NCT03687125 · OUTCOME

Phase 1 and 2: Change From Baseline in Clinical Serum Chemistry Tests: Total Protein

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: MEAN
Unit: gram per liter (g/L)
Interval / dispersion: Standard Deviation
Time frame: Baseline (Day -1), Day 100

What was measured

Clinical serum chemistry tests included total protein. Change from baseline in clinical serum chemistry tests i.e. total protein at Day 100 were reported.

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 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

Group	Source count
Tinostamustine 180 mg/m^2	3
Tinostamustine 220 mg/m^2	3

Reported measurements

Source class 1

Values in gram per liter (g/L) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Tinostamustine 180 mg/m^2	13.67	11.372	Not reported	Not reported	Not reported
Tinostamustine 220 mg/m^2	30.13	32.309	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
11.372
value
13.67
group Id
OG001
spread
32.309
value
30.13

denoms

counts
group Id
OG000
value
3
group Id
OG001
value
3
units
Participants

description

Clinical serum chemistry tests included total protein. Change from baseline in clinical serum chemistry tests i.e. total protein at Day 100 were reported.

dispersion Type

Standard Deviation

groups

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
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

param Type

MEAN

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

Baseline (Day -1), Day 100

title

Phase 1 and 2: Change From Baseline in Clinical Serum Chemistry Tests: Total Protein

type

SECONDARY

unit Of Measure

gram per liter (g/L)

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

Preserved source evidence · Not medical advice