NCT05397171 · ADVERSE EVENTS

Adverse events

A First-in-human Study to Evaluate the Safety and Tolerability of AZD8853 in Participants With Selected Advanced/Metastatic Solid Tumours · Source last updated 2024-10-01

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: From screening (Day -28 to Day -1) up to 90 (±7 days) days after the last dose of AZD8853 (1 Year).
Other-event reporting threshold: 5%

Safety set included all participants who received any amount of IP. All the adverse events from Screening till study termination have been presented here before and after receiving treatment.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
AZD8853 300 mg Participants with advanced/metastatic solid tumors received AZD8853 300 mg every 3 weeks until progressive disease, unacceptable toxicity, or withdrawal of consent.	2 / 3	3 / 3	2 / 3
AZD8853 1000 mg Participants with advanced/metastatic solid tumors received AZD8853 1000 mg every 3 weeks until progressive disease, unacceptable toxicity, or withdrawal of consent.	3 / 6	4 / 6	3 / 6
AZD8853 3000 mg Participants with advanced/metastatic solid tumors received AZD8853 3000 mg every 3 weeks until progressive disease, unacceptable toxicity, or withdrawal of consent.	2 / 7	6 / 7	3 / 7

Group identifiers: EG000: AZD8853 300 mg · EG001: AZD8853 1000 mg · EG002: AZD8853 3000 mg

Serious adverse events

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

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
1
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
7
term
Syncope
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
1
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
7
term
COVID-19
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
1
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
7
term
Clostridium difficile infection
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
1
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
7
term
Anal fistula
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
1
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
7
term
Sepsis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
1
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
7
term
Blood bilirubin increased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
1
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
7
term
Embolism
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
1
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
7
term
Cardiac arrest
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
1
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
7
term
Back pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
1
num At Risk
7
term
Small intestinal obstruction
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
1
num At Risk
7
term
Femoral neck fracture

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
NON_SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
1
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
7
term
Muscular weakness
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
2
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
1
num At Risk
7
term
Pyrexia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
2
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
2
num At Risk
7
term
Decreased appetite
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
1
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
7
term
Blood alkaline phosphatase increased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
1
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
7
term
Anaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
1
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
7
term
Dehydration
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
1
num At Risk
3
group Id
EG001
num Affected
1
num At Risk
6
group Id
EG002
num Affected
3
num At Risk
7
term
Diarrhoea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
1
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
7
term
Hypotension
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
1
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
7
term
Hyponatraemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
1
num At Risk
3
group Id
EG001
num Affected
1
num At Risk
6
group Id
EG002
num Affected
3
num At Risk
7
term
Abdominal pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
1
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
1
num At Risk
7
term
Chills
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
1
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
7
term
Sacral pain

Complete source fields

description

Safety set included all participants who received any amount of IP. All the adverse events from Screening till study termination have been presented here before and after receiving treatment.

event Groups

deaths Num Affected
2
deaths Num At Risk
3
description
Participants with advanced/metastatic solid tumors received AZD8853 300 mg every 3 weeks until progressive disease, unacceptable toxicity, or withdrawal of consent.
id
EG000
other Num Affected
3
other Num At Risk
3
serious Num Affected
2
serious Num At Risk
3
title
AZD8853 300 mg
deaths Num Affected
3
deaths Num At Risk
6
description
Participants with advanced/metastatic solid tumors received AZD8853 1000 mg every 3 weeks until progressive disease, unacceptable toxicity, or withdrawal of consent.
id
EG001
other Num Affected
4
other Num At Risk
6
serious Num Affected
3
serious Num At Risk
6
title
AZD8853 1000 mg
deaths Num Affected
3
deaths Num At Risk
7
description
Participants with advanced/metastatic solid tumors received AZD8853 3000 mg every 3 weeks until progressive disease, unacceptable toxicity, or withdrawal of consent.
id
EG002
other Num Affected
6
other Num At Risk
7
serious Num Affected
2
serious Num At Risk
7
title
AZD8853 3000 mg

frequency Threshold

other Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
1
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
7
term
Muscular weakness
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
2
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
1
num At Risk
7
term
Pyrexia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
2
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
2
num At Risk
7
term
Decreased appetite
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
1
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
7
term
Blood alkaline phosphatase increased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
1
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
7
term
Anaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
1
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
7
term
Dehydration
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
1
num At Risk
3
group Id
EG001
num Affected
1
num At Risk
6
group Id
EG002
num Affected
3
num At Risk
7
term
Diarrhoea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
1
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
7
term
Hypotension
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
1
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
7
term
Hyponatraemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
1
num At Risk
3
group Id
EG001
num Affected
1
num At Risk
6
group Id
EG002
num Affected
3
num At Risk
7
term
Abdominal pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
1
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
1
num At Risk
7
term
Chills
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
1
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
7
term
Sacral pain

serious Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
1
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
7
term
Syncope
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
1
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
7
term
COVID-19
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
1
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
7
term
Clostridium difficile infection
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
1
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
7
term
Anal fistula
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
1
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
7
term
Sepsis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
1
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
7
term
Blood bilirubin increased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
1
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
7
term
Embolism
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
1
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
7
term
Cardiac arrest
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
1
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
7
term
Back pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
1
num At Risk
7
term
Small intestinal obstruction
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
1
num At Risk
7
term
Femoral neck fracture

time Frame

From screening (Day -28 to Day -1) up to 90 (±7 days) days after the last dose of AZD8853 (1 Year).

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice