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NCT01200758 · OUTCOME

Stage I and II (Pooled): Percentage of Responses Showing Time Saved of Staff as Per Physician/Nurse Opinions With Each Administration of Rituximab SC as Compared to Rituximab IV at the End of Cy 8, 15 and 20

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 provide the staff time that could be saved with each administration of rituximab SC as compared with rituximab IV to participants in routine practice afetr Cy 8, 15, 20 and categorized as less than (\<) 1 hr, at least 1 hr but \<2 hrs, at least 2 hrs but \<3 hrs, at least 3 hrs but \<4 hrs, \>/=4 hrs. Staff were asked not to consider the time needed for the first IV administration. Analysis was done in all participants to show a comparison on the time saved by staffs when administered via SC and IV.

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

After Cy8: <1 hour (n=166)
Values in percentage of responses · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Participants11Not reportedNot reportedNot reportedNot reported
After Cy8: ≥1 to <2 hours (n=166)
Values in percentage of responses · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Participants20Not reportedNot reportedNot reportedNot reported
After Cy8: ≥2 to <3 hours (n=166)
Values in percentage of responses · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Participants35Not reportedNot reportedNot reportedNot reported
After Cy8: ≥3 to <4 hours (n=166)
Values in percentage of responses · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Participants18Not reportedNot reportedNot reportedNot reported
After Cy8: ≥4 hours (n=166)
Values in percentage of responses · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Participants16Not reportedNot reportedNot reportedNot reported
After Cy15: <1 hour (n=130)
Values in percentage of responses · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Participants13Not reportedNot reportedNot reportedNot reported
After Cy15: ≥1 to <2 hours (n=130)
Values in percentage of responses · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Participants17Not reportedNot reportedNot reportedNot reported
After Cy15: ≥2 to <3 hours (n=126)
Values in percentage of responses · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Participants34Not reportedNot reportedNot reportedNot reported
After Cy15: ≥3 to <4 hours (n=130)
Values in percentage of responses · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Participants14Not reportedNot reportedNot reportedNot reported
After Cy15: ≥4 hours (n=130)
Values in percentage of responses · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Participants22Not reportedNot reportedNot reportedNot reported
After Cy20: <1 hour (n=126)
Values in percentage of responses · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Participants14Not reportedNot reportedNot reportedNot reported
After Cy20: ≥1 to <2 hours (n=126)
Values in percentage of responses · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Participants32Not reportedNot reportedNot reportedNot reported
After Cy20: ≥2 to <3 hours (n=126)
Values in percentage of responses · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Participants21Not reportedNot reportedNot reportedNot reported
After Cy20: ≥3 to <4 hours (n=126)
Values in percentage of responses · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Participants13Not reportedNot reportedNot reportedNot reported
After Cy20: ≥4 hours (n=126)
Values in percentage of responses · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Participants19Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        11
    title
    After Cy8: <1 hour (n=166)
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        20
    title
    After Cy8: ≥1 to <2 hours (n=166)
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        35
    title
    After Cy8: ≥2 to <3 hours (n=166)
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        18
    title
    After Cy8: ≥3 to <4 hours (n=166)
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        16
    title
    After Cy8: ≥4 hours (n=166)
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        13
    title
    After Cy15: <1 hour (n=130)
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        17
    title
    After Cy15: ≥1 to <2 hours (n=130)
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        34
    title
    After Cy15: ≥2 to <3 hours (n=126)
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        14
    title
    After Cy15: ≥3 to <4 hours (n=130)
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        22
    title
    After Cy15: ≥4 hours (n=130)
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        14
    title
    After Cy20: <1 hour (n=126)
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        32
    title
    After Cy20: ≥1 to <2 hours (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 provide the staff time that could be saved with each administration of rituximab SC as compared with rituximab IV to participants in routine practice afetr Cy 8, 15, 20 and categorized as less than (\<) 1 hr, at least 1 hr but \<2 hrs, at least 2 hrs but \<3 hrs, at least 3 hrs but \<4 hrs, \>/=4 hrs. Staff were asked not to consider the time needed for the first IV administration. Analysis was done in all participants to show a comparison on the time saved by staffs when administered via SC and IV.
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
Stage I and II (Pooled): Percentage of Responses Showing Time Saved of Staff as Per Physician/Nurse Opinions With Each Administration of Rituximab SC as Compared to Rituximab IV at the End of Cy 8, 15 and 20
type
SECONDARY
unit Of Measure
percentage of responses

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

Preserved source evidence · Not medical advice