Skip to content
Triangle logo TriangleGet started
← Full study record

NCT01200758 · OUTCOME

Percentage of Responses Who Showed Rituximab SC Formulation Convenient as Compared to Rituximab IV Formulation as Assessed by Physician/Nurse Opinion

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 responses
Interval / dispersion
Not reported
Time frame
After Cycle 8 of induction treatment (24 weeks) and during the maintenance part of the study after 12 months (i.e., Cycle 15), and after the end of the maintenance treatment, (i.e., Cycle 20) (1 Cycle=4 weeks for Cycle 8 and 8 weeks for Cycles 15 and 20)

What was measured

All investigator physicians and nurses involved in this study were asked to complete question i.e. "Which formulation of rituximab (SC or IV) do you think is more convenient?" based on their experience with the rituximab SC and IV formulations across all participants and presented as rituximab SC is much more convenient; rituximab SC is a little more convenient; both formulations are equally convenient; rituximab IV is a little more convenient; and rituximab IV is much more convenient.

Analysis population: ITT Population. Here, number of participants analyzed = participants evaluable for the outcome measure. Here "n" = number of participants evaluable for this outcome measure at specified timepoint.

Groups in this outcome

All Participants

Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP): First cycle rituximab IV infusion (375 mg/m\^2) + 7 cycles of rituximab SC 1400 mg in combination with up to 8 cycles of CHOP or CVP chemotherapy administered every 3 weeks. Participants achieving at least PR entered rituximab SC (1400 mg) maintenance therapy once every 8 weeks for 24 months. Stage I and II: 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.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
All Participants166

Reported measurements

Cy8: Rituximab SC much more convenient (n=166)
Values in percentage of responses · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Participants81Not reportedNot reportedNot reportedNot reported
Cy8: Rituximab SC little more convenient (n=166)
Values in percentage of responses · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Participants13Not reportedNot reportedNot reportedNot reported
Cy8: Both formulations equally convenient (n=166)
Values in percentage of responses · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Participants2Not reportedNot reportedNot reportedNot reported
Cy8: Rituximab IV little more convenient (n=166)
Values in percentage of responses · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Participants4Not reportedNot reportedNot reportedNot reported
Cy8: Rituximab IV much more convenient (n=166)
Values in percentage of responses · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Participants0Not reportedNot reportedNot reportedNot reported
Cy15: Rituximab SC much more convenient (n=130)
Values in percentage of responses · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Participants88Not reportedNot reportedNot reportedNot reported
Cy15: Rituximab SC little more convenient (n=130)
Values in percentage of responses · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Participants7Not reportedNot reportedNot reportedNot reported
Cy15: Both formulations equally convenient (n=130)
Values in percentage of responses · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Participants5Not reportedNot reportedNot reportedNot reported
Cy15: Rituximab IV little more convenient (n=130)
Values in percentage of responses · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Participants0Not reportedNot reportedNot reportedNot reported
Cy15: Rituximab IV much more convenient (n=130)
Values in percentage of responses · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Participants0Not reportedNot reportedNot reportedNot reported
Cy20: Rituximab SC much more convenient (n=126)
Values in percentage of responses · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Participants88Not reportedNot reportedNot reportedNot reported
Cy20: Rituximab SC little more convenient (n=126)
Values in percentage of responses · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Participants9Not reportedNot reportedNot reportedNot reported
Cy20: Both formulations equally convenient (n=126)
Values in percentage of responses · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Participants2Not reportedNot reportedNot reportedNot reported
Cy20: Rituximab IV little more convenient (n=126)
Values in percentage of responses · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Participants1Not reportedNot reportedNot reportedNot reported
Cy20: Rituximab IV much more convenient (n=126)
Values in percentage of responses · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Participants0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        81
    title
    Cy8: Rituximab SC much more convenient (n=166)
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        13
    title
    Cy8: Rituximab SC little more convenient (n=166)
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    Cy8: Both formulations equally convenient (n=166)
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        4
    title
    Cy8: Rituximab IV little more convenient (n=166)
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Cy8: Rituximab IV much more convenient (n=166)
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        88
    title
    Cy15: Rituximab SC much more convenient (n=130)
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        7
    title
    Cy15: Rituximab SC little more convenient (n=130)
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        5
    title
    Cy15: Both formulations equally convenient (n=130)
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Cy15: Rituximab IV little more convenient (n=130)
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Cy15: Rituximab IV much more convenient (n=130)
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        88
    title
    Cy20: Rituximab SC much more convenient (n=126)
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        9
    title
    Cy20: Rituximab SC little more convenient (n=126)
denoms
  1. counts
    1. group Id
      OG000
      value
      166
    units
    Participants
description
All investigator physicians and nurses involved in this study were asked to complete question i.e. "Which formulation of rituximab (SC or IV) do you think is more convenient?" based on their experience with the rituximab SC and IV formulations across all participants and presented as rituximab SC is much more convenient; rituximab SC is a little more convenient; both formulations are equally convenient; rituximab IV is a little more convenient; and rituximab IV is much more convenient.
groups
  1. description
    Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP): First cycle rituximab IV infusion (375 mg/m\^2) + 7 cycles of rituximab SC 1400 mg in combination with up to 8 cycles of CHOP or CVP chemotherapy administered every 3 weeks. Participants achieving at least PR entered rituximab SC (1400 mg) maintenance therapy once every 8 weeks for 24 months. Stage I and II: 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.
    id
    OG000
    title
    All Participants
param Type
NUMBER
population Description
ITT Population. Here, number of participants analyzed = participants evaluable for the outcome measure. Here "n" = number of participants evaluable for this outcome measure at specified timepoint.
reporting Status
POSTED
time Frame
After Cycle 8 of induction treatment (24 weeks) and during the maintenance part of the study after 12 months (i.e., Cycle 15), and after the end of the maintenance treatment, (i.e., Cycle 20) (1 Cycle=4 weeks for Cycle 8 and 8 weeks for Cycles 15 and 20)
title
Percentage of Responses Who Showed Rituximab SC Formulation Convenient as Compared to Rituximab IV Formulation as Assessed by Physician/Nurse Opinion
type
SECONDARY
unit Of Measure
percentage of responses

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

Preserved source evidence · Not medical advice