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NCT01919619 · ADVERSE EVENTS

Adverse events

Lenalidomide and Ipilimumab After Stem Cell Transplant in Treating Patients With Hematologic or Lymphoid Malignancies · Source last updated 2024-12-03

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
up to 36 months
Other-event reporting threshold
0%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Autologous -Treatment (Lenalidomide and Ipilimumab)

Patients receive lenalidomide PO QD on days 1-21 of courses 1, 3, 5 and 7. Beginning 1-3 days after the last dose of lenalidomide patients receive one dose of ipilimumab IV over 90 minutes of courses 2, 4, 6 and 8. Treatment repeats every 28 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. Ipilimumab: Given IV Lenalidomide: Given PO

10 / 2825 / 287 / 28
Allogeneic - Treatment (Lenalidomide and Ipilimumab)

Patients receive lenalidomide PO QD on days 1-21 of courses 1, 3, 5 and 7. Beginning 1-3 days after the last dose of lenalidomide patients receive one dose of ipilimumab IV over 90 minutes of courses 2, 4, 6 and 8. Treatment repeats every 28 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. Ipilimumab: Given IV Lenalidomide: Given PO

2 / 1313 / 135 / 13

Group identifiers: EG000: Autologous -Treatment (Lenalidomide and Ipilimumab) · EG001: Allogeneic - Treatment (Lenalidomide and Ipilimumab)

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 (4.0)
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      28
      num Events
      10
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      13
      num Events
      2
    term
    Low granulocyte
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      28
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
      num Events
      1
    term
    Low platelet
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      28
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
      num Events
      1
    term
    Viral

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
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      28
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Other
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      28
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Abdominal distension
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      28
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
      num Events
      1
    term
    Abdominal pain
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      28
      num Events
      12
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      13
      num Events
      2
    term
    ALK increased
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      28
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
      num Events
      1
    term
    AL OTH
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      28
      num Events
      13
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      13
      num Events
      7
    term
    ALT increased
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      28
      num Events
      22
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      13
      num Events
      7
    term
    Anemia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      28
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Anorexia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      28
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Arthralgia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      28
      num Events
      13
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      13
      num Events
      6
    term
    AST increased
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      28
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Blurred vision
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      28
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      13
      num Events
      2
    term
    Bacterial
Complete source fields
event Groups
  1. deaths Num Affected
    7
    deaths Num At Risk
    28
    description
    Patients receive lenalidomide PO QD on days 1-21 of courses 1, 3, 5 and 7. Beginning 1-3 days after the last dose of lenalidomide patients receive one dose of ipilimumab IV over 90 minutes of courses 2, 4, 6 and 8. Treatment repeats every 28 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. Ipilimumab: Given IV Lenalidomide: Given PO
    id
    EG000
    other Num Affected
    25
    other Num At Risk
    28
    serious Num Affected
    10
    serious Num At Risk
    28
    title
    Autologous -Treatment (Lenalidomide and Ipilimumab)
  2. deaths Num Affected
    5
    deaths Num At Risk
    13
    description
    Patients receive lenalidomide PO QD on days 1-21 of courses 1, 3, 5 and 7. Beginning 1-3 days after the last dose of lenalidomide patients receive one dose of ipilimumab IV over 90 minutes of courses 2, 4, 6 and 8. Treatment repeats every 28 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. Ipilimumab: Given IV Lenalidomide: Given PO
    id
    EG001
    other Num Affected
    13
    other Num At Risk
    13
    serious Num Affected
    2
    serious Num At Risk
    13
    title
    Allogeneic - Treatment (Lenalidomide and Ipilimumab)
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      28
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Other
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      28
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Abdominal distension
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      28
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
      num Events
      1
    term
    Abdominal pain
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      28
      num Events
      12
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      13
      num Events
      2
    term
    ALK increased
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      28
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
      num Events
      1
    term
    AL OTH
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      28
      num Events
      13
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      13
      num Events
      7
    term
    ALT increased
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      28
      num Events
      22
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      13
      num Events
      7
    term
    Anemia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      28
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Anorexia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      28
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Arthralgia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      28
      num Events
      13
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      13
      num Events
      6
    term
    AST increased
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      28
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Blurred vision
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      28
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      13
      num Events
      2
    term
    Bacterial
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      28
      num Events
      10
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      13
      num Events
      2
    term
    Low granulocyte
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      28
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
      num Events
      1
    term
    Low platelet
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      28
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
      num Events
      1
    term
    Viral
time Frame
up to 36 months

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

Preserved source evidence · Not medical advice