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NCT01159574 · ADVERSE EVENTS

Adverse events

Study of Decadron, Biaxin, and Pomalidomide in Relapsed/Refractory Myeloma · Source last updated 2019-06-11

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
Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Other-event reporting threshold
5%

Adverse events were recorded using the CTCAE version 4.0. The adverse events listed includes serious adverse events. Serious adverse events were recorded from baseline unti

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
All Patients

ClaPd therapy: Dexamethasone (40mg ) will be given on days 1, 8, 15, 22 of a 28-day cycle. Clarithromycin (Biaxin®) will be given orally at a dose of 500 mg twice a day on days 1-28 of a 28 day cycle. Pomalidomide will be given 4mg daily for days 1-21 of each 28 day cycle. Dosing will be in the morning at approximately the same time each day. dexamethasone: 40mg will be given on days 1, 8, 15, 22 of a 28-day cycle clarithromycin: orally at a dose of 500 mg twice a day on days 1-28 of a 28 day cycle Pomalidomide: orally 4mg daily for days 1-21 of each 28 day cycle

59 / 120120 / 120Not reported / Not reported

Group identifiers: EG000: All Patients

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
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      120
      num Events
      1
    term
    acute renal failure
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      120
      num Events
      1
    term
    agitation
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      120
      num Events
      1
    term
    altered mental status
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      120
      num Events
      3
    term
    anemia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      120
      num Events
      1
    term
    atrial fibrillation
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      120
      num Events
      1
    term
    back pain
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      120
      num Events
      1
    term
    behavior changes
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      120
      num Events
      1
    term
    bowel obstruction
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      120
      num Events
      1
    term
    cellulitis
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      120
      num Events
      1
    term
    chest pain
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      120
      num Events
      1
    term
    chronic kidney insufficiency
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      120
      num Events
      1
    term
    complications of MM (leading to death)

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
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      120
    term
    neuro mood
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      120
    term
    psychomotor agitation
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      120
    term
    bone pain
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      120
    term
    renal failure/insufficiency
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      120
    term
    epistaxis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      120
    term
    Skin Infection
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      120
    term
    Thrush
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      120
    term
    cramping
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      120
    term
    dry mouth
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      120
    term
    confusion
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      120
    term
    Lower extremity DVT
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      120
    term
    chest pain (muscular)
Complete source fields
description
Adverse events were recorded using the CTCAE version 4.0. The adverse events listed includes serious adverse events. Serious adverse events were recorded from baseline unti
event Groups
  1. description
    ClaPd therapy: Dexamethasone (40mg ) will be given on days 1, 8, 15, 22 of a 28-day cycle. Clarithromycin (Biaxin®) will be given orally at a dose of 500 mg twice a day on days 1-28 of a 28 day cycle. Pomalidomide will be given 4mg daily for days 1-21 of each 28 day cycle. Dosing will be in the morning at approximately the same time each day. dexamethasone: 40mg will be given on days 1, 8, 15, 22 of a 28-day cycle clarithromycin: orally at a dose of 500 mg twice a day on days 1-28 of a 28 day cycle Pomalidomide: orally 4mg daily for days 1-21 of each 28 day cycle
    id
    EG000
    other Num Affected
    120
    other Num At Risk
    120
    serious Num Affected
    59
    serious Num At Risk
    120
    title
    All Patients
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      120
    term
    neuro mood
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      120
    term
    psychomotor agitation
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      120
    term
    bone pain
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      120
    term
    renal failure/insufficiency
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      120
    term
    epistaxis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      120
    term
    Skin Infection
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      120
    term
    Thrush
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      120
    term
    cramping
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      120
    term
    dry mouth
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      120
    term
    confusion
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      120
    term
    Lower extremity DVT
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      120
    term
    chest pain (muscular)
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      120
      num Events
      1
    term
    acute renal failure
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      120
      num Events
      1
    term
    agitation
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      120
      num Events
      1
    term
    altered mental status
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      120
      num Events
      3
    term
    anemia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      120
      num Events
      1
    term
    atrial fibrillation
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      120
      num Events
      1
    term
    back pain
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      120
      num Events
      1
    term
    behavior changes
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      120
      num Events
      1
    term
    bowel obstruction
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      120
      num Events
      1
    term
    cellulitis
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      120
      num Events
      1
    term
    chest pain
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      120
      num Events
      1
    term
    chronic kidney insufficiency
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      120
      num Events
      1
    term
    complications of MM (leading to death)
time Frame
Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.

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Preserved source evidence · Not medical advice