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NCT02272803 · ADVERSE EVENTS

Adverse events

Phase II Study of Lenalidomide/Dexamethasone With or Without Elotuzumab for Newly Diagnosed MM Patients in Japan · Source last updated 2022-06-22

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 was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months).
Other-event reporting threshold
5%

All randomized participants

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Arm A: Lenalidomide + Dexamethasone + Elotuzumab (BMS-901608)

Lenalidomide 25 mg taken orally once daily, Days 1 - 21 of each cycle Dexamethasone Administered on Days 1, 8, 15, and 22 of each cycle: On weeks when elotuzumab is administered: * 28 mg taken orally (3 - 24 hours prior to start of elotuzumab infusion) AND * 8 mg IV (at least 45 minutes prior to elotuzumab administration) On weeks when elotuzumab is NOT administered: \- 40 mg taken orally Elotuzumab (BMS-901608) * Cycle 1 - 2: 10 mg/kg IV, Days 1, 8, 15, 22 * Cycle 3 - 18: 10 mg/kg IV, Days 1 and 15 * Cycle 19 and beyond: 20 mg/kg IV, Day 1

26 / 4039 / 402 / 40
Arm B: Lenalidomide + Dexamethasone

Lenalidomide 25 mg taken orally once a day, Days 1 - 21 of each cycle Dexamethasone 40 mg taken orally, Days 1, 8, 15, and 22 of each cycle

27 / 4242 / 426 / 42

Group identifiers: EG000: Arm A: Lenalidomide + Dexamethasone + Elotuzumab (BMS-901608) · EG001: Arm B: Lenalidomide + Dexamethasone

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
    24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
    term
    Agranulocytosis
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
    term
    Disseminated intravascular coagulation
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      42
    term
    Cardiac failure
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
    term
    Cardiac failure acute
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
    term
    Cardiac failure congestive
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
    term
    Eosinophilic myocarditis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      42
    term
    Cataract
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
    term
    Cataract subcapsular
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
    term
    Dental caries
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
    term
    Enterocolitis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
    term
    Ileus paralytic
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
    term
    Inguinal hernia

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
    24.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      42
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      42
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      42
    term
    Lymphopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      42
    term
    Neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      42
    term
    Atrial fibrillation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
    term
    Tinnitus
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      42
    term
    Vertigo
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      42
    term
    Cataract
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
    term
    Dry eye
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
    term
    Glaucoma
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
    term
    Abdominal discomfort
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
    term
    Abdominal pain upper
Complete source fields
description
All randomized participants
event Groups
  1. deaths Num Affected
    2
    deaths Num At Risk
    40
    description
    Lenalidomide 25 mg taken orally once daily, Days 1 - 21 of each cycle Dexamethasone Administered on Days 1, 8, 15, and 22 of each cycle: On weeks when elotuzumab is administered: * 28 mg taken orally (3 - 24 hours prior to start of elotuzumab infusion) AND * 8 mg IV (at least 45 minutes prior to elotuzumab administration) On weeks when elotuzumab is NOT administered: \- 40 mg taken orally Elotuzumab (BMS-901608) * Cycle 1 - 2: 10 mg/kg IV, Days 1, 8, 15, 22 * Cycle 3 - 18: 10 mg/kg IV, Days 1 and 15 * Cycle 19 and beyond: 20 mg/kg IV, Day 1
    id
    EG000
    other Num Affected
    39
    other Num At Risk
    40
    serious Num Affected
    26
    serious Num At Risk
    40
    title
    Arm A: Lenalidomide + Dexamethasone + Elotuzumab (BMS-901608)
  2. deaths Num Affected
    6
    deaths Num At Risk
    42
    description
    Lenalidomide 25 mg taken orally once a day, Days 1 - 21 of each cycle Dexamethasone 40 mg taken orally, Days 1, 8, 15, and 22 of each cycle
    id
    EG001
    other Num Affected
    42
    other Num At Risk
    42
    serious Num Affected
    27
    serious Num At Risk
    42
    title
    Arm B: Lenalidomide + Dexamethasone
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      42
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      42
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      42
    term
    Lymphopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      42
    term
    Neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      42
    term
    Atrial fibrillation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
    term
    Tinnitus
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      42
    term
    Vertigo
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      42
    term
    Cataract
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
    term
    Dry eye
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
    term
    Glaucoma
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
    term
    Abdominal discomfort
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
    term
    Abdominal pain upper
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
    term
    Agranulocytosis
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
    term
    Disseminated intravascular coagulation
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      42
    term
    Cardiac failure
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
    term
    Cardiac failure acute
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
    term
    Cardiac failure congestive
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
    term
    Eosinophilic myocarditis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      42
    term
    Cataract
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
    term
    Cataract subcapsular
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
    term
    Dental caries
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
    term
    Enterocolitis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
    term
    Ileus paralytic
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
    term
    Inguinal hernia
time Frame
All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months).

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