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NCT05245682 · ADVERSE EVENTS

Adverse events

Tolinapant and Radiation for Cisplatin-Ineligible, Previously Untreated, Locally Advanced Head and Neck Cancer · Source last updated 2026-08-21

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
2 years post treatment
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Treatment (Tolinapant, Radiation Therapy)

Patients undergo standard of care radiation therapy for a total of 35 fractions over 7 weeks and receive tolinapant PO daily for 7 days during weeks 1, 3, 5, and 7 of radiation therapy in the absence of disease progression or unacceptable toxicity. Tolinapant: Given PO Radiation Therapy: Undergo radiation therapy

0 / 1010 / 100 / 10

Group identifiers: EG000: Treatment (Tolinapant, Radiation Therapy)

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

    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
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Skin and subcutaneous tissue disorders
      stats
      1. group Id
        EG000
        num Affected
        10
        num At Risk
        10
      term
      Radiation Dermatitis
    2. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      stats
      1. group Id
        EG000
        num Affected
        9
        num At Risk
        10
      term
      Fatigue
    3. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      stats
      1. group Id
        EG000
        num Affected
        9
        num At Risk
        10
      term
      Anorexia
    4. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Respiratory, thoracic and mediastinal disorders
      stats
      1. group Id
        EG000
        num Affected
        8
        num At Risk
        10
      term
      Throat/Tumor Pain
    5. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Respiratory, thoracic and mediastinal disorders
      stats
      1. group Id
        EG000
        num Affected
        8
        num At Risk
        10
      term
      Dysphagia
    6. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      stats
      1. group Id
        EG000
        num Affected
        7
        num At Risk
        10
      term
      Dysgeusia
    7. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Metabolism and nutrition disorders
      stats
      1. group Id
        EG000
        num Affected
        5
        num At Risk
        10
      term
      Nausea
    8. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      stats
      1. group Id
        EG000
        num Affected
        5
        num At Risk
        10
      term
      Dry Mouth
    Complete source fields
    event Groups
    1. deaths Num Affected
      0
      deaths Num At Risk
      10
      description
      Patients undergo standard of care radiation therapy for a total of 35 fractions over 7 weeks and receive tolinapant PO daily for 7 days during weeks 1, 3, 5, and 7 of radiation therapy in the absence of disease progression or unacceptable toxicity. Tolinapant: Given PO Radiation Therapy: Undergo radiation therapy
      id
      EG000
      other Num Affected
      10
      other Num At Risk
      10
      serious Num Affected
      0
      serious Num At Risk
      10
      title
      Treatment (Tolinapant, Radiation Therapy)
    frequency Threshold
    5
    other Events
    1. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Skin and subcutaneous tissue disorders
      stats
      1. group Id
        EG000
        num Affected
        10
        num At Risk
        10
      term
      Radiation Dermatitis
    2. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      stats
      1. group Id
        EG000
        num Affected
        9
        num At Risk
        10
      term
      Fatigue
    3. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      stats
      1. group Id
        EG000
        num Affected
        9
        num At Risk
        10
      term
      Anorexia
    4. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Respiratory, thoracic and mediastinal disorders
      stats
      1. group Id
        EG000
        num Affected
        8
        num At Risk
        10
      term
      Throat/Tumor Pain
    5. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Respiratory, thoracic and mediastinal disorders
      stats
      1. group Id
        EG000
        num Affected
        8
        num At Risk
        10
      term
      Dysphagia
    6. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      stats
      1. group Id
        EG000
        num Affected
        7
        num At Risk
        10
      term
      Dysgeusia
    7. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Metabolism and nutrition disorders
      stats
      1. group Id
        EG000
        num Affected
        5
        num At Risk
        10
      term
      Nausea
    8. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      stats
      1. group Id
        EG000
        num Affected
        5
        num At Risk
        10
      term
      Dry Mouth
    time Frame
    2 years post treatment

    Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

    Preserved source evidence · Not medical advice