Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02953652 · OUTCOME

Safety Evaluated as Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v.4.0

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
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Up to approximately 44 months.

What was measured

Safety evaluated as number of participants with treatment-related adverse events as assessed by CTCAE v4.0. From date of first study drug to 30±3 days after the last dosing of the study drug or before the initiation of new cancer treatment.

Analysis population: Safety analysis set (SAF) includes all subjects who received at least one dose of HBI 8000.

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-800055

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
HBI-800051Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        51
denoms
  1. counts
    1. group Id
      OG000
      value
      55
    units
    Participants
description
Safety evaluated as number of participants with treatment-related adverse events as assessed by CTCAE v4.0. From date of first study drug to 30±3 days after the last dosing of the study drug or before the initiation of new cancer treatment.
groups
  1. description
    HBI-8000 Tablets
    id
    OG000
    title
    HBI-8000
param Type
COUNT_OF_PARTICIPANTS
population Description
Safety analysis set (SAF) includes all subjects who received at least one dose of HBI 8000.
reporting Status
POSTED
time Frame
Up to approximately 44 months.
title
Safety Evaluated as Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v.4.0
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice