NCT05949632 · ADVERSE EVENTS
Adverse events
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.
| Safety group | Serious events | Other events | Deaths |
|---|---|---|---|
| INCB099280 400 mg BID Plus Axitinib 5 mg BID | 1 / 5 | 5 / 5 | 0 / 5 |
Serious adverse events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Eye disorders
- source Vocabulary
- MedDRA 27.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 5
- term
- Vision blurred
Other reported adverse events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Ear and labyrinth disorders
- source Vocabulary
- MedDRA 27.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 5
- term
- Hypoacusis
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA 27.0
- stats
- group Id
- EG000
- num Affected
- 3
- num At Risk
- 5
- term
- Diarrhoea
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA 27.0
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 5
- term
- Nausea
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA 27.0
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 5
- term
- Stomatitis
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA 27.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 5
- term
- Constipation
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA 27.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 5
- term
- Dry mouth
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA 27.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 5
- term
- Gastrointestinal pain
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA 27.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 5
- term
- Gastrooesophageal reflux disease
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- MedDRA 27.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 5
- term
- Asthenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- MedDRA 27.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 5
- term
- Chest pain
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Hepatobiliary disorders
- source Vocabulary
- MedDRA 27.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 5
- term
- Hypertransaminasaemia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Infections and infestations
- source Vocabulary
- MedDRA 27.0
- stats
- 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
- 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
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Ear and labyrinth disorders
- source Vocabulary
- MedDRA 27.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 5
- term
- Hypoacusis
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA 27.0
- stats
- group Id
- EG000
- num Affected
- 3
- num At Risk
- 5
- term
- Diarrhoea
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA 27.0
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 5
- term
- Nausea
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA 27.0
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 5
- term
- Stomatitis
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA 27.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 5
- term
- Constipation
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA 27.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 5
- term
- Dry mouth
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA 27.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 5
- term
- Gastrointestinal pain
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA 27.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 5
- term
- Gastrooesophageal reflux disease
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- MedDRA 27.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 5
- term
- Asthenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- MedDRA 27.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 5
- term
- Chest pain
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Hepatobiliary disorders
- source Vocabulary
- MedDRA 27.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 5
- term
- Hypertransaminasaemia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Infections and infestations
- source Vocabulary
- MedDRA 27.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 5
- term
- Catheter site infection
- serious Events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Eye disorders
- source Vocabulary
- MedDRA 27.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 5
- term
- Vision blurred
- time Frame
- up to approximately 1 year
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
Triangle