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NCT00619684 · ADVERSE EVENTS

Adverse events

Lenalidomide in Treating Patients With Progressive or Recurrent Multiple Myeloma After a Donor Stem Cell Transplant · Source last updated 2017-05-18

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
Adverse event followed for 60 days after discontinuation of lenalidomide. Survival follow up up to 4 years.
Other-event reporting threshold
0%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Treatment (Lenalidomide)

Patients receive lenalidomide PO on days 1-21. Courses repeat every 28 days for 2 years or longer in the absence of disease progression or unacceptable toxicity. lenalidomide: Given PO

7 / 1817 / 188 / 18

Group identifiers: EG000: Treatment (Lenalidomide)

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
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      18
      num Events
      3
    term
    Pneumonia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      18
      num Events
      2
    term
    Influenza - H1N1
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      18
      num Events
      1
    term
    Fever, hypoxia, neuralgia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      18
      num Events
      1
    term
    Neuropathy

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
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      18
      num Events
      3
    term
    Diarrhea
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      18
      num Events
      3
    term
    Fatigue
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      18
      num Events
      1
    term
    Depression
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      18
      num Events
      2
    term
    Thrombocytopenia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      18
      num Events
      1
    term
    Anorexia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      18
      num Events
      2
    term
    Nausea
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      18
      num Events
      1
    term
    Muscle spasm
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      18
      num Events
      5
    term
    Constipation
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      18
      num Events
      2
    term
    Peripheral neuropathy
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      18
      num Events
      2
    term
    Rash
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      18
      num Events
      3
    term
    Myalgia
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      18
      num Events
      1
    term
    Fever
Complete source fields
event Groups
  1. deaths Num Affected
    8
    deaths Num At Risk
    18
    description
    Patients receive lenalidomide PO on days 1-21. Courses repeat every 28 days for 2 years or longer in the absence of disease progression or unacceptable toxicity. lenalidomide: Given PO
    id
    EG000
    other Num Affected
    17
    other Num At Risk
    18
    serious Num Affected
    7
    serious Num At Risk
    18
    title
    Treatment (Lenalidomide)
frequency Threshold
0
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      18
      num Events
      3
    term
    Diarrhea
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      18
      num Events
      3
    term
    Fatigue
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      18
      num Events
      1
    term
    Depression
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      18
      num Events
      2
    term
    Thrombocytopenia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      18
      num Events
      1
    term
    Anorexia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      18
      num Events
      2
    term
    Nausea
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      18
      num Events
      1
    term
    Muscle spasm
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      18
      num Events
      5
    term
    Constipation
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      18
      num Events
      2
    term
    Peripheral neuropathy
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      18
      num Events
      2
    term
    Rash
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      18
      num Events
      3
    term
    Myalgia
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      18
      num Events
      1
    term
    Fever
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      18
      num Events
      3
    term
    Pneumonia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      18
      num Events
      2
    term
    Influenza - H1N1
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      18
      num Events
      1
    term
    Fever, hypoxia, neuralgia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      18
      num Events
      1
    term
    Neuropathy
time Frame
Adverse event followed for 60 days after discontinuation of lenalidomide. Survival follow up up to 4 years.

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Preserved source evidence · Not medical advice