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NCT00114101 · ADVERSE EVENTS

Adverse events

Lenalidomide in Treating Patients With Multiple Myeloma Undergoing Autologous Stem Cell Transplant · Source last updated 2026-08-26

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
Not reported
Other-event reporting threshold
0%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Lenalidomide Maintenance

Beginning between day 100-110, patients receive oral lenalidomide once daily - 10 mg/day for the first 3 months, then if tolerated, 15 mg/day.

52 / 231195 / 231Not reported / Not reported
Placebo Maintenance

Beginning between day 100-110, patients receive oral placebo once daily - 10 mg/day for the first 3 months, then if tolerated, 15 mg/day. (closed as of 12/17/09)

33 / 229166 / 229Not reported / Not reported

Group identifiers: EG000: Lenalidomide Maintenance · EG001: Placebo Maintenance

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
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      231
      num Events
      6
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      229
      num Events
      2
    term
    Febrile neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      231
      num Events
      8
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      229
      num Events
      5
    term
    Hemoglobin
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      231
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      229
      num Events
      0
    term
    Hemolysis (e.g. immune hemolytic anemia drug-related hemolysis)
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      231
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      229
      num Events
      1
    term
    Cardiac Arrhythmia - Other
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      231
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      229
      num Events
      1
    term
    Cardiac ischemia/infarction
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      231
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      229
      num Events
      2
    term
    Conduction abnormality/atrioventricular heart block
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      231
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      229
      num Events
      1
    term
    Left ventricular systolic dysfunction
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      231
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      229
      num Events
      0
    term
    Restrictive cardiomyopathy
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      231
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      229
      num Events
      2
    term
    Supraventricular and nodal arrhythmia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      231
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      229
      num Events
      0
    term
    Thyroid function high (hyperthyroidism thyrotoxicosis)
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      231
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      229
      num Events
      1
    term
    Thyroid function, low (hypothyroidism)
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      231
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      229
      num Events
      0
    term
    Cataract

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
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      231
      num Events
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      229
      num Events
      1
    term
    Blood/Bone Marrow - Other
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      231
      num Events
      10
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      229
      num Events
      4
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      26
      num At Risk
      231
      num Events
      45
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      229
      num Events
      22
    term
    Hemoglobin
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      231
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      229
      num Events
      2
    term
    Hemolysis (e.g. immune hemolytic anemia drug-related hemolysis)
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      231
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      229
      num Events
      1
    term
    Cardiac General - Other
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      231
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      229
      num Events
      0
    term
    Conduction abnormality/atrioventricular heart block
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      231
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      229
      num Events
      0
    term
    Edema
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      231
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      229
      num Events
      1
    term
    Left ventricular systolic dysfunction
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      231
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      229
      num Events
      1
    term
    Palpitations
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      231
      num Events
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      229
      num Events
      1
    term
    Supraventricular and nodal arrhythmia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      231
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      229
      num Events
      2
    term
    Ventricular arrhythmia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      231
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      229
      num Events
      1
    term
    Hearing: patients without baseline audiogram and not enrolled in a monitoring program
Complete source fields
event Groups
  1. description
    Beginning between day 100-110, patients receive oral lenalidomide once daily - 10 mg/day for the first 3 months, then if tolerated, 15 mg/day.
    id
    EG000
    other Num Affected
    195
    other Num At Risk
    231
    serious Num Affected
    52
    serious Num At Risk
    231
    title
    Lenalidomide Maintenance
  2. description
    Beginning between day 100-110, patients receive oral placebo once daily - 10 mg/day for the first 3 months, then if tolerated, 15 mg/day. (closed as of 12/17/09)
    id
    EG001
    other Num Affected
    166
    other Num At Risk
    229
    serious Num Affected
    33
    serious Num At Risk
    229
    title
    Placebo Maintenance
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      231
      num Events
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      229
      num Events
      1
    term
    Blood/Bone Marrow - Other
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      231
      num Events
      10
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      229
      num Events
      4
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      26
      num At Risk
      231
      num Events
      45
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      229
      num Events
      22
    term
    Hemoglobin
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      231
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      229
      num Events
      2
    term
    Hemolysis (e.g. immune hemolytic anemia drug-related hemolysis)
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      231
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      229
      num Events
      1
    term
    Cardiac General - Other
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      231
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      229
      num Events
      0
    term
    Conduction abnormality/atrioventricular heart block
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      231
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      229
      num Events
      0
    term
    Edema
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      231
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      229
      num Events
      1
    term
    Left ventricular systolic dysfunction
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      231
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      229
      num Events
      1
    term
    Palpitations
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      231
      num Events
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      229
      num Events
      1
    term
    Supraventricular and nodal arrhythmia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      231
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      229
      num Events
      2
    term
    Ventricular arrhythmia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      231
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      229
      num Events
      1
    term
    Hearing: patients without baseline audiogram and not enrolled in a monitoring program
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      231
      num Events
      6
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      229
      num Events
      2
    term
    Febrile neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      231
      num Events
      8
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      229
      num Events
      5
    term
    Hemoglobin
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      231
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      229
      num Events
      0
    term
    Hemolysis (e.g. immune hemolytic anemia drug-related hemolysis)
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      231
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      229
      num Events
      1
    term
    Cardiac Arrhythmia - Other
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      231
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      229
      num Events
      1
    term
    Cardiac ischemia/infarction
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      231
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      229
      num Events
      2
    term
    Conduction abnormality/atrioventricular heart block
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      231
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      229
      num Events
      1
    term
    Left ventricular systolic dysfunction
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      231
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      229
      num Events
      0
    term
    Restrictive cardiomyopathy
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      231
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      229
      num Events
      2
    term
    Supraventricular and nodal arrhythmia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      231
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      229
      num Events
      0
    term
    Thyroid function high (hyperthyroidism thyrotoxicosis)
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      231
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      229
      num Events
      1
    term
    Thyroid function, low (hypothyroidism)
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      231
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      229
      num Events
      0
    term
    Cataract

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