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NCT05397171 · OUTCOME

Number of Participants With Treatment-emergent Adverse Events (TEAEs)

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.

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
From Day 1 up to 90 (±7 days) days after the last dose of AZD8853 (1 Year)

What was measured

The safety and tolerability of AZD8853 in participants with selected advanced/metastatic solid tumors was assessed. As per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0, severity scale ranged from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death related to adverse event. This outcome measure was assessed only for substudy 1 Part A.

Analysis population: Safety set included all participants who received any amount of IP.

Groups in this outcome

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.

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.

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.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
AZD8853 300 mg3
AZD8853 1000 mg6
AZD8853 3000 mg7

Reported measurements

Any AE
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
AZD8853 300 mg3Not reportedNot reportedNot reportedNot reported
AZD8853 1000 mg4Not reportedNot reportedNot reportedNot reported
AZD8853 3000 mg6Not reportedNot reportedNot reportedNot reported
Any AE possibly related to treatment
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
AZD8853 300 mg1Not reportedNot reportedNot reportedNot reported
AZD8853 1000 mg0Not reportedNot reportedNot reportedNot reported
AZD8853 3000 mg2Not reportedNot reportedNot reportedNot reported
Any serious adverse event (SAE)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
AZD8853 300 mg1Not reportedNot reportedNot reportedNot reported
AZD8853 1000 mg3Not reportedNot reportedNot reportedNot reported
AZD8853 3000 mg2Not reportedNot reportedNot reportedNot reported
Any SAE possibly related to treatment
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
AZD8853 300 mg0Not reportedNot reportedNot reportedNot reported
AZD8853 1000 mg0Not reportedNot reportedNot reportedNot reported
AZD8853 3000 mg0Not reportedNot reportedNot reportedNot reported
Any SAE with outcome death
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
AZD8853 300 mg0Not reportedNot reportedNot reportedNot reported
AZD8853 1000 mg1Not reportedNot reportedNot reportedNot reported
AZD8853 3000 mg0Not reportedNot reportedNot reportedNot reported
Any SAE with outcome death and possibly related to treatment
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
AZD8853 300 mg0Not reportedNot reportedNot reportedNot reported
AZD8853 1000 mg0Not reportedNot reportedNot reportedNot reported
AZD8853 3000 mg0Not reportedNot reportedNot reportedNot reported
Any AE leading to discontinuation of IP
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
AZD8853 300 mg0Not reportedNot reportedNot reportedNot reported
AZD8853 1000 mg1Not reportedNot reportedNot reportedNot reported
AZD8853 3000 mg0Not reportedNot reportedNot reportedNot reported
Any AE leading to discontinuation of IP and possibly related to treatment
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
AZD8853 300 mg0Not reportedNot reportedNot reportedNot reported
AZD8853 1000 mg0Not reportedNot reportedNot reportedNot reported
AZD8853 3000 mg0Not reportedNot reportedNot reportedNot reported
Any AE leading to interruption of IP
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
AZD8853 300 mg0Not reportedNot reportedNot reportedNot reported
AZD8853 1000 mg1Not reportedNot reportedNot reportedNot reported
AZD8853 3000 mg1Not reportedNot reportedNot reportedNot reported
Any SAE leading to discontinuation of IP
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
AZD8853 300 mg0Not reportedNot reportedNot reportedNot reported
AZD8853 1000 mg1Not reportedNot reportedNot reportedNot reported
AZD8853 3000 mg0Not reportedNot reportedNot reportedNot reported
Any SAE leading to discontinuation of IP and possibly related to treatment (IP)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
AZD8853 300 mg0Not reportedNot reportedNot reportedNot reported
AZD8853 1000 mg0Not reportedNot reportedNot reportedNot reported
AZD8853 3000 mg0Not reportedNot reportedNot reportedNot reported
Any AE of greater than or equal to (>=) CTCAE Grade 3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
AZD8853 300 mg1Not reportedNot reportedNot reportedNot reported
AZD8853 1000 mg3Not reportedNot reportedNot reportedNot reported
AZD8853 3000 mg4Not reportedNot reportedNot reportedNot reported
Any AE of >= CTCAE Grade 3 possibly related to treatment
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
AZD8853 300 mg0Not reportedNot reportedNot reportedNot reported
AZD8853 1000 mg0Not reportedNot reportedNot reportedNot reported
AZD8853 3000 mg0Not reportedNot reportedNot reportedNot reported
Any SAE of >= CTCAE Grade 3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
AZD8853 300 mg1Not reportedNot reportedNot reportedNot reported
AZD8853 1000 mg3Not reportedNot reportedNot reportedNot reported
AZD8853 3000 mg2Not reportedNot reportedNot reportedNot reported
Any SAE of >= CTCAE Grade 3 possibly related to treatment
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
AZD8853 300 mg0Not reportedNot reportedNot reportedNot reported
AZD8853 1000 mg0Not reportedNot reportedNot reportedNot reported
AZD8853 3000 mg0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        4
      3. group Id
        OG002
        value
        6
    title
    Any AE
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        2
    title
    Any AE possibly related to treatment
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        3
      3. group Id
        OG002
        value
        2
    title
    Any serious adverse event (SAE)
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
    title
    Any SAE possibly related to treatment
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        0
    title
    Any SAE with outcome death
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
    title
    Any SAE with outcome death and possibly related to treatment
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        0
    title
    Any AE leading to discontinuation of IP
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
    title
    Any AE leading to discontinuation of IP and possibly related to treatment
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        1
    title
    Any AE leading to interruption of IP
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        0
    title
    Any SAE leading to discontinuation of IP
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
    title
    Any SAE leading to discontinuation of IP and possibly related to treatment (IP)
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        3
      3. group Id
        OG002
        value
        4
    title
    Any AE of greater than or equal to (>=) CTCAE Grade 3
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      6
    3. group Id
      OG002
      value
      7
    units
    Participants
description
The safety and tolerability of AZD8853 in participants with selected advanced/metastatic solid tumors was assessed. As per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0, severity scale ranged from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death related to adverse event. This outcome measure was assessed only for substudy 1 Part A.
groups
  1. description
    Participants with advanced/metastatic solid tumors received AZD8853 300 mg every 3 weeks until progressive disease, unacceptable toxicity, or withdrawal of consent.
    id
    OG000
    title
    AZD8853 300 mg
  2. description
    Participants with advanced/metastatic solid tumors received AZD8853 1000 mg every 3 weeks until progressive disease, unacceptable toxicity, or withdrawal of consent.
    id
    OG001
    title
    AZD8853 1000 mg
  3. description
    Participants with advanced/metastatic solid tumors received AZD8853 3000 mg every 3 weeks until progressive disease, unacceptable toxicity, or withdrawal of consent.
    id
    OG002
    title
    AZD8853 3000 mg
param Type
COUNT_OF_PARTICIPANTS
population Description
Safety set included all participants who received any amount of IP.
reporting Status
POSTED
time Frame
From Day 1 up to 90 (±7 days) days after the last dose of AZD8853 (1 Year)
title
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice