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NCT01858558 · ADVERSE EVENTS

Adverse events

Tadalafil and Lenalidomide Maintenance With or Without Activated Marrow Infiltrating Lymphocytes (MILs) in High Risk Myeloma · Source last updated 2020-06-29

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
60 Days from aMILs harvest until Day 60 after transplant
Other-event reporting threshold
0%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
aMIL Arm

Patients receive activated Marrow Infiltrating Lymphocytes (aMIL) aMIL: On day 0, patients will receive auto transplant followed by Tadalafil and aMIL. At day 60, patients will receive Lenalidomide.

64 / 7011 / 701 / 70
No aMIL

Patients do not receive activated Marrow Infiltrating Lymphocytes (aMIL) No aMIL: On day 0, patients will receive auto transplant followed by Tadalafil. At day 60, patients will receive Lenalidomide.

29 / 310 / 311 / 31

Group identifiers: EG000: aMIL Arm · EG001: No aMIL

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
    NON_SYSTEMATIC_ASSESSMENT
    notes
    Grade 3 or higher Adverse Events (AEs) from aMILs harvest to 60 days following autologous stem cell transplant (ASCT)
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      36
      num At Risk
      70
      num Events
      45
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      31
      num Events
      22
    term
    Febrile neutropenia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    Grade 3 or higher AEs from aMILs harvest to 60 days following ASCT
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      70
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      31
      num Events
      1
    term
    Acute Kidney Injury
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    Grade 3 or higher AEs from aMILs harvest to 60 days following ASCT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      70
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      31
      num Events
      0
    term
    Anemia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    Grade 3 or higher AEs from aMILs harvest to 60 days following ASCT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      70
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      31
      num Events
      2
    term
    Atrial Fibrillation
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    Grade 3 or higher AEs from aMILs harvest to 60 days following ASCT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      70
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      31
      num Events
      2
    term
    Back Pain
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    Grade 3 or higher AEs from aMILs harvest to 60 days following ASCT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      70
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      31
      num Events
      0
    term
    Pancytopenia
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    Grade 3 or higher AEs from aMILs harvest to 60 days following ASCT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      70
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      31
      num Events
      0
    term
    Bone Pain
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    Grade 3 or higher AEs from aMILs harvest to 60 days following ASCT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      70
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      31
      num Events
      0
    term
    Colitis
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    Grade 3 or higher AEs from aMILs harvest to 60 days following ASCT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      70
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      31
      num Events
      0
    term
    dehydration
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    Grade 3 or higher AEs from aMILs harvest to 60 days following ASCT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      70
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      31
      num Events
      1
    term
    Device related infection
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    Grade 3 or higher AEs from aMILs harvest to 60 days following ASCT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      70
      num Events
      8
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      31
      num Events
      1
    term
    Diarrhea
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    Grade 3 or higher AEs from aMILs harvest to 60 days following ASCT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      70
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      31
      num Events
      1
    term
    Enterocolitis 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
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Product Issues
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      70
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      31
      num Events
      0
    term
    manufacture failure
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Product Issues
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      70
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      31
      num Events
      0
    term
    product contamination
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    63 participants in the aMILs Arm had infusions, of those, 8 had record of infusion reaction.
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      63
      num Events
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      31
      num Events
      0
    term
    infusion related reaction
Complete source fields
event Groups
  1. deaths Num Affected
    1
    deaths Num At Risk
    70
    description
    Patients receive activated Marrow Infiltrating Lymphocytes (aMIL) aMIL: On day 0, patients will receive auto transplant followed by Tadalafil and aMIL. At day 60, patients will receive Lenalidomide.
    id
    EG000
    other Num Affected
    11
    other Num At Risk
    70
    serious Num Affected
    64
    serious Num At Risk
    70
    title
    aMIL Arm
  2. deaths Num Affected
    1
    deaths Num At Risk
    31
    description
    Patients do not receive activated Marrow Infiltrating Lymphocytes (aMIL) No aMIL: On day 0, patients will receive auto transplant followed by Tadalafil. At day 60, patients will receive Lenalidomide.
    id
    EG001
    other Num Affected
    0
    other Num At Risk
    31
    serious Num Affected
    29
    serious Num At Risk
    31
    title
    No aMIL
frequency Threshold
0
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Product Issues
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      70
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      31
      num Events
      0
    term
    manufacture failure
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Product Issues
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      70
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      31
      num Events
      0
    term
    product contamination
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    63 participants in the aMILs Arm had infusions, of those, 8 had record of infusion reaction.
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      63
      num Events
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      31
      num Events
      0
    term
    infusion related reaction
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    Grade 3 or higher Adverse Events (AEs) from aMILs harvest to 60 days following autologous stem cell transplant (ASCT)
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      36
      num At Risk
      70
      num Events
      45
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      31
      num Events
      22
    term
    Febrile neutropenia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    Grade 3 or higher AEs from aMILs harvest to 60 days following ASCT
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      70
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      31
      num Events
      1
    term
    Acute Kidney Injury
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    Grade 3 or higher AEs from aMILs harvest to 60 days following ASCT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      70
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      31
      num Events
      0
    term
    Anemia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    Grade 3 or higher AEs from aMILs harvest to 60 days following ASCT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      70
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      31
      num Events
      2
    term
    Atrial Fibrillation
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    Grade 3 or higher AEs from aMILs harvest to 60 days following ASCT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      70
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      31
      num Events
      2
    term
    Back Pain
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    Grade 3 or higher AEs from aMILs harvest to 60 days following ASCT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      70
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      31
      num Events
      0
    term
    Pancytopenia
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    Grade 3 or higher AEs from aMILs harvest to 60 days following ASCT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      70
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      31
      num Events
      0
    term
    Bone Pain
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    Grade 3 or higher AEs from aMILs harvest to 60 days following ASCT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      70
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      31
      num Events
      0
    term
    Colitis
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    Grade 3 or higher AEs from aMILs harvest to 60 days following ASCT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      70
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      31
      num Events
      0
    term
    dehydration
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    Grade 3 or higher AEs from aMILs harvest to 60 days following ASCT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      70
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      31
      num Events
      1
    term
    Device related infection
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    Grade 3 or higher AEs from aMILs harvest to 60 days following ASCT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      70
      num Events
      8
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      31
      num Events
      1
    term
    Diarrhea
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    Grade 3 or higher AEs from aMILs harvest to 60 days following ASCT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      70
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      31
      num Events
      1
    term
    Enterocolitis infection
time Frame
60 Days from aMILs harvest until Day 60 after transplant

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

Preserved source evidence · Not medical advice