Lymphoma, Large B-Cell, Diffuse
Conditions
Brief summary
This multicenter, randomized, open label parallel-group study will evaluate the efficacy and safety of subcutaneous versus intravenous MabThera/Rituxan (rituximab) in combination with CHOP chemotherapy in patients with previously untreated CD20-positive diffuse large B-Cell lymphoma. Patients will be randomized to receive either MabThera/Rituxan 1400 mg subcutaneously or MabThera/Rituxan 375 mg/m2 intravenously on Day 1 of each cycle for 8 cycles, in combination with 6-8 cycles of CHOP chemotherapy. Anticipated time on study treatment is 6 months.
Interventions
DRUGCHOP
CHOP chemotherapy: cyclophosphamide, doxorubicin, vincristine, prednisone/prednisolone; 6 or 8 cycles
DRUGrituximab [MabThera/Rituxan]
The first rituximab dose will be administered intravenously on Day of Cycle 1 at a dose of 375 mg/m2. Subsequent doses of 1400 mg are administered subcutaneously on Day 1 of each cycle, for a further 7 cycles
Sponsors
Hoffmann-La Roche
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Adult patients, \>/= 18 and \</= 80 years of age at time of study inclusion * Histologically confirmed, previously untreated CD20-positive diffuse large B-cell lymphoma (DLBCL) according to the WHO classification system * Patients with an International Prognostic Index (IPI) score 1-5, or IPI score 0 with bulky disease, defined as one lesion \>/= 7.5 cm * At least one bi-dimensionally measurable lesion defined as \>/= 1.5 cm in its largest dimension on CT scan, PET-CT scan or MRI * Adequate hematologic function * Eastern Cooperative Oncology Group (EOCD) performance status \</= 2
Exclusion criteria
* Primary or secondary central nervous system lymphoma, histologic evidence of transformation to Burkitt lymphoma, primary mediastinal DLBCL, primary effusion lymphoma, primary cutaneous DLBCL, or primary DLBCL of the testis * Transformed lymphoma or follicular lymphoma IIIB * Prior therapy for DLBCL, with the exception of nodal biopsy or local irradiation * History of other malignancy, except for curatively treated basal or squamous cell carcinoma or melanoma of the skin, carcinoma in situ of the cervix, or a malignancy that has been treated without curative intent and has been in remission without treatment for \>/= 5 years prior to enrolment * Inadequate renal or hepatic function * Known human immunodeficiency virus (HIV) infection or HIV seropositive status * Active hepatitis B virus (HBV) or active hepatitis C virus (HCV) infection. Patients with occult or prior HBV infection as defined by protocol may be included. Patients positive for HCV antibody are eligible only if polymerase chain reaction testing for HCV ribonucleic acid is negative. * History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies or known sensitivity or allergy to murine products * Contraindication to any of the individual components of CHOP, including prior receipt of anthracyclines * Prior treatment with cytotoxic drugs or rituximab for another condition (e.g. rheumatoid arthritis) or prior use of an anti-CD20 antibody * Pregnant or lactating women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Complete Response (CR) or Complete Response Unconfirmed (CRu) | Up to approximately 4.25 years | Tumor response was assessed per criteria published by Cheson et al (1999). According to consensus recommendations, CR was defined as complete disappearance of all clinical and radiographic evidence of disease and disease-related symptoms, regression of lymph nodes to normal size, absence of splenomegaly, and absence of bone marrow involvement. CRu was defined as disappearance of clinical and radiographic evidence of disease and absence of splenomegaly, with regression of lymph nodes by greater than (\>) 75 percent (%) but still \>1.5 centimeters (cm) in size, and indeterminate bone marrow assessment. The percentage of participants with either response at the end of induction (EOI) was determined with corresponding 95% Pearson-Clopper confidence interval (CI). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rituximab Administration Satisfaction Questionnaire (RASQ) Domain Scores | At Cycle 7 (each cycle was 14 or 21 days) | 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. |
| Median Duration of Rituximab Administration for Each Treatment Cycle | Cycles 1, 2, 3, 4, 5, 6, 7, and 8 (each cycle was 14 or 21 days) | Duration of rituximab administration was defined as the time from start to end of the SC injection or IV infusion. The median duration was reported. |
| Percentage of Participants by Time Spent in the Infusion Chair/Bed for Each Treatment Cycle | Cycles 1, 2, 3, 4, 5, 6, 7, and 8 (each cycle was 14 or 21 days) | Chair time was defined as the amount of time the participant occupied an infusion chair/bed for a single treatment cycle of rituximab + CHOP chemotherapy. Where the chair time was not documented for a given cycle, it was reported as Missing. |
| Percentage of Participants by Time Spent in the Hospital for Each Treatment Cycle | Cycles 1, 2, 3, 4, 5, 6, 7, and 8 (each cycle was 14 or 21 days) | Hospital time was defined as the amount of time the participant was in the hospital for the course of one cycle of rituximab + CHOP chemotherapy. Where the hospital time was not documented for a given cycle, it was reported as Missing. |
| Number of Participants With an Event-Free Survival (EFS) Event | Up to approximately 4.25 years | EFS events included disease progression, relapse, initiation of other anti-lymphoma therapy, or death. Tumor response was assessed according to criteria published by Cheson et al (1999). Progression was defined as greater than or equal to (≥) 50% increase in the sum of products of greatest diameters of any previously identified abnormal lymph node or the appearance of any new lesion. Relapse was defined as a new lesion or increase by ≥50% in size of previously involved sites, or ≥50% increase in greatest diameter of any previously identified node \>1 cm, following an earlier assessment of CR or CRu. |
| Duration of EFS | Up to approximately 4.25 years | EFS was defined as the time from randomization to first occurrence of disease progression, relapse, initiation of other anti-lymphoma therapy, or death, whichever occurred first. Tumor response was assessed according to criteria published by Cheson et al (1999). Progression was defined as a ≥50% increase in the sum of products of greatest diameters of any previously identified abnormal lymph node or the appearance of any new lesion. Relapse was defined as a new lesion or increase by ≥50% in size of previously involved sites, or ≥50% increase in greatest diameter of any previously identified node \>1 cm, following an earlier assessment of CR or CRu. |
| Cancer Treatment Satisfaction Questionnaire (CTSQ) Domain Scores | At Cycle 7 (each cycle was 14 or 21 days) | The CTSQ is a validated 16-item questionnaire that measures three domains related to satisfaction with cancer therapy. These include expectations of therapy, feelings about side effects, and satisfaction with therapy. 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. |
| Duration of Disease-Free Survival (DFS) | Up to approximately 4.25 years | DFS was defined as the time from date of initial CR/CRu to the date of relapse or death from any cause. Tumor response was assessed according to criteria published by Cheson et al (1999). Relapse was defined as a new lesion or increase by ≥50% in size of previously involved sites, or ≥50% increase in greatest diameter of any previously identified node \>1 cm, following an earlier assessment of CR or CRu. |
| Number of Participants With Progression, Relapse, or Death | Up to approximately 4.25 years | Tumor response was assessed according to criteria published by Cheson et al (1999). Progression was defined as ≥50% increase in the sum of products of greatest diameters of any previously identified abnormal lymph node or the appearance of any new lesion. Relapse was defined as a new lesion or increase by ≥50% in size of previously involved sites, or ≥50% increase in greatest diameter of any previously identified node \>1 cm, following an earlier assessment of CR or CRu. |
| Duration of Progression-Free Survival (PFS) | Up to approximately 4.25 years | PFS was defined as the time from randomization to first occurrence of disease progression, relapse, or death from any cause. Tumor response was assessed according to criteria published by Cheson et al (1999). Progression was defined as ≥50% increase in the sum of products of greatest diameters of any previously identified abnormal lymph node or the appearance of any new lesion. Relapse was defined as a new lesion or increase by ≥50% in size of previously involved sites, or ≥50% increase in greatest diameter of any previously identified node \>1 cm, following an earlier assessment of CR or CRu. |
| Number of Deaths | Up to approximately 4.25 years | — |
| Duration of Overall Survival (OS) | Up to approximately 4.25 years | OS was defined as the time from randomization to death from any cause. |
| Number of Participants With Relapse or Death at the Time of Primary Analysis | Up to approximately 2 years (assessed at Baseline, Day 1 of each cycle [maximum 8 cycles; each cycle was 14 or 21 days], every 3 months thereafter, and/or 4 weeks after early termination) | Tumor response was assessed according to criteria published by Cheson et al (1999). Relapse was defined as a new lesion or increase by ≥50% in size of previously involved sites, or ≥50% increase in greatest diameter of any previously identified node \>1 cm, following an earlier assessment of CR or CRu. The number of participants who had experienced relapse or death prior to the clinical cut-off date (October 2014) was determined. |
Countries
Algeria, Argentina, Belgium, Brazil, Bulgaria, Canada, Colombia, Finland, France, Greece, Ireland, Israel, Italy, Netherlands, Peru, Poland, Portugal, Russia, Saudi Arabia, Serbia, South Africa, Spain, Thailand, Turkey (Türkiye), Ukraine, United Kingdom, Venezuela
Participant flow
Pre-assignment details
A total of 662 individuals were screened for entry into the study, and 86 failed the screening procedure. Overall, 576 participants were randomized; 572 received treatment and were included in the analyses.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 369 |
| 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. | 203 |
| Total | 572 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 69 | 34 |
| Overall Study | Lack of Compliance | 6 | 1 |
| Overall Study | Lost to Follow-up | 20 | 16 |
| Overall Study | Other | 20 | 5 |
| Overall Study | Protocol Violation | 4 | 4 |
| Overall Study | Stable or Progressed Disease | 5 | 3 |
| Overall Study | Treatment Failure | 1 | 1 |
| Overall Study | Withdrawal by Subject | 14 | 14 |
Baseline characteristics
| Characteristic | Rituximab SC | Rituximab IV | Total |
|---|---|---|---|
| Age, Continuous | 60.4 years STANDARD_DEVIATION 13.78 | 61.0 years STANDARD_DEVIATION 12.63 | 60.6 years STANDARD_DEVIATION 13.38 |
| Sex: Female, Male Female | 165 Participants | 100 Participants | 265 Participants |
| Sex: Female, Male Male | 204 Participants | 103 Participants | 307 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 319 / 369 | 172 / 203 |
| serious Total, serious adverse events | 155 / 369 | 77 / 203 |
Outcome results
Primary
Percentage of Participants With Complete Response (CR) or Complete Response Unconfirmed (CRu)
Tumor response was assessed per criteria published by Cheson et al (1999). According to consensus recommendations, CR was defined as complete disappearance of all clinical and radiographic evidence of disease and disease-related symptoms, regression of lymph nodes to normal size, absence of splenomegaly, and absence of bone marrow involvement. CRu was defined as disappearance of clinical and radiographic evidence of disease and absence of splenomegaly, with regression of lymph nodes by greater than (\>) 75 percent (%) but still \>1.5 centimeters (cm) in size, and indeterminate bone marrow assessment. The percentage of participants with either response at the end of induction (EOI) was determined with corresponding 95% Pearson-Clopper confidence interval (CI).
Time frame: Up to approximately 4.25 years
Population: Intent-to-Treat (ITT) Population: All participants who completed Baseline and at least one on-treatment efficacy assessment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Rituximab SC | Percentage of Participants With Complete Response (CR) or Complete Response Unconfirmed (CRu) | 50.6 percentage of participants |
| Rituximab IV | Percentage of Participants With Complete Response (CR) or Complete Response Unconfirmed (CRu) | 42.4 percentage of participants |
p-value: 0.07695% CI: [-1.1, 17.5]Chi-squared
Secondary
Cancer Treatment Satisfaction Questionnaire (CTSQ) Domain Scores
The CTSQ is a validated 16-item questionnaire that measures three domains related to satisfaction with cancer therapy. These include expectations of therapy, feelings about side effects, and satisfaction with therapy. 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.
Time frame: At Cycle 7 (each cycle was 14 or 21 days)
Population: ITT Population (CTSQ Subpopulation): All participants who completed the CTSQ at Cycles 3 and 7; number (n) = number of participants in the analysis for the specified domain.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rituximab SC | Cancer Treatment Satisfaction Questionnaire (CTSQ) Domain Scores | Feelings about Side Effects (n=276,141) | 60.69 units on a scale | Standard Deviation 21.594 |
| Rituximab SC | Cancer Treatment Satisfaction Questionnaire (CTSQ) Domain Scores | Expectations of Therapy (n=280,141) | 79.35 units on a scale | Standard Deviation 17.422 |
| Rituximab SC | Cancer Treatment Satisfaction Questionnaire (CTSQ) Domain Scores | Satisfaction with Therapy (n=278,141) | 85.92 units on a scale | Standard Deviation 11.428 |
| Rituximab IV | Cancer Treatment Satisfaction Questionnaire (CTSQ) Domain Scores | Expectations of Therapy (n=280,141) | 82.94 units on a scale | Standard Deviation 16.536 |
| Rituximab IV | Cancer Treatment Satisfaction Questionnaire (CTSQ) Domain Scores | Feelings about Side Effects (n=276,141) | 57.62 units on a scale | Standard Deviation 23.339 |
| Rituximab IV | Cancer Treatment Satisfaction Questionnaire (CTSQ) Domain Scores | Satisfaction with Therapy (n=278,141) | 83.60 units on a scale | Standard Deviation 13.451 |
Secondary
Duration of Disease-Free Survival (DFS)
DFS was defined as the time from date of initial CR/CRu to the date of relapse or death from any cause. Tumor response was assessed according to criteria published by Cheson et al (1999). Relapse was defined as a new lesion or increase by ≥50% in size of previously involved sites, or ≥50% increase in greatest diameter of any previously identified node \>1 cm, following an earlier assessment of CR or CRu.
Time frame: Up to approximately 4.25 years
Population: ITT Population (Responder Subpopulation).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Rituximab SC | Duration of Disease-Free Survival (DFS) | NA months |
| Rituximab IV | Duration of Disease-Free Survival (DFS) | NA months |
Secondary
Duration of EFS
EFS was defined as the time from randomization to first occurrence of disease progression, relapse, initiation of other anti-lymphoma therapy, or death, whichever occurred first. Tumor response was assessed according to criteria published by Cheson et al (1999). Progression was defined as a ≥50% increase in the sum of products of greatest diameters of any previously identified abnormal lymph node or the appearance of any new lesion. Relapse was defined as a new lesion or increase by ≥50% in size of previously involved sites, or ≥50% increase in greatest diameter of any previously identified node \>1 cm, following an earlier assessment of CR or CRu.
Time frame: Up to approximately 4.25 years
Population: ITT Population.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Rituximab SC | Duration of EFS | NA months |
| Rituximab IV | Duration of EFS | NA months |
Secondary
Duration of Overall Survival (OS)
OS was defined as the time from randomization to death from any cause.
Time frame: Up to approximately 4.25 years
Population: ITT Population.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Rituximab SC | Duration of Overall Survival (OS) | NA months |
| Rituximab IV | Duration of Overall Survival (OS) | NA months |
Secondary
Duration of Progression-Free Survival (PFS)
PFS was defined as the time from randomization to first occurrence of disease progression, relapse, or death from any cause. Tumor response was assessed according to criteria published by Cheson et al (1999). Progression was defined as ≥50% increase in the sum of products of greatest diameters of any previously identified abnormal lymph node or the appearance of any new lesion. Relapse was defined as a new lesion or increase by ≥50% in size of previously involved sites, or ≥50% increase in greatest diameter of any previously identified node \>1 cm, following an earlier assessment of CR or CRu.
Time frame: Up to approximately 4.25 years
Population: ITT Population.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Rituximab SC | Duration of Progression-Free Survival (PFS) | NA months |
| Rituximab IV | Duration of Progression-Free Survival (PFS) | NA months |
Secondary
Median Duration of Rituximab Administration for Each Treatment Cycle
Duration of rituximab administration was defined as the time from start to end of the SC injection or IV infusion. The median duration was reported.
Time frame: Cycles 1, 2, 3, 4, 5, 6, 7, and 8 (each cycle was 14 or 21 days)
Population: Safety Population; n = number of participants in the analysis for the specified timepoint.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Rituximab SC | Median Duration of Rituximab Administration for Each Treatment Cycle | Cycle 1 (n=346,190) | 4.0 hours |
| Rituximab SC | Median Duration of Rituximab Administration for Each Treatment Cycle | Cycle 5 (n=332,165) | 0.1 hours |
| Rituximab SC | Median Duration of Rituximab Administration for Each Treatment Cycle | Cycle 3 (n=349,177) | 0.1 hours |
| Rituximab SC | Median Duration of Rituximab Administration for Each Treatment Cycle | Cycle 6 (n=319,162) | 0.1 hours |
| Rituximab SC | Median Duration of Rituximab Administration for Each Treatment Cycle | Cycle 2 (n=361,178) | 0.1 hours |
| Rituximab SC | Median Duration of Rituximab Administration for Each Treatment Cycle | Cycle 7 (n=304,156) | 0.1 hours |
| Rituximab SC | Median Duration of Rituximab Administration for Each Treatment Cycle | Cycle 4 (n=346,173) | 0.1 hours |
| Rituximab SC | Median Duration of Rituximab Administration for Each Treatment Cycle | Cycle 8 (n=305,152) | 0.1 hours |
| Rituximab SC | Median Duration of Rituximab Administration for Each Treatment Cycle | Overall (n=368,201) | 4.7 hours |
| Rituximab IV | Median Duration of Rituximab Administration for Each Treatment Cycle | Cycle 8 (n=305,152) | 2.55 hours |
| Rituximab IV | Median Duration of Rituximab Administration for Each Treatment Cycle | Overall (n=368,201) | 19.00 hours |
| Rituximab IV | Median Duration of Rituximab Administration for Each Treatment Cycle | Cycle 1 (n=346,190) | 4.0 hours |
| Rituximab IV | Median Duration of Rituximab Administration for Each Treatment Cycle | Cycle 2 (n=361,178) | 3.0 hours |
| Rituximab IV | Median Duration of Rituximab Administration for Each Treatment Cycle | Cycle 3 (n=349,177) | 2.8 hours |
| Rituximab IV | Median Duration of Rituximab Administration for Each Treatment Cycle | Cycle 4 (n=346,173) | 2.7 hours |
| Rituximab IV | Median Duration of Rituximab Administration for Each Treatment Cycle | Cycle 5 (n=332,165) | 2.6 hours |
| Rituximab IV | Median Duration of Rituximab Administration for Each Treatment Cycle | Cycle 6 (n=319,162) | 2.7 hours |
| Rituximab IV | Median Duration of Rituximab Administration for Each Treatment Cycle | Cycle 7 (n=304,156) | 2.7 hours |
Secondary
Number of Deaths
Time frame: Up to approximately 4.25 years
Population: ITT Population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Rituximab SC | Number of Deaths | 56 participants |
| Rituximab IV | Number of Deaths | 22 participants |
Secondary
Number of Participants With an Event-Free Survival (EFS) Event
EFS events included disease progression, relapse, initiation of other anti-lymphoma therapy, or death. Tumor response was assessed according to criteria published by Cheson et al (1999). Progression was defined as greater than or equal to (≥) 50% increase in the sum of products of greatest diameters of any previously identified abnormal lymph node or the appearance of any new lesion. Relapse was defined as a new lesion or increase by ≥50% in size of previously involved sites, or ≥50% increase in greatest diameter of any previously identified node \>1 cm, following an earlier assessment of CR or CRu.
Time frame: Up to approximately 4.25 years
Population: ITT Population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Rituximab SC | Number of Participants With an Event-Free Survival (EFS) Event | 116 participants |
| Rituximab IV | Number of Participants With an Event-Free Survival (EFS) Event | 53 participants |
Secondary
Number of Participants With Progression, Relapse, or Death
Tumor response was assessed according to criteria published by Cheson et al (1999). Progression was defined as ≥50% increase in the sum of products of greatest diameters of any previously identified abnormal lymph node or the appearance of any new lesion. Relapse was defined as a new lesion or increase by ≥50% in size of previously involved sites, or ≥50% increase in greatest diameter of any previously identified node \>1 cm, following an earlier assessment of CR or CRu.
Time frame: Up to approximately 4.25 years
Population: ITT Population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Rituximab SC | Number of Participants With Progression, Relapse, or Death | 95 participants |
| Rituximab IV | Number of Participants With Progression, Relapse, or Death | 38 participants |
Secondary
Number of Participants With Relapse or Death at the Time of Primary Analysis
Tumor response was assessed according to criteria published by Cheson et al (1999). Relapse was defined as a new lesion or increase by ≥50% in size of previously involved sites, or ≥50% increase in greatest diameter of any previously identified node \>1 cm, following an earlier assessment of CR or CRu. The number of participants who had experienced relapse or death prior to the clinical cut-off date (October 2014) was determined.
Time frame: Up to approximately 2 years (assessed at Baseline, Day 1 of each cycle [maximum 8 cycles; each cycle was 14 or 21 days], every 3 months thereafter, and/or 4 weeks after early termination)
Population: ITT Population (Responder Subpopulation): All participants who achieved CR or CRu after 4 cycles.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Rituximab SC | Number of Participants With Relapse or Death at the Time of Primary Analysis | 12 participants |
| Rituximab IV | Number of Participants With Relapse or Death at the Time of Primary Analysis | 5 participants |
Secondary
Percentage of Participants by Time Spent in the Hospital for Each Treatment Cycle
Hospital time was defined as the amount of time the participant was in the hospital for the course of one cycle of rituximab + CHOP chemotherapy. Where the hospital time was not documented for a given cycle, it was reported as Missing.
Time frame: Cycles 1, 2, 3, 4, 5, 6, 7, and 8 (each cycle was 14 or 21 days)
Population: Safety Population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Rituximab SC | Percentage of Participants by Time Spent in the Hospital for Each Treatment Cycle | 12 to 24 hours (Cycle 4) | 2.0 percentage of participants |
| Rituximab SC | Percentage of Participants by Time Spent in the Hospital for Each Treatment Cycle | 2 to 4 hours (Cycle 1) | 3.0 percentage of participants |
| Rituximab SC | Percentage of Participants by Time Spent in the Hospital for Each Treatment Cycle | More than 24 hours (Cycle 4) | 10.2 percentage of participants |
| Rituximab SC | Percentage of Participants by Time Spent in the Hospital for Each Treatment Cycle | 6 to 12 hours (Cycle 2) | 16.3 percentage of participants |
| Rituximab SC | Percentage of Participants by Time Spent in the Hospital for Each Treatment Cycle | Missing (Cycle 4) | 2.0 percentage of participants |
| Rituximab SC | Percentage of Participants by Time Spent in the Hospital for Each Treatment Cycle | 4 to 6 hours (Cycle 1) | 19.8 percentage of participants |
| Rituximab SC | Percentage of Participants by Time Spent in the Hospital for Each Treatment Cycle | Less Than 2 hours (Cycle 5) | 5.0 percentage of participants |
| Rituximab SC | Percentage of Participants by Time Spent in the Hospital for Each Treatment Cycle | 12 to 24 hours (Cycle 2) | 3.8 percentage of participants |
| Rituximab SC | Percentage of Participants by Time Spent in the Hospital for Each Treatment Cycle | 2 to 4 hours (Cycle 5) | 39.5 percentage of participants |
| Rituximab SC | Percentage of Participants by Time Spent in the Hospital for Each Treatment Cycle | More than 24 hours (Cycle 1) | 26.8 percentage of participants |
| Rituximab SC | Percentage of Participants by Time Spent in the Hospital for Each Treatment Cycle | 4 to 6 hours (Cycle 5) | 26.4 percentage of participants |
| Rituximab SC | Percentage of Participants by Time Spent in the Hospital for Each Treatment Cycle | More than 24 hours (Cycle 2) | 10.3 percentage of participants |
| Rituximab SC | Percentage of Participants by Time Spent in the Hospital for Each Treatment Cycle | 6 to 12 hours (Cycle 5) | 16.0 percentage of participants |
| Rituximab SC | Percentage of Participants by Time Spent in the Hospital for Each Treatment Cycle | 6 to 12 hours (Cycle 1) | 39.0 percentage of participants |
| Rituximab SC | Percentage of Participants by Time Spent in the Hospital for Each Treatment Cycle | 12 to 24 hours (Cycle 5) | 2.1 percentage of participants |
| Rituximab SC | Percentage of Participants by Time Spent in the Hospital for Each Treatment Cycle | Missing (Cycle 2) | 4.9 percentage of participants |
| Rituximab SC | Percentage of Participants by Time Spent in the Hospital for Each Treatment Cycle | 2 to 4 hours (Cycle 7) | 40.8 percentage of participants |
| Rituximab SC | Percentage of Participants by Time Spent in the Hospital for Each Treatment Cycle | More than 24 hours (Cycle 5) | 8.9 percentage of participants |
| Rituximab SC | Percentage of Participants by Time Spent in the Hospital for Each Treatment Cycle | Missing (Cycle 7) | 2.5 percentage of participants |
| Rituximab SC | Percentage of Participants by Time Spent in the Hospital for Each Treatment Cycle | Missing (Cycle 5) | 2.1 percentage of participants |
| Rituximab SC | Percentage of Participants by Time Spent in the Hospital for Each Treatment Cycle | Less Than 2 hours (Cycle 3) | 3.6 percentage of participants |
| Rituximab SC | Percentage of Participants by Time Spent in the Hospital for Each Treatment Cycle | Less Than 2 hours (Cycle 6) | 4.3 percentage of participants |
| Rituximab SC | Percentage of Participants by Time Spent in the Hospital for Each Treatment Cycle | 12 to 24 hours (Cycle 1) | 8.9 percentage of participants |
| Rituximab SC | Percentage of Participants by Time Spent in the Hospital for Each Treatment Cycle | 2 to 4 hours (Cycle 6) | 39.6 percentage of participants |
| Rituximab SC | Percentage of Participants by Time Spent in the Hospital for Each Treatment Cycle | 2 to 4 hours (Cycle 3) | 37.2 percentage of participants |
| Rituximab SC | Percentage of Participants by Time Spent in the Hospital for Each Treatment Cycle | 4 to 6 hours (Cycle 6) | 26.4 percentage of participants |
| Rituximab SC | Percentage of Participants by Time Spent in the Hospital for Each Treatment Cycle | Less Than 2 hours (Cycle 4) | 4.5 percentage of participants |
| Rituximab SC | Percentage of Participants by Time Spent in the Hospital for Each Treatment Cycle | 6 to 12 hours (Cycle 6) | 16.3 percentage of participants |
| Rituximab SC | Percentage of Participants by Time Spent in the Hospital for Each Treatment Cycle | 4 to 6 hours (Cycle 3) | 30.2 percentage of participants |
| Rituximab SC | Percentage of Participants by Time Spent in the Hospital for Each Treatment Cycle | 12 to 24 hours (Cycle 6) | 2.5 percentage of participants |
| Rituximab SC | Percentage of Participants by Time Spent in the Hospital for Each Treatment Cycle | Missing (Cycle 1) | 2.2 percentage of participants |
| Rituximab SC | Percentage of Participants by Time Spent in the Hospital for Each Treatment Cycle | More than 24 hours (Cycle 6) | 8.6 percentage of participants |
| Rituximab SC | Percentage of Participants by Time Spent in the Hospital for Each Treatment Cycle | 6 to 12 hours (Cycle 3) | 14.5 percentage of participants |
| Rituximab SC | Percentage of Participants by Time Spent in the Hospital for Each Treatment Cycle | Missing (Cycle 6) | 2.5 percentage of participants |
| Rituximab SC | Percentage of Participants by Time Spent in the Hospital for Each Treatment Cycle | 6 to 12 hours (Cycle 7) | 10.4 percentage of participants |
| Rituximab SC | Percentage of Participants by Time Spent in the Hospital for Each Treatment Cycle | Less Than 2 hours (Cycle 7) | 17.7 percentage of participants |
| Rituximab SC | Percentage of Participants by Time Spent in the Hospital for Each Treatment Cycle | 12 to 24 hours (Cycle 3) | 2.8 percentage of participants |
| Rituximab SC | Percentage of Participants by Time Spent in the Hospital for Each Treatment Cycle | Less than 2 hours (Cycle 2) | 3.8 percentage of participants |
| Rituximab SC | Percentage of Participants by Time Spent in the Hospital for Each Treatment Cycle | 4 to 6 hours (Cycle 7) | 19.9 percentage of participants |
| Rituximab SC | Percentage of Participants by Time Spent in the Hospital for Each Treatment Cycle | More than 24 hours (Cycle 3) | 9.8 percentage of participants |
| Rituximab SC | Percentage of Participants by Time Spent in the Hospital for Each Treatment Cycle | 12 to 24 hours (Cycle 7) | 2.8 percentage of participants |
| Rituximab SC | Percentage of Participants by Time Spent in the Hospital for Each Treatment Cycle | Less than 2 hours (Cycle 1) | 0.3 percentage of participants |
| Rituximab SC | Percentage of Participants by Time Spent in the Hospital for Each Treatment Cycle | Less Than 2 hours (Cycle 8) | 18.0 percentage of participants |
| Rituximab SC | Percentage of Participants by Time Spent in the Hospital for Each Treatment Cycle | Missing (Cycle 3) | 2.0 percentage of participants |
| Rituximab SC | Percentage of Participants by Time Spent in the Hospital for Each Treatment Cycle | 2 to 4 hours (Cycle 8) | 40.5 percentage of participants |
| Rituximab SC | Percentage of Participants by Time Spent in the Hospital for Each Treatment Cycle | 2 to 4 hours (Cycle 4) | 36.3 percentage of participants |
| Rituximab SC | Percentage of Participants by Time Spent in the Hospital for Each Treatment Cycle | 4 to 6 hours (Cycle 8) | 21.9 percentage of participants |
| Rituximab SC | Percentage of Participants by Time Spent in the Hospital for Each Treatment Cycle | 2 to 4 hours (Cycle 2) | 33.1 percentage of participants |
| Rituximab SC | Percentage of Participants by Time Spent in the Hospital for Each Treatment Cycle | 6 to 12 hours (Cycle 8) | 8.7 percentage of participants |
| Rituximab SC | Percentage of Participants by Time Spent in the Hospital for Each Treatment Cycle | 4 to 6 hours (Cycle 4) | 27.5 percentage of participants |
| Rituximab SC | Percentage of Participants by Time Spent in the Hospital for Each Treatment Cycle | 12 to 24 hours (Cycle 8) | 2.6 percentage of participants |
| Rituximab SC | Percentage of Participants by Time Spent in the Hospital for Each Treatment Cycle | More than 24 hours (Cycle 7) | 5.7 percentage of participants |
| Rituximab SC | Percentage of Participants by Time Spent in the Hospital for Each Treatment Cycle | More than 24 hours (Cycle 8) | 5.8 percentage of participants |
| Rituximab SC | Percentage of Participants by Time Spent in the Hospital for Each Treatment Cycle | 6 to 12 hours (Cycle 4) | 17.6 percentage of participants |
| Rituximab SC | Percentage of Participants by Time Spent in the Hospital for Each Treatment Cycle | Missing (Cycle 8) | 2.6 percentage of participants |
| Rituximab SC | Percentage of Participants by Time Spent in the Hospital for Each Treatment Cycle | 4 to 6 hours (Cycle 2) | 27.9 percentage of participants |
| Rituximab IV | Percentage of Participants by Time Spent in the Hospital for Each Treatment Cycle | Missing (Cycle 8) | 3.1 percentage of participants |
| Rituximab IV | Percentage of Participants by Time Spent in the Hospital for Each Treatment Cycle | Missing (Cycle 3) | 2.7 percentage of participants |
| Rituximab IV | Percentage of Participants by Time Spent in the Hospital for Each Treatment Cycle | Less Than 2 hours (Cycle 4) | 0 percentage of participants |
| Rituximab IV | Percentage of Participants by Time Spent in the Hospital for Each Treatment Cycle | 4 to 6 hours (Cycle 7) | 36.4 percentage of participants |
| Rituximab IV | Percentage of Participants by Time Spent in the Hospital for Each Treatment Cycle | More than 24 hours (Cycle 7) | 3.7 percentage of participants |
| Rituximab IV | Percentage of Participants by Time Spent in the Hospital for Each Treatment Cycle | Missing (Cycle 7) | 3.1 percentage of participants |
| Rituximab IV | Percentage of Participants by Time Spent in the Hospital for Each Treatment Cycle | 2 to 4 hours (Cycle 1) | 1.5 percentage of participants |
