NCT01716806 · OUTCOME

Number of Participants With Nivolumab Antitherapeutic Antibodies (ATA) (Part D Only)

A Study of Brentuximab Vedotin With Hodgkin Lymphoma (HL) and CD30-expressing Peripheral T-cell Lymphoma (PTCL) · Source last updated 2024-06-11

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 30 months

Analysis population: Subject with baseline negative anti-drug antibody (ADA)

Groups in this outcome

Part D

BV in combination with nivolumab as frontline therapy in adults aged 60 and above with cHL. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle. Nivolumab (3 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle.

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
Part D	17

Reported measurements

Cycle 1 (Pre-dose nivolumab)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part D	0	Not reported	Not reported	Not reported	Not reported

First Positive Cycle (pre-dose) - Cycle 2

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

First Positive Cycle (pre-dose) - Cycle 8

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

Any positive post-baseline

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part D	5	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
0
title
Cycle 1 (Pre-dose nivolumab)
categories
measurements
group Id
OG000
value
4
title
First Positive Cycle (pre-dose) - Cycle 2
categories
measurements
group Id
OG000
value
1
title
First Positive Cycle (pre-dose) - Cycle 8
categories
measurements
group Id
OG000
value
5
title
Any positive post-baseline

denoms

counts
group Id
OG000
value
17
units
Participants

groups

description
BV in combination with nivolumab as frontline therapy in adults aged 60 and above with cHL. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle. Nivolumab (3 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle.
id
OG000
title
Part D

param Type

COUNT_OF_PARTICIPANTS

population Description

Subject with baseline negative anti-drug antibody (ADA)

reporting Status

POSTED

time Frame

Up to 30 months

title

Number of Participants With Nivolumab Antitherapeutic Antibodies (ATA) (Part D Only)

type

SECONDARY

unit Of Measure

Participants

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

Preserved source evidence · Not medical advice