Skip to content
Triangle logo TriangleGet started
← Full study record

NCT01553149 · ADVERSE EVENTS

Adverse events

Low-Dose or High-Dose Lenalidomide in Treating Younger Patients With Recurrent, Refractory, or Progressive Pilocytic Astrocytoma or Optic Pathway Glioma · Source last updated 2025-01-07

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
AEs and OAEs: Up to 6 months post-treatment planned as 3 years; All-Cause Mortality: up to 5 years
Other-event reporting threshold
0%

Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Arm I (Low-dose Lenalidomide)

Patients receive low-dose lenalidomide PO QD on days 1-21. Treatment repeats every 28 days for up to 26 courses in the absence of disease progression or unacceptable toxicity. Lenalidomide: Given PO Pharmacological Study: Correlative studies

6 / 3715 / 374 / 37
Arm II (High-dose Lenalidomide)

Patients receive high-dose lenalidomide PO QD on days 1-21. Treatment repeats every 28 days for up to 26 courses in the absence of disease progression or unacceptable toxicity. Lenalidomide: Given PO Pharmacological Study: Correlative studies

16 / 3730 / 374 / 37

Group identifiers: EG000: Arm I (Low-dose Lenalidomide) · EG001: Arm II (High-dose 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
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      37
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      37
      num Events
      1
    term
    Thrombotic thrombocytopenic purpura
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      37
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      37
      num Events
      1
    term
    Adrenal insufficiency
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      37
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      37
      num Events
      1
    term
    Hypothyroidism
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      37
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      37
      num Events
      0
    term
    Blurred vision
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      37
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      37
      num Events
      1
    term
    Eye pain
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      37
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      37
      num Events
      1
    term
    Vomiting
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      37
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      37
      num Events
      1
    term
    Chills
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      37
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      37
      num Events
      1
    term
    Fever
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      37
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      37
      num Events
      1
    term
    Lung infection
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      37
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      37
      num Events
      1
    term
    Upper respiratory infection
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      37
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      37
      num Events
      1
    term
    Lymphocyte count decreased
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      37
      num Events
      2
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      37
      num Events
      5
    term
    Neutrophil count decreased

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
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      37
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      37
      num Events
      2
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      37
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      37
      num Events
      1
    term
    Eye disorders - Other, specify
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      37
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      37
      num Events
      1
    term
    Optic nerve disorder
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      37
      num Events
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      37
      num Events
      0
    term
    Diarrhea
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      37
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      37
      num Events
      1
    term
    Nausea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      37
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      37
      num Events
      0
    term
    Vomiting
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      37
      num Events
      0
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      37
      num Events
      4
    term
    Fatigue
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      37
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      37
      num Events
      1
    term
    Bronchial infection
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      37
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      37
      num Events
      0
    term
    Enterocolitis infectious
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      37
      num Events
      0
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      37
      num Events
      3
    term
    Lung infection
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      37
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      37
      num Events
      0
    term
    Skin infection
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      37
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      37
      num Events
      1
    term
    Upper respiratory infection
Complete source fields
description
Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
event Groups
  1. deaths Num Affected
    4
    deaths Num At Risk
    37
    description
    Patients receive low-dose lenalidomide PO QD on days 1-21. Treatment repeats every 28 days for up to 26 courses in the absence of disease progression or unacceptable toxicity. Lenalidomide: Given PO Pharmacological Study: Correlative studies
    id
    EG000
    other Num Affected
    15
    other Num At Risk
    37
    serious Num Affected
    6
    serious Num At Risk
    37
    title
    Arm I (Low-dose Lenalidomide)
  2. deaths Num Affected
    4
    deaths Num At Risk
    37
    description
    Patients receive high-dose lenalidomide PO QD on days 1-21. Treatment repeats every 28 days for up to 26 courses in the absence of disease progression or unacceptable toxicity. Lenalidomide: Given PO Pharmacological Study: Correlative studies
    id
    EG001
    other Num Affected
    30
    other Num At Risk
    37
    serious Num Affected
    16
    serious Num At Risk
    37
    title
    Arm II (High-dose Lenalidomide)
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      37
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      37
      num Events
      2
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      37
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      37
      num Events
      1
    term
    Eye disorders - Other, specify
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      37
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      37
      num Events
      1
    term
    Optic nerve disorder
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      37
      num Events
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      37
      num Events
      0
    term
    Diarrhea
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      37
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      37
      num Events
      1
    term
    Nausea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      37
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      37
      num Events
      0
    term
    Vomiting
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      37
      num Events
      0
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      37
      num Events
      4
    term
    Fatigue
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      37
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      37
      num Events
      1
    term
    Bronchial infection
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      37
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      37
      num Events
      0
    term
    Enterocolitis infectious
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      37
      num Events
      0
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      37
      num Events
      3
    term
    Lung infection
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      37
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      37
      num Events
      0
    term
    Skin infection
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      37
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      37
      num Events
      1
    term
    Upper respiratory infection
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      37
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      37
      num Events
      1
    term
    Thrombotic thrombocytopenic purpura
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      37
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      37
      num Events
      1
    term
    Adrenal insufficiency
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      37
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      37
      num Events
      1
    term
    Hypothyroidism
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      37
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      37
      num Events
      0
    term
    Blurred vision
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      37
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      37
      num Events
      1
    term
    Eye pain
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      37
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      37
      num Events
      1
    term
    Vomiting
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      37
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      37
      num Events
      1
    term
    Chills
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      37
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      37
      num Events
      1
    term
    Fever
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      37
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      37
      num Events
      1
    term
    Lung infection
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      37
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      37
      num Events
      1
    term
    Upper respiratory infection
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      37
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      37
      num Events
      1
    term
    Lymphocyte count decreased
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      37
      num Events
      2
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      37
      num Events
      5
    term
    Neutrophil count decreased
time Frame
AEs and OAEs: Up to 6 months post-treatment planned as 3 years; All-Cause Mortality: up to 5 years

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice