Trial Outcomes & Findings for Compare Efficacy, Safety, and Immunogenicity of Proposed Rituximab Biosimilar (DRL_RI) With MabThera® in LTB Follicular Lymphoma (NCT NCT03976102)
NCT ID: NCT03976102
Last Updated: 2024-01-22
Results Overview
Best Overall Response Rate (BORR) is defined as the proportion of participants in each treatment group that achieved a best overall response of either Complete response (CR), unconfirmed Complete response (CRu) or Partial response (PR), up to Month 7 (Week 28) based on central radiology review in accordance with the Cheson, 1999 response criteria for Non-Hodgkin's Lymphomas. As per Cheson 1999, response criteria for target lesions and assessed by radiology: Complete response (CR): All lesions with a longest diameter should be regressed to normal size (≤ 15 mm) or short axis regressed to ≤ 10 mm with confirmed Bone marrow normalization; unconfirmed Complete response (CRu): All lesions with a longest diameter should be regressed to normal size (≤ 15 mm) or short axis regressed to ≤ 10 mm with non-confirmed Bone marrow normalization; Partial Response (PR): ≥ 50 % decrease of sum of products of diameter(SPD) of all the target lesions; Overall Response (OR)=CR+CRu+PR.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
317 participants
Primary outcome timeframe
Month 7 (Week 28)
Results posted on
2024-01-22
Participant Flow
The trial was conducted at 4 sites in the United States from 15 May 2019 to 27 February 2023. The final participant was examined or received an intervention for the purposes of final collection of data for the primary outcome on 28 September 2022.
All the assessments were performed as per the schedule of the assessments.
Participant milestones
| Measure |
Arm A: DRL_RI
Randomized participants were administered rituximab biosimilar-Dr. Reddy's Lab (DRL\_RI) 375mg/m\^2 via intravenous (IV) infusion on Days 1, 8, 15, 22 and Weeks 12, 20, 28 and 36.
|
Arm B: MabThera®
Randomized participants were administered MabThera® 375 mg/m\^2 via IV infusion on Days 1, 8, 15, 22 and Weeks 12, 20, 28 and 36
|
|---|---|---|
|
Overall Study
STARTED
|
162
|
155
|
|
Overall Study
COMPLETED
|
143
|
129
|
|
Overall Study
NOT COMPLETED
|
19
|
26
|
Reasons for withdrawal
| Measure |
Arm A: DRL_RI
Randomized participants were administered rituximab biosimilar-Dr. Reddy's Lab (DRL\_RI) 375mg/m\^2 via intravenous (IV) infusion on Days 1, 8, 15, 22 and Weeks 12, 20, 28 and 36.
|
Arm B: MabThera®
Randomized participants were administered MabThera® 375 mg/m\^2 via IV infusion on Days 1, 8, 15, 22 and Weeks 12, 20, 28 and 36
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
4
|
4
|
|
Overall Study
Adverse Event
|
2
|
4
|
|
Overall Study
Not related to Covid-19
|
9
|
13
|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
|
Overall Study
Death
|
3
|
2
|
|
Overall Study
Physician Decision
|
1
|
1
|
Baseline Characteristics
Compare Efficacy, Safety, and Immunogenicity of Proposed Rituximab Biosimilar (DRL_RI) With MabThera® in LTB Follicular Lymphoma
Baseline characteristics by cohort
| Measure |
Arm A: DRL_RI
n=162 Participants
Randomized participants were administered DRL\_RI 375 mg/m\^2 via IV infusion on Days 1, 8, 15, 22 and Weeks 12, 20, 28 and 36
|
Arm B: MabThera®
n=155 Participants
Randomized participants were administered MabThera® 375 mg/m\^2 via IV infusion on Days 1, 8, 15, 22 and Weeks 12, 20, 28 and 36
|
Total
n=317 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.6 Years
STANDARD_DEVIATION 12.37 • n=99 Participants
|
55.8 Years
STANDARD_DEVIATION 13.03 • n=107 Participants
|
56.7 Years
STANDARD_DEVIATION 12.70 • n=206 Participants
|
|
Sex: Female, Male
Female
|
82 Participants
n=99 Participants
|
78 Participants
n=107 Participants
|
160 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
80 Participants
n=99 Participants
|
77 Participants
n=107 Participants
|
157 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
44 Participants
n=99 Participants
|
45 Participants
n=107 Participants
|
89 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
118 Participants
n=99 Participants
|
110 Participants
n=107 Participants
|
228 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
104 Participants
n=99 Participants
|
107 Participants
n=107 Participants
|
211 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian
|
51 Participants
n=99 Participants
|
46 Participants
n=107 Participants
|
97 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Aboriginal/Torres Strait Islander
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
5 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Month 7 (Week 28)Population: The ITT Analysis Set included all randomized participants.
Best Overall Response Rate (BORR) is defined as the proportion of participants in each treatment group that achieved a best overall response of either Complete response (CR), unconfirmed Complete response (CRu) or Partial response (PR), up to Month 7 (Week 28) based on central radiology review in accordance with the Cheson, 1999 response criteria for Non-Hodgkin's Lymphomas. As per Cheson 1999, response criteria for target lesions and assessed by radiology: Complete response (CR): All lesions with a longest diameter should be regressed to normal size (≤ 15 mm) or short axis regressed to ≤ 10 mm with confirmed Bone marrow normalization; unconfirmed Complete response (CRu): All lesions with a longest diameter should be regressed to normal size (≤ 15 mm) or short axis regressed to ≤ 10 mm with non-confirmed Bone marrow normalization; Partial Response (PR): ≥ 50 % decrease of sum of products of diameter(SPD) of all the target lesions; Overall Response (OR)=CR+CRu+PR.
Outcome measures
| Measure |
Arm A: DRL_RI
n=162 Participants
Randomized participants were administered DRL\_RI 375mg/m\^2 via IV infusion on Days 1, 8, 15, 22 and Weeks 12, 20, 28 and 36.
|
Arm B: MabThera®
n=155 Participants
Randomized participants were administered MabThera® 375 mg/m\^2 via IV infusion on Days 1, 8, 15, 22 and Weeks 12, 20, 28 and 36.
|
|---|---|---|
|
Best Overall Response Rate (BORR) for Low Tumor Burden Follicular Lymphoma
|
80.2 percentage of participants
Interval 73.3 to 86.1
|
79.4 percentage of participants
Interval 72.1 to 85.4
|
SECONDARY outcome
Timeframe: Week 12, Week 28Population: The ITT Analysis Set included all randomized participants.
The overall response rate (ORR) is defined as proportion of participants in each treatment group achieved a complete response or partial response at week 12 and week 28 based on central radiology review in accordance with published response criteria for malignant lymphoma. As per Cheson 1999, response criteria for target lesions and assessed by radiology: Complete response (CR): All lesions with a longest diameter should be regressed to normal size (≤ 15 mm) or short axis regressed to ≤ 10 mm with confirmed Bone marrow normalization; unconfirmed Complete response (uCR): All lesions with a longest diameter should be regressed to normal size (≤ 15 mm) or short axis regressed to ≤ 10 mm with non-confirmed Bone marrow normalization; Partial Response (PR): ≥ 50 % decrease of sum of products of diameter(SPD) of all the target lesions; Overall Response (OR)=CR+uCR+PR.
Outcome measures
| Measure |
Arm A: DRL_RI
n=162 Participants
Randomized participants were administered DRL\_RI 375mg/m\^2 via IV infusion on Days 1, 8, 15, 22 and Weeks 12, 20, 28 and 36.
|
Arm B: MabThera®
n=155 Participants
Randomized participants were administered MabThera® 375 mg/m\^2 via IV infusion on Days 1, 8, 15, 22 and Weeks 12, 20, 28 and 36.
|
|---|---|---|
|
Overall Response Rate (ORR)
Week 12
|
62.3 percentage of particpants
Interval 54.4 to 69.8
|
63.9 percentage of particpants
Interval 55.8 to 71.4
|
|
Overall Response Rate (ORR)
Week 28
|
75.3 percentage of particpants
Interval 67.9 to 81.7
|
73.5 percentage of particpants
Interval 65.9 to 80.3
|
SECONDARY outcome
Timeframe: Week 28Population: The ITT Analysis Set included all randomized participants.
Complete Response rate is defined as the proportion of participants in each treatment group who achieved complete response up to particular visit based on investigator assessment in accordance with the response criteria for malignant lymphoma. As per Cheson 1999, response criteria for target lesions and assessed by radiology: Complete response (CR): All lesions with a longest diameter should be regressed to normal size (≤ 15 mm) or short axis regressed to ≤ 10 mm with confirmed Bone marrow normalization.
Outcome measures
| Measure |
Arm A: DRL_RI
n=162 Participants
Randomized participants were administered DRL\_RI 375mg/m\^2 via IV infusion on Days 1, 8, 15, 22 and Weeks 12, 20, 28 and 36.
|
Arm B: MabThera®
n=155 Participants
Randomized participants were administered MabThera® 375 mg/m\^2 via IV infusion on Days 1, 8, 15, 22 and Weeks 12, 20, 28 and 36.
|
|---|---|---|
|
Complete Response Rate
|
32.7 percentage of participants
Interval 25.6 to 40.5
|
34.2 percentage of participants
Interval 26.8 to 42.2
|
SECONDARY outcome
Timeframe: Week 28Population: The ITT Analysis Set included all randomized participants.
Complete Response Rate as a Best Response is defined as the proportion of participants in each treatment group that achieved the best complete response up to Week 28 based on central radiology review in accordance with the Cheson 1999, response criteria for malignant lymphoma. As per Cheson 1999, response criteria for target lesions and assessed by radiology: Complete response (CR): All lesions with a longest diameter should be regressed to normal size (≤ 15 mm) or short axis regressed to ≤ 10 mm with confirmed Bone marrow normalization.
Outcome measures
| Measure |
Arm A: DRL_RI
n=162 Participants
Randomized participants were administered DRL\_RI 375mg/m\^2 via IV infusion on Days 1, 8, 15, 22 and Weeks 12, 20, 28 and 36.
|
Arm B: MabThera®
n=155 Participants
Randomized participants were administered MabThera® 375 mg/m\^2 via IV infusion on Days 1, 8, 15, 22 and Weeks 12, 20, 28 and 36.
|
|---|---|---|
|
Complete Response Rate as a Best Response
|
34.0 percentage of participants
Interval 26.7 to 41.8
|
35.5 percentage of participants
Interval 28.0 to 43.6
|
SECONDARY outcome
Timeframe: Week 52Population: The ITT Analysis Set included all randomized participants. The number analyzed are the participants with complete response, unconfirmed complete response or partial response.
Duration of response (DOR) defined as the time from date of the first documentation of tumor response (Complete Response, unconfirmed complete response or partial response) to the date of first documentation of progressive disease (PD) or to death due to any cause up to 52 weeks/ End of study (EOS). Progression is defined as per Cheson 1999, response criteria is: Target Nodal SPD Progression: at least one node must be abnormal, and the SPD of all nodes must increase by ≥ 50% from its nadir SPD. Target Extranodal SPD Progression: at least one extranodal lesion must be present and the SPD of all extranodal lesions must increase by ≥ 50% from its nadir SPD. Also, if a patient had any unequivocal progression in non-target lesions; and detection of any new nodal lesion (longest diameter \[LDi\] 15mm with an absolute increase of 5mm) his/her response was considered as Progressive disease.
Outcome measures
| Measure |
Arm A: DRL_RI
n=134 Participants
Randomized participants were administered DRL\_RI 375mg/m\^2 via IV infusion on Days 1, 8, 15, 22 and Weeks 12, 20, 28 and 36.
|
Arm B: MabThera®
n=130 Participants
Randomized participants were administered MabThera® 375 mg/m\^2 via IV infusion on Days 1, 8, 15, 22 and Weeks 12, 20, 28 and 36.
|
|---|---|---|
|
Duration of Response (DOR)
|
NA Weeks
The median and 95% CI were calculated with the Kaplan Meier process (a process in medical research to measure the proportion of participants surviving for a certain time after receiving treatment) and were non estimable as there was insufficient number of participants with the event of interest (less than 50%) occurred in the study.
|
NA Weeks
The median and 95% CI were calculated with the Kaplan Meier process (a process in medical research to measure the proportion of participants surviving for a certain time after receiving treatment) and were non estimable as there was insufficient number of participants with the event of interest (less than 50%) occurred in the study.
|
SECONDARY outcome
Timeframe: Week 52Population: The ITT Analysis Set included all randomized participants.
Progression-free survival (PFS) is defined as the time from date of randomization to the date of documented progressive disease or death due to any cause. Progression is defined as per Cheson 1999, response criteria is: Target Nodal SPD Progression: at least one node must be abnormal, and the SPD of all nodes must increase by ≥ 50% from its nadir SPD. Target Extranodal SPD Progression: at least one extranodal lesion must be present and the SPD of all extranodal lesions must increase by ≥ 50% from its nadir SPD. Also, if a patient had any unequivocal progression in non-target lesions; and detection of any new nodal lesion (LDi 15mm with an absolute increase of 5mm) his/her response was considered as Progressive disease.
Outcome measures
| Measure |
Arm A: DRL_RI
n=162 Participants
Randomized participants were administered DRL\_RI 375mg/m\^2 via IV infusion on Days 1, 8, 15, 22 and Weeks 12, 20, 28 and 36.
|
Arm B: MabThera®
n=155 Participants
Randomized participants were administered MabThera® 375 mg/m\^2 via IV infusion on Days 1, 8, 15, 22 and Weeks 12, 20, 28 and 36.
|
|---|---|---|
|
Progression-free Survival (PFS)
|
NA Weeks
The median and 95% CI were calculated with the Kaplan Meier process (a process in medical research to measure the proportion of participants surviving for a certain time after receiving treatment) and were non estimable as there was insufficient number of participants with the event of interest (less than 50%) occurred in the study.
|
NA Weeks
The median and 95% CI were calculated with the Kaplan Meier process (a process in medical research to measure the proportion of participants surviving for a certain time after receiving treatment) and were non estimable as there was insufficient number of participants with the event of interest (less than 50%) occurred in the study.
|
SECONDARY outcome
Timeframe: Week 52Population: The ITT Analysis Set included all randomized participants.
The Overall survival (OS) defined as the time from date of randomization to the date of death from any cause up to 52 weeks or EOS.
Outcome measures
| Measure |
Arm A: DRL_RI
n=162 Participants
Randomized participants were administered DRL\_RI 375mg/m\^2 via IV infusion on Days 1, 8, 15, 22 and Weeks 12, 20, 28 and 36.
|
Arm B: MabThera®
n=155 Participants
Randomized participants were administered MabThera® 375 mg/m\^2 via IV infusion on Days 1, 8, 15, 22 and Weeks 12, 20, 28 and 36.
|
|---|---|---|
|
Overall Survival (OS)
|
NA Weeks
The median and 95% CI were calculated with the Kaplan Meier process (a process in medical research to measure the proportion of participants surviving for a certain time after receiving treatment) and were non estimable as there was insufficient number of participants with the event of interest (less than 50%) occurred in the study.
|
NA Weeks
The median and 95% CI were calculated with the Kaplan Meier process (a process in medical research to measure the proportion of participants surviving for a certain time after receiving treatment) and were non estimable as there was insufficient number of participants with the event of interest (less than 50%) occurred in the study.
|
SECONDARY outcome
Timeframe: From Screening (Day -28 to -1) up to 52 weeksPopulation: The Safety Analysis Set (SAF) will include all the participants who have received at least one dose of study drug. The SAF will be used for safety analysis.
The safety and tolerability of DRL\_RI and MabThera® in participants with CD20-positive, LTB-FL was evaluated.
Outcome measures
| Measure |
Arm A: DRL_RI
n=162 Participants
Randomized participants were administered DRL\_RI 375mg/m\^2 via IV infusion on Days 1, 8, 15, 22 and Weeks 12, 20, 28 and 36.
|
Arm B: MabThera®
n=153 Participants
Randomized participants were administered MabThera® 375 mg/m\^2 via IV infusion on Days 1, 8, 15, 22 and Weeks 12, 20, 28 and 36.
|
|---|---|---|
|
Number of Participants With Adverse Events
Serious TEAEs
|
22 Participants
|
21 Participants
|
|
Number of Participants With Adverse Events
Treatment-emergent adverse events (TEAEs)
|
113 Participants
|
103 Participants
|
|
Number of Participants With Adverse Events
Non-TEAEs
|
13 Participants
|
18 Participants
|
|
Number of Participants With Adverse Events
Infusion related AEs
|
28 Participants
|
32 Participants
|
|
Number of Participants With Adverse Events
TEAE>=Common terminology Criteria for Adverse events (CTCAE) grade 3
|
30 Participants
|
24 Participants
|
|
Number of Participants With Adverse Events
TEAEs related to study drug
|
48 Participants
|
50 Participants
|
|
Number of Participants With Adverse Events
Fatal TEAEs
|
3 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: On Day 1, Week 2, Week 3, Week 4, Week 12 post dosePopulation: The ITT Analysis Set included all randomized participants.
