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NCT00580372 · ADVERSE EVENTS

Adverse events

UARK 89-001 Phase II Study of Intensive "TOTAL THERAPY" For Untreated or Minimally Treated Patients With Multiple Myeloma · Source last updated 2016-09-20

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
Not reported
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Study Treatment

Protocol therapy consists of a remission induction phase with mutually non-cross resistant combinations of vincristine, adriamycin, dexamethasone (VAD), high-dose cyclophosphamide with stem cell procurement and etoposide, dexamethasone, cytarabine, cisplatin (EDAP) followed by two courses of melphalan-based high-dose therapy supported by autologous stem cell transplants 4-6 months apart. Maintenance with interferon alpha will be administered until disease progression. VAD: 3 Cycles (3rd cycle optional): Vincristine 0.5 mg/d d 1 - 4 CI Adriamycin 10 mg/m2/d d 1 - 4 CI Dexamethasone 40 mg/d d 1-4, 9-12, 17-20 High-Dose cyclophosphamide: Approximately 5-6 weeks after VAD 2 or 3: Cytoxan 1.2g/m2/d d 1 - 5 Mesna 3.6 g/m2 d 1 Hemopoietic stem cell procurement: Collection target = 10 x 10\^6 cells/kg EDAP: Approximately 5-6 weeks after high-dose cyclophosphamide

231 / 231231 / 231Not reported / Not reported

Group identifiers: EG000: Study Treatment

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      155
      num At Risk
      231
    term
    Blood/bone marrow Grade 4
  2. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      231
    term
    Anemia Grade 4
  3. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      136
      num At Risk
      231
    term
    Neutropeni Grade 4
  4. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      150
      num At Risk
      231
    term
    WBC Grade 4
  5. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      37
      num At Risk
      231
    term
    Thrombocyt Grade 4
  6. organ System
    Endocrine disorders
    stats
    1. group Id
      EG000
      num Affected
      41
      num At Risk
      231
    term
    Hepatobiliary/pancreas grade 3
  7. organ System
    Endocrine disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      231
    term
    Hepatobiliary/pancreas grade 4
  8. organ System
    Endocrine disorders
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      231
    term
    Alkaline grade 3
  9. organ System
    Endocrine disorders
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      231
    term
    Bilirubin grade 3
  10. organ System
    Endocrine disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      231
    term
    Bilirubin grade 4
  11. organ System
    Endocrine disorders
    stats
    1. group Id
      EG000
      num Affected
      26
      num At Risk
      231
    term
    Hypoalbumi grade 3
  12. organ System
    Endocrine disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      231
    term
    SGOT (AST) grade 3

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      52
      num At Risk
      231
    term
    Anemia grade 2
  2. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      34
      num At Risk
      231
    term
    Thrombocyt grade 2
  3. organ System
    Endocrine disorders
    stats
    1. group Id
      EG000
      num Affected
      30
      num At Risk
      231
    term
    Hepatobiliary/ pancreas grade 1
  4. organ System
    Endocrine disorders
    stats
    1. group Id
      EG000
      num Affected
      138
      num At Risk
      231
    term
    Hepatobiliary/pancreas grade 2
  5. organ System
    Endocrine disorders
    stats
    1. group Id
      EG000
      num Affected
      70
      num At Risk
      231
    term
    Alkaline grade 1
  6. organ System
    Endocrine disorders
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      231
    term
    Alkaline grade 2
  7. organ System
    Endocrine disorders
    stats
    1. group Id
      EG000
      num Affected
      38
      num At Risk
      231
    term
    Bilirubin grade 1
  8. organ System
    Endocrine disorders
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      231
    term
    Bilirubin grade 2
  9. organ System
    Endocrine disorders
    stats
    1. group Id
      EG000
      num Affected
      34
      num At Risk
      231
    term
    Hypoalbumi grade 1
  10. organ System
    Endocrine disorders
    stats
    1. group Id
      EG000
      num Affected
      150
      num At Risk
      231
    term
    Hypoalbumi grade 2
  11. organ System
    Endocrine disorders
    stats
    1. group Id
      EG000
      num Affected
      78
      num At Risk
      231
    term
    SGOT (AST) grade 1
  12. organ System
    Endocrine disorders
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      231
    term
    SGOT (AST) grade 2
Complete source fields
event Groups
  1. description
    Protocol therapy consists of a remission induction phase with mutually non-cross resistant combinations of vincristine, adriamycin, dexamethasone (VAD), high-dose cyclophosphamide with stem cell procurement and etoposide, dexamethasone, cytarabine, cisplatin (EDAP) followed by two courses of melphalan-based high-dose therapy supported by autologous stem cell transplants 4-6 months apart. Maintenance with interferon alpha will be administered until disease progression. VAD: 3 Cycles (3rd cycle optional): Vincristine 0.5 mg/d d 1 - 4 CI Adriamycin 10 mg/m2/d d 1 - 4 CI Dexamethasone 40 mg/d d 1-4, 9-12, 17-20 High-Dose cyclophosphamide: Approximately 5-6 weeks after VAD 2 or 3: Cytoxan 1.2g/m2/d d 1 - 5 Mesna 3.6 g/m2 d 1 Hemopoietic stem cell procurement: Collection target = 10 x 10\^6 cells/kg EDAP: Approximately 5-6 weeks after high-dose cyclophosphamide
    id
    EG000
    other Num Affected
    231
    other Num At Risk
    231
    serious Num Affected
    231
    serious Num At Risk
    231
    title
    Study Treatment
frequency Threshold
5
other Events
  1. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      52
      num At Risk
      231
    term
    Anemia grade 2
  2. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      34
      num At Risk
      231
    term
    Thrombocyt grade 2
  3. organ System
    Endocrine disorders
    stats
    1. group Id
      EG000
      num Affected
      30
      num At Risk
      231
    term
    Hepatobiliary/ pancreas grade 1
  4. organ System
    Endocrine disorders
    stats
    1. group Id
      EG000
      num Affected
      138
      num At Risk
      231
    term
    Hepatobiliary/pancreas grade 2
  5. organ System
    Endocrine disorders
    stats
    1. group Id
      EG000
      num Affected
      70
      num At Risk
      231
    term
    Alkaline grade 1
  6. organ System
    Endocrine disorders
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      231
    term
    Alkaline grade 2
  7. organ System
    Endocrine disorders
    stats
    1. group Id
      EG000
      num Affected
      38
      num At Risk
      231
    term
    Bilirubin grade 1
  8. organ System
    Endocrine disorders
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      231
    term
    Bilirubin grade 2
  9. organ System
    Endocrine disorders
    stats
    1. group Id
      EG000
      num Affected
      34
      num At Risk
      231
    term
    Hypoalbumi grade 1
  10. organ System
    Endocrine disorders
    stats
    1. group Id
      EG000
      num Affected
      150
      num At Risk
      231
    term
    Hypoalbumi grade 2
  11. organ System
    Endocrine disorders
    stats
    1. group Id
      EG000
      num Affected
      78
      num At Risk
      231
    term
    SGOT (AST) grade 1
  12. organ System
    Endocrine disorders
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      231
    term
    SGOT (AST) grade 2
serious Events
  1. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      155
      num At Risk
      231
    term
    Blood/bone marrow Grade 4
  2. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      231
    term
    Anemia Grade 4
  3. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      136
      num At Risk
      231
    term
    Neutropeni Grade 4
  4. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      150
      num At Risk
      231
    term
    WBC Grade 4
  5. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      37
      num At Risk
      231
    term
    Thrombocyt Grade 4
  6. organ System
    Endocrine disorders
    stats
    1. group Id
      EG000
      num Affected
      41
      num At Risk
      231
    term
    Hepatobiliary/pancreas grade 3
  7. organ System
    Endocrine disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      231
    term
    Hepatobiliary/pancreas grade 4
  8. organ System
    Endocrine disorders
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      231
    term
    Alkaline grade 3
  9. organ System
    Endocrine disorders
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      231
    term
    Bilirubin grade 3
  10. organ System
    Endocrine disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      231
    term
    Bilirubin grade 4
  11. organ System
    Endocrine disorders
    stats
    1. group Id
      EG000
      num Affected
      26
      num At Risk
      231
    term
    Hypoalbumi grade 3
  12. organ System
    Endocrine disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      231
    term
    SGOT (AST) grade 3

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Preserved source evidence · Not medical advice