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NCT01079936 · ADVERSE EVENTS

Adverse events

Lenalidomide and High-Dose Melphalan · Source last updated 2016-06-06

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 collection from the start of preparative regiment up to Day 30 following stem cell transplant.
Other-event reporting threshold
0%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
25 Mg Lenalidomide

Lenalidomide dose level 25 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m\^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.

0 / 33 / 3Not reported / Not reported
50 mg Lenalidomide

Lenalidomide dose level 50 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m\^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.

0 / 66 / 6Not reported / Not reported
75 mg Lenalidomide

Lenalidomide dose level 75 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m\^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.

1 / 2422 / 24Not reported / Not reported
100 mg Lenalidomide

Lenalidomide dose level 100 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m\^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.

1 / 2625 / 26Not reported / Not reported

Group identifiers: EG000: 25 Mg Lenalidomide · EG001: 50 mg Lenalidomide · EG002: 75 mg Lenalidomide · EG003: 100 mg 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
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      24
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      26
      num Events
      1
    term
    Blood Platelets
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      24
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      26
      num Events
      0
    term
    Infection

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 (2.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      24
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      26
      num Events
      1
    term
    Change in Platelet levels
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      24
      num Events
      2
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      26
      num Events
      2
    term
    High blood pressure
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      24
      num Events
      2
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      26
      num Events
      3
    term
    Tachycardia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      24
      num Events
      9
    4. group Id
      EG003
      num Affected
      13
      num At Risk
      26
      num Events
      13
    term
    Flu like symptoms
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      24
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      26
      num Events
      0
    term
    Herpetic lip leson
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      24
      num Events
      2
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      26
      num Events
      2
    term
    Creatinine increased
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      24
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      26
      num Events
      0
    term
    GU HEM
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      24
      num Events
      4
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      26
      num Events
      1
    term
    Alanine aminotransferase increased
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
      num Events
      1
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      24
      num Events
      4
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      26
      num Events
      3
    term
    Hepatobiliary disorders
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      6
      num Events
      2
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      24
      num Events
      2
    4. group Id
      EG003
      num Affected
      11
      num At Risk
      26
      num Events
      11
    term
    Infection
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      24
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      26
      num Events
      1
    term
    Other Neurologic Disorder
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      24
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      26
      num Events
      1
    term
    Pulmonary Edema
Complete source fields
event Groups
  1. description
    Lenalidomide dose level 25 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m\^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
    id
    EG000
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    0
    serious Num At Risk
    3
    title
    25 Mg Lenalidomide
  2. description
    Lenalidomide dose level 50 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m\^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
    id
    EG001
    other Num Affected
    6
    other Num At Risk
    6
    serious Num Affected
    0
    serious Num At Risk
    6
    title
    50 mg Lenalidomide
  3. description
    Lenalidomide dose level 75 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m\^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
    id
    EG002
    other Num Affected
    22
    other Num At Risk
    24
    serious Num Affected
    1
    serious Num At Risk
    24
    title
    75 mg Lenalidomide
  4. description
    Lenalidomide dose level 100 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m\^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
    id
    EG003
    other Num Affected
    25
    other Num At Risk
    26
    serious Num Affected
    1
    serious Num At Risk
    26
    title
    100 mg Lenalidomide
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      24
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      26
      num Events
      1
    term
    Change in Platelet levels
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      24
      num Events
      2
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      26
      num Events
      2
    term
    High blood pressure
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      24
      num Events
      2
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      26
      num Events
      3
    term
    Tachycardia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      24
      num Events
      9
    4. group Id
      EG003
      num Affected
      13
      num At Risk
      26
      num Events
      13
    term
    Flu like symptoms
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      24
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      26
      num Events
      0
    term
    Herpetic lip leson
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      24
      num Events
      2
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      26
      num Events
      2
    term
    Creatinine increased
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      24
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      26
      num Events
      0
    term
    GU HEM
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      24
      num Events
      4
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      26
      num Events
      1
    term
    Alanine aminotransferase increased
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
      num Events
      1
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      24
      num Events
      4
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      26
      num Events
      3
    term
    Hepatobiliary disorders
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      6
      num Events
      2
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      24
      num Events
      2
    4. group Id
      EG003
      num Affected
      11
      num At Risk
      26
      num Events
      11
    term
    Infection
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      24
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      26
      num Events
      1
    term
    Other Neurologic Disorder
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      24
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      26
      num Events
      1
    term
    Pulmonary Edema
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      24
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      26
      num Events
      1
    term
    Blood Platelets
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      24
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      26
      num Events
      0
    term
    Infection
time Frame
Adverse event collection from the start of preparative regiment up to Day 30 following stem cell transplant.

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