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NCT00792142 · ADVERSE EVENTS

Adverse events

Bortezomib, Thalidomide, and Dexamethasone After Melphalan and Stem Cell Transplant in Treating Patients With Stage I-III Multiple Myeloma · Source last updated 2021-08-19

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
Adverse events were collected over a period of 3 years and 11 months.
Other-event reporting threshold
0%

"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Treatment (Stem Cell Transplant, Maintenance Treatment)

Patients receive high-dose melphalan IV 200mg/m\^2 over 30 minutes on days -2 and -1 and undergo autologous peripheral blood stem cell transplantation (Minimum dose of 2 X 10(6) CD34 + cells/kg ) on day 0. Patients receive filgrastim 5ug/kg IV or SQ beginning on day 5 and continuing until blood counts recover. Beginning 4 to 8 weeks after transplantation, patients receive maintenance therapy comprising 1.3 mg/m\^2 of bortezomib IV on days 1, 8, and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients also receive 40mg of oral dexamethasone on days 1 to 4. Treatment with dexamethasone repeats every month for 12 months in the absence of disease progression or unacceptable toxicity. Beginning 2 weeks after completion of bortezomib, patients receive 50mg/day of oral thalidomide once daily until disease progression.

9 / 4540 / 45Not reported / Not reported

Group identifiers: EG000: Treatment (Stem Cell Transplant, Maintenance Treatment)

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
    Cardiac disorders
    source Vocabulary
    meddra10.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      45
      num Events
      1
    term
    Myocardial ischemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    meddra10.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      45
      num Events
      1
    term
    Sinus bradycardia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    meddra10.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      45
      num Events
      1
    term
    Gastrointestinal disorder
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    meddra10.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      45
      num Events
      1
    term
    Disease progression
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    meddra10.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      45
      num Events
      1
    term
    Bronchitis
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    meddra10.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      45
      num Events
      1
    term
    Peripheral nerve infection
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    meddra10.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      45
      num Events
      1
    term
    Serum phosphate decreased
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    meddra10.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      45
      num Events
      1
    term
    Chest wall pain
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    meddra10.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      45
      num Events
      1
    term
    Headache
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    meddra10.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      45
      num Events
      1
    term
    Vascular disorder

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
    meddra10.0
    stats
    1. group Id
      EG000
      num Affected
      31
      num At Risk
      45
      num Events
      143
    term
    Hemoglobin decreased
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    meddra10.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      45
      num Events
      1
    term
    Hemolysis
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    meddra10.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      45
      num Events
      2
    term
    Lymphatic disorder
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    meddra10.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      45
      num Events
      1
    term
    Palpitations
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    meddra10.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      45
      num Events
      4
    term
    Sinus bradycardia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    meddra10.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      45
      num Events
      1
    term
    Ear disorder
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    meddra10.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      45
      num Events
      1
    term
    Ear pain
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    meddra10.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      45
      num Events
      1
    term
    External ear pain
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    meddra10.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      45
      num Events
      10
    term
    Hearing loss
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    meddra10.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      45
      num Events
      2
    term
    Tinnitus
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    meddra10.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      45
      num Events
      3
    term
    Cataract
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    meddra10.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      45
      num Events
      2
    term
    Dry eye syndrome
Complete source fields
description
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
event Groups
  1. description
    Patients receive high-dose melphalan IV 200mg/m\^2 over 30 minutes on days -2 and -1 and undergo autologous peripheral blood stem cell transplantation (Minimum dose of 2 X 10(6) CD34 + cells/kg ) on day 0. Patients receive filgrastim 5ug/kg IV or SQ beginning on day 5 and continuing until blood counts recover. Beginning 4 to 8 weeks after transplantation, patients receive maintenance therapy comprising 1.3 mg/m\^2 of bortezomib IV on days 1, 8, and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients also receive 40mg of oral dexamethasone on days 1 to 4. Treatment with dexamethasone repeats every month for 12 months in the absence of disease progression or unacceptable toxicity. Beginning 2 weeks after completion of bortezomib, patients receive 50mg/day of oral thalidomide once daily until disease progression.
    id
    EG000
    other Num Affected
    40
    other Num At Risk
    45
    serious Num Affected
    9
    serious Num At Risk
    45
    title
    Treatment (Stem Cell Transplant, Maintenance Treatment)
frequency Threshold
0
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    meddra10.0
    stats
    1. group Id
      EG000
      num Affected
      31
      num At Risk
      45
      num Events
      143
    term
    Hemoglobin decreased
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    meddra10.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      45
      num Events
      1
    term
    Hemolysis
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    meddra10.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      45
      num Events
      2
    term
    Lymphatic disorder
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    meddra10.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      45
      num Events
      1
    term
    Palpitations
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    meddra10.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      45
      num Events
      4
    term
    Sinus bradycardia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    meddra10.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      45
      num Events
      1
    term
    Ear disorder
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    meddra10.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      45
      num Events
      1
    term
    Ear pain
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    meddra10.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      45
      num Events
      1
    term
    External ear pain
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    meddra10.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      45
      num Events
      10
    term
    Hearing loss
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    meddra10.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      45
      num Events
      2
    term
    Tinnitus
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    meddra10.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      45
      num Events
      3
    term
    Cataract
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    meddra10.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      45
      num Events
      2
    term
    Dry eye syndrome
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    meddra10.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      45
      num Events
      1
    term
    Myocardial ischemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    meddra10.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      45
      num Events
      1
    term
    Sinus bradycardia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    meddra10.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      45
      num Events
      1
    term
    Gastrointestinal disorder
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    meddra10.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      45
      num Events
      1
    term
    Disease progression
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    meddra10.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      45
      num Events
      1
    term
    Bronchitis
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    meddra10.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      45
      num Events
      1
    term
    Peripheral nerve infection
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    meddra10.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      45
      num Events
      1
    term
    Serum phosphate decreased
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    meddra10.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      45
      num Events
      1
    term
    Chest wall pain
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    meddra10.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      45
      num Events
      1
    term
    Headache
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    meddra10.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      45
      num Events
      1
    term
    Vascular disorder
time Frame
Adverse events were collected over a period of 3 years and 11 months.

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Preserved source evidence · Not medical advice