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NCT01131169 · ADVERSE EVENTS

Adverse events

Busulfan, Melphalan, Fludarabine and T-Cell Depleted Allogeneic Hematopoietic Stem Cell Transplantation Followed by Post Transplantation Donor Lymphocyte Infusions · Source last updated 2021-12-02

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
Through study completion, an average of 3 years
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Relapsed Multiple Myeloma

This is a two arm phase II trial to assess the progression-free and overall survival as well as the safety and efficacy of allogeneic hematopoietic stem cell transplantation using a preparative regimen with busulfan, melphalan, fludarabine, and anti-thymocyte globulin (ATG), and a T cell depleted stem cell transplant from a histocompatible related or unrelated donor in patients with relapsed or high-risk multiple myeloma

29 / 4747 / 4717 / 47
High-risk Multiple Myeloma

This is a two arm phase II trial to assess the progression-free and overall survival as well as the safety and efficacy of allogeneic hematopoietic stem cell transplantation using a preparative regimen with busulfan, melphalan, fludarabine, and anti-thymocyte globulin (ATG), and a T cell depleted stem cell transplant from a histocompatible related or unrelated donor in patients with relapsed or high-risk multiple myeloma.

11 / 1919 / 199 / 19

Group identifiers: EG000: Relapsed Multiple Myeloma · EG001: High-risk Multiple Myeloma

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
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      19
    term
    Abdominal pain
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    term
    Acute kidney injury
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      19
    term
    Alanine aminotransferase increased
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      19
    term
    Alkaline phosphatase increased
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      19
    term
    Anemia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      19
    term
    Aspartate aminotransferase increased
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    term
    Back pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      19
    term
    Blood bilirubin increased
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    term
    Cardiac disorders - Other, specify
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    term
    Catheter related infection
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    term
    Confusion
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      19
    term
    Creatinine increased

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
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    term
    Hypomagnesemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    term
    Hypotension
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    term
    Pain
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    term
    Renal and urinary disorders - Other, specify
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      19
    term
    Fatigue
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      19
    term
    Hypoglycemia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      19
    term
    Weight loss
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      19
    term
    Mucositis oral
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    term
    Hypertriglyceridemia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      19
    term
    Hypermagnesemia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      19
    term
    Anorexia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      19
    term
    Activated partial thromboplastin time prolonged
Complete source fields
event Groups
  1. deaths Num Affected
    17
    deaths Num At Risk
    47
    description
    This is a two arm phase II trial to assess the progression-free and overall survival as well as the safety and efficacy of allogeneic hematopoietic stem cell transplantation using a preparative regimen with busulfan, melphalan, fludarabine, and anti-thymocyte globulin (ATG), and a T cell depleted stem cell transplant from a histocompatible related or unrelated donor in patients with relapsed or high-risk multiple myeloma
    id
    EG000
    other Num Affected
    47
    other Num At Risk
    47
    serious Num Affected
    29
    serious Num At Risk
    47
    title
    Relapsed Multiple Myeloma
  2. deaths Num Affected
    9
    deaths Num At Risk
    19
    description
    This is a two arm phase II trial to assess the progression-free and overall survival as well as the safety and efficacy of allogeneic hematopoietic stem cell transplantation using a preparative regimen with busulfan, melphalan, fludarabine, and anti-thymocyte globulin (ATG), and a T cell depleted stem cell transplant from a histocompatible related or unrelated donor in patients with relapsed or high-risk multiple myeloma.
    id
    EG001
    other Num Affected
    19
    other Num At Risk
    19
    serious Num Affected
    11
    serious Num At Risk
    19
    title
    High-risk Multiple Myeloma
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    term
    Hypomagnesemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    term
    Hypotension
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    term
    Pain
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    term
    Renal and urinary disorders - Other, specify
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      19
    term
    Fatigue
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      19
    term
    Hypoglycemia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      19
    term
    Weight loss
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      19
    term
    Mucositis oral
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    term
    Hypertriglyceridemia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      19
    term
    Hypermagnesemia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      19
    term
    Anorexia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      19
    term
    Activated partial thromboplastin time prolonged
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      19
    term
    Abdominal pain
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    term
    Acute kidney injury
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      19
    term
    Alanine aminotransferase increased
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      19
    term
    Alkaline phosphatase increased
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      19
    term
    Anemia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      19
    term
    Aspartate aminotransferase increased
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    term
    Back pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      19
    term
    Blood bilirubin increased
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    term
    Cardiac disorders - Other, specify
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    term
    Catheter related infection
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    term
    Confusion
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      19
    term
    Creatinine increased
time Frame
Through study completion, an average of 3 years

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Preserved source evidence · Not medical advice