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NCT00064337 · ADVERSE EVENTS

Adverse events

S0115, High-Dose Melphalan and Autologous Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma or Primary Systemic Amyloidosis · Source last updated 2018-08-09

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
PBSCC or Induction/PBSCC

Induction/PBSCC - High Risk MM or MM with Light Chain Amyloidosis/Light Chain Disposition; PBSCC - Light Chain Amyloidosis/Light Chain Disposition

4 / 9283 / 92Not reported / Not reported
Autologous Transplants

Autologous Transplants � All patients

3 / 6562 / 65Not reported / Not reported
Dex/Thal

Dex/Thal - High Risk MM or MM with Light Chain Amyloidosis/Light Chain Disposition

1 / 1212 / 12Not reported / Not reported

Group identifiers: EG000: PBSCC or Induction/PBSCC · EG001: Autologous Transplants · EG002: Dex/Thal

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
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      92
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      65
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    term
    Cardiac General-Other
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      92
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      65
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    term
    Cardiac-ischemia/infarction
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      92
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      65
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    term
    Left ventricular diastolic dysfunction
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      92
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      65
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    term
    SVT and nodal arrhythmia - Nodal/junctional
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      92
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      65
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    term
    Constitutional Symptoms-Other
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      92
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      65
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    term
    Cardiac troponin I (cTnI)
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      92
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      65
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      12
    term
    Death - Disease progression NOS
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      92
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      65
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    term
    Renal failure

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
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      92
    2. group Id
      EG001
      num Affected
      20
      num At Risk
      65
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    term
    Febrile neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      43
      num At Risk
      92
    2. group Id
      EG001
      num Affected
      48
      num At Risk
      65
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      12
    term
    Hemoglobin
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      92
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      65
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    term
    Lymphatics-Other
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      92
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      65
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    term
    Cardiac Arrhythmia-Other
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      92
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      65
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    term
    Cardiac General-Other
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      92
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      65
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      12
    term
    Auditory/Ear-Other
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      92
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      65
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      12
    term
    Cushingoid appearance
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      92
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      65
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      12
    term
    Dry eye syndrome
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      92
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      65
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      12
    term
    Ocular/Visual-Other
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      92
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      65
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      12
    term
    Vision-blurred vision
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      92
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      65
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      12
    term
    Constipation
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      92
    2. group Id
      EG001
      num Affected
      41
      num At Risk
      65
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      12
    term
    Diarrhea
Complete source fields
event Groups
  1. description
    Induction/PBSCC - High Risk MM or MM with Light Chain Amyloidosis/Light Chain Disposition; PBSCC - Light Chain Amyloidosis/Light Chain Disposition
    id
    EG000
    other Num Affected
    83
    other Num At Risk
    92
    serious Num Affected
    4
    serious Num At Risk
    92
    title
    PBSCC or Induction/PBSCC
  2. description
    Autologous Transplants � All patients
    id
    EG001
    other Num Affected
    62
    other Num At Risk
    65
    serious Num Affected
    3
    serious Num At Risk
    65
    title
    Autologous Transplants
  3. description
    Dex/Thal - High Risk MM or MM with Light Chain Amyloidosis/Light Chain Disposition
    id
    EG002
    other Num Affected
    12
    other Num At Risk
    12
    serious Num Affected
    1
    serious Num At Risk
    12
    title
    Dex/Thal
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      92
    2. group Id
      EG001
      num Affected
      20
      num At Risk
      65
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    term
    Febrile neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      43
      num At Risk
      92
    2. group Id
      EG001
      num Affected
      48
      num At Risk
      65
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      12
    term
    Hemoglobin
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      92
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      65
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    term
    Lymphatics-Other
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      92
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      65
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    term
    Cardiac Arrhythmia-Other
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      92
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      65
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    term
    Cardiac General-Other
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      92
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      65
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      12
    term
    Auditory/Ear-Other
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      92
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      65
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      12
    term
    Cushingoid appearance
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      92
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      65
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      12
    term
    Dry eye syndrome
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      92
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      65
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      12
    term
    Ocular/Visual-Other
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      92
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      65
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      12
    term
    Vision-blurred vision
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      92
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      65
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      12
    term
    Constipation
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      92
    2. group Id
      EG001
      num Affected
      41
      num At Risk
      65
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      12
    term
    Diarrhea
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      92
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      65
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    term
    Cardiac General-Other
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      92
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      65
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    term
    Cardiac-ischemia/infarction
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      92
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      65
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    term
    Left ventricular diastolic dysfunction
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      92
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      65
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    term
    SVT and nodal arrhythmia - Nodal/junctional
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      92
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      65
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    term
    Constitutional Symptoms-Other
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      92
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      65
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    term
    Cardiac troponin I (cTnI)
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      92
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      65
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      12
    term
    Death - Disease progression NOS
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      92
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      65
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    term
    Renal failure

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