10 mg/kg IV; Days 1, 8,15, 22 Cycles 1-2 10 mg/kg IV; Days 1 \& 15 Cycles 3-8 Other Name: HuLuc63 •Drug: Lenalidomide 25 mg Oral; Days 1-21 days Cycles 1-24 Other Name: REVLIMID Elotuzumab: 10 mg/kg IV; Days 1, 8,15, 22 Cycles 1-2 10 mg/kg IV; Days 1 \& 15 Cycles 3-8 Lenalidomide: 25 mg Oral; Days 1-21 days Cycles 1-24

1 / 1111 / 110 / 11

Group identifiers: EG000: Elo / Len / Dex · EG001: Elo / Len

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
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      40
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Hypophosphatemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Neutrophil count decreased
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      40
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      11
      num Events
      1
    term
    Cholecystitis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Cataract
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Lymphocyte count increased
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Myocardial infarction
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Diabetic ketoacidosis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Hyperglycemia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Sepsis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Hypophosphatemia

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
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      36
      num At Risk
      40
      num Events
      72
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      11
      num Events
      47
    term
    Fatigue
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      32
      num At Risk
      40
      num Events
      70
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      11
      num Events
      24
    term
    Diarrhea
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      40
      num Events
      82
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      11
      num Events
      43
    term
    Hyperglycemia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      40
      num Events
      97
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      11
      num Events
      11
    term
    White blood cell decreased
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      40
      num Events
      28
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      11
      num Events
      7
    term
    Insomnia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      40
      num Events
      29
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      11
      num Events
      17
    term
    Nausea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      40
      num Events
      48
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      11
      num Events
      13
    term
    Anemia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      40
      num Events
      78
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      11
      num Events
      26
    term
    Hypophosphatemia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      40
      num Events
      33
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      11
      num Events
      11
    term
    Upper respiratory infection
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      40
      num Events
      29
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      11
      num Events
      16
    term
    Constipation
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      40
      num Events
      131
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      11
      num Events
      28
    term
    Neutrophil count decreased
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      40
      num Events
      71
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      11
      num Events
      16
    term
    Platelet count decreased
Complete source fields
event Groups
  1. deaths Num Affected
    2
    deaths Num At Risk
    40
    description
    •Drug: Elotuzumab 10 mg/kg IV; Days 1, 8,15, 22 Cycles 1-2 10 mg/kg IV; Days 1 \& 15 Cycles 3-8 Other Name: HuLuc63 •Drug: Lenalidomide 25 mg Oral; Days 1-21 days Cycles 1-24 Other Name: REVLIMID •Drug: Dexamethasone 40 mg Oral; Days 1, 8, 15, 22 Cycles 1-2 40 mg Oral; Days 1, 8, 15 Cycles 3-8 Other Name: Decadron Elotuzumab: 10 mg/kg IV; Days 1, 8,15, 22 Cycles 1-2 10 mg/kg IV; Days 1 \& 15 Cycles 3-8 Lenalidomide: 25 mg Oral; Days 1-21 days Cycles 1-24 Dexamethasone: 40 mg Oral; Days 1, 8, 15, 22 Cycles 1-2 40 mg Oral; Days 1, 8, 15 Cycles 3-8
    id
    EG000
    other Num Affected
    40
    other Num At Risk
    40
    serious Num Affected
    8
    serious Num At Risk
    40
    title
    Elo / Len / Dex
  2. deaths Num Affected
    0
    deaths Num At Risk
    11
    description
    •Drug: Elotuzumab 10 mg/kg IV; Days 1, 8,15, 22 Cycles 1-2 10 mg/kg IV; Days 1 \& 15 Cycles 3-8 Other Name: HuLuc63 •Drug: Lenalidomide 25 mg Oral; Days 1-21 days Cycles 1-24 Other Name: REVLIMID Elotuzumab: 10 mg/kg IV; Days 1, 8,15, 22 Cycles 1-2 10 mg/kg IV; Days 1 \& 15 Cycles 3-8 Lenalidomide: 25 mg Oral; Days 1-21 days Cycles 1-24
    id
    EG001
    other Num Affected
    11
    other Num At Risk
    11
    serious Num Affected
    1
    serious Num At Risk
    11
    title
    Elo / Len
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      36
      num At Risk
      40
      num Events
      72
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      11
      num Events
      47
    term
    Fatigue
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      32
      num At Risk
      40
      num Events
      70
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      11
      num Events
      24
    term
    Diarrhea
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      40
      num Events
      82
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      11
      num Events
      43
    term
    Hyperglycemia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      40
      num Events
      97
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      11
      num Events
      11
    term
    White blood cell decreased
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      40
      num Events
      28
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      11
      num Events
      7
    term
    Insomnia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      40
      num Events
      29
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      11
      num Events
      17
    term
    Nausea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      40
      num Events
      48
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      11
      num Events
      13
    term
    Anemia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      40
      num Events
      78
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      11
      num Events
      26
    term
    Hypophosphatemia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      40
      num Events
      33
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      11
      num Events
      11
    term
    Upper respiratory infection
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      40
      num Events
      29
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      11
      num Events
      16
    term
    Constipation
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      40
      num Events
      131
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      11
      num Events
      28
    term
    Neutrophil count decreased
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      40
      num Events
      71
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      11
      num Events
      16
    term
    Platelet count decreased
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      40
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Hypophosphatemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Neutrophil count decreased
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      40
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      11
      num Events
      1
    term
    Cholecystitis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Cataract
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Lymphocyte count increased
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Myocardial infarction
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Diabetic ketoacidosis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Hyperglycemia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Sepsis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Hypophosphatemia
time Frame
Adverse Events assessed/monitored from the day of consent up to the end of treatment for an average of 26 months All-Cause Mortality as well as Serious Adverse Events were collected up to +/- 60 months. These duration may vary individually based on possible dose delays as well as follow up study visit delays or some participants possibly coming off study early.

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