NCT03589469 · OUTCOME

Number of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiograms (ECGs)

Study to Evaluate the Efficacy and Safety of Loncastuximab Tesirine in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma · Source last updated 2023-08-29

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: Baseline up to 599 days

What was measured

Clinically significant changes from baseline for 12-lead ECGs were measured as abnormal QT interval corrected by Fridericia formula (QTcF) and QT interval corrected by Bazett formula (QTcB) values.

Analysis population: All-treated population - all participants who received at least 1 dose of treatment.

Groups in this outcome

Loncastuximab Tesirine

Participants received loncastuximab tesirine as an IV infusion over 30 minutes on Day 1 of each cycle (every 3 weeks) at a dose of 150 μg/kg Q3W for 2 cycles, then 75 μg/kg Q3W for subsequent cycles for up to one year or until disease progression, unacceptable toxicity, or other discontinuation criteria, whichever occurred first.

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
Loncastuximab Tesirine	145

Reported measurements

QTcB maximum change from baseline: >30, <=60 msec

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Loncastuximab Tesirine	30	Not reported	Not reported	Not reported	Not reported

QTcB maximum change from baseline: >60 msec

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Loncastuximab Tesirine	4	Not reported	Not reported	Not reported	Not reported

QTcF maximum change from baseline: >30, <=60 msec

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Loncastuximab Tesirine	23	Not reported	Not reported	Not reported	Not reported

QTcF maximum change from baseline: >60 msec

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Loncastuximab Tesirine	1	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
30
title
QTcB maximum change from baseline: >30, <=60 msec
categories
measurements
group Id
OG000
value
4
title
QTcB maximum change from baseline: >60 msec
categories
measurements
group Id
OG000
value
23
title
QTcF maximum change from baseline: >30, <=60 msec
categories
measurements
group Id
OG000
value
1
title
QTcF maximum change from baseline: >60 msec

denoms

counts
group Id
OG000
value
145
units
Participants

description

Clinically significant changes from baseline for 12-lead ECGs were measured as abnormal QT interval corrected by Fridericia formula (QTcF) and QT interval corrected by Bazett formula (QTcB) values.

groups

description
Participants received loncastuximab tesirine as an IV infusion over 30 minutes on Day 1 of each cycle (every 3 weeks) at a dose of 150 μg/kg Q3W for 2 cycles, then 75 μg/kg Q3W for subsequent cycles for up to one year or until disease progression, unacceptable toxicity, or other discontinuation criteria, whichever occurred first.
id
OG000
title
Loncastuximab Tesirine

param Type

COUNT_OF_PARTICIPANTS

population Description

All-treated population - all participants who received at least 1 dose of treatment.

reporting Status

POSTED

time Frame

Baseline up to 599 days

title

Number of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiograms (ECGs)

type

SECONDARY

unit Of Measure

Participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice