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NCT02953652 · ADVERSE EVENTS

Adverse events

Efficacy and Safety of Oral HBI-8000 in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL) · Source last updated 2024-09-19

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
From date of the first study drug to 30 ± 3 days after the last dosing of the study drug or before the initiation of new cancer treatment, an average of around 7 months.
Other-event reporting threshold
5%

Other (Not Including Serious) Adverse Events: Adverse events include Serious Adverse Events.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
HBI-8000

HBI-8000 Tablets

15 / 5555 / 551 / 55

Group identifiers: EG000: HBI-8000

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 21.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      55
      num Events
      2
    term
    Febrile neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      55
      num Events
      1
    term
    Aplastic anaemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      55
      num Events
      1
    term
    Angina unstable
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      55
      num Events
      1
    term
    Fatigue
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      55
      num Events
      1
    term
    Pyrexia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      55
      num Events
      2
    term
    Pneumocystis jirovecii pneumonia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      55
      num Events
      1
    term
    Pharyngitis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      55
      num Events
      1
    term
    Pneumonia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      55
      num Events
      1
    term
    C-reactive protein increased
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      55
      num Events
      1
    term
    Hyponatraemia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      55
      num Events
      1
    term
    Peripheral T-cell lymphoma unspecified
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      55
      num Events
      1
    term
    Acute kidney injury

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 21.1
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      55
      num Events
      19
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      55
      num Events
      16
    term
    Thrombocytopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      55
      num Events
      11
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      55
      num Events
      6
    term
    Leukopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      55
      num Events
      5
    term
    Lymphopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      55
      num Events
      3
    term
    Febrile neutropenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      55
      num Events
      3
    term
    Palpitations
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      55
      num Events
      19
    term
    Diarrhoea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      55
      num Events
      12
    term
    Nausea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      55
      num Events
      3
    term
    Abdominal pain
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      55
      num Events
      3
    term
    Toothache
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      55
      num Events
      3
    term
    Vomiting
Complete source fields
description
Other (Not Including Serious) Adverse Events: Adverse events include Serious Adverse Events.
event Groups
  1. deaths Num Affected
    1
    deaths Num At Risk
    55
    description
    HBI-8000 Tablets
    id
    EG000
    other Num Affected
    55
    other Num At Risk
    55
    serious Num Affected
    15
    serious Num At Risk
    55
    title
    HBI-8000
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      55
      num Events
      19
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      55
      num Events
      16
    term
    Thrombocytopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      55
      num Events
      11
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      55
      num Events
      6
    term
    Leukopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      55
      num Events
      5
    term
    Lymphopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      55
      num Events
      3
    term
    Febrile neutropenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      55
      num Events
      3
    term
    Palpitations
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      55
      num Events
      19
    term
    Diarrhoea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      55
      num Events
      12
    term
    Nausea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      55
      num Events
      3
    term
    Abdominal pain
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      55
      num Events
      3
    term
    Toothache
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      55
      num Events
      3
    term
    Vomiting
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      55
      num Events
      2
    term
    Febrile neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      55
      num Events
      1
    term
    Aplastic anaemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      55
      num Events
      1
    term
    Angina unstable
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      55
      num Events
      1
    term
    Fatigue
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      55
      num Events
      1
    term
    Pyrexia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      55
      num Events
      2
    term
    Pneumocystis jirovecii pneumonia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      55
      num Events
      1
    term
    Pharyngitis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      55
      num Events
      1
    term
    Pneumonia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      55
      num Events
      1
    term
    C-reactive protein increased
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      55
      num Events
      1
    term
    Hyponatraemia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      55
      num Events
      1
    term
    Peripheral T-cell lymphoma unspecified
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      55
      num Events
      1
    term
    Acute kidney injury
time Frame
From date of the first study drug to 30 ± 3 days after the last dosing of the study drug or before the initiation of new cancer treatment, an average of around 7 months.

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