NCT01200758 · OUTCOME

Stage I: Percentage of Participants With Overall Response at the End of Induction Treatment Assessed Using International Working Group Response Criteria for NHL

A Study of Rituximab (MabThera) Subcutaneous (SC) Versus Rituximab (MabThera) Intravenous in Participannts With Follicular Non-Hodgkin's Lymphoma · Source last updated 2018-11-27

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: 95% Confidence Interval
Time frame: Stage I: Baseline up to end of induction treatment Cy8 (24 weeks) (1 Cy=3 weeks)

What was measured

Overall Response comprised CR, CRu, or PR. A participant was defined as a responder if they sustained a CR, CRu or PR at the end of induction treatment. Response assessment was based on clinical examination and CT scans. Assessment of tumor response was performed according to the International Working Group response criteria for NHL. CR: complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy; CRu: CR along with regression in lymph node mass by \>75% in the SPD; PR: ≥50% decrease in SPD of 6 largest dominant nodes or nodal masses. The 95% CI was estimated for one sample binomial using Pearson-Clopper.

Analysis population: Stage I ITT Population included all participants who were randomized in Stage I irrespective whether they received study drug or not.

Groups in this outcome

Stage I: Rituximab IV + Chemotherapy (CHOP/CVP)

Eight cycles of rituximab IV infusion (375 mg/m\^2; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR during induction, entered rituximab IV maintenance therapy (375 mg/m\^2) once every 8 weeks for 24 months.

Stage I: Rituximab SC + Chemotherapy (CHOP/CVP)

First cycle of rituximab IV (375 mg/m\^2) + 7 cycles of rituximab subcutaneously (SC) (1400 mg; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR during induction, entered rituximab SC (1400 mg) maintenance therapy once every 8 weeks for 24 months.

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
Stage I: Rituximab IV + Chemotherapy (CHOP/CVP)	64
Stage I: Rituximab SC + Chemotherapy (CHOP/CVP)	63

Reported measurements

Source class 1

Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Stage I: Rituximab IV + Chemotherapy (CHOP/CVP)	82.8	Not reported	71.3	91.1	Not reported
Stage I: Rituximab SC + Chemotherapy (CHOP/CVP)	90.5	Not reported	80.4	96.4	Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

ci Lower Limit
-5.0
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
20.3
estimate Comment
The 95% CI for the difference in response rates was estimated using the Hauck-Anderson method.
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.2047
param Type
Difference in response rates
param Value
7.66
statistical Method
Chi-squared
ci Lower Limit
0.68
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
5.71
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
param Type
Odds Ratio (OR)
param Value
1.97

Complete source fields

analyses

ci Lower Limit
-5.0
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
20.3
estimate Comment
The 95% CI for the difference in response rates was estimated using the Hauck-Anderson method.
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.2047
param Type
Difference in response rates
param Value
7.66
statistical Method
Chi-squared
ci Lower Limit
0.68
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
5.71
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
param Type
Odds Ratio (OR)
param Value
1.97

classes

categories
measurements
group Id
OG000
lower Limit
71.3
upper Limit
91.1
value
82.8
group Id
OG001
lower Limit
80.4
upper Limit
96.4
value
90.5

denoms

counts
group Id
OG000
value
64
group Id
OG001
value
63
units
Participants

description

dispersion Type

95% Confidence Interval

groups

description
Eight cycles of rituximab IV infusion (375 mg/m\^2; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR during induction, entered rituximab IV maintenance therapy (375 mg/m\^2) once every 8 weeks for 24 months.
id
OG000
title
Stage I: Rituximab IV + Chemotherapy (CHOP/CVP)
description
First cycle of rituximab IV (375 mg/m\^2) + 7 cycles of rituximab subcutaneously (SC) (1400 mg; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR during induction, entered rituximab SC (1400 mg) maintenance therapy once every 8 weeks for 24 months.
id
OG001
title
Stage I: Rituximab SC + Chemotherapy (CHOP/CVP)

param Type

NUMBER

population Description

Stage I ITT Population included all participants who were randomized in Stage I irrespective whether they received study drug or not.

reporting Status

POSTED

time Frame

Stage I: Baseline up to end of induction treatment Cy8 (24 weeks) (1 Cy=3 weeks)

title

Stage I: Percentage of Participants With Overall Response at the End of Induction Treatment Assessed Using International Working Group Response Criteria for NHL

type

SECONDARY

unit Of Measure

percentage of participants

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Preserved source evidence · Not medical advice