Skip to content
Triangle logo TriangleGet started
← Full study record

NCT00609167 · ADVERSE EVENTS

Adverse events

Cyclophosphamide, Bortezomib, and Dexamethasone in Treating Patients With Newly Diagnosed Multiple Myeloma · Source last updated 2011-05-17

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%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
CyBorD (Bortezomib 1.3mg/m^2)

Bortezomib 1.3mg/m\^2 by IV days 1, 4, 8 \& 11 Cyclophosphamide 300mg/m\^2 PO days 1, 8, 15 \& 22 Dexamethasone 40mg PO days 1-4, 9-12, 17-20

4 / 3333 / 33Not reported / Not reported
CyBorD (Bortezomib 1.5mg/m^2)

Bortezomib 1.5mg/m\^2 by IV days 1, 8, 15 \& 22 Cyclophosphamide 300mg/m\^2 PO days 1, 8, 15 \& 22 Dexamethasone 40mg PO cycle 1-2 days 1-4, 9-12, 17-20, cycle 3 and beyond days 1, 8, 15 \& 22

3 / 3027 / 30Not reported / Not reported

Group identifiers: EG000: CyBorD (Bortezomib 1.3mg/m^2) · EG001: CyBorD (Bortezomib 1.5mg/m^2)

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
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 9
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      30
      num Events
      1
    term
    Febrile neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 9
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
      num Events
      0
    term
    Colonic obstruction
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 9
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
      num Events
      0
    term
    Blood Infection
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 9
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      33
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      30
      num Events
      1
    term
    Lung (pneumonia) infection
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 9
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
      num Events
      0
    term
    Neutrophil count decreased
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA 9
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
      num Events
      0
    term
    Hypercalcemia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA 9
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      33
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      30
      num Events
      1
    term
    Hyponatremia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 9
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      33
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      30
      num Events
      1
    term
    Dyspnea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 9
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      33
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      30
      num Events
      1
    term
    Pneumonitis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 9
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      33
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      30
      num Events
      1
    term
    Pulmonary
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA 9
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
      num Events
      0
    term
    Thrombosis

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
    MedDRA 9
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      33
      num Events
      6
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      30
      num Events
      2
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 9
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      33
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      30
      num Events
      4
    term
    Hemolysis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 9
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
      num Events
      0
    term
    Ischemia/Infarction
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 9
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      33
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      30
      num Events
      1
    term
    Sinus tachycardia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 9
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      33
      num Events
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      30
      num Events
      1
    term
    Constipation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 9
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      33
      num Events
      0
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      30
      num Events
      5
    term
    Diarrhea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 9
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
      num Events
      0
    term
    Dyspepsia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 9
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
      num Events
      0
    term
    Ileus
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 9
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      33
      num Events
      0
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      30
      num Events
      3
    term
    Nausea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 9
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      33
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      30
      num Events
      1
    term
    Vomiting
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 9
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
      num Events
      1
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      30
      num Events
      4
    term
    Edema limbs
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 9
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      33
      num Events
      52
    2. group Id
      EG001
      num Affected
      24
      num At Risk
      30
      num Events
      75
    term
    Fatigue
Complete source fields
event Groups
  1. description
    Bortezomib 1.3mg/m\^2 by IV days 1, 4, 8 \& 11 Cyclophosphamide 300mg/m\^2 PO days 1, 8, 15 \& 22 Dexamethasone 40mg PO days 1-4, 9-12, 17-20
    id
    EG000
    other Num Affected
    33
    other Num At Risk
    33
    serious Num Affected
    4
    serious Num At Risk
    33
    title
    CyBorD (Bortezomib 1.3mg/m^2)
  2. description
    Bortezomib 1.5mg/m\^2 by IV days 1, 8, 15 \& 22 Cyclophosphamide 300mg/m\^2 PO days 1, 8, 15 \& 22 Dexamethasone 40mg PO cycle 1-2 days 1-4, 9-12, 17-20, cycle 3 and beyond days 1, 8, 15 \& 22
    id
    EG001
    other Num Affected
    27
    other Num At Risk
    30
    serious Num Affected
    3
    serious Num At Risk
    30
    title
    CyBorD (Bortezomib 1.5mg/m^2)
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 9
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      33
      num Events
      6
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      30
      num Events
      2
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 9
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      33
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      30
      num Events
      4
    term
    Hemolysis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 9
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
      num Events
      0
    term
    Ischemia/Infarction
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 9
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      33
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      30
      num Events
      1
    term
    Sinus tachycardia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 9
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      33
      num Events
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      30
      num Events
      1
    term
    Constipation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 9
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      33
      num Events
      0
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      30
      num Events
      5
    term
    Diarrhea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 9
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
      num Events
      0
    term
    Dyspepsia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 9
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
      num Events
      0
    term
    Ileus
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 9
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      33
      num Events
      0
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      30
      num Events
      3
    term
    Nausea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 9
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      33
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      30
      num Events
      1
    term
    Vomiting
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 9
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
      num Events
      1
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      30
      num Events
      4
    term
    Edema limbs
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 9
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      33
      num Events
      52
    2. group Id
      EG001
      num Affected
      24
      num At Risk
      30
      num Events
      75
    term
    Fatigue
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 9
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      30
      num Events
      1
    term
    Febrile neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 9
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
      num Events
      0
    term
    Colonic obstruction
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 9
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
      num Events
      0
    term
    Blood Infection
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 9
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      33
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      30
      num Events
      1
    term
    Lung (pneumonia) infection
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 9
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
      num Events
      0
    term
    Neutrophil count decreased
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA 9
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
      num Events
      0
    term
    Hypercalcemia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA 9
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      33
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      30
      num Events
      1
    term
    Hyponatremia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 9
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      33
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      30
      num Events
      1
    term
    Dyspnea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 9
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      33
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      30
      num Events
      1
    term
    Pneumonitis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 9
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      33
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      30
      num Events
      1
    term
    Pulmonary
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA 9
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
      num Events
      0
    term
    Thrombosis

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice