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NCT01649856 · OUTCOME

Rituximab Administration Satisfaction Questionnaire (RASQ) Domain Scores

A Study of Subcutaneous Versus Intravenous MabThera/Rituxan (Rituximab) in Combination With CHOP Chemotherapy in Patients With Previously Untreated CD20-Positive Diffuse Large B-Cell Lymphoma · Source last updated 2017-10-11

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

Measure
MEAN
Unit
units on a scale
Interval / dispersion
Standard Deviation
Time frame
At Cycle 7 (each cycle was 14 or 21 days)

What was measured

The RASQ is a 20-item questionnaire that measures five domains related to the impact of treatment administration. These include physical impact, psychological impact, impact on activities of daily living (ADLs), convenience, and satisfaction. Each domain is scored on a scale of 0 to 100, with higher scores indicative of more positive feelings toward therapy. The score for each domain was averaged among all participants.

Analysis population: ITT Population (RASQ Subpopulation): All participants who completed the RASQ at Cycles 3 and 7; n = number of participants in the analysis for the specified domain.

Groups in this outcome

Rituximab SC

Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For Cycle 1, rituximab was administered at a dose of 375 mg/m\^2 via IV infusion; subsequent doses were given as 1400 mg via SC injection. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.

Rituximab IV

Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For all cycles, rituximab was administered at a dose of 375 mg/m\^2 via IV infusion. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.

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

Analysis denominator · Participants

GroupSource count
Rituximab SC284
Rituximab IV144

Reported measurements

Physical Impact (n=278,140)
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Rituximab SC86.2414.012Not reportedNot reportedNot reported
Rituximab IV81.4916.848Not reportedNot reportedNot reported
Psychological Impact (n=277,141)
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Rituximab SC85.6513.920Not reportedNot reportedNot reported
Rituximab IV78.6518.233Not reportedNot reportedNot reported
Impact on ADLs (n=266,140)
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Rituximab SC83.7716.117Not reportedNot reportedNot reported
Rituximab IV57.3819.230Not reportedNot reportedNot reported
Convenience (n=279,143)
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Rituximab SC82.3213.428Not reportedNot reportedNot reported
Rituximab IV60.1417.473Not reportedNot reportedNot reported
Satisfaction (n=282,141)
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Rituximab SC89.5812.051Not reportedNot reportedNot reported
Rituximab IV77.3918.232Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        14.012
        value
        86.24
      2. group Id
        OG001
        spread
        16.848
        value
        81.49
    title
    Physical Impact (n=278,140)
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        13.920
        value
        85.65
      2. group Id
        OG001
        spread
        18.233
        value
        78.65
    title
    Psychological Impact (n=277,141)
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        16.117
        value
        83.77
      2. group Id
        OG001
        spread
        19.230
        value
        57.38
    title
    Impact on ADLs (n=266,140)
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        13.428
        value
        82.32
      2. group Id
        OG001
        spread
        17.473
        value
        60.14
    title
    Convenience (n=279,143)
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        12.051
        value
        89.58
      2. group Id
        OG001
        spread
        18.232
        value
        77.39
    title
    Satisfaction (n=282,141)
denoms
  1. counts
    1. group Id
      OG000
      value
      284
    2. group Id
      OG001
      value
      144
    units
    Participants
description
The RASQ is a 20-item questionnaire that measures five domains related to the impact of treatment administration. These include physical impact, psychological impact, impact on activities of daily living (ADLs), convenience, and satisfaction. Each domain is scored on a scale of 0 to 100, with higher scores indicative of more positive feelings toward therapy. The score for each domain was averaged among all participants.
dispersion Type
Standard Deviation
groups
  1. description
    Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For Cycle 1, rituximab was administered at a dose of 375 mg/m\^2 via IV infusion; subsequent doses were given as 1400 mg via SC injection. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.
    id
    OG000
    title
    Rituximab SC
  2. description
    Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For all cycles, rituximab was administered at a dose of 375 mg/m\^2 via IV infusion. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.
    id
    OG001
    title
    Rituximab IV
param Type
MEAN
population Description
ITT Population (RASQ Subpopulation): All participants who completed the RASQ at Cycles 3 and 7; n = number of participants in the analysis for the specified domain.
reporting Status
POSTED
time Frame
At Cycle 7 (each cycle was 14 or 21 days)
title
Rituximab Administration Satisfaction Questionnaire (RASQ) Domain Scores
type
SECONDARY
unit Of Measure
units on a scale

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Preserved source evidence · Not medical advice