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NCT01731886 · ADVERSE EVENTS

Adverse events

Lenalidomide and Dexamethasone With/Without Stem Cell Transplant in Patients With Multiple Myeloma · Source last updated 2020-02-05

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
3 years
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Arm A: Low-dose Dexamethasone + Stem Cell Transplantation

Subjects will receive the current standard of care treatment. Lenalidomide and dexamethasone for four 28-day cycles followed by stem cell collection and autologous peripheral blood stem cell transplant. After 90 days, start the maintenance phase (lenalidomide days 1-21 every 28 days for two years or until your disease progresses).

7 / 3121 / 3114 / 31
Arm B: Low-dose Dexamethasone

Subjects will receive the new treatment that will be compared with the standard of care. Lenalidomide and dexamethasone for eight 28-day cycles. After four cycles your stem cells will be collected (stem cell collection). After an additional four cycles of lenalidomide (a total of 8 cycles), start the maintenance phase (lenalidomide days 1-21 every 28 days for two years or until your disease progresses). Only includes subjects who received drug.

7 / 2819 / 2811 / 28

Group identifiers: EG000: Arm A: Low-dose Dexamethasone + Stem Cell Transplantation · EG001: Arm B: Low-dose 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
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      31
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      28
      num Events
      1
    term
    Presyncope
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      28
      num Events
      2
    term
    Bone Pain
  3. 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
      31
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      28
      num Events
      0
    term
    Febrile Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Anal/Perianal
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      28
      num Events
      1
    term
    Infection with Grade 3 or 4 Neutrophils
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      31
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      28
      num Events
      1
    term
    Infection
  6. 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
      31
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      28
      num Events
      0
    term
    Lung Infection
  7. 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
      31
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      28
      num Events
      2
    term
    Myelodysplastic Syndrome
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      28
      num Events
      0
    term
    Neoplasms
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      28
      num Events
      0
    term
    Pain
  10. 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
      31
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      28
      num Events
      1
    term
    Pain of skin
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      31
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      28
      num Events
      1
    term
    Abdominal Pain
  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
      31
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      28
      num Events
      1
    term
    Back Pain

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
      2
      num At Risk
      31
      num Events
      12
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      28
      num Events
      14
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      31
      num Events
      7
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      28
      num Events
      11
    term
    Diarrhea
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      31
      num Events
      22
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      28
      num Events
      7
    term
    Decreased Neutrophil Count
  4. 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
      31
      num Events
      13
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      28
      num Events
      7
    term
    Decreased WBC Count
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      31
      num Events
      24
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      28
      num Events
      1
    term
    Decreased Platelet Count
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      31
      num Events
      11
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      28
      num Events
      26
    term
    Abnormal Neutrophils/Granulocytes (ANC/AGC)
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      31
      num Events
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      28
      num Events
      6
    term
    Pain in extremity
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      31
      num Events
      6
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      28
      num Events
      3
    term
    Increased Alanine Aminotransferase
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      31
      num Events
      7
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      28
      num Events
      3
    term
    Cough
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      31
      num Events
      4
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      28
      num Events
      7
    term
    Insomnia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      31
      num Events
      5
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      28
      num Events
      7
    term
    Infection
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      31
      num Events
      3
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      28
      num Events
      8
    term
    Abnormal Leukocytes
Complete source fields
event Groups
  1. deaths Num Affected
    14
    deaths Num At Risk
    31
    description
    Subjects will receive the current standard of care treatment. Lenalidomide and dexamethasone for four 28-day cycles followed by stem cell collection and autologous peripheral blood stem cell transplant. After 90 days, start the maintenance phase (lenalidomide days 1-21 every 28 days for two years or until your disease progresses).
    id
    EG000
    other Num Affected
    21
    other Num At Risk
    31
    serious Num Affected
    7
    serious Num At Risk
    31
    title
    Arm A: Low-dose Dexamethasone + Stem Cell Transplantation
  2. deaths Num Affected
    11
    deaths Num At Risk
    28
    description
    Subjects will receive the new treatment that will be compared with the standard of care. Lenalidomide and dexamethasone for eight 28-day cycles. After four cycles your stem cells will be collected (stem cell collection). After an additional four cycles of lenalidomide (a total of 8 cycles), start the maintenance phase (lenalidomide days 1-21 every 28 days for two years or until your disease progresses). Only includes subjects who received drug.
    id
    EG001
    other Num Affected
    19
    other Num At Risk
    28
    serious Num Affected
    7
    serious Num At Risk
    28
    title
    Arm B: Low-dose Dexamethasone
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
      2
      num At Risk
      31
      num Events
      12
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      28
      num Events
      14
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      31
      num Events
      7
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      28
      num Events
      11
    term
    Diarrhea
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      31
      num Events
      22
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      28
      num Events
      7
    term
    Decreased Neutrophil Count
  4. 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
      31
      num Events
      13
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      28
      num Events
      7
    term
    Decreased WBC Count
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      31
      num Events
      24
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      28
      num Events
      1
    term
    Decreased Platelet Count
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      31
      num Events
      11
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      28
      num Events
      26
    term
    Abnormal Neutrophils/Granulocytes (ANC/AGC)
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      31
      num Events
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      28
      num Events
      6
    term
    Pain in extremity
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      31
      num Events
      6
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      28
      num Events
      3
    term
    Increased Alanine Aminotransferase
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      31
      num Events
      7
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      28
      num Events
      3
    term
    Cough
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      31
      num Events
      4
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      28
      num Events
      7
    term
    Insomnia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      31
      num Events
      5
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      28
      num Events
      7
    term
    Infection
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      31
      num Events
      3
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      28
      num Events
      8
    term
    Abnormal Leukocytes
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      31
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      28
      num Events
      1
    term
    Presyncope
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      28
      num Events
      2
    term
    Bone Pain
  3. 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
      31
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      28
      num Events
      0
    term
    Febrile Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Anal/Perianal
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      28
      num Events
      1
    term
    Infection with Grade 3 or 4 Neutrophils
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      31
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      28
      num Events
      1
    term
    Infection
  6. 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
      31
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      28
      num Events
      0
    term
    Lung Infection
  7. 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
      31
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      28
      num Events
      2
    term
    Myelodysplastic Syndrome
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      28
      num Events
      0
    term
    Neoplasms
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      28
      num Events
      0
    term
    Pain
  10. 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
      31
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      28
      num Events
      1
    term
    Pain of skin
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      31
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      28
      num Events
      1
    term
    Abdominal Pain
  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
      31
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      28
      num Events
      1
    term
    Back Pain
time Frame
3 years

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Preserved source evidence · Not medical advice