| Rituximab IV | Percentage of Participants by Time Spent in the Hospital for Each Treatment Cycle | Less than 2 hours (Cycle 1) | 0 percentage of participants |
| Rituximab IV | Percentage of Participants by Time Spent in the Hospital for Each Treatment Cycle | 4 to 6 hours (Cycle 1) | 20.7 percentage of participants |
| Rituximab IV | Percentage of Participants by Time Spent in the Hospital for Each Treatment Cycle | 6 to 12 hours (Cycle 1) | 43.8 percentage of participants |
| Rituximab IV | Percentage of Participants by Time Spent in the Hospital for Each Treatment Cycle | More than 24 hours (Cycle 1) | 24.1 percentage of participants |
| Rituximab IV | Percentage of Participants by Time Spent in the Hospital for Each Treatment Cycle | Missing (Cycle 1) | 3.0 percentage of participants |
| Rituximab IV | Percentage of Participants by Time Spent in the Hospital for Each Treatment Cycle | Less than 2 hours (Cycle 2) | 0 percentage of participants |
| Rituximab IV | Percentage of Participants by Time Spent in the Hospital for Each Treatment Cycle | 2 to 4 hours (Cycle 2) | 10.1 percentage of participants |
| Rituximab IV | Percentage of Participants by Time Spent in the Hospital for Each Treatment Cycle | 4 to 6 hours (Cycle 2) | 33.5 percentage of participants |
| Rituximab IV | Percentage of Participants by Time Spent in the Hospital for Each Treatment Cycle | 6 to 12 hours (Cycle 2) | 38.8 percentage of participants |
| Rituximab IV | Percentage of Participants by Time Spent in the Hospital for Each Treatment Cycle | 12 to 24 hours (Cycle 2) | 1.1 percentage of participants |
| Rituximab IV | Percentage of Participants by Time Spent in the Hospital for Each Treatment Cycle | More than 24 hours (Cycle 2) | 11.7 percentage of participants |
| Rituximab IV | Percentage of Participants by Time Spent in the Hospital for Each Treatment Cycle | Missing (Cycle 2) | 4.8 percentage of participants |
| Rituximab IV | Percentage of Participants by Time Spent in the Hospital for Each Treatment Cycle | Less Than 2 hours (Cycle 3) | 0.5 percentage of participants |
| Rituximab IV | Percentage of Participants by Time Spent in the Hospital for Each Treatment Cycle | 2 to 4 hours (Cycle 3) | 11.9 percentage of participants |
| Rituximab IV | Percentage of Participants by Time Spent in the Hospital for Each Treatment Cycle | 4 to 6 hours (Cycle 3) | 30.8 percentage of participants |
| Rituximab IV | Percentage of Participants by Time Spent in the Hospital for Each Treatment Cycle | 6 to 12 hours (Cycle 3) | 41.6 percentage of participants |
| Rituximab IV | Percentage of Participants by Time Spent in the Hospital for Each Treatment Cycle | 12 to 24 hours (Cycle 3) | 2.2 percentage of participants |
| Rituximab IV | Percentage of Participants by Time Spent in the Hospital for Each Treatment Cycle | More than 24 hours (Cycle 3) | 10.3 percentage of participants |
| Rituximab IV | Percentage of Participants by Time Spent in the Hospital for Each Treatment Cycle | 2 to 4 hours (Cycle 4) | 10.0 percentage of participants |
| Rituximab IV | Percentage of Participants by Time Spent in the Hospital for Each Treatment Cycle | 4 to 6 hours (Cycle 4) | 31.1 percentage of participants |
| Rituximab IV | Percentage of Participants by Time Spent in the Hospital for Each Treatment Cycle | 6 to 12 hours (Cycle 4) | 42.2 percentage of participants |
| Rituximab IV | Percentage of Participants by Time Spent in the Hospital for Each Treatment Cycle | 12 to 24 hours (Cycle 4) | 2.8 percentage of participants |
| Rituximab IV | Percentage of Participants by Time Spent in the Hospital for Each Treatment Cycle | More than 24 hours (Cycle 4) | 10.6 percentage of participants |
| Rituximab IV | Percentage of Participants by Time Spent in the Hospital for Each Treatment Cycle | Missing (Cycle 4) | 3.3 percentage of participants |
| Rituximab IV | Percentage of Participants by Time Spent in the Hospital for Each Treatment Cycle | Less Than 2 hours (Cycle 5) | 0.6 percentage of participants |
| Rituximab IV | Percentage of Participants by Time Spent in the Hospital for Each Treatment Cycle | 2 to 4 hours (Cycle 5) | 11.5 percentage of participants |
| Rituximab IV | Percentage of Participants by Time Spent in the Hospital for Each Treatment Cycle | 4 to 6 hours (Cycle 5) | 34.5 percentage of participants |
| Rituximab IV | Percentage of Participants by Time Spent in the Hospital for Each Treatment Cycle | 6 to 12 hours (Cycle 5) | 37.4 percentage of participants |
| Rituximab IV | Percentage of Participants by Time Spent in the Hospital for Each Treatment Cycle | 12 to 24 hours (Cycle 5) | 1.7 percentage of participants |
| Rituximab IV | Percentage of Participants by Time Spent in the Hospital for Each Treatment Cycle | More than 24 hours (Cycle 5) | 10.9 percentage of participants |
| Rituximab IV | Percentage of Participants by Time Spent in the Hospital for Each Treatment Cycle | Missing (Cycle 5) | 3.4 percentage of participants |
| Rituximab IV | Percentage of Participants by Time Spent in the Hospital for Each Treatment Cycle | Less Than 2 hours (Cycle 6) | 0.6 percentage of participants |
| Rituximab IV | Percentage of Participants by Time Spent in the Hospital for Each Treatment Cycle | 2 to 4 hours (Cycle 6) | 12.6 percentage of participants |
| Rituximab IV | Percentage of Participants by Time Spent in the Hospital for Each Treatment Cycle | 4 to 6 hours (Cycle 6) | 34.1 percentage of participants |
| Rituximab IV | Percentage of Participants by Time Spent in the Hospital for Each Treatment Cycle | 6 to 12 hours (Cycle 6) | 38.3 percentage of participants |
| Rituximab IV | Percentage of Participants by Time Spent in the Hospital for Each Treatment Cycle | 12 to 24 hours (Cycle 6) | 2.4 percentage of participants |
| Rituximab IV | Percentage of Participants by Time Spent in the Hospital for Each Treatment Cycle | More than 24 hours (Cycle 6) | 9.0 percentage of participants |
| Rituximab IV | Percentage of Participants by Time Spent in the Hospital for Each Treatment Cycle | Missing (Cycle 6) | 3.0 percentage of participants |
| Rituximab IV | Percentage of Participants by Time Spent in the Hospital for Each Treatment Cycle | Less Than 2 hours (Cycle 7) | 0 percentage of participants |
| Rituximab IV | Percentage of Participants by Time Spent in the Hospital for Each Treatment Cycle | 2 to 4 hours (Cycle 7) | 23.5 percentage of participants |
| Rituximab IV | Percentage of Participants by Time Spent in the Hospital for Each Treatment Cycle | 6 to 12 hours (Cycle 7) | 30.9 percentage of participants |
| Rituximab IV | Percentage of Participants by Time Spent in the Hospital for Each Treatment Cycle | 12 to 24 hours (Cycle 7) | 2.5 percentage of participants |
| Rituximab IV | Percentage of Participants by Time Spent in the Hospital for Each Treatment Cycle | Less Than 2 hours (Cycle 8) | 0 percentage of participants |
| Rituximab IV | Percentage of Participants by Time Spent in the Hospital for Each Treatment Cycle | 2 to 4 hours (Cycle 8) | 25.8 percentage of participants |
| Rituximab IV | Percentage of Participants by Time Spent in the Hospital for Each Treatment Cycle | 4 to 6 hours (Cycle 8) | 34.0 percentage of participants |
| Rituximab IV | Percentage of Participants by Time Spent in the Hospital for Each Treatment Cycle | 6 to 12 hours (Cycle 8) | 30.8 percentage of participants |
| Rituximab IV | Percentage of Participants by Time Spent in the Hospital for Each Treatment Cycle | 12 to 24 hours (Cycle 8) | 1.3 percentage of participants |
| Rituximab IV | Percentage of Participants by Time Spent in the Hospital for Each Treatment Cycle | More than 24 hours (Cycle 8) | 5.0 percentage of participants |
| Rituximab IV | Percentage of Participants by Time Spent in the Hospital for Each Treatment Cycle | 12 to 24 hours (Cycle 1) | 6.9 percentage of participants |
Secondary
Percentage of Participants by Time Spent in the Infusion Chair/Bed for Each Treatment Cycle
Chair time was defined as the amount of time the participant occupied an infusion chair/bed for a single treatment cycle of rituximab + CHOP chemotherapy. Where the chair time was not documented for a given cycle, it was reported as Missing.
Time frame: Cycles 1, 2, 3, 4, 5, 6, 7, and 8 (each cycle was 14 or 21 days)
Population: Safety Population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Rituximab SC | Percentage of Participants by Time Spent in the Infusion Chair/Bed for Each Treatment Cycle | Less than 30 minutes (Cycle 1) | 0 percentage of participants |
| Rituximab SC | Percentage of Participants by Time Spent in the Infusion Chair/Bed for Each Treatment Cycle | 30 minutes to 1 hour (Cycle 2) | 2.4 percentage of participants |
| Rituximab SC | Percentage of Participants by Time Spent in the Infusion Chair/Bed for Each Treatment Cycle | 2 to 4 hours (Cycle 4) | 55.0 percentage of participants |
| Rituximab SC | Percentage of Participants by Time Spent in the Infusion Chair/Bed for Each Treatment Cycle | 1 to 2 hours (Cycle 6) | 23.0 percentage of participants |
| Rituximab SC | Percentage of Participants by Time Spent in the Infusion Chair/Bed for Each Treatment Cycle | More than 12 hours (Cycle 6) | 0 percentage of participants |
| Rituximab SC | Percentage of Participants by Time Spent in the Infusion Chair/Bed for Each Treatment Cycle | 4 to 12 hours (Cycle 8) | 5.8 percentage of participants |
| Rituximab SC | Percentage of Participants by Time Spent in the Infusion Chair/Bed for Each Treatment Cycle | 30 minutes to 1 hour (Cycle 1) | 0 percentage of participants |
| Rituximab SC | Percentage of Participants by Time Spent in the Infusion Chair/Bed for Each Treatment Cycle | 1 to 2 hours (Cycle 1) | 1.4 percentage of participants |
| Rituximab SC | Percentage of Participants by Time Spent in the Infusion Chair/Bed for Each Treatment Cycle | 2 to 4 hours (Cycle 1) | 20.6 percentage of participants |
| Rituximab SC | Percentage of Participants by Time Spent in the Infusion Chair/Bed for Each Treatment Cycle | 4 to 12 hours (Cycle 1) | 69.4 percentage of participants |
| Rituximab SC | Percentage of Participants by Time Spent in the Infusion Chair/Bed for Each Treatment Cycle | More than 12 hours (Cycle 1) | 7.3 percentage of participants |
| Rituximab SC | Percentage of Participants by Time Spent in the Infusion Chair/Bed for Each Treatment Cycle | Missing (Cycle 1) | 1.4 percentage of participants |
| Rituximab SC | Percentage of Participants by Time Spent in the Infusion Chair/Bed for Each Treatment Cycle | Less than 30 minutes (Cycle 2) | 7.3 percentage of participants |
| Rituximab SC | Percentage of Participants by Time Spent in the Infusion Chair/Bed for Each Treatment Cycle | 1 to 2 hours (Cycle 2) | 17.1 percentage of participants |
| Rituximab SC | Percentage of Participants by Time Spent in the Infusion Chair/Bed for Each Treatment Cycle | 2 to 4 hours (Cycle 2) | 56.1 percentage of participants |
| Rituximab SC | Percentage of Participants by Time Spent in the Infusion Chair/Bed for Each Treatment Cycle | 4 to 12 hours (Cycle 2) | 12.2 percentage of participants |
| Rituximab SC | Percentage of Participants by Time Spent in the Infusion Chair/Bed for Each Treatment Cycle | More than 12 hours (Cycle 2) | 0.3 percentage of participants |
| Rituximab SC | Percentage of Participants by Time Spent in the Infusion Chair/Bed for Each Treatment Cycle | Missing (Cycle 2) | 4.6 percentage of participants |
| Rituximab SC | Percentage of Participants by Time Spent in the Infusion Chair/Bed for Each Treatment Cycle | Less than 30 minutes (Cycle 3) | 5.6 percentage of participants |
| Rituximab SC | Percentage of Participants by Time Spent in the Infusion Chair/Bed for Each Treatment Cycle | 30 minutes to 1 hour (Cycle 3) | 2.0 percentage of participants |
| Rituximab SC | Percentage of Participants by Time Spent in the Infusion Chair/Bed for Each Treatment Cycle | 1 to 2 hours (Cycle 3) | 22.1 percentage of participants |
| Rituximab SC | Percentage of Participants by Time Spent in the Infusion Chair/Bed for Each Treatment Cycle | 2 to 4 hours (Cycle 3) | 55.9 percentage of participants |
| Rituximab SC | Percentage of Participants by Time Spent in the Infusion Chair/Bed for Each Treatment Cycle | 4 to 12 hours (Cycle 3) | 12.6 percentage of participants |
| Rituximab SC | Percentage of Participants by Time Spent in the Infusion Chair/Bed for Each Treatment Cycle | More than 12 hours (Cycle 3) | 0.3 percentage of participants |
| Rituximab SC | Percentage of Participants by Time Spent in the Infusion Chair/Bed for Each Treatment Cycle | Missing (Cycle 3) | 1.7 percentage of participants |
| Rituximab SC | Percentage of Participants by Time Spent in the Infusion Chair/Bed for Each Treatment Cycle | Less than 30 minutes (Cycle 4) | 5.1 percentage of participants |
| Rituximab SC | Percentage of Participants by Time Spent in the Infusion Chair/Bed for Each Treatment Cycle | 30 minutes to 1 hour (Cycle 4) | 2.8 percentage of participants |
| Rituximab SC | Percentage of Participants by Time Spent in the Infusion Chair/Bed for Each Treatment Cycle | 1 to 2 hours (Cycle 4) | 21.8 percentage of participants |
| Rituximab SC | Percentage of Participants by Time Spent in the Infusion Chair/Bed for Each Treatment Cycle | 4 to 12 hours (Cycle 4) | 13.9 percentage of participants |
| Rituximab SC | Percentage of Participants by Time Spent in the Infusion Chair/Bed for Each Treatment Cycle | More than 12 hours (Cycle 4) | 0.3 percentage of participants |
| Rituximab SC | Percentage of Participants by Time Spent in the Infusion Chair/Bed for Each Treatment Cycle | Missing (Cycle 4) | 1.1 percentage of participants |
| Rituximab SC | Percentage of Participants by Time Spent in the Infusion Chair/Bed for Each Treatment Cycle | Less than 30 minutes (Cycle 5) | 5.0 percentage of participants |
| Rituximab SC | Percentage of Participants by Time Spent in the Infusion Chair/Bed for Each Treatment Cycle | 30 minutes to 1 hour (Cycle 5) | 2.4 percentage of participants |
| Rituximab SC | Percentage of Participants by Time Spent in the Infusion Chair/Bed for Each Treatment Cycle | 1 to 2 hours (Cycle 5) | 25.2 percentage of participants |
| Rituximab SC | Percentage of Participants by Time Spent in the Infusion Chair/Bed for Each Treatment Cycle | 2 to 4 hours (Cycle 5) | 53.4 percentage of participants |
| Rituximab SC | Percentage of Participants by Time Spent in the Infusion Chair/Bed for Each Treatment Cycle | 4 to 12 hours (Cycle 5) | 12.8 percentage of participants |
| Rituximab SC | Percentage of Participants by Time Spent in the Infusion Chair/Bed for Each Treatment Cycle | More than 12 hours (Cycle 5) | 0 percentage of participants |
| Rituximab SC | Percentage of Participants by Time Spent in the Infusion Chair/Bed for Each Treatment Cycle | Missing (Cycle 5) | 1.2 percentage of participants |
| Rituximab SC | Percentage of Participants by Time Spent in the Infusion Chair/Bed for Each Treatment Cycle | Less than 30 minutes (Cycle 6) | 3.4 percentage of participants |
| Rituximab SC | Percentage of Participants by Time Spent in the Infusion Chair/Bed for Each Treatment Cycle | 30 minutes to 1 hour (Cycle 6) | 3.1 percentage of participants |
| Rituximab SC | Percentage of Participants by Time Spent in the Infusion Chair/Bed for Each Treatment Cycle | 2 to 4 hours (Cycle 6) | 56.7 percentage of participants |
| Rituximab SC | Percentage of Participants by Time Spent in the Infusion Chair/Bed for Each Treatment Cycle | 4 to 12 hours (Cycle 6) | 12.3 percentage of participants |
| Rituximab SC | Percentage of Participants by Time Spent in the Infusion Chair/Bed for Each Treatment Cycle | Missing (Cycle 6) | 1.5 percentage of participants |
| Rituximab SC | Percentage of Participants by Time Spent in the Infusion Chair/Bed for Each Treatment Cycle | Less than 30 minutes (Cycle 7) | 18.7 percentage of participants |
| Rituximab SC | Percentage of Participants by Time Spent in the Infusion Chair/Bed for Each Treatment Cycle | 30 minutes to 1 hour (Cycle 7) | 7.0 percentage of participants |
| Rituximab SC | Percentage of Participants by Time Spent in the Infusion Chair/Bed for Each Treatment Cycle | 1 to 2 hours (Cycle 7) | 26.9 percentage of participants |
| Rituximab SC | Percentage of Participants by Time Spent in the Infusion Chair/Bed for Each Treatment Cycle | 2 to 4 hours (Cycle 7) | 40.2 percentage of participants |
| Rituximab SC | Percentage of Participants by Time Spent in the Infusion Chair/Bed for Each Treatment Cycle | 4 to 12 hours (Cycle 7) | 6.0 percentage of participants |
| Rituximab SC | Percentage of Participants by Time Spent in the Infusion Chair/Bed for Each Treatment Cycle | More than 12 hours (Cycle 7) | 0 percentage of participants |
| Rituximab SC | Percentage of Participants by Time Spent in the Infusion Chair/Bed for Each Treatment Cycle | Missing (Cycle 7) | 1.3 percentage of participants |
| Rituximab SC | Percentage of Participants by Time Spent in the Infusion Chair/Bed for Each Treatment Cycle | Less than 30 minutes (Cycle 8) | 20.3 percentage of participants |
| Rituximab SC | Percentage of Participants by Time Spent in the Infusion Chair/Bed for Each Treatment Cycle | 30 minutes to 1 hour (Cycle 8) | 6.4 percentage of participants |
| Rituximab SC | Percentage of Participants by Time Spent in the Infusion Chair/Bed for Each Treatment Cycle | 1 to 2 hours (Cycle 8) | 29.3 percentage of participants |
| Rituximab SC | Percentage of Participants by Time Spent in the Infusion Chair/Bed for Each Treatment Cycle | 2 to 4 hours (Cycle 8) | 36.7 percentage of participants |
| Rituximab SC | Percentage of Participants by Time Spent in the Infusion Chair/Bed for Each Treatment Cycle | More than 12 hours (Cycle 8) | 0 percentage of participants |
| Rituximab SC | Percentage of Participants by Time Spent in the Infusion Chair/Bed for Each Treatment Cycle | Missing (Cycle 8) | 1.6 percentage of participants |
| Rituximab IV | Percentage of Participants by Time Spent in the Infusion Chair/Bed for Each Treatment Cycle | 1 to 2 hours (Cycle 8) | 4.4 percentage of participants |
| Rituximab IV | Percentage of Participants by Time Spent in the Infusion Chair/Bed for Each Treatment Cycle | Less than 30 minutes (Cycle 2) | 0 percentage of participants |
| Rituximab IV | Percentage of Participants by Time Spent in the Infusion Chair/Bed for Each Treatment Cycle | 4 to 12 hours (Cycle 4) | 60.6 percentage of participants |
| Rituximab IV | Percentage of Participants by Time Spent in the Infusion Chair/Bed for Each Treatment Cycle | 30 minutes to 1 hour (Cycle 2) | 0 percentage of participants |
| Rituximab IV | Percentage of Participants by Time Spent in the Infusion Chair/Bed for Each Treatment Cycle | Missing (Cycle 6) | 1.8 percentage of participants |
| Rituximab IV | Percentage of Participants by Time Spent in the Infusion Chair/Bed for Each Treatment Cycle | 2 to 4 hours (Cycle 4) | 36.7 percentage of participants |
| Rituximab IV | Percentage of Participants by Time Spent in the Infusion Chair/Bed for Each Treatment Cycle | 30 minutes to 1 hour (Cycle 6) | 0 percentage of participants |
| Rituximab IV | Percentage of Participants by Time Spent in the Infusion Chair/Bed for Each Treatment Cycle | More than 12 hours (Cycle 4) | 0.6 percentage of participants |
| Rituximab IV | Percentage of Participants by Time Spent in the Infusion Chair/Bed for Each Treatment Cycle | Missing (Cycle 7) | 1.9 percentage of participants |
| Rituximab IV | Percentage of Participants by Time Spent in the Infusion Chair/Bed for Each Treatment Cycle | More than 12 hours (Cycle 6) | 0 percentage of participants |
| Rituximab IV | Percentage of Participants by Time Spent in the Infusion Chair/Bed for Each Treatment Cycle | Missing (Cycle 4) | 1.1 percentage of participants |
| Rituximab IV | Percentage of Participants by Time Spent in the Infusion Chair/Bed for Each Treatment Cycle | 4 to 12 hours (Cycle 8) | 43.4 percentage of participants |
| Rituximab IV | Percentage of Participants by Time Spent in the Infusion Chair/Bed for Each Treatment Cycle | Less than 30 minutes (Cycle 1) | 0 percentage of participants |
| Rituximab IV | Percentage of Participants by Time Spent in the Infusion Chair/Bed for Each Treatment Cycle | Less than 30 minutes (Cycle 7) | 0 percentage of participants |
| Rituximab IV | Percentage of Participants by Time Spent in the Infusion Chair/Bed for Each Treatment Cycle | 30 minutes to 1 hour (Cycle 1) | 0.5 percentage of participants |
| Rituximab IV | Percentage of Participants by Time Spent in the Infusion Chair/Bed for Each Treatment Cycle | Less than 30 minutes (Cycle 5) | 0.6 percentage of participants |
| Rituximab IV | Percentage of Participants by Time Spent in the Infusion Chair/Bed for Each Treatment Cycle | 1 to 2 hours (Cycle 1) | 0 percentage of participants |
| Rituximab IV | Percentage of Participants by Time Spent in the Infusion Chair/Bed for Each Treatment Cycle | More than 12 hours (Cycle 8) | 0 percentage of participants |
| Rituximab IV | Percentage of Participants by Time Spent in the Infusion Chair/Bed for Each Treatment Cycle | 2 to 4 hours (Cycle 1) | 17.2 percentage of participants |
| Rituximab IV | Percentage of Participants by Time Spent in the Infusion Chair/Bed for Each Treatment Cycle | 30 minutes to 1 hour (Cycle 5) | 0 percentage of participants |
| Rituximab IV | Percentage of Participants by Time Spent in the Infusion Chair/Bed for Each Treatment Cycle | 4 to 12 hours (Cycle 1) | 72.4 percentage of participants |
| Rituximab IV | Percentage of Participants by Time Spent in the Infusion Chair/Bed for Each Treatment Cycle | 30 minutes to 1 hour (Cycle 7) | 0 percentage of participants |
| Rituximab IV | Percentage of Participants by Time Spent in the Infusion Chair/Bed for Each Treatment Cycle | More than 12 hours (Cycle 1) | 7.9 percentage of participants |
| Rituximab IV | Percentage of Participants by Time Spent in the Infusion Chair/Bed for Each Treatment Cycle | 1 to 2 hours (Cycle 5) | 1.1 percentage of participants |
| Rituximab IV | Percentage of Participants by Time Spent in the Infusion Chair/Bed for Each Treatment Cycle | Missing (Cycle 1) | 2.0 percentage of participants |
| Rituximab IV | Percentage of Participants by Time Spent in the Infusion Chair/Bed for Each Treatment Cycle | Less than 30 minutes (Cycle 8) | 0.6 percentage of participants |
