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NCT04703192 · ADVERSE EVENTS

Adverse events

Valemetostat Tosylate (DS-3201b), an Enhancer of Zeste Homolog (EZH) 1/2 Dual Inhibitor, for Relapsed/Refractory Peripheral T-Cell Lymphoma (VALENTINE-PTCL01) · Source last updated 2026-07-20

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 (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
Other-event reporting threshold
5.0%

TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Cohort 1: Relapsed/Refractory Peripheral T-Cell Lymphoma (PTCL)

Participants were administered valemetostat tosylate at a dose of 200 mg/day and had an eligible peripheral T-cell lymphoma .

53 / 133120 / 13352 / 133
Cohort 2: Relapsed/Refractory Adult T-cell Leukemia/Lymphoma

Participants were administered valemetostat tosylate at a dose of 200 mg/day and had an eligible adult T-cell leukemia/lymphoma.

15 / 2222 / 2216 / 22

Group identifiers: EG000: Cohort 1: Relapsed/Refractory Peripheral T-Cell Lymphoma (PTCL) · EG001: Cohort 2: Relapsed/Refractory Adult T-cell Leukemia/Lymphoma

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
    MedDRA26.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      133
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
      num Events
      0
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      133
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
      num Events
      0
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      133
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      22
      num Events
      1
    term
    Thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      133
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      22
      num Events
      1
    term
    Coombs negative haemolytic anaemia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      133
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
      num Events
      0
    term
    Atrial fibrillation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      133
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
      num Events
      0
    term
    Atrial flutter
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      133
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
      num Events
      0
    term
    Cardiac failure
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      133
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
      num Events
      0
    term
    Cardiac failure congestive
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      133
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
      num Events
      0
    term
    Diplopia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA26.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      133
      num Events
      2
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      22
      num Events
      3
    term
    Diarrhoea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      133
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
      num Events
      0
    term
    Abdominal pain
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      133
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
      num Events
      0
    term
    Constipation

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
    MedDRA26.0
    stats
    1. group Id
      EG000
      num Affected
      47
      num At Risk
      133
      num Events
      139
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      22
      num Events
      41
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA26.0
    stats
    1. group Id
      EG000
      num Affected
      35
      num At Risk
      133
      num Events
      104
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      22
      num Events
      13
    term
    Thrombocytopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA26.0
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      133
      num Events
      60
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
      num Events
      0
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA26.0
    stats
    1. group Id
      EG000
      num Affected
      38
      num At Risk
      133
      num Events
      56
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      22
      num Events
      5
    term
    Diarrhoea
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA26.0
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      133
      num Events
      28
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      22
      num Events
      5
    term
    Nausea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA26.0
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      133
      num Events
      13
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
      num Events
      0
    term
    Constipation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA26.0
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      133
      num Events
      13
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      22
      num Events
      4
    term
    Vomiting
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA26.0
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      133
      num Events
      28
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      22
      num Events
      2
    term
    Fatigue
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA26.0
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      133
      num Events
      27
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      22
      num Events
      3
    term
    Pyrexia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA26.0
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      133
      num Events
      22
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      22
      num Events
      2
    term
    Asthenia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA26.0
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      133
      num Events
      18
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      22
      num Events
      2
    term
    Oedema peripheral
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA26.0
    stats
    1. group Id
      EG000
      num Affected
      27
      num At Risk
      133
      num Events
      33
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      22
      num Events
      4
    term
    COVID-19
Complete source fields
description
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
event Groups
  1. deaths Num Affected
    52
    deaths Num At Risk
    133
    description
    Participants were administered valemetostat tosylate at a dose of 200 mg/day and had an eligible peripheral T-cell lymphoma .
    id
    EG000
    other Num Affected
    120
    other Num At Risk
    133
    serious Num Affected
    53
    serious Num At Risk
    133
    title
    Cohort 1: Relapsed/Refractory Peripheral T-Cell Lymphoma (PTCL)
  2. deaths Num Affected
    16
    deaths Num At Risk
    22
    description
    Participants were administered valemetostat tosylate at a dose of 200 mg/day and had an eligible adult T-cell leukemia/lymphoma.
    id
    EG001
    other Num Affected
    22
    other Num At Risk
    22
    serious Num Affected
    15
    serious Num At Risk
    22
    title
    Cohort 2: Relapsed/Refractory Adult T-cell Leukemia/Lymphoma
frequency Threshold
5.0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA26.0
    stats
    1. group Id
      EG000
      num Affected
      47
      num At Risk
      133
      num Events
      139
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      22
      num Events
      41
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA26.0
    stats
    1. group Id
      EG000
      num Affected
      35
      num At Risk
      133
      num Events
      104
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      22
      num Events
      13
    term
    Thrombocytopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA26.0
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      133
      num Events
      60
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
      num Events
      0
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA26.0
    stats
    1. group Id
      EG000
      num Affected
      38
      num At Risk
      133
      num Events
      56
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      22
      num Events
      5
    term
    Diarrhoea
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA26.0
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      133
      num Events
      28
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      22
      num Events
      5
    term
    Nausea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA26.0
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      133
      num Events
      13
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
      num Events
      0
    term
    Constipation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA26.0
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      133
      num Events
      13
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      22
      num Events
      4
    term
    Vomiting
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA26.0
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      133
      num Events
      28
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      22
      num Events
      2
    term
    Fatigue
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA26.0
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      133
      num Events
      27
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      22
      num Events
      3
    term
    Pyrexia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA26.0
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      133
      num Events
      22
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      22
      num Events
      2
    term
    Asthenia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA26.0
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      133
      num Events
      18
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      22
      num Events
      2
    term
    Oedema peripheral
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA26.0
    stats
    1. group Id
      EG000
      num Affected
      27
      num At Risk
      133
      num Events
      33
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      22
      num Events
      4
    term
    COVID-19
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA26.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      133
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
      num Events
      0
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      133
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
      num Events
      0
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      133
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      22
      num Events
      1
    term
    Thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      133
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      22
      num Events
      1
    term
    Coombs negative haemolytic anaemia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      133
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
      num Events
      0
    term
    Atrial fibrillation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      133
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
      num Events
      0
    term
    Atrial flutter
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      133
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
      num Events
      0
    term
    Cardiac failure
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      133
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
      num Events
      0
    term
    Cardiac failure congestive
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      133
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
      num Events
      0
    term
    Diplopia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA26.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      133
      num Events
      2
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      22
      num Events
      3
    term
    Diarrhoea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      133
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
      num Events
      0
    term
    Abdominal pain
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      133
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
      num Events
      0
    term
    Constipation
time Frame
Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months

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