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NCT03687125 · OUTCOME

Phase 1 and 2: Number of Participants With Neutrophil and Platelet Engraftment Failure

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
Not reported
Unit
Not reported
Interval / dispersion
Not reported
Time frame
up to 6 months

What was measured

Neutrophil engraftment was defined as the first of 3 consecutive days with absolute neutrophil count (ANC) \>0.5 × 10 \^9/L. Platelet engraftment was defined as the first of 3 consecutive days of platelet count \>20 × 10 \^9/L without platelet transfusion in the prior 7 days. Number of participants with neutrophil and platelet engraftment failure was reported.

Analysis population: The study was early terminated on 17 April 2019, due to safety signals during Phase 1. Hence, data for this outcome measure was not collected as planned, analyzed and reported at specific time point.

Groups in this outcome

Tinostamustine 180 mg/m^2

Participants received single dose of tinostamustine 180 mg/m\^2 IV injection on Day -1 followed by ASCT on Day 1.

Tinostamustine 220 mg/m^2

Participants received single dose of tinostamustine 220 mg/m\^2 IV injection on Day -1 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^20
Tinostamustine 220 mg/m^20

Reported measurements

No numerical measurement classes were posted for this outcome. Missing is not zero.

Complete source fields
denoms
  1. counts
    1. group Id
      OG000
      value
      0
    2. group Id
      OG001
      value
      0
    units
    Participants
description
Neutrophil engraftment was defined as the first of 3 consecutive days with absolute neutrophil count (ANC) \>0.5 × 10 \^9/L. Platelet engraftment was defined as the first of 3 consecutive days of platelet count \>20 × 10 \^9/L without platelet transfusion in the prior 7 days. Number of participants with neutrophil and platelet engraftment failure was reported.
groups
  1. description
    Participants received single dose of tinostamustine 180 mg/m\^2 IV injection on Day -1 followed by 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 on Day -1 followed by ASCT on Day 1.
    id
    OG001
    title
    Tinostamustine 220 mg/m^2
population Description
The study was early terminated on 17 April 2019, due to safety signals during Phase 1. Hence, data for this outcome measure was not collected as planned, analyzed and reported at specific time point.
reporting Status
POSTED
time Frame
up to 6 months
title
Phase 1 and 2: Number of Participants With Neutrophil and Platelet Engraftment Failure
type
SECONDARY

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

Preserved source evidence · Not medical advice