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NCT01169337 · ADVERSE EVENTS

Adverse events

Lenalidomide or Observation in Treating Patients With Asymptomatic High-Risk Smoldering Multiple Myeloma · Source last updated 2026-08-04

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
Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years
Other-event reporting threshold
5%

Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Arm A (Lenalidomide; Phase II)

Patients receive lenalidomide PO QD on days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

23 / 4414 / 447 / 44
Arm A (Lenalidomide; Phase III)

Patients receive lenalidomide PO QD on days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

40 / 8820 / 882 / 90
Arm B (Observation; Phase III)

Patients undergo observation until progression to symptomatic myeloma.

8 / 865 / 864 / 92

Group identifiers: EG000: Arm A (Lenalidomide; Phase II) · EG001: Arm A (Lenalidomide; Phase III) · EG002: Arm B (Observation; Phase III)

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
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      44
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      88
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      86
    term
    Hearing impaired
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      44
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      88
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      86
    term
    Vertigo
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      44
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      88
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      86
    term
    Febrile neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      44
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      88
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      86
    term
    Blood and lymphatic disorders - Other
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      44
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      88
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      86
    term
    Myocardial infarction
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      44
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      88
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      86
    term
    Fatigue
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      44
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      88
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      86
    term
    Erythroderma
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      44
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      88
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      86
    term
    Pruritus
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      44
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      88
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      86
    term
    Rash maculo-papular
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      44
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      88
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      86
    term
    Constipation
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      44
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      88
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      86
    term
    Diarrhea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      44
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      88
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      86
    term
    Vomiting

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
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      44
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      88
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      86
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      44
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      88
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      86
    term
    Fatigue
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      44
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      88
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      86
    term
    Constipation
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      44
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      88
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      86
    term
    Lymphocyte count decreased
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      44
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      88
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      86
    term
    Neutrophil count decreased
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      44
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      88
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      86
    term
    Platelet count decreased
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      44
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      88
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      86
    term
    White blood cell decreased
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      44
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      88
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      86
    term
    Rash maculo-papular
Complete source fields
description
Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
event Groups
  1. deaths Num Affected
    7
    deaths Num At Risk
    44
    description
    Patients receive lenalidomide PO QD on days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
    id
    EG000
    other Num Affected
    14
    other Num At Risk
    44
    serious Num Affected
    23
    serious Num At Risk
    44
    title
    Arm A (Lenalidomide; Phase II)
  2. deaths Num Affected
    2
    deaths Num At Risk
    90
    description
    Patients receive lenalidomide PO QD on days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
    id
    EG001
    other Num Affected
    20
    other Num At Risk
    88
    serious Num Affected
    40
    serious Num At Risk
    88
    title
    Arm A (Lenalidomide; Phase III)
  3. deaths Num Affected
    4
    deaths Num At Risk
    92
    description
    Patients undergo observation until progression to symptomatic myeloma.
    id
    EG002
    other Num Affected
    5
    other Num At Risk
    86
    serious Num Affected
    8
    serious Num At Risk
    86
    title
    Arm B (Observation; Phase III)
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      44
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      88
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      86
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      44
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      88
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      86
    term
    Fatigue
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      44
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      88
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      86
    term
    Constipation
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      44
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      88
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      86
    term
    Lymphocyte count decreased
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      44
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      88
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      86
    term
    Neutrophil count decreased
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      44
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      88
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      86
    term
    Platelet count decreased
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      44
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      88
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      86
    term
    White blood cell decreased
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      44
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      88
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      86
    term
    Rash maculo-papular
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      44
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      88
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      86
    term
    Hearing impaired
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      44
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      88
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      86
    term
    Vertigo
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      44
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      88
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      86
    term
    Febrile neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      44
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      88
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      86
    term
    Blood and lymphatic disorders - Other
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      44
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      88
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      86
    term
    Myocardial infarction
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      44
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      88
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      86
    term
    Fatigue
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      44
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      88
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      86
    term
    Erythroderma
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      44
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      88
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      86
    term
    Pruritus
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      44
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      88
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      86
    term
    Rash maculo-papular
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      44
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      88
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      86
    term
    Constipation
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      44
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      88
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      86
    term
    Diarrhea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      44
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      88
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      86
    term
    Vomiting
time Frame
Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years

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