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NCT05140382 · OUTCOME

Number of Participants With Adverse Events (AE) and Serious AEs (SAE)

AZD4573 as Monotherapy or in Combinations With Anti-cancer Agents in Patients With r/r PTCL or r/r cHL · Source last updated 2024-08-28

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 treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).

What was measured

The safety and tolerability of AZD4573 was assessed.

Analysis population: Safety set included all participants who received at least 1 dose of any study intervention.

Groups in this outcome

Cohort 1 Non-NK PTCL

Participants with non-NK PTCL received 12 mg dose of AZD4573 once weekly until disease progression.

Cohort 2 NK PTCL

Participants with NK PTCL received 12 mg dose of AZD4573 once weekly until disease progression.

Cohort 3 cHL

Participants with cHL received 12 mg dose of AZD4573 once weekly until disease progression.

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

Analysis denominator · Participants

GroupSource count
Cohort 1 Non-NK PTCL31
Cohort 2 NK PTCL2
Cohort 3 cHL19

Reported measurements

Any AE
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 1 Non-NK PTCL31Not reportedNot reportedNot reportedNot reported
Cohort 2 NK PTCL2Not reportedNot reportedNot reportedNot reported
Cohort 3 cHL18Not reportedNot reportedNot reportedNot reported
Any AE possibly related to treatment
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 1 Non-NK PTCL31Not reportedNot reportedNot reportedNot reported
Cohort 2 NK PTCL2Not reportedNot reportedNot reportedNot reported
Cohort 3 cHL16Not reportedNot reportedNot reportedNot reported
Any AE of Common Terminology Criteria for Adverse Events (CTCAE) grade 3 or higher
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 1 Non-NK PTCL29Not reportedNot reportedNot reportedNot reported
Cohort 2 NK PTCL2Not reportedNot reportedNot reportedNot reported
Cohort 3 cHL15Not reportedNot reportedNot reportedNot reported
Any AE of CTCAE grade 3 or higher, possibly related to treatment
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 1 Non-NK PTCL27Not reportedNot reportedNot reportedNot reported
Cohort 2 NK PTCL2Not reportedNot reportedNot reportedNot reported
Cohort 3 cHL13Not reportedNot reportedNot reportedNot reported
Any AE with outcome = death
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 1 Non-NK PTCL2Not reportedNot reportedNot reportedNot reported
Cohort 2 NK PTCL1Not reportedNot reportedNot reportedNot reported
Cohort 3 cHL0Not reportedNot reportedNot reportedNot reported
Any AE with outcome = death, possibly related to treatment
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 1 Non-NK PTCL2Not reportedNot reportedNot reportedNot reported
Cohort 2 NK PTCL0Not reportedNot reportedNot reportedNot reported
Cohort 3 cHL0Not reportedNot reportedNot reportedNot reported
Any SAE (including events with outcome = death)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 1 Non-NK PTCL21Not reportedNot reportedNot reportedNot reported
Cohort 2 NK PTCL2Not reportedNot reportedNot reportedNot reported
Cohort 3 cHL11Not reportedNot reportedNot reportedNot reported
Any SAE (including events with outcome = death), possibly related to treatment
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 1 Non-NK PTCL16Not reportedNot reportedNot reportedNot reported
Cohort 2 NK PTCL1Not reportedNot reportedNot reportedNot reported
Cohort 3 cHL8Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        31
      2. group Id
        OG001
        value
        2
      3. group Id
        OG002
        value
        18
    title
    Any AE
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        31
      2. group Id
        OG001
        value
        2
      3. group Id
        OG002
        value
        16
    title
    Any AE possibly related to treatment
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        29
      2. group Id
        OG001
        value
        2
      3. group Id
        OG002
        value
        15
    title
    Any AE of Common Terminology Criteria for Adverse Events (CTCAE) grade 3 or higher
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        27
      2. group Id
        OG001
        value
        2
      3. group Id
        OG002
        value
        13
    title
    Any AE of CTCAE grade 3 or higher, possibly related to treatment
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        0
    title
    Any AE with outcome = death
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
    title
    Any AE with outcome = death, possibly related to treatment
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        21
      2. group Id
        OG001
        value
        2
      3. group Id
        OG002
        value
        11
    title
    Any SAE (including events with outcome = death)
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        16
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        8
    title
    Any SAE (including events with outcome = death), possibly related to treatment
denoms
  1. counts
    1. group Id
      OG000
      value
      31
    2. group Id
      OG001
      value
      2
    3. group Id
      OG002
      value
      19
    units
    Participants
description
The safety and tolerability of AZD4573 was assessed.
groups
  1. description
    Participants with non-NK PTCL received 12 mg dose of AZD4573 once weekly until disease progression.
    id
    OG000
    title
    Cohort 1 Non-NK PTCL
  2. description
    Participants with NK PTCL received 12 mg dose of AZD4573 once weekly until disease progression.
    id
    OG001
    title
    Cohort 2 NK PTCL
  3. description
    Participants with cHL received 12 mg dose of AZD4573 once weekly until disease progression.
    id
    OG002
    title
    Cohort 3 cHL
param Type
COUNT_OF_PARTICIPANTS
population Description
Safety set included all participants who received at least 1 dose of any study intervention.
reporting Status
POSTED
time Frame
From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
title
Number of Participants With Adverse Events (AE) and Serious AEs (SAE)
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice