NCT00719472 · OUTCOME

Maximum Serum Concentration (Cmax) of Rituximab Post-dose at the First Alternative Dosing Rate (Cycle 2) and the Last Cycle (Either Cycle 6 or 8)

A Study of Rituximab Alternative Dosing Rate in Patients With Previously Untreated Diffuse Large B-cell or Follicular Non-Hodgkin's Lymphoma (RATE) · Source last updated 2017-05-15

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

Measure: MEAN
Unit: µg/mL
Interval / dispersion: Standard Deviation
Time frame: Day 1 of Cycles 2 and either 6 or 8 (last cycle)

What was measured

Serum samples for rituximab pharmacokinetic analysis were taken pre-dose (within 15 minutes before rituximab infusion) and post-dose (within 15 minutes after the end of the rituximab infusion) after the first faster infusion (Cycle 2) and after the last infusion (either Cycle 6 or 8). An enzyme-linked immunosorbent assay (ELISA) was used to measure rituximab levels in the serum samples.

Analysis population: Pharmacokinetic evaluable population: All patients who received at least 1 infusion of rituximab and had rituximab concentration data.

Groups in this outcome

Rituximab 375 mg/m^2

Patients received 6 or 8 21-day cycles of CHOP (cyclophosphamide, hydroxydaunorubicin \[doxorubicin\], Oncovin \[vincristine\], prednisone) or CVP (cyclophosphamide, vincristine, prednisone) in combination with rituximab 375 mg/m\^2 administered by intravenous (IV) infusion on Day 1 of each 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
Rituximab 375 mg/m^2	335

Reported measurements

Cycle 2 (n=335)

Values in µg/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Rituximab 375 mg/m^2	228.0	63.7	Not reported	Not reported	Not reported

Cycle 6 (n=238)

Values in µg/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Rituximab 375 mg/m^2	275.0	71.5	Not reported	Not reported	Not reported

Cycle 8 (n=36)

Values in µg/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Rituximab 375 mg/m^2	299.0	90.6	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
63.7
value
228.0
title
Cycle 2 (n=335)
categories
measurements
group Id
OG000
spread
71.5
value
275.0
title
Cycle 6 (n=238)
categories
measurements
group Id
OG000
spread
90.6
value
299.0
title
Cycle 8 (n=36)

denoms

counts
group Id
OG000
value
335
units
Participants

description

dispersion Type

Standard Deviation

groups

description
Patients received 6 or 8 21-day cycles of CHOP (cyclophosphamide, hydroxydaunorubicin \[doxorubicin\], Oncovin \[vincristine\], prednisone) or CVP (cyclophosphamide, vincristine, prednisone) in combination with rituximab 375 mg/m\^2 administered by intravenous (IV) infusion on Day 1 of each cycle.
id
OG000
title
Rituximab 375 mg/m^2

param Type

MEAN

population Description

Pharmacokinetic evaluable population: All patients who received at least 1 infusion of rituximab and had rituximab concentration data.

reporting Status

POSTED

time Frame

Day 1 of Cycles 2 and either 6 or 8 (last cycle)

title

Maximum Serum Concentration (Cmax) of Rituximab Post-dose at the First Alternative Dosing Rate (Cycle 2) and the Last Cycle (Either Cycle 6 or 8)

type

SECONDARY

unit Of Measure

µg/mL

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

Preserved source evidence · Not medical advice