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NCT00765102 · ADVERSE EVENTS

Adverse events

Trial of Romidepsin and Bortezomib for Multiple Myeloma · Source last updated 2019-11-25

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
up to 9 months
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Romidepsin + Bortezomib

Romidepsin was given as an infusion on Days 1, 8 and 15 of each 28-day cycle. Bortezomib was administered twice a week for two consecutive weeks (Days 1, 4, 8 and 11) followed by a 17-day rest period. Patients were treated to a maximum response plus two additional cycles or a maximum of eight cycles.

14 / 3232 / 32Not reported / Not reported

Group identifiers: EG000: Romidepsin + Bortezomib

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 (10.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      32
    term
    Febrile neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (10.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      32
    term
    Thrombocytopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (10.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      32
    term
    Vomiting
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (10.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      32
    term
    Asthenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (10.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      32
    term
    Pyrexia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    MedDRA (10.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      32
    term
    Hypersensitivity
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (10.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      32
    term
    Pneumonia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (10.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      32
    term
    Pneumonia primary atypical
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (10.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      32
    term
    Pneumonia staphylococcal
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (10.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      32
    term
    Sepsis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (10.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      32
    term
    Septic shock
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (10.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      32
    term
    Urosepsis

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 (10.1)
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      32
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (10.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      32
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (10.1)
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      32
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (10.1)
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      32
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (10.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      32
    term
    Abdominal pain
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (10.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      32
    term
    Aphthous stomatitis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (10.1)
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      32
    term
    Constipation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (10.1)
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      32
    term
    Diarrhoea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (10.1)
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      32
    term
    Nausea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (10.1)
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      32
    term
    Vomiting
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (10.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      32
    term
    Asthenia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (10.1)
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      32
    term
    Fatigue
Complete source fields
event Groups
  1. description
    Romidepsin was given as an infusion on Days 1, 8 and 15 of each 28-day cycle. Bortezomib was administered twice a week for two consecutive weeks (Days 1, 4, 8 and 11) followed by a 17-day rest period. Patients were treated to a maximum response plus two additional cycles or a maximum of eight cycles.
    id
    EG000
    other Num Affected
    32
    other Num At Risk
    32
    serious Num Affected
    14
    serious Num At Risk
    32
    title
    Romidepsin + Bortezomib
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (10.1)
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      32
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (10.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      32
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (10.1)
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      32
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (10.1)
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      32
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (10.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      32
    term
    Abdominal pain
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (10.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      32
    term
    Aphthous stomatitis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (10.1)
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      32
    term
    Constipation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (10.1)
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      32
    term
    Diarrhoea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (10.1)
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      32
    term
    Nausea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (10.1)
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      32
    term
    Vomiting
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (10.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      32
    term
    Asthenia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (10.1)
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      32
    term
    Fatigue
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (10.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      32
    term
    Febrile neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (10.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      32
    term
    Thrombocytopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (10.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      32
    term
    Vomiting
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (10.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      32
    term
    Asthenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (10.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      32
    term
    Pyrexia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    MedDRA (10.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      32
    term
    Hypersensitivity
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (10.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      32
    term
    Pneumonia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (10.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      32
    term
    Pneumonia primary atypical
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (10.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      32
    term
    Pneumonia staphylococcal
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (10.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      32
    term
    Sepsis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (10.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      32
    term
    Septic shock
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (10.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      32
    term
    Urosepsis
time Frame
up to 9 months

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