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NCT00948922 · ADVERSE EVENTS

Adverse events

Melphalan+Bortezomib as a Conditioning Regimen for Autologous and Allogeneic Stem Cell Transplants in Multiple Myeloma · Source last updated 2019-09-18

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
7 years, 8 months
Other-event reporting threshold
0%

All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
A: Allogeneic Stem Cell Transplant

Allogeneic Stem Cell Transplant: Fludarabine+Melphalan+Bortezomib followed by Allogeneic Rescue.

13 / 320 / 323 / 32
B: Autologous Stem Cell Transplant

Autologous Stem Cell Transplant: Melphalan+Bortezomib followed by Autologous Rescue.

18 / 421 / 421 / 42
BE: Group B Expansion

Group B Expansion on Bortezomib Maintenance: Autologous Only.

10 / 390 / 390 / 39

Group identifiers: EG000: A: Allogeneic Stem Cell Transplant · EG001: B: Autologous Stem Cell Transplant · EG002: BE: Group B Expansion

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
    organ System
    Immune system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      32
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      39
      num Events
      0
    term
    Allergic reaction
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      32
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      39
      num Events
      0
    term
    Blood/Bone Marrow - Other
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      32
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      39
      num Events
      0
    term
    Haptoglobin
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      32
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      39
      num Events
      0
    term
    Hemolysis
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      32
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      39
      num Events
      2
    term
    Neutrophil count decreased
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      32
      num Events
      0
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      42
      num Events
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      39
      num Events
      0
    term
    Supraventricular and nodal arrhythmia - Atrial fibrillation
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      32
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      39
      num Events
      0
    term
    Cardiac General - Other
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      32
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      39
      num Events
      1
    term
    Cardiopulmonary arrest, cause unknown (non-fatal)
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      32
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      39
      num Events
      0
    term
    Hypotension
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      32
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      39
      num Events
      0
    term
    Fatigue
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      32
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      39
      num Events
      0
    term
    Fever (in the absence of neutropenia)
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      32
      num Events
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      39
      num Events
      0
    term
    Death not associated with CTCAE term

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
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      32
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      39
      num Events
      0
    term
    Lymphopenia
Complete source fields
description
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
event Groups
  1. deaths Num Affected
    3
    deaths Num At Risk
    32
    description
    Allogeneic Stem Cell Transplant: Fludarabine+Melphalan+Bortezomib followed by Allogeneic Rescue.
    id
    EG000
    other Num Affected
    0
    other Num At Risk
    32
    serious Num Affected
    13
    serious Num At Risk
    32
    title
    A: Allogeneic Stem Cell Transplant
  2. deaths Num Affected
    1
    deaths Num At Risk
    42
    description
    Autologous Stem Cell Transplant: Melphalan+Bortezomib followed by Autologous Rescue.
    id
    EG001
    other Num Affected
    1
    other Num At Risk
    42
    serious Num Affected
    18
    serious Num At Risk
    42
    title
    B: Autologous Stem Cell Transplant
  3. deaths Num Affected
    0
    deaths Num At Risk
    39
    description
    Group B Expansion on Bortezomib Maintenance: Autologous Only.
    id
    EG002
    other Num Affected
    0
    other Num At Risk
    39
    serious Num Affected
    10
    serious Num At Risk
    39
    title
    BE: Group B Expansion
frequency Threshold
0
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      32
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      39
      num Events
      0
    term
    Lymphopenia
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      32
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      39
      num Events
      0
    term
    Allergic reaction
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      32
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      39
      num Events
      0
    term
    Blood/Bone Marrow - Other
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      32
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      39
      num Events
      0
    term
    Haptoglobin
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      32
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      39
      num Events
      0
    term
    Hemolysis
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      32
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      39
      num Events
      2
    term
    Neutrophil count decreased
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      32
      num Events
      0
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      42
      num Events
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      39
      num Events
      0
    term
    Supraventricular and nodal arrhythmia - Atrial fibrillation
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      32
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      39
      num Events
      0
    term
    Cardiac General - Other
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      32
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      39
      num Events
      1
    term
    Cardiopulmonary arrest, cause unknown (non-fatal)
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      32
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      39
      num Events
      0
    term
    Hypotension
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      32
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      39
      num Events
      0
    term
    Fatigue
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      32
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      39
      num Events
      0
    term
    Fever (in the absence of neutropenia)
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      32
      num Events
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      39
      num Events
      0
    term
    Death not associated with CTCAE term
time Frame
7 years, 8 months

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