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NCT00784823 · ADVERSE EVENTS

Adverse events

Study Combining Bortezomib With High Dose Melphalan to Treat Multiple Myeloma · Source last updated 2022-08-11

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
0%

The limited number of patients limited our ability to analyze groups separately for adverse event reporting. As a result, adverse events were collected irrespective of dose and therefore cannot be separated further.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Phase I Cohort

Bortezomib was dose escalated at 1, 1.3, and 1.6 mg/m2 (3 × 3 design) on days -4 and -1 before transplantation with melphalan 200 mg/m2 given on day -2.

6 / 1212 / 12Not reported / Not reported
Phase II Cohort

Bortezomib 1.6 mg/m2 (3 × 3 design) on days -4 and -1 before transplantation with melphalan 200 mg/m2 given on day -2.

6 / 2020 / 20Not reported / Not reported

Group identifiers: EG000: Phase I Cohort · EG001: Phase II Cohort

Serious adverse events

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

  1. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      20
    term
    Death
  2. organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
    term
    Seizure
  3. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
    term
    Diarrhea
  4. organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      20
    term
    ICU Admission For Respiratory Distress
  5. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
    term
    Engraftment Syndrome
  6. organ System
    Immune system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      20
    term
    Guillain-Barre Syndrome
  7. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
    term
    Neutropenic Fever
  8. organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      20
    term
    Pulmonary Embolus

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
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
    term
    Hypotension
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      20
    term
    Hypertension
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      20
    term
    Nausea
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      20
    term
    Diarrhea
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      20
    term
    Vomiting
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      20
    term
    Anorexia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      20
    term
    Mucositis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
    term
    Esophagitis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      20
    term
    Dysphagia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      20
    term
    Pancreatitis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      20
    term
    Pancreatic Enzyme Elevations
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      20
    term
    Neuropathy
Complete source fields
description
The limited number of patients limited our ability to analyze groups separately for adverse event reporting. As a result, adverse events were collected irrespective of dose and therefore cannot be separated further.
event Groups
  1. description
    Bortezomib was dose escalated at 1, 1.3, and 1.6 mg/m2 (3 × 3 design) on days -4 and -1 before transplantation with melphalan 200 mg/m2 given on day -2.
    id
    EG000
    other Num Affected
    12
    other Num At Risk
    12
    serious Num Affected
    6
    serious Num At Risk
    12
    title
    Phase I Cohort
  2. description
    Bortezomib 1.6 mg/m2 (3 × 3 design) on days -4 and -1 before transplantation with melphalan 200 mg/m2 given on day -2.
    id
    EG001
    other Num Affected
    20
    other Num At Risk
    20
    serious Num Affected
    6
    serious Num At Risk
    20
    title
    Phase II Cohort
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
    term
    Hypotension
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      20
    term
    Hypertension
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      20
    term
    Nausea
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      20
    term
    Diarrhea
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      20
    term
    Vomiting
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      20
    term
    Anorexia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      20
    term
    Mucositis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
    term
    Esophagitis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      20
    term
    Dysphagia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      20
    term
    Pancreatitis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      20
    term
    Pancreatic Enzyme Elevations
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      20
    term
    Neuropathy
serious Events
  1. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      20
    term
    Death
  2. organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
    term
    Seizure
  3. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
    term
    Diarrhea
  4. organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      20
    term
    ICU Admission For Respiratory Distress
  5. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
    term
    Engraftment Syndrome
  6. organ System
    Immune system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      20
    term
    Guillain-Barre Syndrome
  7. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
    term
    Neutropenic Fever
  8. organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      20
    term
    Pulmonary Embolus

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