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NCT05140382 · OUTCOME

Objective Response Rate (ORR)

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
NUMBER
Unit
Percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
From Screening (Day -30 to Day-1) until disease progression or survival until death (26 months)

What was measured

Objective response rate is defined as the proportion of participants who have a tumour response of complete response \[CR\] or partial response \[PR\] according to the Lugano (2014) response criteria for malignant lymphoma.

Analysis population: Response evaluable set included all dosed participants who had measurable disease at baseline.

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

Source class 1
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Cohort 1 Non-NK PTCL22.6Not reported9.5941.10Not reported
Cohort 2 NK PTCL0Not reported084.19Not reported
Cohort 3 cHL21.1Not reported6.0545.57Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        9.59
        upper Limit
        41.10
        value
        22.6
      2. group Id
        OG001
        lower Limit
        0
        upper Limit
        84.19
        value
        0
      3. group Id
        OG002
        lower Limit
        6.05
        upper Limit
        45.57
        value
        21.1
denoms
  1. counts
    1. group Id
      OG000
      value
      31
    2. group Id
      OG001
      value
      2
    3. group Id
      OG002
      value
      19
    units
    Participants
description
Objective response rate is defined as the proportion of participants who have a tumour response of complete response \[CR\] or partial response \[PR\] according to the Lugano (2014) response criteria for malignant lymphoma.
dispersion Type
95% Confidence Interval
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
NUMBER
population Description
Response evaluable set included all dosed participants who had measurable disease at baseline.
reporting Status
POSTED
time Frame
From Screening (Day -30 to Day-1) until disease progression or survival until death (26 months)
title
Objective Response Rate (ORR)
type
PRIMARY
unit Of Measure
Percentage of participants

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

Preserved source evidence · Not medical advice