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NCT01050790 · ADVERSE EVENTS

Adverse events

Lenalidomide + Azacitidine for Adaptive Immunotherapy -> Auto SCT in Multiple Myeloma · Source last updated 2018-06-26

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
1 year the subject will be on study and evaluated for adverse events.
Other-event reporting threshold
5%

Medical history and physical before treatment, Days 1, 5 and 22 of the 1st cycle and before cycles 2 and 3, before ALI. Blood for study specific tests drawn before ALI and 2, 4 and 8 weeks after and if relapse occurs. Chest x ray before ALI. Bone marrow Biopsy at baseline and after cycle 3.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
5-azacytidine + Lenalidomide -> Auto Stem Cell Transplant

azacitidine: 75 mg/sq m daily for 5 days lenalidomide: 10 mg p.o. daily, Days 6-21

9 / 1712 / 17Not reported / Not reported

Group identifiers: EG000: 5-azacytidine + Lenalidomide -> Auto Stem Cell Transplant

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
    notes
    Hospitalization. Received radiation therapy with improvement. Grade 3: Severe pain; pain or analgesics severely interfering with ADL.
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE VERSION 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
      num Events
      1
    term
    Pain - Pack
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Hospitalization, disease progression and death occurred after 100 days. Grade 5, death.
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTCAE VERSION 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
      num Events
      1
    term
    Renal failure
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Hospitalization. Grade 3, Severe pain; pain or analgesics severely interfering with ADL.
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE VERSION 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
      num Events
      1
    term
    Pain - Abdomen NOS
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Grade 3, Symptomatic, interfering with ADL; O2 indicated.
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE VERSION 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
      num Events
      1
    term
    Pneumonitis/pulmonary infiltrates
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Hospitalization.
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE VERSION 3.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      17
      num Events
      2
    term
    Dyspnea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Neurology, Grade 2: Mild mood alteration not interfering with function .
    organ System
    Psychiatric disorders
    source Vocabulary
    CTCAE VERSION 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
      num Events
      1
    term
    Mood alteration - Anxiety
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Hospitalization.
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE VERSION 3.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      17
      num Events
      2
    term
    Infection with normal ANC or Grade 1 or 2 neutrophils - blood
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Hospitalization.
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE VERSION 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
      num Events
      2
    term
    Hypotension
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Neurology. Hospitalization.
    organ System
    Psychiatric disorders
    source Vocabulary
    CTCAE VERSION 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
      num Events
      1
    term
    Mental Status
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Hospitalization. Grade 3: Requiring more than one drug or more intensive therapy than previously.
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE VERSION 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
      num Events
      1
    term
    Hypertension

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
    notes
    Grade 2-3.
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE VERSION 3.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      17
      num Events
      3
    term
    Low Hemoglobin
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Grade 2-3.
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE VERSION 3.0
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      17
      num Events
      27
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Grade 2-3.
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE VERSION 3.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      17
      num Events
      4
    term
    Thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Grade 2-3.
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE VERSION 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
      num Events
      4
    term
    High Creatinine
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Grade 2-3.
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE VERSION 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
      num Events
      1
    term
    High AST
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Grade 2-3.
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE VERSION 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
      num Events
      1
    term
    High ALT
Complete source fields
description
Medical history and physical before treatment, Days 1, 5 and 22 of the 1st cycle and before cycles 2 and 3, before ALI. Blood for study specific tests drawn before ALI and 2, 4 and 8 weeks after and if relapse occurs. Chest x ray before ALI. Bone marrow Biopsy at baseline and after cycle 3.
event Groups
  1. description
    azacitidine: 75 mg/sq m daily for 5 days lenalidomide: 10 mg p.o. daily, Days 6-21
    id
    EG000
    other Num Affected
    12
    other Num At Risk
    17
    serious Num Affected
    9
    serious Num At Risk
    17
    title
    5-azacytidine + Lenalidomide -> Auto Stem Cell Transplant
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Grade 2-3.
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE VERSION 3.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      17
      num Events
      3
    term
    Low Hemoglobin
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Grade 2-3.
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE VERSION 3.0
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      17
      num Events
      27
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Grade 2-3.
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE VERSION 3.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      17
      num Events
      4
    term
    Thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Grade 2-3.
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE VERSION 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
      num Events
      4
    term
    High Creatinine
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Grade 2-3.
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE VERSION 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
      num Events
      1
    term
    High AST
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Grade 2-3.
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE VERSION 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
      num Events
      1
    term
    High ALT
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Hospitalization. Received radiation therapy with improvement. Grade 3: Severe pain; pain or analgesics severely interfering with ADL.
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE VERSION 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
      num Events
      1
    term
    Pain - Pack
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Hospitalization, disease progression and death occurred after 100 days. Grade 5, death.
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTCAE VERSION 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
      num Events
      1
    term
    Renal failure
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Hospitalization. Grade 3, Severe pain; pain or analgesics severely interfering with ADL.
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE VERSION 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
      num Events
      1
    term
    Pain - Abdomen NOS
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Grade 3, Symptomatic, interfering with ADL; O2 indicated.
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE VERSION 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
      num Events
      1
    term
    Pneumonitis/pulmonary infiltrates
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Hospitalization.
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE VERSION 3.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      17
      num Events
      2
    term
    Dyspnea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Neurology, Grade 2: Mild mood alteration not interfering with function .
    organ System
    Psychiatric disorders
    source Vocabulary
    CTCAE VERSION 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
      num Events
      1
    term
    Mood alteration - Anxiety
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Hospitalization.
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE VERSION 3.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      17
      num Events
      2
    term
    Infection with normal ANC or Grade 1 or 2 neutrophils - blood
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Hospitalization.
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE VERSION 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
      num Events
      2
    term
    Hypotension
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Neurology. Hospitalization.
    organ System
    Psychiatric disorders
    source Vocabulary
    CTCAE VERSION 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
      num Events
      1
    term
    Mental Status
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Hospitalization. Grade 3: Requiring more than one drug or more intensive therapy than previously.
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE VERSION 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
      num Events
      1
    term
    Hypertension
time Frame
1 year the subject will be on study and evaluated for adverse events.

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Preserved source evidence · Not medical advice