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NCT05949632 · ADVERSE EVENTS

Adverse events

A Study of INCB099280 in Combination With Axitinib in Adults With Advanced Solid Tumors · Source last updated 2026-06-04

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
up to approximately 1 year
Other-event reporting threshold
0%

Adverse events have been reported for the Safety Population, comprised of all participants who received at least 1 dose of INCB099280 or axitinib.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
INCB099280 400 mg BID Plus Axitinib 5 mg BID

Participants received INCB099280 400 milligrams (mg) twice daily (BID) and axitinib 5 mg BID in consecutive 21-day cycles for up to 2 years as long as they were receiving benefit and did not meet any criteria for study withdrawal.

1 / 55 / 50 / 5

Group identifiers: EG000: INCB099280 400 mg BID Plus Axitinib 5 mg BID

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
    Eye disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
    term
    Vision blurred

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
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
    term
    Hypoacusis
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      5
    term
    Diarrhoea
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      5
    term
    Nausea
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      5
    term
    Stomatitis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
    term
    Constipation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
    term
    Dry mouth
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
    term
    Gastrointestinal pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
    term
    Gastrooesophageal reflux disease
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
    term
    Asthenia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
    term
    Chest pain
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
    term
    Hypertransaminasaemia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
    term
    Catheter site infection
Complete source fields
description
Adverse events have been reported for the Safety Population, comprised of all participants who received at least 1 dose of INCB099280 or axitinib.
event Groups
  1. deaths Num Affected
    0
    deaths Num At Risk
    5
    description
    Participants received INCB099280 400 milligrams (mg) twice daily (BID) and axitinib 5 mg BID in consecutive 21-day cycles for up to 2 years as long as they were receiving benefit and did not meet any criteria for study withdrawal.
    id
    EG000
    other Num Affected
    5
    other Num At Risk
    5
    serious Num Affected
    1
    serious Num At Risk
    5
    title
    INCB099280 400 mg BID Plus Axitinib 5 mg BID
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
    term
    Hypoacusis
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      5
    term
    Diarrhoea
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      5
    term
    Nausea
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      5
    term
    Stomatitis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
    term
    Constipation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
    term
    Dry mouth
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
    term
    Gastrointestinal pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
    term
    Gastrooesophageal reflux disease
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
    term
    Asthenia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
    term
    Chest pain
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
    term
    Hypertransaminasaemia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
    term
    Catheter site infection
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
    term
    Vision blurred
time Frame
up to approximately 1 year

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Preserved source evidence · Not medical advice