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NCT01383759 · ADVERSE EVENTS

Adverse events

Bortezomib/Dexamethasone (BD), Followed By Autologous Stem Cell Transplantation and Maintenance Bortezomib/Dexamethasone For the Initial Treatment of Monoclonal Immunoglobulin Deposition Disease (MIDD) Associated With Multiple Myeloma and AL Amyloidosis · Source last updated 2020-04-07

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
1 year
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Amyloidosis

Participants with newly diagnosed AL amyloidosis

17 / 1919 / 197 / 19
Monoclonal Ig DepositionDisease (MIDD)

Participants with newly diagnosed Monoclonal Ig DepositionDisease (MIDD)

1 / 11 / 10 / 1

Group identifiers: EG000: Amyloidosis · EG001: Monoclonal Ig DepositionDisease (MIDD)

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
    Injury, poisoning and procedural complications
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      19
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    term
    Fall
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      19
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    term
    Hypoxia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      19
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    term
    Syncope
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      19
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    term
    Diarrhea
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      19
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    term
    Dehydration
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      19
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      1
    term
    Hip fracture
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      19
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    term
    Hypokalemia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      19
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    term
    Hypotension
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      19
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    term
    Constipation
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      19
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    term
    Hyperkalemia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      19
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    term
    Hypertension
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      19
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    term
    Abdominal pain

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
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      19
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    term
    Abdominal pain
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      19
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    term
    Activated partial thromboplastin time prolonged
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      19
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      1
    term
    Alanine aminotransferase increased
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      19
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      1
    term
    Alkaline phosphatase increased
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      19
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    term
    Allergic reaction
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      19
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    term
    Allergic rhinitis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      19
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    term
    Anemia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      19
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    term
    Anxiety
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      19
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    term
    Arthralgia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      19
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      1
    term
    Aspartate aminotransferase increased
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      19
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    term
    Atrial fibrillation
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      19
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      1
    term
    Back pain
Complete source fields
event Groups
  1. deaths Num Affected
    7
    deaths Num At Risk
    19
    description
    Participants with newly diagnosed AL amyloidosis
    id
    EG000
    other Num Affected
    19
    other Num At Risk
    19
    serious Num Affected
    17
    serious Num At Risk
    19
    title
    Amyloidosis
  2. deaths Num Affected
    0
    deaths Num At Risk
    1
    description
    Participants with newly diagnosed Monoclonal Ig DepositionDisease (MIDD)
    id
    EG001
    other Num Affected
    1
    other Num At Risk
    1
    serious Num Affected
    1
    serious Num At Risk
    1
    title
    Monoclonal Ig DepositionDisease (MIDD)
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      19
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    term
    Abdominal pain
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      19
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    term
    Activated partial thromboplastin time prolonged
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      19
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      1
    term
    Alanine aminotransferase increased
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      19
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      1
    term
    Alkaline phosphatase increased
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      19
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    term
    Allergic reaction
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      19
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    term
    Allergic rhinitis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      19
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    term
    Anemia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      19
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    term
    Anxiety
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      19
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    term
    Arthralgia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      19
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      1
    term
    Aspartate aminotransferase increased
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      19
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    term
    Atrial fibrillation
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      19
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      1
    term
    Back pain
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      19
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    term
    Fall
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      19
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    term
    Hypoxia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      19
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    term
    Syncope
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      19
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    term
    Diarrhea
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      19
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    term
    Dehydration
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      19
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      1
    term
    Hip fracture
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      19
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    term
    Hypokalemia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      19
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    term
    Hypotension
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      19
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    term
    Constipation
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      19
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    term
    Hyperkalemia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      19
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    term
    Hypertension
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      19
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    term
    Abdominal pain
time Frame
1 year

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