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NCT03213704 · ADVERSE EVENTS

Adverse events

Larotrectinib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With NTRK Fusions (A Pediatric MATCH Treatment Trial) · Source last updated 2026-06-17

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 monitored/assessed from enrollment to 30 days after the end of treatment, up to 2 years. All-Cause Mortality monitored/assessed up to 5 years
Other-event reporting threshold
0%

Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Treatment (Larotrectinib Sulfate)

Patients receive larotrectinib sulfate PO or via NG- or G-tube BID on days 1-28. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients undergo a CT scan, MRI, an x-ray, bone scan, and/or MIBG scintigraphy during screening and on study. Patients also undergo bone marrow aspiration and/or biopsy during screening and may undergo blood sample collection on study.

2 / 97 / 93 / 9

Group identifiers: EG000: Treatment (Larotrectinib Sulfate)

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
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9
    term
    Diarrhea
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9
    term
    Nausea
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9
    term
    Disease progression
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9
    term
    Fever
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9
    term
    Sepsis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9
    term
    Neutrophil count decreased
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9
    term
    Depressed level of consciousness
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9
    term
    Hypotension
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9
    term
    Hypoglycemia

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
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      9
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9
    term
    Blood and lymphatic system disorders - Other, specify
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9
    term
    Sinus bradycardia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      9
    term
    Sinus tachycardia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9
    term
    Eye disorders - Other, specify
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9
    term
    Scleral disorder
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9
    term
    Abdominal pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      9
    term
    Constipation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      9
    term
    Diarrhea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9
    term
    Gastroesophageal reflux disease
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9
    term
    Gastrointestinal disorders - Other, specify
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9
    term
    Mucositis/stomatitis (functional/symptomatic) - Oral cavity
Complete source fields
description
Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
event Groups
  1. deaths Num Affected
    3
    deaths Num At Risk
    9
    description
    Patients receive larotrectinib sulfate PO or via NG- or G-tube BID on days 1-28. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients undergo a CT scan, MRI, an x-ray, bone scan, and/or MIBG scintigraphy during screening and on study. Patients also undergo bone marrow aspiration and/or biopsy during screening and may undergo blood sample collection on study.
    id
    EG000
    other Num Affected
    7
    other Num At Risk
    9
    serious Num Affected
    2
    serious Num At Risk
    9
    title
    Treatment (Larotrectinib Sulfate)
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      9
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9
    term
    Blood and lymphatic system disorders - Other, specify
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9
    term
    Sinus bradycardia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      9
    term
    Sinus tachycardia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9
    term
    Eye disorders - Other, specify
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9
    term
    Scleral disorder
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9
    term
    Abdominal pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      9
    term
    Constipation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      9
    term
    Diarrhea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9
    term
    Gastroesophageal reflux disease
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9
    term
    Gastrointestinal disorders - Other, specify
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9
    term
    Mucositis/stomatitis (functional/symptomatic) - Oral cavity
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9
    term
    Diarrhea
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9
    term
    Nausea
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9
    term
    Disease progression
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9
    term
    Fever
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9
    term
    Sepsis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9
    term
    Neutrophil count decreased
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9
    term
    Depressed level of consciousness
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9
    term
    Hypotension
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9
    term
    Hypoglycemia
time Frame
Adverse Events monitored/assessed from enrollment to 30 days after the end of treatment, up to 2 years. All-Cause Mortality monitored/assessed up to 5 years

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Preserved source evidence · Not medical advice