NCT04380753 · ADVERSE EVENTS

Adverse events

AMG 510 Ethnic Sensitivity Study (CodeBreaK 105). · Source last updated 2026-05-06

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: Day 1 until the end of study (or primary data cut-off date for ongoing participants); median [min, max] duration was 5.57 [1.5, 13.7] months
Other-event reporting threshold: 5%

Safety analysis set: all enrolled participants who received at least 1 dose of sotorasib.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Sotorasib Participants received Sotorasib 960 mg PO QD until there was evidence of disease progression, intolerance to study medication, or withdrawal of consent.	6 / 12	11 / 12	2 / 12

Group identifiers: EG000: Sotorasib

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
Gastrointestinal disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
1
num At Risk
12
term
Ileus
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
1
num At Risk
12
term
Pyrexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
1
num At Risk
12
term
Pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
1
num At Risk
12
term
Liver function test abnormal
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
1
num At Risk
12
term
Arthralgia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
1
num At Risk
12
term
Spinal cord compression
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
1
num At Risk
12
term
Dyspnoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
2
num At Risk
12
term
Pneumothorax

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
Blood and lymphatic system disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
1
num At Risk
12
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
1
num At Risk
12
term
Tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
1
num At Risk
12
term
Adrenal insufficiency
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
1
num At Risk
12
term
Euthyroid sick syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
1
num At Risk
12
term
Abdominal distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
3
num At Risk
12
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
1
num At Risk
12
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
1
num At Risk
12
term
Dry mouth
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
2
num At Risk
12
term
Gastritis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
1
num At Risk
12
term
Gastrooesophageal reflux disease
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
1
num At Risk
12
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
1
num At Risk
12
term
Mucosal inflammation

Complete source fields

description

Safety analysis set: all enrolled participants who received at least 1 dose of sotorasib.

event Groups

deaths Num Affected
2
deaths Num At Risk
12
description
Participants received Sotorasib 960 mg PO QD until there was evidence of disease progression, intolerance to study medication, or withdrawal of consent.
id
EG000
other Num Affected
11
other Num At Risk
12
serious Num Affected
6
serious Num At Risk
12
title
Sotorasib

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
1
num At Risk
12
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
1
num At Risk
12
term
Tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
1
num At Risk
12
term
Adrenal insufficiency
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
1
num At Risk
12
term
Euthyroid sick syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
1
num At Risk
12
term
Abdominal distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
3
num At Risk
12
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
1
num At Risk
12
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
1
num At Risk
12
term
Dry mouth
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
2
num At Risk
12
term
Gastritis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
1
num At Risk
12
term
Gastrooesophageal reflux disease
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
1
num At Risk
12
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
1
num At Risk
12
term
Mucosal inflammation

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
1
num At Risk
12
term
Ileus
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
1
num At Risk
12
term
Pyrexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
1
num At Risk
12
term
Pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
1
num At Risk
12
term
Liver function test abnormal
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
1
num At Risk
12
term
Arthralgia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
1
num At Risk
12
term
Spinal cord compression
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
1
num At Risk
12
term
Dyspnoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
2
num At Risk
12
term
Pneumothorax

time Frame

Day 1 until the end of study (or primary data cut-off date for ongoing participants); median [min, max] duration was 5.57 [1.5, 13.7] months

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Preserved source evidence · Not medical advice