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NCT04105010 · OUTCOME

Part B: CT-based Objective Response Rate (ORR) by Independent Review Committee (IRC)

Assessing An Oral Janus Kinase Inhibitor, AZD4205 as Monotherapy in Patients Who Have PTCL (JACKPOT8) · Source last updated 2025-04-04

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
Up to approximately 3 years

What was measured

ORR is the percentage of patients with at least one visit response of Complete Response (CR) or Partial Response (PR) based on CT scans evaluated by IRC per Lugano criteria.

Analysis population: Evaluable for CT-based Response Set (all dosed and central pathology confirmed Peripheral T Cell Lymphoma (PTCL) patients with baseline measurable disease assessed by IRC using CT imaging)

Groups in this outcome

AZD4205 Group D

Group D: Open label AZD4205 at 150 mg (RP2D), once daily (Phase 2) AZD4205: AZD4205 will be administered orally as capsules. AZD4205 treatment will be continued until disease progression or intolerant adverse reactions

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

Analysis denominator · Participants

GroupSource count
AZD4205 Group D102

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
AZD4205 Group D43.1Not reported33.453.3Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY
    p Value
    <0.0001
    statistical Method
    Binomial test against a null
Complete source fields
analyses
  1. group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY
    p Value
    <0.0001
    statistical Method
    Binomial test against a null
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        33.4
        upper Limit
        53.3
        value
        43.1
denoms
  1. counts
    1. group Id
      OG000
      value
      102
    units
    Participants
description
ORR is the percentage of patients with at least one visit response of Complete Response (CR) or Partial Response (PR) based on CT scans evaluated by IRC per Lugano criteria.
dispersion Type
95% Confidence Interval
groups
  1. description
    Group D: Open label AZD4205 at 150 mg (RP2D), once daily (Phase 2) AZD4205: AZD4205 will be administered orally as capsules. AZD4205 treatment will be continued until disease progression or intolerant adverse reactions
    id
    OG000
    title
    AZD4205 Group D
param Type
NUMBER
population Description
Evaluable for CT-based Response Set (all dosed and central pathology confirmed Peripheral T Cell Lymphoma (PTCL) patients with baseline measurable disease assessed by IRC using CT imaging)
reporting Status
POSTED
time Frame
Up to approximately 3 years
title
Part B: CT-based Objective Response Rate (ORR) by Independent Review Committee (IRC)
type
PRIMARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice