NCT06039384 · 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 574 days
- Other-event reporting threshold
- 5%
Treatment-emergent adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of INCB099280 or adagrasib. Treatment groups were determined according to the actual treatment the participant received regardless of assigned study drug treatment.
| Safety group | Serious events | Other events | Deaths |
|---|---|---|---|
| INCB099280 50 mg QD Plus Adagrasib 400 mg BID | 0 / 3 | 3 / 3 | 1 / 3 |
| INCB099280 100 mg BID Plus Adagrasib 400 mg BID | 1 / 3 | 3 / 3 | 1 / 3 |
Serious adverse events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- MedDRA 27.1
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 3
- num Events
- 1
- term
- Pyrexia
Other reported adverse events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA 27.1
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 3
- num Events
- 1
- term
- Abdominal distension
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Musculoskeletal and connective tissue disorders
- source Vocabulary
- MedDRA 27.1
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 3
- num Events
- 1
- term
- Arthralgia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Investigations
- source Vocabulary
- MedDRA 27.1
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 3
- num Events
- 2
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- term
- Blood creatinine increased
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA 27.1
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 3
- num Events
- 2
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 3
- num Events
- 1
- term
- Constipation
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Metabolism and nutrition disorders
- source Vocabulary
- MedDRA 27.1
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 3
- num Events
- 1
- term
- Decreased appetite
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA 27.1
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 3
- num Events
- 2
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 3
- num Events
- 2
- term
- Diarrhoea
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Respiratory, thoracic and mediastinal disorders
- source Vocabulary
- MedDRA 27.1
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 3
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- term
- Dyspnoea
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Investigations
- source Vocabulary
- MedDRA 27.1
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 3
- num Events
- 1
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 3
- num Events
- 1
- term
- Electrocardiogram QT prolonged
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Injury, poisoning and procedural complications
- source Vocabulary
- MedDRA 27.1
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 3
- num Events
- 2
- term
- Fall
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- MedDRA 27.1
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 3
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- term
- Fatigue
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Infections and infestations
- source Vocabulary
- MedDRA 27.1
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 3
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- term
- Gastroenteritis viral
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA 27.1
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 3
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- term
- Gastrooesophageal reflux disease
Complete source fields
- description
- Treatment-emergent adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of INCB099280 or adagrasib. Treatment groups were determined according to the actual treatment the participant received regardless of assigned study drug treatment.
- event Groups
- deaths Num Affected
- 1
- deaths Num At Risk
- 3
- description
- Participants received INCB099280 50 milligrams (mg) once daily (QD) plus adagrasib 400 mg twice daily (BID) for up to 2 years.
- id
- EG000
- other Num Affected
- 3
- other Num At Risk
- 3
- serious Num Affected
- 0
- serious Num At Risk
- 3
- title
- INCB099280 50 mg QD Plus Adagrasib 400 mg BID
- deaths Num Affected
- 1
- deaths Num At Risk
- 3
- description
- Participants received INCB099280 100 mg BID plus adagrasib 400 mg BID for up to 2 years.
- id
- EG001
- other Num Affected
- 3
- other Num At Risk
- 3
- serious Num Affected
- 1
- serious Num At Risk
- 3
- title
- INCB099280 100 mg BID Plus Adagrasib 400 mg BID
- frequency Threshold
- 5
- other Events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA 27.1
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 3
- num Events
- 1
- term
- Abdominal distension
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Musculoskeletal and connective tissue disorders
- source Vocabulary
- MedDRA 27.1
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 3
- num Events
- 1
- term
- Arthralgia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Investigations
- source Vocabulary
- MedDRA 27.1
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 3
- num Events
- 2
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- term
- Blood creatinine increased
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA 27.1
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 3
- num Events
- 2
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 3
- num Events
- 1
- term
- Constipation
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Metabolism and nutrition disorders
- source Vocabulary
- MedDRA 27.1
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 3
- num Events
- 1
- term
- Decreased appetite
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA 27.1
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 3
- num Events
- 2
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 3
- num Events
- 2
- term
- Diarrhoea
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Respiratory, thoracic and mediastinal disorders
- source Vocabulary
- MedDRA 27.1
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 3
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- term
- Dyspnoea
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Investigations
- source Vocabulary
- MedDRA 27.1
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 3
- num Events
- 1
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 3
- num Events
- 1
- term
- Electrocardiogram QT prolonged
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Injury, poisoning and procedural complications
- source Vocabulary
- MedDRA 27.1
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 3
- num Events
- 2
- term
- Fall
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- MedDRA 27.1
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 3
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- term
- Fatigue
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Infections and infestations
- source Vocabulary
- MedDRA 27.1
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 3
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- term
- Gastroenteritis viral
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA 27.1
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 3
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- term
- Gastrooesophageal reflux disease
- serious Events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- MedDRA 27.1
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 3
- num Events
- 1
- term
- Pyrexia
- time Frame
- up to 574 days
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Independent clinical review pending · Not medical advice
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