Skip to content
← Full study record

NCT02953652 · OUTCOME

Median Duration of Response (DOR)

Efficacy and Safety of Oral HBI-8000 in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL) · Source last updated 2024-09-19

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
MEDIAN
Unit
Months
Interval / dispersion
95% Confidence Interval
Time frame
Up to approximately 47 months.

What was measured

DOR was defined as the duration of response from first response (CR/PR) to disease progression or death, whichever occurs first. CR or PR according to the IWC 2014 criteria was assessed by an IOERC.

Analysis population: Subjects who achieved PR or CR in the PPS

Groups in this outcome

HBI-8000

HBI-8000 Tablets

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

Analysis denominator · Participants

GroupSource count
HBI-800021

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
HBI-800025.7Not reported5.4NANot estimable due to the low number of events
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Not estimable due to the low number of events
        group Id
        OG000
        lower Limit
        5.4
        upper Limit
        NA
        value
        25.7
denoms
  1. counts
    1. group Id
      OG000
      value
      21
    units
    Participants
description
DOR was defined as the duration of response from first response (CR/PR) to disease progression or death, whichever occurs first. CR or PR according to the IWC 2014 criteria was assessed by an IOERC.
dispersion Type
95% Confidence Interval
groups
  1. description
    HBI-8000 Tablets
    id
    OG000
    title
    HBI-8000
param Type
MEDIAN
population Description
Subjects who achieved PR or CR in the PPS
reporting Status
POSTED
time Frame
Up to approximately 47 months.
title
Median Duration of Response (DOR)
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice