Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02953652 · OUTCOME

Median Duration of Progression-free Survival (PFS)

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

PFS was defined as the duration from the date of the first study drug dose to the disease progression or death, whichever occurs first. PD was defined using the IWC 2014 criteria, as any new lesion or an individual node/lesion must be abnormal with: "LDi \>1.5 cm" and "increase by 50% from perpendicular diameters nadir" and "an increase in LDi or shortest axis perpendicular to the LDi from nadir, 0.5 cm for lesions \<2 cm or 1.0 cm for lesions \>2 cm".

Analysis population: 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-800046

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
HBI-80005.5Not reported2.924.0Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2.9
        upper Limit
        24.0
        value
        5.5
denoms
  1. counts
    1. group Id
      OG000
      value
      46
    units
    Participants
description
PFS was defined as the duration from the date of the first study drug dose to the disease progression or death, whichever occurs first. PD was defined using the IWC 2014 criteria, as any new lesion or an individual node/lesion must be abnormal with: "LDi \>1.5 cm" and "increase by 50% from perpendicular diameters nadir" and "an increase in LDi or shortest axis perpendicular to the LDi from nadir, 0.5 cm for lesions \<2 cm or 1.0 cm for lesions \>2 cm".
dispersion Type
95% Confidence Interval
groups
  1. description
    HBI-8000 Tablets
    id
    OG000
    title
    HBI-8000
param Type
MEDIAN
population Description
PPS
reporting Status
POSTED
time Frame
Up to approximately 47 months.
title
Median Duration of Progression-free Survival (PFS)
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice