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NCT00865969 · ADVERSE EVENTS

Adverse events

Belinostat in Relapsed or Refractory Peripheral T-Cell Lymphoma · Source last updated 2021-10-29

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 25 months
Other-event reporting threshold
5%

Participants were carefully monitored for all adverse events that occurred from the time Informed Consent was obtained until 30 days after the last study drug administration.

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

Belinostat 1000 mg/m\^2 administered as a 30 minute IV infusion on Days 1-5 of every 3-week cycle until disease progression or unmanageable treatment-related toxicities.

61 / 129125 / 12922 / 129

Group identifiers: EG000: Belinostat

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
    Infections and infestations
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      129
    term
    Pneumonia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      129
    term
    Pyrexia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      129
    term
    Infection
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      129
    term
    Anaemia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      129
    term
    Blood creatinine increased
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      129
    term
    Multi-organ disorder
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      129
    term
    Thrombocytopenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      129
    term
    Bronchitis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      129
    term
    Cardiac failure
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      129
    term
    Deep vein thrombosis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      129
    term
    Fatigue
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      129
    term
    Febrile neutropenia

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
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      55
      num At Risk
      129
    term
    Nausea
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      47
      num At Risk
      129
    term
    Fatigue
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      45
      num At Risk
      129
    term
    Pyrexia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      41
      num At Risk
      129
    term
    Anemia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      37
      num At Risk
      129
    term
    Vomiting
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      29
      num At Risk
      129
    term
    Constipation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      129
    term
    Diarrhea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      29
      num At Risk
      129
    term
    Dyspnea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      27
      num At Risk
      129
    term
    Edema Peripheral
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      26
      num At Risk
      129
    term
    Rash
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      129
    term
    Cough
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      129
    term
    Chills
Complete source fields
description
Participants were carefully monitored for all adverse events that occurred from the time Informed Consent was obtained until 30 days after the last study drug administration.
event Groups
  1. deaths Num Affected
    22
    deaths Num At Risk
    129
    description
    Belinostat 1000 mg/m\^2 administered as a 30 minute IV infusion on Days 1-5 of every 3-week cycle until disease progression or unmanageable treatment-related toxicities.
    id
    EG000
    other Num Affected
    125
    other Num At Risk
    129
    serious Num Affected
    61
    serious Num At Risk
    129
    title
    Belinostat
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      55
      num At Risk
      129
    term
    Nausea
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      47
      num At Risk
      129
    term
    Fatigue
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      45
      num At Risk
      129
    term
    Pyrexia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      41
      num At Risk
      129
    term
    Anemia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      37
      num At Risk
      129
    term
    Vomiting
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      29
      num At Risk
      129
    term
    Constipation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      129
    term
    Diarrhea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      29
      num At Risk
      129
    term
    Dyspnea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      27
      num At Risk
      129
    term
    Edema Peripheral
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      26
      num At Risk
      129
    term
    Rash
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      129
    term
    Cough
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      129
    term
    Chills
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      129
    term
    Pneumonia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      129
    term
    Pyrexia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      129
    term
    Infection
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      129
    term
    Anaemia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      129
    term
    Blood creatinine increased
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      129
    term
    Multi-organ disorder
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      129
    term
    Thrombocytopenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      129
    term
    Bronchitis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      129
    term
    Cardiac failure
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      129
    term
    Deep vein thrombosis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      129
    term
    Fatigue
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      129
    term
    Febrile neutropenia
time Frame
Up to 25 months

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