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NCT00843882 · ADVERSE EVENTS

Adverse events

Lenalidomide With or Without Epoetin Alfa in Treating Patients With Myelodysplastic Syndrome and Anemia · Source last updated 2026-09-02

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
Other-event reporting threshold
5%

Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Arm A (Step 1; Regardless of Chromosome 5q31.1 Status)

Patients receive lenalidomide PO QD on days 1-21.

123 / 139137 / 13929 / 141
Arm B (Step 1 Randomization; Lenalidomide + Epoetin Alfa)

Patients receive lenalidomide PO QD on days 1-21 and epoetin alfa SC once weekly.

98 / 106105 / 10629 / 106
Arm B (Step 2 Cross-over; Lenalidomide + Epoetin Alfa)

Patients receive lenalidomide PO QD on days 1-21 and epoetin alfa SC once weekly.

49 / 5352 / 530 / 53

Group identifiers: EG000: Arm A (Step 1; Regardless of Chromosome 5q31.1 Status) · EG001: Arm B (Step 1 Randomization; Lenalidomide + Epoetin Alfa) · EG002: Arm B (Step 2 Cross-over; Lenalidomide + Epoetin Alfa)

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
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      80
      num At Risk
      139
    2. group Id
      EG001
      num Affected
      65
      num At Risk
      106
    3. group Id
      EG002
      num Affected
      30
      num At Risk
      53
    term
    Anemia
  2. 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
      139
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      106
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      53
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      139
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      106
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      53
    term
    Acute coronary syndrome
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      139
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      106
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      53
    term
    Atrial fibrillation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      139
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      106
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      53
    term
    Chest pain - cardiac
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      139
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      106
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      53
    term
    Heart failure
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      139
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      106
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      53
    term
    Left ventricular systolic dysfunction
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      139
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      106
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      53
    term
    Myocardial infarction
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      139
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      106
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      53
    term
    Cardiac disorders - Other, specify
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      139
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      106
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      53
    term
    Edema limbs
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      139
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      106
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      53
    term
    Fatigue
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      139
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      106
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      53
    term
    Fever

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
      108
      num At Risk
      139
    2. group Id
      EG001
      num Affected
      92
      num At Risk
      106
    3. group Id
      EG002
      num Affected
      43
      num At Risk
      53
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      139
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      106
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      53
    term
    Fatigue
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      139
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      106
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      53
    term
    Rash maculo-papular
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      139
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      106
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      53
    term
    Diarrhea
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      62
      num At Risk
      139
    2. group Id
      EG001
      num Affected
      50
      num At Risk
      106
    3. group Id
      EG002
      num Affected
      15
      num At Risk
      53
    term
    Creatinine increased
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      99
      num At Risk
      139
    2. group Id
      EG001
      num Affected
      73
      num At Risk
      106
    3. group Id
      EG002
      num Affected
      43
      num At Risk
      53
    term
    Neutrophil count decreased
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      108
      num At Risk
      139
    2. group Id
      EG001
      num Affected
      77
      num At Risk
      106
    3. group Id
      EG002
      num Affected
      38
      num At Risk
      53
    term
    Platelet count decreased
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      114
      num At Risk
      139
    2. group Id
      EG001
      num Affected
      91
      num At Risk
      106
    3. group Id
      EG002
      num Affected
      47
      num At Risk
      53
    term
    White blood cell decreased
Complete source fields
description
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
event Groups
  1. deaths Num Affected
    29
    deaths Num At Risk
    141
    description
    Patients receive lenalidomide PO QD on days 1-21.
    id
    EG000
    other Num Affected
    137
    other Num At Risk
    139
    serious Num Affected
    123
    serious Num At Risk
    139
    title
    Arm A (Step 1; Regardless of Chromosome 5q31.1 Status)
  2. deaths Num Affected
    29
    deaths Num At Risk
    106
    description
    Patients receive lenalidomide PO QD on days 1-21 and epoetin alfa SC once weekly.
    id
    EG001
    other Num Affected
    105
    other Num At Risk
    106
    serious Num Affected
    98
    serious Num At Risk
    106
    title
    Arm B (Step 1 Randomization; Lenalidomide + Epoetin Alfa)
  3. deaths Num Affected
    0
    deaths Num At Risk
    53
    description
    Patients receive lenalidomide PO QD on days 1-21 and epoetin alfa SC once weekly.
    id
    EG002
    other Num Affected
    52
    other Num At Risk
    53
    serious Num Affected
    49
    serious Num At Risk
    53
    title
    Arm B (Step 2 Cross-over; Lenalidomide + Epoetin Alfa)
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
      108
      num At Risk
      139
    2. group Id
      EG001
      num Affected
      92
      num At Risk
      106
    3. group Id
      EG002
      num Affected
      43
      num At Risk
      53
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      139
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      106
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      53
    term
    Fatigue
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      139
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      106
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      53
    term
    Rash maculo-papular
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      139
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      106
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      53
    term
    Diarrhea
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      62
      num At Risk
      139
    2. group Id
      EG001
      num Affected
      50
      num At Risk
      106
    3. group Id
      EG002
      num Affected
      15
      num At Risk
      53
    term
    Creatinine increased
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      99
      num At Risk
      139
    2. group Id
      EG001
      num Affected
      73
      num At Risk
      106
    3. group Id
      EG002
      num Affected
      43
      num At Risk
      53
    term
    Neutrophil count decreased
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      108
      num At Risk
      139
    2. group Id
      EG001
      num Affected
      77
      num At Risk
      106
    3. group Id
      EG002
      num Affected
      38
      num At Risk
      53
    term
    Platelet count decreased
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      114
      num At Risk
      139
    2. group Id
      EG001
      num Affected
      91
      num At Risk
      106
    3. group Id
      EG002
      num Affected
      47
      num At Risk
      53
    term
    White blood cell decreased
serious 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
      80
      num At Risk
      139
    2. group Id
      EG001
      num Affected
      65
      num At Risk
      106
    3. group Id
      EG002
      num Affected
      30
      num At Risk
      53
    term
    Anemia
  2. 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
      139
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      106
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      53
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      139
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      106
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      53
    term
    Acute coronary syndrome
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      139
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      106
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      53
    term
    Atrial fibrillation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      139
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      106
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      53
    term
    Chest pain - cardiac
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      139
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      106
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      53
    term
    Heart failure
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      139
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      106
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      53
    term
    Left ventricular systolic dysfunction
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      139
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      106
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      53
    term
    Myocardial infarction
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      139
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      106
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      53
    term
    Cardiac disorders - Other, specify
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      139
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      106
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      53
    term
    Edema limbs
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      139
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      106
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      53
    term
    Fatigue
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      139
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      106
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      53
    term
    Fever
time Frame
Assessed every 4 weeks while on treatment and for 30 days after the end of treatment

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