| Rituximab IV | Percentage of Participants by Time Spent in the Infusion Chair/Bed for Each Treatment Cycle | 2 to 4 hours (Cycle 5) | 40.2 percentage of participants |
| Rituximab IV | Percentage of Participants by Time Spent in the Infusion Chair/Bed for Each Treatment Cycle | 1 to 2 hours (Cycle 2) | 1.1 percentage of participants |
| Rituximab IV | Percentage of Participants by Time Spent in the Infusion Chair/Bed for Each Treatment Cycle | 1 to 2 hours (Cycle 7) | 4.9 percentage of participants |
| Rituximab IV | Percentage of Participants by Time Spent in the Infusion Chair/Bed for Each Treatment Cycle | 2 to 4 hours (Cycle 2) | 36.2 percentage of participants |
| Rituximab IV | Percentage of Participants by Time Spent in the Infusion Chair/Bed for Each Treatment Cycle | 4 to 12 hours (Cycle 5) | 56.3 percentage of participants |
| Rituximab IV | Percentage of Participants by Time Spent in the Infusion Chair/Bed for Each Treatment Cycle | 4 to 12 hours (Cycle 2) | 60.1 percentage of participants |
| Rituximab IV | Percentage of Participants by Time Spent in the Infusion Chair/Bed for Each Treatment Cycle | 2 to 4 hours (Cycle 8) | 50.9 percentage of participants |
| Rituximab IV | Percentage of Participants by Time Spent in the Infusion Chair/Bed for Each Treatment Cycle | More than 12 hours (Cycle 2) | 1.1 percentage of participants |
| Rituximab IV | Percentage of Participants by Time Spent in the Infusion Chair/Bed for Each Treatment Cycle | More than 12 hours (Cycle 5) | 0.6 percentage of participants |
| Rituximab IV | Percentage of Participants by Time Spent in the Infusion Chair/Bed for Each Treatment Cycle | Missing (Cycle 2) | 1.6 percentage of participants |
| Rituximab IV | Percentage of Participants by Time Spent in the Infusion Chair/Bed for Each Treatment Cycle | 2 to 4 hours (Cycle 7) | 48.8 percentage of participants |
| Rituximab IV | Percentage of Participants by Time Spent in the Infusion Chair/Bed for Each Treatment Cycle | Less than 30 minutes (Cycle 3) | 0 percentage of participants |
| Rituximab IV | Percentage of Participants by Time Spent in the Infusion Chair/Bed for Each Treatment Cycle | Missing (Cycle 5) | 1.1 percentage of participants |
| Rituximab IV | Percentage of Participants by Time Spent in the Infusion Chair/Bed for Each Treatment Cycle | 30 minutes to 1 hour (Cycle 3) | 0 percentage of participants |
| Rituximab IV | Percentage of Participants by Time Spent in the Infusion Chair/Bed for Each Treatment Cycle | 30 minutes to 1 hour (Cycle 8) | 0 percentage of participants |
| Rituximab IV | Percentage of Participants by Time Spent in the Infusion Chair/Bed for Each Treatment Cycle | 1 to 2 hours (Cycle 3) | 0.5 percentage of participants |
| Rituximab IV | Percentage of Participants by Time Spent in the Infusion Chair/Bed for Each Treatment Cycle | Less than 30 minutes (Cycle 6) | 0.6 percentage of participants |
| Rituximab IV | Percentage of Participants by Time Spent in the Infusion Chair/Bed for Each Treatment Cycle | 2 to 4 hours (Cycle 3) | 38.9 percentage of participants |
| Rituximab IV | Percentage of Participants by Time Spent in the Infusion Chair/Bed for Each Treatment Cycle | 4 to 12 hours (Cycle 7) | 44.4 percentage of participants |
| Rituximab IV | Percentage of Participants by Time Spent in the Infusion Chair/Bed for Each Treatment Cycle | 4 to 12 hours (Cycle 3) | 58.4 percentage of participants |
| Rituximab IV | Percentage of Participants by Time Spent in the Infusion Chair/Bed for Each Treatment Cycle | 1 to 2 hours (Cycle 6) | 1.8 percentage of participants |
| Rituximab IV | Percentage of Participants by Time Spent in the Infusion Chair/Bed for Each Treatment Cycle | More than 12 hours (Cycle 3) | 0.5 percentage of participants |
| Rituximab IV | Percentage of Participants by Time Spent in the Infusion Chair/Bed for Each Treatment Cycle | Missing (Cycle 8) | 0.6 percentage of participants |
| Rituximab IV | Percentage of Participants by Time Spent in the Infusion Chair/Bed for Each Treatment Cycle | Missing (Cycle 3) | 1.6 percentage of participants |
| Rituximab IV | Percentage of Participants by Time Spent in the Infusion Chair/Bed for Each Treatment Cycle | 2 to 4 hours (Cycle 6) | 42.5 percentage of participants |
| Rituximab IV | Percentage of Participants by Time Spent in the Infusion Chair/Bed for Each Treatment Cycle | Less than 30 minutes (Cycle 4) | 0 percentage of participants |
| Rituximab IV | Percentage of Participants by Time Spent in the Infusion Chair/Bed for Each Treatment Cycle | More than 12 hours (Cycle 7) | 0 percentage of participants |
| Rituximab IV | Percentage of Participants by Time Spent in the Infusion Chair/Bed for Each Treatment Cycle | 30 minutes to 1 hour (Cycle 4) | 0 percentage of participants |
| Rituximab IV | Percentage of Participants by Time Spent in the Infusion Chair/Bed for Each Treatment Cycle | 4 to 12 hours (Cycle 6) | 53.3 percentage of participants |
| Rituximab IV | Percentage of Participants by Time Spent in the Infusion Chair/Bed for Each Treatment Cycle | 1 to 2 hours (Cycle 4) | 1.1 percentage of participants |
Secondary
Rituximab Administration Satisfaction Questionnaire (RASQ) Domain Scores
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.
Time frame: At Cycle 7 (each cycle was 14 or 21 days)
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rituximab SC | Rituximab Administration Satisfaction Questionnaire (RASQ) Domain Scores | Physical Impact (n=278,140) | 86.24 units on a scale | Standard Deviation 14.012 |
| Rituximab SC | Rituximab Administration Satisfaction Questionnaire (RASQ) Domain Scores | Convenience (n=279,143) | 82.32 units on a scale | Standard Deviation 13.428 |
| Rituximab SC | Rituximab Administration Satisfaction Questionnaire (RASQ) Domain Scores | Psychological Impact (n=277,141) | 85.65 units on a scale | Standard Deviation 13.92 |
| Rituximab SC | Rituximab Administration Satisfaction Questionnaire (RASQ) Domain Scores | Satisfaction (n=282,141) | 89.58 units on a scale | Standard Deviation 12.051 |
| Rituximab SC | Rituximab Administration Satisfaction Questionnaire (RASQ) Domain Scores | Impact on ADLs (n=266,140) | 83.77 units on a scale | Standard Deviation 16.117 |
| Rituximab IV | Rituximab Administration Satisfaction Questionnaire (RASQ) Domain Scores | Satisfaction (n=282,141) | 77.39 units on a scale | Standard Deviation 18.232 |
| Rituximab IV | Rituximab Administration Satisfaction Questionnaire (RASQ) Domain Scores | Impact on ADLs (n=266,140) | 57.38 units on a scale | Standard Deviation 19.23 |
| Rituximab IV | Rituximab Administration Satisfaction Questionnaire (RASQ) Domain Scores | Physical Impact (n=278,140) | 81.49 units on a scale | Standard Deviation 16.848 |
| Rituximab IV | Rituximab Administration Satisfaction Questionnaire (RASQ) Domain Scores | Psychological Impact (n=277,141) | 78.65 units on a scale | Standard Deviation 18.233 |
| Rituximab IV | Rituximab Administration Satisfaction Questionnaire (RASQ) Domain Scores | Convenience (n=279,143) | 60.14 units on a scale | Standard Deviation 17.473 |