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NCT00581919 · ADVERSE EVENTS

Adverse events

Ph 2 Bortezomib, Dexamethasone, + Doxorubicin With ALCAR for Previously Treated Multiple Myeloma · Source last updated 2019-12-13

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 while subjects were receiving study treatment through 30 days post last dose of study treatment, up to 28 weeks.
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Bort, Dex, and Dox With ALCAR

Bortezomib 1.3 mg/m2 IV days 1, 4, 8, and 11 Dexamethasone 20 mg PO days 1, 4, 8, and 11 Doxorubicin 15 mg/m2 IV days 1 and 8 Acetyl-L-Carnitine (ALCAR) 1.5 g PO BID days 1-21 Maximum of 8 cycles. Each cycle is 21 days long

10 / 3232 / 32Not reported / Not reported

Group identifiers: EG000: Bort, Dex, and Dox With ALCAR

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
    Vascular disorders
    source Vocabulary
    CTCAE version 3
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      32
    term
    Thrombosis/embolism - DVT
  2. organ System
    General disorders
    source Vocabulary
    CTCAE version 3
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      32
    term
    Fever (in the absence of neutropenia)
  3. organ System
    Nervous system disorders
    source Vocabulary
    CTCAE version 3
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      32
    term
    CNS Hemorrhage/bleeding
  4. organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE version 3
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      32
    term
    Hemorrhage - Other, specify: GI-esophagus
  5. organ System
    Infections and infestations
    source Vocabulary
    CTCAE version 3
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      32
    term
    Febrile neutropenia - pneumonia
  6. organ System
    Infections and infestations
    source Vocabulary
    CTCAE version 3
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      32
    term
    Infection with unknown ANC
  7. organ System
    Infections and infestations
    source Vocabulary
    CTCAE version 3
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      32
    term
    Infection without Neutropenia
  8. organ System
    Infections and infestations
    source Vocabulary
    CTCAE version 3
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      32
    term
    Infection/Febrile Neutropenia
  9. organ System
    Infections and infestations
    source Vocabulary
    CTCAE version 3
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      32
    term
    Infection/Febrile Neutropenia - Other, specify: Normal ANC, Gr 1 or 2 neutrophils
  10. organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE version 3
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      32
    term
    Muscle weakness (not due to neuropathy)
  11. organ System
    Nervous system disorders
    source Vocabulary
    CTCAE version 3
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      32
    term
    Neurology - Other, specify: encephalopathy
  12. organ System
    Nervous system disorders
    source Vocabulary
    CTCAE version 3
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      32
    term
    Neurology - Other, specify: vocal cord paralysis

Other reported adverse events

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

  1. organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE version 3
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      32
    term
    abdominal pain
  2. organ System
    Investigations
    source Vocabulary
    CTCAE version 3
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      32
    term
    Alkaline phosphatase increased
  3. organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE version 3
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      32
    term
    Alopecia
  4. organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE version 3
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      32
    term
    Anemia
  5. organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE version 3
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      32
    term
    Anorexia
  6. organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE version 3
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      32
    term
    back pain
  7. organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE version 3
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      32
    term
    Bloating
  8. organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE version 3
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      32
    term
    Bone pain
  9. organ System
    Eye disorders
    source Vocabulary
    CTCAE version 3
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      32
    term
    Blurred vision
  10. organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    CTCAE version 3
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      32
    term
    Bruising
  11. organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE version 3
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      32
    term
    Colitis
  12. organ System
    Psychiatric disorders
    source Vocabulary
    CTCAE version 3
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      32
    term
    Confusion
Complete source fields
event Groups
  1. description
    Bortezomib 1.3 mg/m2 IV days 1, 4, 8, and 11 Dexamethasone 20 mg PO days 1, 4, 8, and 11 Doxorubicin 15 mg/m2 IV days 1 and 8 Acetyl-L-Carnitine (ALCAR) 1.5 g PO BID days 1-21 Maximum of 8 cycles. Each cycle is 21 days long
    id
    EG000
    other Num Affected
    32
    other Num At Risk
    32
    serious Num Affected
    10
    serious Num At Risk
    32
    title
    Bort, Dex, and Dox With ALCAR
frequency Threshold
5
other Events
  1. organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE version 3
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      32
    term
    abdominal pain
  2. organ System
    Investigations
    source Vocabulary
    CTCAE version 3
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      32
    term
    Alkaline phosphatase increased
  3. organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE version 3
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      32
    term
    Alopecia
  4. organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE version 3
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      32
    term
    Anemia
  5. organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE version 3
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      32
    term
    Anorexia
  6. organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE version 3
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      32
    term
    back pain
  7. organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE version 3
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      32
    term
    Bloating
  8. organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE version 3
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      32
    term
    Bone pain
  9. organ System
    Eye disorders
    source Vocabulary
    CTCAE version 3
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      32
    term
    Blurred vision
  10. organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    CTCAE version 3
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      32
    term
    Bruising
  11. organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE version 3
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      32
    term
    Colitis
  12. organ System
    Psychiatric disorders
    source Vocabulary
    CTCAE version 3
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      32
    term
    Confusion
serious Events
  1. organ System
    Vascular disorders
    source Vocabulary
    CTCAE version 3
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      32
    term
    Thrombosis/embolism - DVT
  2. organ System
    General disorders
    source Vocabulary
    CTCAE version 3
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      32
    term
    Fever (in the absence of neutropenia)
  3. organ System
    Nervous system disorders
    source Vocabulary
    CTCAE version 3
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      32
    term
    CNS Hemorrhage/bleeding
  4. organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE version 3
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      32
    term
    Hemorrhage - Other, specify: GI-esophagus
  5. organ System
    Infections and infestations
    source Vocabulary
    CTCAE version 3
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      32
    term
    Febrile neutropenia - pneumonia
  6. organ System
    Infections and infestations
    source Vocabulary
    CTCAE version 3
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      32
    term
    Infection with unknown ANC
  7. organ System
    Infections and infestations
    source Vocabulary
    CTCAE version 3
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      32
    term
    Infection without Neutropenia
  8. organ System
    Infections and infestations
    source Vocabulary
    CTCAE version 3
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      32
    term
    Infection/Febrile Neutropenia
  9. organ System
    Infections and infestations
    source Vocabulary
    CTCAE version 3
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      32
    term
    Infection/Febrile Neutropenia - Other, specify: Normal ANC, Gr 1 or 2 neutrophils
  10. organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE version 3
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      32
    term
    Muscle weakness (not due to neuropathy)
  11. organ System
    Nervous system disorders
    source Vocabulary
    CTCAE version 3
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      32
    term
    Neurology - Other, specify: encephalopathy
  12. organ System
    Nervous system disorders
    source Vocabulary
    CTCAE version 3
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      32
    term
    Neurology - Other, specify: vocal cord paralysis
time Frame
Adverse Events were collected while subjects were receiving study treatment through 30 days post last dose of study treatment, up to 28 weeks.

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