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Trial record 12 of 30 for:    Guatemala | Dominican Republic

A Study of Participant Preference With Subcutaneous Versus Intravenous MabThera/Rituxan in Participants With CD20+ Diffuse Large B-Cell Lymphoma or CD20+ Follicular Non-Hodgkin's Lymphoma Grades 1, 2 or 3a

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ClinicalTrials.gov Identifier: NCT01724021
Recruitment Status : Completed
First Posted : November 9, 2012
Results First Posted : August 29, 2016
Last Update Posted : January 23, 2018
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Diffuse Large B-Cell Lymphoma, Non-Hodgkin's Lymphoma
Interventions Drug: Cyclophosphamide, Hydroxydaunorubicin, Oncovin, Prednisone/Prednisolone (CHOP)
Drug: Cyclophosphamide, Vincristine, Prednisone/Prednisolone (CVP)
Drug: Bendamustine
Drug: Rituximab
Enrollment 743

Recruitment Details  
Pre-assignment Details A total of 743 participants were enrolled across all the sites and were included in the intent to treat (ITT) population. Three participants were enrolled but died prior to receiving study medication and were not included in the safety population. The Participant Flow represents the safety population.
Arm/Group Title Arm A Arm B
Hide Arm/Group Description Participants in Arm A received one cycle of rituximab 375 milligram per metre square (mg/m^2) intravenously (IV), then three cycles of rituximab 1400mg subcutaneously (SC), followed by four cycles of rituximab 375 mg/m^2 IV in combination with a standard chemotherapy of cyclophosphamide, hydroxydaunorubicin, Oncovin, prednisone/prednisolone (CHOP), cyclophosphamide, vincristine, prednisone/prednisolone (CVP), or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator. Participants in Arm B received four cycles of rituximab 375 mg/m^2 IV followed by four cycles of rituximab 1400mg SC in combination with a standard chemotherapy of CHOP, CVP, or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
Period Title: Overall Study
Started 371 369
Completed 244 236
Not Completed 127 133
Reason Not Completed
Adverse Event             11             6
Death             46             58
Participant request/ Withdrew consent             18             14
Lost to Follow-up             15             15
Reason Not Specified             36             39
Missing             1             1
Arm/Group Title Arm A Arm B Total
Hide Arm/Group Description Participants in Arm A received one cycle of rituximab 375 mg/m^2 intravenously (IV), then three cycles of rituximab 1400mg subcutaneously (SC), followed by four cycles of rituximab 375 mg/m^2 IV in combination with a standard chemotherapy of cyclophosphamide, hydroxydaunorubicin, Oncovin, prednisone/prednisolone (CHOP), cyclophosphamide, vincristine, prednisone/prednisolone (CVP), or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator. Participants in Arm B received four cycles of rituximab 375 mg/m^2 IV followed by four cycles of rituximab 1400mg SC in combination with a standard chemotherapy of CHOP, CVP, or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator. Total of all reporting groups
Overall Number of Baseline Participants 371 369 740
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 371 participants 369 participants 740 participants
58.2  (13.18) 59.4  (12.64) 58.8  (12.92)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 371 participants 369 participants 740 participants
Female
187
  50.4%
180
  48.8%
367
  49.6%
Male
184
  49.6%
189
  51.2%
373
  50.4%
1.Primary Outcome
Title Percentage of Participants Indicating a Preference for Rituximab Subcutaneous (SC) Over Rituximab Intravenously (IV) at Cycle 6
Hide Description Participants who preferred rituximab SC over rituximab IV, along with the corresponding 95% confidence interval (CI), were estimated using the patient preference questionnaire (PPQ) after completing cycle 6.
Time Frame Cycle 6 (Up to 24 weeks)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who were randomized in the study. Number of participants analyzed specifies number of participants who were evaluable for the outcome measure.
Arm/Group Title Arm A Arm B
Hide Arm/Group Description:
Participants in Arm A received one cycle of rituximab 375 mg/m^2 intravenously (IV), then three cycles of rituximab 1400mg subcutaneously (SC), followed by four cycles of rituximab 375 mg/m^2 IV in combination with a standard chemotherapy of cyclophosphamide, hydroxydaunorubicin, Oncovin, prednisone/prednisolone (CHOP), cyclophosphamide, vincristine, prednisone/prednisolone (CVP), or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
Participants in Arm B received four cycles of rituximab 375 mg/m^2 IV followed by four cycles of rituximab 1400mg SC in combination with a standard chemotherapy of CHOP, CVP, or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
Overall Number of Participants Analyzed 372 371
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
79.1
(74.2 to 83.5)
80.6
(75.7 to 84.8)
2.Primary Outcome
Title Percentage of Participants Indicating a Preference for Rituximab Subcutaneous (SC) Over Rituximab Intravenously (IV) at Cycle 8
Hide Description Participants who preferred rituximab SC over rituximab IV, along with the corresponding 95% confidence interval (CI), were estimated using the patient preference questionnaire (PPQ) after completing Cycle 8.
Time Frame Cycle 8 (Up to 32 weeks)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who were randomized in the study. Number of participants analyzed specifies number of participants who were evaluable for the outcome measure.
Arm/Group Title Arm A Arm B
Hide Arm/Group Description:
Participants in Arm A received one cycle of rituximab 375 mg/m^2 intravenously (IV), then three cycles of rituximab 1400mg subcutaneously (SC), followed by four cycles of rituximab 375 mg/m^2 IV in combination with a standard chemotherapy of cyclophosphamide, hydroxydaunorubicin, Oncovin, prednisone/prednisolone (CHOP), cyclophosphamide, vincristine, prednisone/prednisolone (CVP), or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
Participants in Arm B received four cycles of rituximab 375 mg/m^2 IV followed by four cycles of rituximab 1400mg SC in combination with a standard chemotherapy of CHOP, CVP, or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
Overall Number of Participants Analyzed 372 371
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
77.1
(71.9 to 81.8)
84.2
(79.6 to 88.2)
3.Secondary Outcome
Title Number of Participants With Treatment Emergent Adverse Events (AEs)
Hide Description An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Time Frame Randomization of first participant to clinical cutoff date (Up to 4 years)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The safety population included all participants who received at least one dose of rituximab. Number of participants analyzed specifies number of participants who were evaluable for the outcome measure.
Arm/Group Title Arm A Arm B
Hide Arm/Group Description:
Participants in Arm A received one cycle of rituximab 375 mg/m^2 intravenously (IV), then three cycles of rituximab 1400mg subcutaneously (SC), followed by four cycles of rituximab 375 mg/m^2 IV in combination with a standard chemotherapy of cyclophosphamide, hydroxydaunorubicin, Oncovin, prednisone/prednisolone (CHOP), cyclophosphamide, vincristine, prednisone/prednisolone (CVP), or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
Participants in Arm B received four cycles of rituximab 375 mg/m^2 IV followed by four cycles of rituximab 1400mg SC in combination with a standard chemotherapy of CHOP, CVP, or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
Overall Number of Participants Analyzed 371 369
Measure Type: Number
Unit of Measure: participants
352 347
4.Secondary Outcome
Title Time Required for Rituximab Administration (Subcutaneous [SC] or Intravenous [IV])
Hide Description Administration time was defined as the time from start to end of the SC injection or from start to end of the IV infusion
Time Frame Cycle 1-4, Cycle 5-8 for both SC and IV (Up to 32 weeks)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who were randomized in the study.
Arm/Group Title Rituximab Intravenous (IV) Rituximab Subcutaneous (SC)
Hide Arm/Group Description:
Rituximab was administered at a dose of 375 mg/m2 body surface area (BSA) as a single IV infusion, followed by administration of chemotherapy. At Cycle 1, Day 1, the first rituximab dose for both Arms A and B was always administered as a slow IV infusion, according to local standard practice. Faster infusion rates were permitted after Cycle 1, according to local practice. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
Each treatment cycle consisted of a single SC injection of rituximab administered at a fixed dose of 1400 mg. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
Overall Number of Participants Analyzed 740 687
Median (Full Range)
Unit of Measure: minutes
840
(0 to 3967.0)
22
(0 to 1242.0)
5.Secondary Outcome
Title Cancer Therapy Satisfaction Questionnaire (CTSQ) Score
Hide Description CTSQ is a validated 16-item questionnaire that measures three domains related to participants’ 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 During Cycle 4, 8 of treatment (Up to 32 weeks)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who were randomized in the study. Here, "Number Analyzed" represents the number of participants who were evaluable at specified time points.
Arm/Group Title Rituximab Intravenous (IV) Rituximab Subcutaneous (SC)
Hide Arm/Group Description:
Rituximab was administered at a dose of 375 mg/m2 body surface area (BSA) as a single IV infusion, followed by administration of chemotherapy. At Cycle 1, Day 1, the first rituximab dose for both Arms A and B was always administered as a slow IV infusion, according to local standard practice. Faster infusion rates were permitted after Cycle 1, according to local practice. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
Each treatment cycle consisted of a single SC injection of rituximab administered at a fixed dose of 1400 mg. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
Overall Number of Participants Analyzed 740 687
Mean (Standard Deviation)
Unit of Measure: units on a scale
Expectations of therapy domain Number Analyzed 631 participants 627 participants
80.88  (18.315) 82.07  (17.817)
Feelings about side effects domain Number Analyzed 630 participants 624 participants
60.63  (22.316) 61.64  (22.324)
Satisfaction with therapy domain Number Analyzed 619 participants 623 participants
84.59  (12.218) 85.42  (11.259)
6.Secondary Outcome
Title Rituximab Administration Satisfaction Questionnaire (RASQ) Score
Hide 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.
Time Frame During Cycle 4, 8 of treatment (Up to 32 weeks)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who were randomized in the study. Here, "Number Analyzed" represents the number of participants who were evaluable at specified time points.
Arm/Group Title Rituximab Intravenous (IV) Rituximab Subcutaneous (SC)
Hide Arm/Group Description:
Rituximab was administered at a dose of 375 mg/m2 body surface area (BSA) as a single IV infusion, followed by administration of chemotherapy. At Cycle 1, Day 1, the first rituximab dose for both Arms A and B was always administered as a slow IV infusion, according to local standard practice. Faster infusion rates were permitted after Cycle 1, according to local practice. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
Each treatment cycle consisted of a single SC injection of rituximab administered at a fixed dose of 1400 mg. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
Overall Number of Participants Analyzed 740 687
Mean (Standard Deviation)
Unit of Measure: units on a scale
Physical impact domain Number Analyzed 622 participants 618 participants
82.14  (15.629) 82.08  (15.882)
Psychological Impact domain Number Analyzed 614 participants 612 participants
77.73  (16.377) 84.00  (14.358)
Impact on activitiesf daily living Number Analyzed 604 participants 600 participants
59.49  (22.233) 81.86  (15.844)
Convenience domain Number Analyzed 620 participants 599 participants
59.05  (20.757) 81.05  (13.088)
Satisfaction domain Number Analyzed 617 participants 624 participants
74.88  (19.349) 87.26  (14.972)
7.Secondary Outcome
Title Complete Response (CR) Rate
Hide Description CR rate was assessed according to the International Working Group (IWG) Response Criteria (CHESON ET AL. 1999) and included CR and CR unconfirmed (CRu). 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 > 75 % but still >1.5 cm in size, and indeterminate bone marrow assessment. Tumor assessments were based on computed tomography (CT) scans with contrast of the neck, chest, and abdomen (if detectable by these techniques) or other diagnostic means, if applicable. Other methods (e.g., MRI) were acceptable for participants in whom contrast CT scans were contraindicated. Due to the limited availability of FDG-PET scanners, an FDG-PET scan was not mandated in the study.
Time Frame 28 days (± 3 days) after Day 1 of the last dose of induction treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who were randomized in the study. Number of participants analyzed specifies number of participants who were evaluable for the outcome measure.
Arm/Group Title Arm A Arm B
Hide Arm/Group Description:
Participants in Arm A received one cycle of rituximab 375 mg/m^2 intravenously (IV), then three cycles of rituximab 1400mg subcutaneously (SC), followed by four cycles of rituximab 375 mg/m^2 IV in combination with a standard chemotherapy of cyclophosphamide, hydroxydaunorubicin, Oncovin, prednisone/prednisolone (CHOP), cyclophosphamide, vincristine, prednisone/prednisolone (CVP), or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
Participants in Arm B received four cycles of rituximab 375 mg/m^2 IV followed by four cycles of rituximab 1400mg SC in combination with a standard chemotherapy of CHOP, CVP, or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
Overall Number of Participants Analyzed 307 315
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
49.2
(43.5 to 54.9)
52.7
(47.0 to 58.3)
8.Secondary Outcome
Title Event-free Survival (EFS)
Hide Description EFS was defined as the time from randomization to first occurrence of progression or relapse according to IWG response criteria. IWG criteria is defined using the following response categories: CR: Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy; partial response (PR): At least a 50% decrease in sum of the product of the diameters (SPD) of up to six of the largest dominant nodes or nodal masses; stable disease (SD): participants fails to attain the criteria needed for a CR or PR, but does not fulfill those for progressive disease (PD); PD: Lymph nodes considered abnormal if the long axis is more than 1.5 centimeter (cm) regardless of the short axis. Lymph node has a long axis of 1.1 to 1.5 cm, it is considered abnormal if its short axis is more than 1.0. Lymph nodes less than or equal to (<=) 1.0 × <= 1.0 cm would not be considered as abnormal for PD.
Time Frame From the time of randomization until disease progression or 24 months post treatment follow up or which ever occur first (Up to 4 years)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who were randomized in the study.
Arm/Group Title Arm A Arm B
Hide Arm/Group Description:
Participants in Arm A received one cycle of rituximab 375 mg/m^2 intravenously (IV), then three cycles of rituximab 1400mg subcutaneously (SC), followed by four cycles of rituximab 375 mg/m^2 IV in combination with a standard chemotherapy of cyclophosphamide, hydroxydaunorubicin, Oncovin, prednisone/prednisolone (CHOP), cyclophosphamide, vincristine, prednisone/prednisolone (CVP), or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
Participants in Arm B received four cycles of rituximab 375 mg/m^2 IV followed by four cycles of rituximab 1400mg SC in combination with a standard chemotherapy of CHOP, CVP, or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
Overall Number of Participants Analyzed 372 371
Median (95% Confidence Interval)
Unit of Measure: months
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
[1]
Median (and it's CI) was not reached for this Outcome Measure.
9.Secondary Outcome
Title Disease-free Survival (DFS)
Hide Description DFS was defined as the period from the data of the initial CR/CRu until the date of relapse or death from any cause, whichever occurred first.
Time Frame From the time of randomization until disease progression or 24 months post treatment follow up or which ever occur first (Up to 4 years)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who were randomized in the study.
Arm/Group Title Arm A Arm B
Hide Arm/Group Description:
Participants in Arm A received one cycle of rituximab 375 mg/m^2 intravenously (IV), then three cycles of rituximab 1400mg subcutaneously (SC), followed by four cycles of rituximab 375 mg/m^2 IV in combination with a standard chemotherapy of cyclophosphamide, hydroxydaunorubicin, Oncovin, prednisone/prednisolone (CHOP), cyclophosphamide, vincristine, prednisone/prednisolone (CVP), or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
Participants in Arm B received four cycles of rituximab 375 mg/m^2 IV followed by four cycles of rituximab 1400mg SC in combination with a standard chemotherapy of CHOP, CVP, or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
Overall Number of Participants Analyzed 372 371
Median (95% Confidence Interval)
Unit of Measure: months
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
[1]
Median (and it's CI) was not reached for this Outcome Measure.
10.Secondary Outcome
Title Progression-free Survival (PFS)
Hide Description PFS was defined as the time from randomization to the first occurrence of progression or relapse, according to the IWG response criteria. IWG criteria is defined criteria using the following response categories: CR: Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy; PR: At least a 50% decrease in SPD of up to six of the largest dominant nodes or nodal masses; SD: participants fails to attain the criteria needed for a CR or PR, but does not fulfill those for PD; PD: Lymph nodes considered abnormal if the long axis is more than 1.5 cm regardless of the short axis. Lymph node has a long axis of 1.1 to 1.5 cm, it is considered abnormal if its short axis is more than 1.0. Lymph nodes <= 1.0 × <= 1.0 cm would not be considered as abnormal for PD.
Time Frame From the time of randomization until disease progression or 24 months post treatment follow up or which ever occur first (Up to 4 years)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who were randomized in the study.
Arm/Group Title Arm A Arm B
Hide Arm/Group Description:
Participants in Arm A received one cycle of rituximab 375 mg/m^2 intravenously (IV), then three cycles of rituximab 1400mg subcutaneously (SC), followed by four cycles of rituximab 375 mg/m^2 IV in combination with a standard chemotherapy of cyclophosphamide, hydroxydaunorubicin, Oncovin, prednisone/prednisolone (CHOP), cyclophosphamide, vincristine, prednisone/prednisolone (CVP), or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
Participants in Arm B received four cycles of rituximab 375 mg/m^2 IV followed by four cycles of rituximab 1400mg SC in combination with a standard chemotherapy of CHOP, CVP, or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
Overall Number of Participants Analyzed 372 371
Median (95% Confidence Interval)
Unit of Measure: months
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
[1]
Median (and it's CI) was not reached for this Outcome Measure.
11.Secondary Outcome
Title Overall Survival (OS)
Hide Description OS was defined as the time from randomization to death from any cause.
Time Frame From the time of randomization until disease progression or 24 months post treatment follow up or which ever occur first (Up to 4 years)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who were randomized in the study.
Arm/Group Title Arm A Arm B
Hide Arm/Group Description:
Participants in Arm A received one cycle of rituximab 375 mg/m^2 intravenously (IV), then three cycles of rituximab 1400mg subcutaneously (SC), followed by four cycles of rituximab 375 mg/m^2 IV in combination with a standard chemotherapy of cyclophosphamide, hydroxydaunorubicin, Oncovin, prednisone/prednisolone (CHOP), cyclophosphamide, vincristine, prednisone/prednisolone (CVP), or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
Participants in Arm B received four cycles of rituximab 375 mg/m^2 IV followed by four cycles of rituximab 1400mg SC in combination with a standard chemotherapy of CHOP, CVP, or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
Overall Number of Participants Analyzed 372 371
Median (95% Confidence Interval)
Unit of Measure: months
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
[1]
Median (and it's CI) was not reached for this Outcome Measure.
12.Secondary Outcome
Title Percentage of Participants With Anti-Rituximab Antibodies Over Time
Hide Description [Not Specified]
Time Frame Pre-dose Cycle 1 to 8, interim staging, final staging, 6, 12 months follow-up, end of study (Up to 4 years)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The safety population included all participants who received at least one dose of rituximab. Here, "Number Analyzed" represents the number of participants who were evaluable at specified time points.
Arm/Group Title Arm A Arm B
Hide Arm/Group Description:
Participants in Arm A received one cycle of rituximab 375 mg/m^2 intravenously (IV), then three cycles of rituximab 1400mg subcutaneously (SC), followed by four cycles of rituximab 375 mg/m^2 IV in combination with a standard chemotherapy of cyclophosphamide, hydroxydaunorubicin, Oncovin, prednisone/prednisolone (CHOP), cyclophosphamide, vincristine, prednisone/prednisolone (CVP), or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
Participants in Arm B received four cycles of rituximab 375 mg/m^2 IV followed by four cycles of rituximab 1400mg SC in combination with a standard chemotherapy of CHOP, CVP, or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
Overall Number of Participants Analyzed 371 369
Measure Type: Number
Unit of Measure: percentage of participants
Cycle 1 Number Analyzed 342 participants 335 participants
2.0 3.0
Cycle 2 Number Analyzed 333 participants 325 participants
2.1 2.2
Cycle 3 Number Analyzed 328 participants 322 participants
0.3 0.9
Cycle 4 Number Analyzed 323 participants 323 participants
0 0.3
Interim staging Number Analyzed 283 participants 281 participants
0 0
Cycle 5 Number Analyzed 237 participants 253 participants
0 0
Cycle 6 Number Analyzed 300 participants 289 participants
0 0
Cycle 7 Number Analyzed 288 participants 290 participants
0 0
Cycle 8 Number Analyzed 281 participants 283 participants
0 0
Final staging Number Analyzed 261 participants 260 participants
0 0
Follow-up, 6 months Number Analyzed 166 participants 183 participants
1.8 0
Follow-up, 12 months Number Analyzed 141 participants 161 participants
2.1 0.6
End of study/early treatment termination Number Analyzed 174 participants 171 participants
0.6 0.6
13.Secondary Outcome
Title Percentage of Participants With Anti-Recombinant Human Hyaluronidase (rHuPH20) Antibodies Over Time
Hide Description [Not Specified]
Time Frame Pre-dose Cycle 1 to 8, interim staging, final staging, 6, 12 months follow-up, end of study (Up to 4 years)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The safety population included all participants who received at least one dose of rituximab. Here, "Number Analyzed" represents the number of participants who were evaluable at specified time points.
Arm/Group Title Arm A Arm B
Hide Arm/Group Description:
Participants in Arm A received one cycle of rituximab 375 mg/m^2 intravenously (IV), then three cycles of rituximab 1400mg subcutaneously (SC), followed by four cycles of rituximab 375 mg/m^2 IV in combination with a standard chemotherapy of cyclophosphamide, hydroxydaunorubicin, Oncovin, prednisone/prednisolone (CHOP), cyclophosphamide, vincristine, prednisone/prednisolone (CVP), or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
Participants in Arm B received four cycles of rituximab 375 mg/m^2 IV followed by four cycles of rituximab 1400mg SC in combination with a standard chemotherapy of CHOP, CVP, or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
Overall Number of Participants Analyzed 371 369
Measure Type: Number
Unit of Measure: percentage of participants
Cycle 1 Number Analyzed 35 participants 32 participants
11.4 15.6
Cycle 2 Number Analyzed 342 participants 33 participants
7.0 18.2
Cycle 3 Number Analyzed 339 participants 34 participants
7.1 23.5
Cycle 4 Number Analyzed 327 participants 34 participants
7.0 14.7
Interim staging Number Analyzed 279 participants 269 participants
9.0 9.7
Cycle 5 Number Analyzed 24 participants 266 participants
12.5 10.2
Cycle 6 Number Analyzed 25 participants 303 participants
16.0 11.6
Cycle 7 Number Analyzed 21 participants 303 participants
23.8 10.9
Cycle 8 Number Analyzed 15 participants 291 participants
13.3 11.0
Final staging Number Analyzed 240 participants 261 participants
10.0 12.6
Follow-up, 6 months Number Analyzed 155 participants 172 participants
6.5 13.4
Follow-up, 12 months Number Analyzed 142 participants 161 participants
7.7 8.7
End of study/early treatment termination Number Analyzed 171 participants 175 participants
3.5 6.3
14.Secondary Outcome
Title Summary of Observed Serum Rituximab Concentration
Hide Description [Not Specified]
Time Frame Pre-dose Cycle 1 to 8, interim staging, final staging, 6, 12 months follow-up, end of study (Up to 4 years)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The safety population included all participants who received at least one dose of rituximab. Here, "Number Analyzed" represents the number of participants who were evaluable at specified time points.
Arm/Group Title Arm A Arm B
Hide Arm/Group Description:
Participants in Arm A received one cycle of rituximab 375 mg/m^2 intravenously (IV), then three cycles of rituximab 1400mg subcutaneously (SC), followed by four cycles of rituximab 375 mg/m^2 IV in combination with a standard chemotherapy of cyclophosphamide, hydroxydaunorubicin, Oncovin, prednisone/prednisolone (CHOP), cyclophosphamide, vincristine, prednisone/prednisolone (CVP), or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
Participants in Arm B received four cycles of rituximab 375 mg/m^2 IV followed by four cycles of rituximab 1400mg SC in combination with a standard chemotherapy of CHOP, CVP, or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
Overall Number of Participants Analyzed 371 369
Mean (Standard Deviation)
Unit of Measure: microgram per milliter
Cycle 1 Number Analyzed 285 participants 281 participants
3355.9  (21600.95) 970.1  (9415.93)
Cycle 2 Number Analyzed 284 participants 280 participants
25053.1  (19590.17) 24541.1  (18141.76)
Cycle 3 Number Analyzed 281 participants 281 participants
62977.0  (30037.98) 46093.9  (31214.30)
Cycle 4 Number Analyzed 282 participants 285 participants
87956.6  (40441.84) 59485.5  (29183.17)
Interim staging Number Analyzed 256 participants 251 participants
117273.6  (52227.06) 77665.3  (29161.77)
Cycle 5 Number Analyzed 212 participants 226 participants
108030.9  (54335.08) 70387.3  (30256.48)
Cycle 6 Number Analyzed 282 participants 266 participants
100927.7  (49287.42) 98679.7  (40001.55)
Cycle 7 Number Analyzed 272 participants 268 participants
95614.0  (45499.56) 117172.0  (44501.74)
Cycle 8 Number Analyzed 267 participants 266 participants
104873.0  (50346.69) 137048.1  (53669.39)
Final staging Number Analyzed 253 participants 252 participants
86806.6  (43005.90) 120995.7  (58731.10)
Follow-up, 6 months Number Analyzed 164 participants 183 participants
7802.9  (15672.57) 8042.9  (12247.05)
Follow-up, 12 months Number Analyzed 139 participants 163 participants
2380.1  (8494.06) 1685.3  (6669.84)
End of study/early treatment termination Number Analyzed 173 participants 168 participants
9302.0  (27234.88) 9553.9  (30723.30)
Time Frame Randomization of first participant to clinical cutoff date (Up to 4 years)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm A Arm B
Hide Arm/Group Description Participants in Arm A received one cycle of rituximab 375 mg/m^2 intravenously (IV), then three cycles of rituximab 1400mg subcutaneously (SC), followed by four cycles of rituximab 375 mg/m^2 IV in combination with a standard chemotherapy of cyclophosphamide, hydroxydaunorubicin, Oncovin, prednisone/prednisolone (CHOP), cyclophosphamide, vincristine, prednisone/prednisolone (CVP), or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator. Participants in Arm B received four cycles of rituximab 375 mg/m^2 IV followed by four cycles of rituximab 1400mg SC in combination with a standard chemotherapy of CHOP, CVP, or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
All-Cause Mortality
Arm A Arm B
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Arm A Arm B
Affected / at Risk (%) Affected / at Risk (%)
Total   126/371 (33.96%)   116/369 (31.44%) 
Blood and lymphatic system disorders     
Febrile Neutropenia  1  31/371 (8.36%)  30/369 (8.13%) 
Neutropenia  2  16/371 (4.31%)  13/369 (3.52%) 
Anaemia  2  3/371 (0.81%)  5/369 (1.36%) 
Leukopenia  2  5/371 (1.35%)  1/369 (0.27%) 
Pancytopenia  2  1/371 (0.27%)  2/369 (0.54%) 
Lymphopenia  2  0/371 (0.00%)  1/369 (0.27%) 
Cardiac disorders     
Atrial fibrillation  2  2/371 (0.54%)  1/369 (0.27%) 
Cardiac failure  2  1/371 (0.27%)  2/369 (0.54%) 
Acute coronary syndrome  2  1/371 (0.27%)  0/369 (0.00%) 
Angina pectoris  2  0/371 (0.00%)  1/369 (0.27%) 
Bradycardia  2  0/371 (0.00%)  1/369 (0.27%) 
Myocardial infarction  2  0/371 (0.00%)  1/369 (0.27%) 
Endocrine disorders     
Diabetes insipidus  2  1/371 (0.27%)  0/369 (0.00%) 
Hyperthyroidism  2  0/371 (0.00%)  1/369 (0.27%) 
Gastrointestinal disorders     
Diarrhoea  1  1/371 (0.27%)  3/369 (0.81%) 
Vomiting  2  2/371 (0.54%)  2/369 (0.54%) 
Abdominal pain  2  2/371 (0.54%)  1/369 (0.27%) 
Constipation  2  2/371 (0.54%)  1/369 (0.27%) 
Intestinal perforation  2  1/371 (0.27%)  2/369 (0.54%) 
Abdominal pain lower  2  0/371 (0.00%)  1/369 (0.27%) 
Abdominal wall haematoma  2  0/371 (0.00%)  1/369 (0.27%) 
Anal fistula  2  0/371 (0.00%)  1/369 (0.27%) 
Enterocolitis  2  0/371 (0.00%)  1/369 (0.27%) 
Gastrointestinal obstruction  2  0/371 (0.00%)  1/369 (0.27%) 
Ileal perforation  2  1/371 (0.27%)  0/369 (0.00%) 
Ileus  2  0/371 (0.00%)  1/369 (0.27%) 
Ileus paralytic  2  0/371 (0.00%)  1/369 (0.27%) 
Intra-abdominal haemorrhage  2  1/371 (0.27%)  0/369 (0.00%) 
Oesophagitis  2  1/371 (0.27%)  0/369 (0.00%) 
Small intestinal perforation  2  1/371 (0.27%)  0/369 (0.00%) 
Subileus  2  0/371 (0.00%)  1/369 (0.27%) 
Upper gastrointestinal haemorrhage  2  0/371 (0.00%)  1/369 (0.27%) 
General disorders     
Pyrexia  2  10/371 (2.70%)  3/369 (0.81%) 
Asthenia  2  4/371 (1.08%)  1/369 (0.27%) 
General physical health deterioration  2  3/371 (0.81%)  0/369 (0.00%) 
Chest pain  2  1/371 (0.27%)  0/369 (0.00%) 
Injection site warmth  2  1/371 (0.27%)  0/369 (0.00%) 
Adverse drug reaction  2  1/371 (0.27%)  0/369 (0.00%) 
Hepatobiliary disorders     
Cholecystitis Acute  2  0/371 (0.00%)  1/369 (0.27%) 
Cholestasis  2  1/371 (0.27%)  0/369 (0.00%) 
Immune system disorders     
Hypersensitivity  2  0/371 (0.00%)  2/369 (0.54%) 
Anaphylactic reaction  2  1/371 (0.27%)  0/369 (0.00%) 
Cytokine release syndrome  2  0/371 (0.00%)  1/369 (0.27%) 
Infections and infestations     
Pneumonia  2  12/371 (3.23%)  9/369 (2.44%) 
Sepsis  2  3/371 (0.81%)  5/369 (1.36%) 
Lung Infection  2  3/371 (0.81%)  3/369 (0.81%) 
Herpes Zoster  2  1/371 (0.27%)  3/369 (0.81%) 
Urinary Tract Infection  2  3/371 (0.81%)  3/369 (0.81%) 
Septic Shock  2  2/371 (0.54%)  2/369 (0.54%) 
Atypical pneumonia  2  1/371 (0.27%)  2/369 (0.54%) 
Bronchitis  2  1/371 (0.27%)  3/369 (0.81%) 
Infection  2  3/371 (0.81%)  0/369 (0.00%) 
Upper Respiratory Tract Infection  2  1/371 (0.27%)  2/369 (0.54%) 
Cellulitis  2  1/371 (0.27%)  1/369 (0.27%) 
Erysipelas  2  1/371 (0.27%)  1/369 (0.27%) 
Gastroenteritis  2  1/371 (0.27%)  1/369 (0.27%) 
Influenza  2  2/371 (0.54%)  0/369 (0.00%) 
Neutropenic sepsis  2  0/371 (0.00%)  1/369 (0.27%) 
Pneumocystis Jirovecii Pneumonia  2  2/371 (0.54%)  0/369 (0.00%) 
Pneumonia viral  2  1/371 (0.27%)  1/369 (0.27%) 
Respiratory Tract Infection  2  0/371 (0.00%)  2/369 (0.54%) 
Soft tissue infection  2  0/371 (0.00%)  2/369 (0.54%) 
Anal abscess  2  1/371 (0.27%)  0/369 (0.00%) 
Appendicitis  2  1/371 (0.27%)  0/369 (0.00%) 
Bronchopulmonary Aspergillosis  2  0/371 (0.00%)  2/369 (0.54%) 
Cystitis  2  1/371 (0.27%)  0/369 (0.00%) 
Diverticulitis  2  1/371 (0.27%)  0/369 (0.00%) 
Fungal infection  2  1/371 (0.27%)  0/369 (0.00%) 
Gastroenteritis Bacterial  2  0/371 (0.00%)  1/369 (0.27%) 
Injection site abscess  2  0/371 (0.00%)  1/369 (0.27%) 
Kidney infection  2  1/371 (0.27%)  0/369 (0.00%) 
Localised infection  2  0/371 (0.00%)  1/369 (0.27%) 
Lower respiratory tract infection  2  1/371 (0.27%)  0/369 (0.00%) 
Lymph node abscess  2  0/371 (0.00%)  1/369 (0.27%) 
Mucosal infection  2  0/371 (0.00%)  1/369 (0.27%) 
Oral fungal infection  2  1/371 (0.27%)  0/369 (0.00%) 
Oropharyngeal candidiasis  1  0/371 (0.00%)  1/369 (0.27%) 
Peritonsillitis  2  0/371 (0.00%)  1/369 (0.27%) 
Post procedural infection  2  0/371 (0.00%)  1/369 (0.27%) 
Progressive multifocal leukoencephalopathy  2  1/371 (0.27%)  0/369 (0.00%) 
Pyoderma  2  1/371 (0.27%)  0/369 (0.00%) 
Skin infection  2  1/371 (0.27%)  0/369 (0.00%) 
Staphylococcal sepsis  2  1/371 (0.27%)  0/369 (0.00%) 
Subcutaneous abscess  2  0/371 (0.00%)  1/369 (0.27%) 
Tooth infection  1  1/371 (0.27%)  0/369 (0.00%) 
Viral infection  2  0/371 (0.00%)  1/369 (0.27%) 
Bacteraemia  2  0/371 (0.00%)  1/369 (0.27%) 
Genital infection bacterial  2  0/371 (0.00%)  1/369 (0.27%) 
Oral candidiasis  2  1/371 (0.27%)  0/369 (0.00%) 
Systemic infection  2  1/371 (0.27%)  0/369 (0.00%) 
Varicella zoster virus infection  2  1/371 (0.27%)  0/369 (0.00%) 
Injury, poisoning and procedural complications     
Fall  2  2/371 (0.54%)  1/369 (0.27%) 
Overdose  2  0/371 (0.00%)  1/369 (0.27%) 
Radius fracture  2  1/371 (0.27%)  0/369 (0.00%) 
Spinal fracture  2  0/371 (0.00%)  1/369 (0.27%) 
Spinal compression fracture  2  1/371 (0.27%)  0/369 (0.00%) 
Investigations     
Neutrophil count decreased  2  11/371 (2.96%)  10/369 (2.71%) 
White blood cell count decreased  2  3/371 (0.81%)  3/369 (0.81%) 
Alanine aminotransferase increased  2  1/371 (0.27%)  0/369 (0.00%) 
Platelet count decreased  2  1/371 (0.27%)  0/369 (0.00%) 
Body temperature increased  2  1/371 (0.27%)  0/369 (0.00%) 
Metabolism and nutrition disorders     
Dehydration  2  1/371 (0.27%)  1/369 (0.27%) 
Hyperglycaemia  1  0/371 (0.00%)  2/369 (0.54%) 
Decreased appetite  2  0/371 (0.00%)  1/369 (0.27%) 
Gout  2  1/371 (0.27%)  0/369 (0.00%) 
Hypernataemia  2  0/371 (0.00%)  1/369 (0.27%) 
Hyponatraemia  2  0/371 (0.00%)  1/369 (0.27%) 
Tumor lysis syndrome  2  1/371 (0.27%)  0/369 (0.00%) 
Musculoskeletal and connective tissue disorders     
Back pain  2  1/371 (0.27%)  0/369 (0.00%) 
Bone pain  2  1/371 (0.27%)  0/369 (0.00%) 
Gouty arthritis  2  0/371 (0.00%)  1/369 (0.27%) 
Myofascial pain syndrome  2  1/371 (0.27%)  0/369 (0.00%) 
Myopathy  2  0/371 (0.00%)  1/369 (0.27%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Papillary thyroid cancer  2  0/371 (0.00%)  1/369 (0.27%) 
Renal cell cancer  2  0/371 (0.00%)  1/369 (0.27%) 
Lung adenocarcinoma  2  0/371 (0.00%)  1/369 (0.27%) 
Neoplasm  2  1/371 (0.27%)  0/369 (0.00%) 
Nervous system disorders     
Dizziness  2  2/371 (0.54%)  0/369 (0.00%) 
Syncope  2  2/371 (0.54%)  1/369 (0.27%) 
Depressed level of consciousness  2  0/371 (0.00%)  1/369 (0.27%) 
Haemorrhage intracranial  1  1/371 (0.27%)  0/369 (0.00%) 
Headache  2  1/371 (0.27%)  0/369 (0.00%) 
