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NCT01724177 · ADVERSE EVENTS

Adverse events

A Phase 2 Study of Lenalidomide in Patients With Relapsed or Recurrent Adult T-cell Leukemia-lymphoma · Source last updated 2018-05-29

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
From the first day of lenalidomide treatment through 28 days after the last dose of lenalidomide. up to clinical cut-off date of 19 May 2017; maximum duration of study drug was 130.4 weeks
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Lenalidomide

Lenalidomide 25 mg administered orally once daily (QD) until progressive disease or unacceptable toxicity

11 / 2626 / 2622 / 26

Group identifiers: EG000: 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
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA (15.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      26
    term
    Erythema multiforme
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA (15.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      26
    term
    Rash
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA (15.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      26
    term
    Toxic skin eruption
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (15.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      26
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (15.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      26
    term
    Anaemia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (15.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      26
    term
    Non-cardiac chest pain
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (15.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      26
    term
    Pyrexia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (15.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      26
    term
    Enterocolitis infectious
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (15.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      26
    term
    Meningitis bacterial
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (15.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      26
    term
    Pneumonia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA (15.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      26
    term
    Syncope
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA (15.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      26
    term
    Transient ischaemic attack

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 (15.1)
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      26
    term
    Thrombocytopenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (15.1)
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      26
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (15.1)
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      26
    term
    Lymphopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (15.1)
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      26
    term
    Anaemia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (15.1)
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      26
    term
    Leukopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (15.1)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      26
    term
    Leukocytosis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (15.1)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      26
    term
    Basophilia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (15.1)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      26
    term
    Eosinophilia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (15.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      26
    term
    Disseminated intravascular coagulation
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA (15.1)
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      26
    term
    Hypoalbuminaemia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA (15.1)
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      26
    term
    Hypoproteinaemia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA (15.1)
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      26
    term
    Hypocalcaemia
Complete source fields
event Groups
  1. deaths Num Affected
    22
    deaths Num At Risk
    26
    description
    Lenalidomide 25 mg administered orally once daily (QD) until progressive disease or unacceptable toxicity
    id
    EG000
    other Num Affected
    26
    other Num At Risk
    26
    serious Num Affected
    11
    serious Num At Risk
    26
    title
    Lenalidomide
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (15.1)
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      26
    term
    Thrombocytopenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (15.1)
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      26
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (15.1)
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      26
    term
    Lymphopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (15.1)
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      26
    term
    Anaemia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (15.1)
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      26
    term
    Leukopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (15.1)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      26
    term
    Leukocytosis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (15.1)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      26
    term
    Basophilia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (15.1)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      26
    term
    Eosinophilia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (15.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      26
    term
    Disseminated intravascular coagulation
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA (15.1)
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      26
    term
    Hypoalbuminaemia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA (15.1)
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      26
    term
    Hypoproteinaemia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA (15.1)
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      26
    term
    Hypocalcaemia
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA (15.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      26
    term
    Erythema multiforme
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA (15.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      26
    term
    Rash
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA (15.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      26
    term
    Toxic skin eruption
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (15.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      26
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (15.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      26
    term
    Anaemia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (15.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      26
    term
    Non-cardiac chest pain
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (15.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      26
    term
    Pyrexia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (15.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      26
    term
    Enterocolitis infectious
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (15.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      26
    term
    Meningitis bacterial
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (15.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      26
    term
    Pneumonia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA (15.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      26
    term
    Syncope
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA (15.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      26
    term
    Transient ischaemic attack
time Frame
From the first day of lenalidomide treatment through 28 days after the last dose of lenalidomide. up to clinical cut-off date of 19 May 2017; maximum duration of study drug was 130.4 weeks

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Preserved source evidence · Independent clinical review pending · Not medical advice