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NCT01241708 · ADVERSE EVENTS

Adverse events

Tandem Auto Stem Cell Transplant With Melphalan Followed by Melphalan and Bortezomib in Patients With Multiple Myeloma · Source last updated 2025-09-17

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
All-Cause Mortality was assessed for up to 3 years. Serious Adverse Events were assessed up to 100 days after bone marrow transplant
Other-event reporting threshold
0%

SAEs are reported through 100 days after bone marrow transplant. Other (Not Including Serious) Adverse Events were not analyzed

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Tandem Transplantation With Melphalan and Bortezomib

Tandem autologous hematopoietic stem cell transplantation with melphalan followed by melphalan and bortezomib in patients with multiple myeloma Bortezomib: Bortezomib 1.6mg/m2 on day -4 and day -1

67 / 1420 / 046 / 142

Group identifiers: EG000: Tandem Transplantation With Melphalan and Bortezomib

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
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      142
    term
    Febrile Neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      142
    term
    Infection
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      26
      num At Risk
      142
    term
    Disease Progression
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      142
    term
    Fever
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      142
    term
    Engraftment Syndrome
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      142
    term
    Failure to Thrive
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      142
    term
    RSV
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      142
    term
    Nausea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      142
    term
    Diarrhea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      142
    term
    Perrirectal Abcess
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      142
    term
    Subdermal Hematoma
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      142
    term
    Acute Renal Insufficiency

Other reported adverse events

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

    Complete source fields
    description
    SAEs are reported through 100 days after bone marrow transplant. Other (Not Including Serious) Adverse Events were not analyzed
    event Groups
    1. deaths Num Affected
      46
      deaths Num At Risk
      142
      description
      Tandem autologous hematopoietic stem cell transplantation with melphalan followed by melphalan and bortezomib in patients with multiple myeloma Bortezomib: Bortezomib 1.6mg/m2 on day -4 and day -1
      id
      EG000
      other Num Affected
      0
      other Num At Risk
      0
      serious Num Affected
      67
      serious Num At Risk
      142
      title
      Tandem Transplantation With Melphalan and Bortezomib
    frequency Threshold
    0
    serious Events
    1. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Blood and lymphatic system disorders
      stats
      1. group Id
        EG000
        num Affected
        3
        num At Risk
        142
      term
      Febrile Neutropenia
    2. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Infections and infestations
      stats
      1. group Id
        EG000
        num Affected
        15
        num At Risk
        142
      term
      Infection
    3. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Investigations
      stats
      1. group Id
        EG000
        num Affected
        26
        num At Risk
        142
      term
      Disease Progression
    4. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Investigations
      stats
      1. group Id
        EG000
        num Affected
        3
        num At Risk
        142
      term
      Fever
    5. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Immune system disorders
      stats
      1. group Id
        EG000
        num Affected
        4
        num At Risk
        142
      term
      Engraftment Syndrome
    6. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Investigations
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        142
      term
      Failure to Thrive
    7. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Infections and infestations
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        142
      term
      RSV
    8. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        142
      term
      Nausea
    9. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        142
      term
      Diarrhea
    10. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Infections and infestations
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        142
      term
      Perrirectal Abcess
    11. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Vascular disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        142
      term
      Subdermal Hematoma
    12. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Renal and urinary disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        142
      term
      Acute Renal Insufficiency
    time Frame
    All-Cause Mortality was assessed for up to 3 years. Serious Adverse Events were assessed up to 100 days after bone marrow transplant

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    Preserved source evidence · Not medical advice