Hemiparesis  2  0/371 (0.00%)  1/369 (0.27%) 
Hypertensive encephalopathy  2  0/371 (0.00%)  1/369 (0.27%) 
Neuropathy peripheral  2  0/371 (0.00%)  1/369 (0.27%) 
Paraparesis  2  0/371 (0.00%)  1/369 (0.27%) 
Peripheral sensory neuropathy  2  0/371 (0.00%)  1/369 (0.27%) 
Transient ischaemic attack  2  0/371 (0.00%)  1/369 (0.27%) 
Vith nerve paralysis  2  1/371 (0.27%)  0/369 (0.00%) 
Encephalopathy  2  0/371 (0.00%)  1/369 (0.27%) 
Psychiatric disorders     
Anxiety  2  0/371 (0.00%)  1/369 (0.27%) 
Depression  2  1/371 (0.27%)  1/369 (0.27%) 
Suicide attempt  2  0/371 (0.00%)  1/369 (0.27%) 
Renal and urinary disorders     
Nephropathy toxic  2  1/371 (0.27%)  0/369 (0.00%) 
Urinary tract pain  2  0/371 (0.00%)  1/369 (0.27%) 
Acute kidney injury  2  1/371 (0.27%)  2/369 (0.54%) 
Respiratory, thoracic and mediastinal disorders     
Pulmonary embolism  1  3/371 (0.81%)  1/369 (0.27%) 
Dyspnoea  1  2/371 (0.54%)  0/369 (0.00%) 
Interstitial lung disease  1  2/371 (0.54%)  0/369 (0.00%) 
Acute respiratory distress syndrome  2  1/371 (0.27%)  0/369 (0.00%) 
Bronchospasm  2  1/371 (0.27%)  0/369 (0.00%) 
Pleural effusion  2  0/371 (0.00%)  1/369 (0.27%) 
Respiratory failure  2  0/371 (0.00%)  1/369 (0.27%) 
Skin and subcutaneous tissue disorders     
Rash  2  2/371 (0.54%)  1/369 (0.27%) 
Angioedema  2  1/371 (0.27%)  0/369 (0.00%) 
Purpura  2  1/371 (0.27%)  0/369 (0.00%) 
Stevens-Johnson syndrome  2  0/371 (0.00%)  1/369 (0.27%) 
Vascular disorders     
Deep vein thrombosis  2  0/371 (0.00%)  3/369 (0.81%) 
Circulatory collapse  2  0/371 (0.00%)  1/369 (0.27%) 
Orthostatic hypotension  1  1/371 (0.27%)  0/369 (0.00%) 
Vasculitis  2  0/371 (0.00%)  1/369 (0.27%) 
Venous thrombosis  2  0/371 (0.00%)  1/369 (0.27%) 
Venous thrombosis limb  2  0/371 (0.00%)  1/369 (0.27%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15.0
2
Term from vocabulary, MedDRA 19.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Arm A Arm B
Affected / at Risk (%) Affected / at Risk (%)
Total   318/371 (85.71%)   317/369 (85.91%) 
Blood and lymphatic system disorders     
Neutropenia  2  51/371 (13.75%)  70/369 (18.97%) 
Anaemia  2  79/371 (21.29%)  68/369 (18.43%) 
Leukopenia  2  38/371 (10.24%)  32/369 (8.67%) 
Gastrointestinal disorders     
Nausea  1  83/371 (22.37%)  102/369 (27.64%) 
Constipation  2  59/371 (15.90%)  60/369 (16.26%) 
Vomiting  2  44/371 (11.86%)  57/369 (15.45%) 
Diarrhoea  2  45/371 (12.13%)  50/369 (13.55%) 
Stomatitis  2  23/371 (6.20%)  23/369 (6.23%) 
Abdominal pain  2  23/371 (6.20%)  19/369 (5.15%) 
Abdominal pain upper  2  17/371 (4.58%)  22/369 (5.96%) 
General disorders     
Fatigue  2  69/371 (18.60%)  91/369 (24.66%) 
Pyrexia  2  55/371 (14.82%)  48/369 (13.01%) 
Mucosal inflammation  2  25/371 (6.74%)  26/369 (7.05%) 
Chills  2  29/371 (7.82%)  15/369 (4.07%) 
Oedema peripheral  2  17/371 (4.58%)  22/369 (5.96%) 
Infections and infestations     
Nasopharyngitis  2  20/371 (5.39%)  19/369 (5.15%) 
Upper respiratory tract infection  2  22/371 (5.93%)  20/369 (5.42%) 
Investigations     
Neutrophil count decreased  2  63/371 (16.98%)  69/369 (18.70%) 
White blood cell count decreased  2  37/371 (9.97%)  33/369 (8.94%) 
Metabolism and nutrition disorders     
Decreased appetite  2  34/371 (9.16%)  32/369 (8.67%) 
Nervous system disorders     
Neuropathy peripheral  2  37/371 (9.97%)  47/369 (12.74%) 
Headache  2  27/371 (7.28%)  29/369 (7.86%) 
Paraesthesia  2  18/371 (4.85%)  36/369 (9.76%) 
Psychiatric disorders     
Insomnia  2  25/371 (6.74%)  31/369 (8.40%) 
Respiratory, thoracic and mediastinal disorders     
Cough  2  45/371 (12.13%)  38/369 (10.30%) 
Dyspnoea  2  20/371 (5.39%)  21/369 (5.69%) 
Skin and subcutaneous tissue disorders     
Alopecia  2  60/371 (16.17%)  56/369 (15.18%) 
Pruritus  2  29/371 (7.82%)  17/369 (4.61%) 
Rash  2  19/371 (5.12%)  21/369 (5.69%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15.0
2
Term from vocabulary, MedDRA 19.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Results Point of Contact
Name/Title: Medical Communications
Organization: Hoffmann-La Roche
Phone: 800-821-8590