NCT03817853 · OUTCOME

Objective Response Rate (ORR) at the End of Induction (EOI) Therapy

An Open-Label, Single Arm Study of Obinutuzumab Short Duration Infusion in Patients With Previously Untreated Advanced Follicular Lymphoma · Source last updated 2024-04-04

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure: NUMBER
Unit: Percentage of Participants
Interval / dispersion: Not reported
Time frame: Baseline up to end of induction therapy (up to approximately 6 months)

What was measured

ORR at EOI therapy was defined as the percentage of particpants with either a CR, CR unconfirmed or PR at the EOI visit, as determined by the investigator and according to the guidelines used at the site.

Analysis population: The safety population included all participants who received at least one dose of obinutuzumab.

Groups in this outcome

All Participants

Participants were enrolled in an induction phase and received 6-8 cycles of obinutuzumab, combined with 6 or 8 cycles of standard chemotherapy (cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone/methylprednisolone \[CHOP - 21-day cycle) or bendamustine (28-day cycle), or cyclophosphamide, vincristine, and prednisone/prednisolone/methylprednisolone \[CVP - 21-day cycle\]). Participants received an additional two doses of obinutuzumab on Days 8 and 15 of Cycle 1. The investigator was free to choose the chemotherapy for each participant.

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
All Participants	113

Reported measurements

Complete Response

Analysis denominator · Participants

Group	Source count
All Participants	77

Values in Percentage of Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
All Participants	68.1	Not reported	Not reported	Not reported	Not reported

Complete Response unconfirmed

Analysis denominator · Participants

Group	Source count
All Participants	0

Partial Response

Analysis denominator · Participants

Group	Source count
All Participants	22

Values in Percentage of Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
All Participants	19.5	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
68.1
denoms
counts
group Id
OG000
value
77
units
Participants
title
Complete Response
denoms
counts
group Id
OG000
value
0
units
Participants
title
Complete Response unconfirmed
categories
measurements
group Id
OG000
value
19.5
denoms
counts
group Id
OG000
value
22
units
Participants
title
Partial Response

denoms

counts
group Id
OG000
value
113
units
Participants

description

groups

description
Participants were enrolled in an induction phase and received 6-8 cycles of obinutuzumab, combined with 6 or 8 cycles of standard chemotherapy (cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone/methylprednisolone \[CHOP - 21-day cycle) or bendamustine (28-day cycle), or cyclophosphamide, vincristine, and prednisone/prednisolone/methylprednisolone \[CVP - 21-day cycle\]). Participants received an additional two doses of obinutuzumab on Days 8 and 15 of Cycle 1. The investigator was free to choose the chemotherapy for each participant.
id
OG000
title
All Participants

param Type

NUMBER

population Description

The safety population included all participants who received at least one dose of obinutuzumab.

reporting Status

POSTED

time Frame

Baseline up to end of induction therapy (up to approximately 6 months)

title

Objective Response Rate (ORR) at the End of Induction (EOI) Therapy

type

SECONDARY

unit Of Measure

Percentage of Participants

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

Preserved source evidence · Not medical advice