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NCT01160484 · ADVERSE EVENTS

Adverse events

Pegylated Liposomal Doxorubicin, Bortezomib, Dexamethasone and Lenalidomide for Relapsed/Refractory Multiple Myeloma · Source last updated 2015-05-04

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
Severity and frequency of adverse events (AEs) were evaluated at each visit. Serious adverse events (SAEs) were followed until resolution or until clearly determined be unrelated to study treatment.
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
DVD-R Single Arm

40 mg dexamethasone will be administered IV on Days 1, 4, 8, and 11 of each cycle. 1.0 mg/m2 Bortezomib will be administered IV over 3 to 5 seconds followed by a standard saline flush, on Days 1, 4, 8, and 11 immediately following the dexamethasone infusion. 4.0 mg/m2 PLD will be given as a 90 minute infusion on Day 1 of Cycle 1 and subsequent doses may be administered over 30 to 60 minutes on Days 4, 8 and 11 of Cycle 1 and on Days 1, 4, 8, and 11 of each subsequent cycle, following the bortezomib administration. 10 mg/day lenalidomide will be administered PO on days 1-14 of a 28-day treatment cycle, followed by a 14-day rest period, following the PLD administration.

10 / 4023 / 40Not reported / Not reported

Group identifiers: EG000: DVD-R Single Arm

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
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    NCI CTCAE V3.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      40
      num Events
      5
    term
    Pneumonia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    NCI CTCAE V3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
      num Events
      1
    term
    Upper respiratory infection
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    NCI CTCAE V3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
      num Events
      1
    term
    Abdominal pain
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    NCI CTCAE V3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
      num Events
      1
    term
    Dyspnea
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    NCI CTCAE V3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
      num Events
      1
    term
    Vomiting
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    NCI CTCAE V3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
      num Events
      1
    term
    Cellulitis
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    NCI CTCAE V3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
      num Events
      1
    term
    Disphagia
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    NCI CTCAE V3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
      num Events
      1
    term
    Allergic reaction
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    NCI CTCAE V3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
      num Events
      1
    term
    Loss of balance
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    NCI CTCAE V3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
      num Events
      1
    term
    Pulmonary emboli
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    NCI CTCAE V3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
      num Events
      1
    term
    Septic thrombophlebitis
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    NCI CTCAE V3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
      num Events
      1
    term
    Syncopal episode

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
    General disorders
    source Vocabulary
    NCI CTCAE V3.0
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      40
      num Events
      16
    term
    Fatigue
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    NCI CTCAE V3.0
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      40
      num Events
      14
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    NCI CTCAE V3.0
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      40
      num Events
      14
    term
    Thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    NCI CTCAE V3.0
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      40
      num Events
      12
    term
    Anemia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    NCI CTCAE V3.0
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      40
      num Events
      12
    term
    Edema
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    NCI CTCAE V3.0
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      40
      num Events
      12
    term
    Upper respiratory infection
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    NCI CTCAE V3.0
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      40
      num Events
      10
    term
    Periphenal neurophaty
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    NCI CTCAE V3.0
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      40
      num Events
      10
    term
    Diarrhea
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    NCI CTCAE V3.0
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      40
      num Events
      10
    term
    Nausea
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    NCI CTCAE V3.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      40
      num Events
      9
    term
    Confusion
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    NCI CTCAE V3.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      40
      num Events
      8
    term
    Hypocalcemia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    NCI CTCAE V3.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      40
      num Events
      7
    term
    Leukopenia
Complete source fields
event Groups
  1. description
    40 mg dexamethasone will be administered IV on Days 1, 4, 8, and 11 of each cycle. 1.0 mg/m2 Bortezomib will be administered IV over 3 to 5 seconds followed by a standard saline flush, on Days 1, 4, 8, and 11 immediately following the dexamethasone infusion. 4.0 mg/m2 PLD will be given as a 90 minute infusion on Day 1 of Cycle 1 and subsequent doses may be administered over 30 to 60 minutes on Days 4, 8 and 11 of Cycle 1 and on Days 1, 4, 8, and 11 of each subsequent cycle, following the bortezomib administration. 10 mg/day lenalidomide will be administered PO on days 1-14 of a 28-day treatment cycle, followed by a 14-day rest period, following the PLD administration.
    id
    EG000
    other Num Affected
    23
    other Num At Risk
    40
    serious Num Affected
    10
    serious Num At Risk
    40
    title
    DVD-R Single Arm
frequency Threshold
5
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    NCI CTCAE V3.0
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      40
      num Events
      16
    term
    Fatigue
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    NCI CTCAE V3.0
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      40
      num Events
      14
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    NCI CTCAE V3.0
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      40
      num Events
      14
    term
    Thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    NCI CTCAE V3.0
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      40
      num Events
      12
    term
    Anemia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    NCI CTCAE V3.0
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      40
      num Events
      12
    term
    Edema
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    NCI CTCAE V3.0
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      40
      num Events
      12
    term
    Upper respiratory infection
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    NCI CTCAE V3.0
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      40
      num Events
      10
    term
    Periphenal neurophaty
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    NCI CTCAE V3.0
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      40
      num Events
      10
    term
    Diarrhea
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    NCI CTCAE V3.0
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      40
      num Events
      10
    term
    Nausea
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    NCI CTCAE V3.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      40
      num Events
      9
    term
    Confusion
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    NCI CTCAE V3.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      40
      num Events
      8
    term
    Hypocalcemia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    NCI CTCAE V3.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      40
      num Events
      7
    term
    Leukopenia
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    NCI CTCAE V3.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      40
      num Events
      5
    term
    Pneumonia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    NCI CTCAE V3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
      num Events
      1
    term
    Upper respiratory infection
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    NCI CTCAE V3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
      num Events
      1
    term
    Abdominal pain
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    NCI CTCAE V3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
      num Events
      1
    term
    Dyspnea
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    NCI CTCAE V3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
      num Events
      1
    term
    Vomiting
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    NCI CTCAE V3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
      num Events
      1
    term
    Cellulitis
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    NCI CTCAE V3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
      num Events
      1
    term
    Disphagia
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    NCI CTCAE V3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
      num Events
      1
    term
    Allergic reaction
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    NCI CTCAE V3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
      num Events
      1
    term
    Loss of balance
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    NCI CTCAE V3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
      num Events
      1
    term
    Pulmonary emboli
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    NCI CTCAE V3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
      num Events
      1
    term
    Septic thrombophlebitis
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    NCI CTCAE V3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
      num Events
      1
    term
    Syncopal episode
time Frame
Severity and frequency of adverse events (AEs) were evaluated at each visit. Serious adverse events (SAEs) were followed until resolution or until clearly determined be unrelated to study treatment.

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