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NCT03687125 · OUTCOME

Phase 1 and 2: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)

Tinostamustine Conditioning and Autologous Stem Cell · Source last updated 2021-06-18

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
From first dose of tinostamustine up to end of study (up to 6 months)

What was measured

An Adverse Event (AE) was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. Serious adverse event (SAE) was defined as AE resulting in any of the following outcomes deemed significant for any other reason: death, was life-threatening (participant was at immediate risk of death from event as it occurred), requires in-patient hospitalization (formal admission to a hospital for medical reasons) or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, results in a congenital anomaly/birth defect. TEAE was defined as an adverse event that started on or after the first dose of tinostamustine through Day 107, or after the end of the study if thought to be related to study drug.

Analysis population: Safety population included all participants who received tinostamustine. The study was early terminated on 17 April 2019, due to safety signals during Phase 1, participants were not enrolled in Phase 2.

Groups in this outcome

Tinostamustine 180 mg/m^2

Participants received single dose of tinostamustine 180 mg/m\^2 IV injection followed by autologous stem cell transplantation (ASCT) on Day 1.

Tinostamustine 220 mg/m^2

Participants received single dose of tinostamustine 220 mg/m\^2 IV injection followed by ASCT on Day 1.

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

Analysis denominator · Participants

GroupSource count
Tinostamustine 180 mg/m^23
Tinostamustine 220 mg/m^23

Reported measurements

Participants with TEAEs
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tinostamustine 180 mg/m^23Not reportedNot reportedNot reportedNot reported
Tinostamustine 220 mg/m^23Not reportedNot reportedNot reportedNot reported
Participants with TESAEs
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tinostamustine 180 mg/m^21Not reportedNot reportedNot reportedNot reported
Tinostamustine 220 mg/m^22Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        3
    title
    Participants with TEAEs
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        2
    title
    Participants with TESAEs
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      3
    units
    Participants
description
An Adverse Event (AE) was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. Serious adverse event (SAE) was defined as AE resulting in any of the following outcomes deemed significant for any other reason: death, was life-threatening (participant was at immediate risk of death from event as it occurred), requires in-patient hospitalization (formal admission to a hospital for medical reasons) or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, results in a congenital anomaly/birth defect. TEAE was defined as an adverse event that started on or after the first dose of tinostamustine through Day 107, or after the end of the study if thought to be related to study drug.
groups
  1. description
    Participants received single dose of tinostamustine 180 mg/m\^2 IV injection followed by autologous stem cell transplantation (ASCT) on Day 1.
    id
    OG000
    title
    Tinostamustine 180 mg/m^2
  2. description
    Participants received single dose of tinostamustine 220 mg/m\^2 IV injection followed by ASCT on Day 1.
    id
    OG001
    title
    Tinostamustine 220 mg/m^2
param Type
COUNT_OF_PARTICIPANTS
population Description
Safety population included all participants who received tinostamustine. The study was early terminated on 17 April 2019, due to safety signals during Phase 1, participants were not enrolled in Phase 2.
reporting Status
POSTED
time Frame
From first dose of tinostamustine up to end of study (up to 6 months)
title
Phase 1 and 2: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice