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NCT00274651 · ADVERSE EVENTS

Adverse events

A Phase II Clinical Trial of PXD101 in Patients With Recurrent or Refractory Cutaneous and Peripheral T-Cell Lymphomas · Source last updated 2015-07-28

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
Throughout study, up to 4 weeks after last drug administration
Other-event reporting threshold
5%

Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Arm A (CTCL, ITT Population)

CTCL patients will receive 1000 mg/m2 of PXD101 IV belinostat: 1000 mg/m2 for 5 days every 21 days; IV

7 / 2929 / 29Not reported / Not reported
Arm B (PTCL, ITT Population)

PTCL patients will receive 1000 mg/m2 of PXD101 IV belinostat: 1000 mg/m2 for 5 days every 21 days; IV

8 / 2423 / 24Not reported / Not reported

Group identifiers: EG000: Arm A (CTCL, ITT Population) · EG001: Arm B (PTCL, ITT Population)

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
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      29
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      24
      num Events
      0
    term
    Dehydration
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      29
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      24
      num Events
      1
    term
    Disease progression
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      29
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      24
      num Events
      0
    term
    Staphylococcal skin infection
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      29
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      24
      num Events
      3
    term
    Abdominal pain
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      29
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      24
      num Events
      0
    term
    Gait disturbance
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      29
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      24
      num Events
      0
    term
    Oedema peripheral
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      29
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      24
      num Events
      0
    term
    Apraxia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      29
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      24
      num Events
      0
    term
    Jugular vein thrombosis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      29
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      24
      num Events
      0
    term
    Implant site abscess
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      29
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      24
      num Events
      0
    term
    Sepsis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      29
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      24
      num Events
      1
    term
    Thrombocytopenia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      29
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      24
      num Events
      1
    term
    Ventricular fibrillation

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
    General disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      29
      num Events
      11
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      24
      num Events
      11
    term
    Fatigue
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      29
      num Events
      9
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      24
      num Events
      16
    term
    Pyrexia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      29
      num Events
      6
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      24
      num Events
      3
    term
    Infusion site pain
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      29
      num Events
      7
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      24
      num Events
      1
    term
    Oedema peripheral
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      29
      num Events
      0
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      24
      num Events
      9
    term
    Injection site reaction
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      29
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      24
      num Events
      2
    term
    Asthenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      29
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      24
      num Events
      0
    term
    Chest pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      29
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      24
      num Events
      0
    term
    Chills
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      29
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      24
      num Events
      2
    term
    Disease progression
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      29
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      24
      num Events
      0
    term
    Gait disturbance
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      29
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      24
      num Events
      2
    term
    Oedema
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      29
      num Events
      29
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      24
      num Events
      32
    term
    Nausea
Complete source fields
description
Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.
event Groups
  1. description
    CTCL patients will receive 1000 mg/m2 of PXD101 IV belinostat: 1000 mg/m2 for 5 days every 21 days; IV
    id
    EG000
    other Num Affected
    29
    other Num At Risk
    29
    serious Num Affected
    7
    serious Num At Risk
    29
    title
    Arm A (CTCL, ITT Population)
  2. description
    PTCL patients will receive 1000 mg/m2 of PXD101 IV belinostat: 1000 mg/m2 for 5 days every 21 days; IV
    id
    EG001
    other Num Affected
    23
    other Num At Risk
    24
    serious Num Affected
    8
    serious Num At Risk
    24
    title
    Arm B (PTCL, ITT Population)
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      29
      num Events
      11
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      24
      num Events
      11
    term
    Fatigue
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      29
      num Events
      9
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      24
      num Events
      16
    term
    Pyrexia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      29
      num Events
      6
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      24
      num Events
      3
    term
    Infusion site pain
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      29
      num Events
      7
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      24
      num Events
      1
    term
    Oedema peripheral
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      29
      num Events
      0
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      24
      num Events
      9
    term
    Injection site reaction
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      29
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      24
      num Events
      2
    term
    Asthenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      29
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      24
      num Events
      0
    term
    Chest pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      29
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      24
      num Events
      0
    term
    Chills
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      29
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      24
      num Events
      2
    term
    Disease progression
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      29
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      24
      num Events
      0
    term
    Gait disturbance
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      29
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      24
      num Events
      2
    term
    Oedema
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      29
      num Events
      29
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      24
      num Events
      32
    term
    Nausea
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      29
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      24
      num Events
      0
    term
    Dehydration
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      29
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      24
      num Events
      1
    term
    Disease progression
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      29
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      24
      num Events
      0
    term
    Staphylococcal skin infection
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      29
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      24
      num Events
      3
    term
    Abdominal pain
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      29
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      24
      num Events
      0
    term
    Gait disturbance
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      29
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      24
      num Events
      0
    term
    Oedema peripheral
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      29
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      24
      num Events
      0
    term
    Apraxia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      29
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      24
      num Events
      0
    term
    Jugular vein thrombosis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      29
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      24
      num Events
      0
    term
    Implant site abscess
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      29
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      24
      num Events
      0
    term
    Sepsis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      29
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      24
      num Events
      1
    term
    Thrombocytopenia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      29
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      24
      num Events
      1
    term
    Ventricular fibrillation
time Frame
Throughout study, up to 4 weeks after last drug administration

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