NCT06024174 · ADVERSE EVENTS

Adverse events

A Study of BMS-986466 With Adagrasib With or Without Cetuximab in Participants With Kirsten Rat Sarcoma Virus Glycine 12 to Cysteine (KRAS G12C)-Mutant Solid Tumors · Source last updated 2025-07-22

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: All cause mortality, and serious and non-serious adverse events were collected from from first dose until 100 days after last dose (Up to approximately 5 months).
Other-event reporting threshold: 5%

All treated population include all participants who received at least 1 dose of study intervention.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Part 1: Drug-Drug Interaction (DDI) - BMS986466 10 MG + Adagrasib 400MG BID Participants with KRAS G12C-mutant Advanced Solid Tumors were treated with a single dose of BMS-986466 10 mg orally (PO) on Cycle 1 Day 1 and Day 9 and followed by regular administration from Cycle 3 Day 1 till study discontinuation. Participants were also administered with adagrasib 400 mg twice a day (BID) starting on Cycle 1 Day 4.	1 / 5	4 / 5	0 / 5

Group identifiers: EG000: Part 1: Drug-Drug Interaction (DDI) - BMS986466 10 MG + Adagrasib 400MG BID

Serious adverse events

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

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
27.0
stats
group Id
EG000
num Affected
1
num At Risk
5
term
Pyrexia

Other reported adverse events

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

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
27.0
stats
group Id
EG000
num Affected
2
num At Risk
5
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
27.0
stats
group Id
EG000
num Affected
2
num At Risk
5
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
27.0
stats
group Id
EG000
num Affected
1
num At Risk
5
term
Epigastric discomfort
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
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
27.0
stats
group Id
EG000
num Affected
1
num At Risk
5
term
Proctalgia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
27.0
stats
group Id
EG000
num Affected
1
num At Risk
5
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
27.0
stats
group Id
EG000
num Affected
1
num At Risk
5
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
27.0
stats
group Id
EG000
num Affected
1
num At Risk
5
term
Alanine aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
27.0
stats
group Id
EG000
num Affected
1
num At Risk
5
term
Amylase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
27.0
stats
group Id
EG000
num Affected
1
num At Risk
5
term
Aspartate aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
27.0
stats
group Id
EG000
num Affected
1
num At Risk
5
term
Lipase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
27.0
stats
group Id
EG000
num Affected
1
num At Risk
5
term
Decreased appetite

Complete source fields

description

All treated population include all participants who received at least 1 dose of study intervention.

event Groups

deaths Num Affected
0
deaths Num At Risk
5
description
Participants with KRAS G12C-mutant Advanced Solid Tumors were treated with a single dose of BMS-986466 10 mg orally (PO) on Cycle 1 Day 1 and Day 9 and followed by regular administration from Cycle 3 Day 1 till study discontinuation. Participants were also administered with adagrasib 400 mg twice a day (BID) starting on Cycle 1 Day 4.
id
EG000
other Num Affected
4
other Num At Risk
5
serious Num Affected
1
serious Num At Risk
5
title
Part 1: Drug-Drug Interaction (DDI) - BMS986466 10 MG + Adagrasib 400MG BID

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
27.0
stats
group Id
EG000
num Affected
2
num At Risk
5
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
27.0
stats
group Id
EG000
num Affected
2
num At Risk
5
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
27.0
stats
group Id
EG000
num Affected
1
num At Risk
5
term
Epigastric discomfort
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
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
27.0
stats
group Id
EG000
num Affected
1
num At Risk
5
term
Proctalgia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
27.0
stats
group Id
EG000
num Affected
1
num At Risk
5
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
27.0
stats
group Id
EG000
num Affected
1
num At Risk
5
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
27.0
stats
group Id
EG000
num Affected
1
num At Risk
5
term
Alanine aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
27.0
stats
group Id
EG000
num Affected
1
num At Risk
5
term
Amylase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
27.0
stats
group Id
EG000
num Affected
1
num At Risk
5
term
Aspartate aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
27.0
stats
group Id
EG000
num Affected
1
num At Risk
5
term
Lipase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
27.0
stats
group Id
EG000
num Affected
1
num At Risk
5
term
Decreased appetite

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
27.0
stats
group Id
EG000
num Affected
1
num At Risk
5
term
Pyrexia

time Frame

All cause mortality, and serious and non-serious adverse events were collected from from first dose until 100 days after last dose (Up to approximately 5 months).

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Preserved source evidence · Not medical advice