The immunogenicity of the Proposed Rituximab Biosimilar (DRL\_RI) with MabThera® among trial participants was compared.
Outcome measures
| Measure |
Arm A: DRL_RI
n=48 Participants
Randomized participants were administered DRL\_RI 375mg/m\^2 via IV infusion on Days 1, 8, 15, 22 and Weeks 12, 20, 28 and 36.
|
Arm B: MabThera®
n=41 Participants
Randomized participants were administered MabThera® 375 mg/m\^2 via IV infusion on Days 1, 8, 15, 22 and Weeks 12, 20, 28 and 36.
|
|---|---|---|
|
Number of Participants With Positive Anti-drug Antibody (ADA)
Day 1
|
2 Participants
|
0 Participants
|
|
Number of Participants With Positive Anti-drug Antibody (ADA)
Week 2
|
2 Participants
|
0 Participants
|
|
Number of Participants With Positive Anti-drug Antibody (ADA)
Week 3
|
1 Participants
|
0 Participants
|
|
Number of Participants With Positive Anti-drug Antibody (ADA)
Week 4
|
2 Participants
|
0 Participants
|
|
Number of Participants With Positive Anti-drug Antibody (ADA)
Week 12
|
2 Participants
|
0 Participants
|
Adverse Events
Arm A: DRL_RI
Serious events: 22 serious events
Other events: 47 other events
Deaths: 3 deaths
Arm B: MabThera®
Serious events: 21 serious events
Other events: 49 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Arm A: DRL_RI
n=162 participants at risk
Randomized participants were administered DRL\_RI 375mg/m\^2 via IV infusion on Days 1, 8, 15, 22 and Weeks 12, 20, 28 and 36.
|
Arm B: MabThera®
n=153 participants at risk
Randomized participants were administered MabThera® 375 mg/m\^2 via IV infusion on Days 1, 8, 15, 22 and Weeks 12, 20, 28 and 36.
|
|---|---|---|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/162 • From Screening (Day -28 to -1) up to 52 weeks
The SAF include all participants who have received at least 1 dose of study drug and will be used for safety analysis. The number of participants analyzed for safety analysis is different from ITT analysis population (ITT population was defined as all patients randomized). Two participants were randomized but did not receive the treatment with MabThera and therefore were not included in the SAF but included in ITT.
|
0.65%
1/153 • Number of events 2 • From Screening (Day -28 to -1) up to 52 weeks
The SAF include all participants who have received at least 1 dose of study drug and will be used for safety analysis. The number of participants analyzed for safety analysis is different from ITT analysis population (ITT population was defined as all patients randomized). Two participants were randomized but did not receive the treatment with MabThera and therefore were not included in the SAF but included in ITT.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.62%
1/162 • Number of events 1 • From Screening (Day -28 to -1) up to 52 weeks
The SAF include all participants who have received at least 1 dose of study drug and will be used for safety analysis. The number of participants analyzed for safety analysis is different from ITT analysis population (ITT population was defined as all patients randomized). Two participants were randomized but did not receive the treatment with MabThera and therefore were not included in the SAF but included in ITT.
|
0.00%
0/153 • From Screening (Day -28 to -1) up to 52 weeks
The SAF include all participants who have received at least 1 dose of study drug and will be used for safety analysis. The number of participants analyzed for safety analysis is different from ITT analysis population (ITT population was defined as all patients randomized). Two participants were randomized but did not receive the treatment with MabThera and therefore were not included in the SAF but included in ITT.
|
|
Cardiac disorders
Angina unstable
|
0.62%
1/162 • Number of events 1 • From Screening (Day -28 to -1) up to 52 weeks
The SAF include all participants who have received at least 1 dose of study drug and will be used for safety analysis. The number of participants analyzed for safety analysis is different from ITT analysis population (ITT population was defined as all patients randomized). Two participants were randomized but did not receive the treatment with MabThera and therefore were not included in the SAF but included in ITT.
|
0.00%
0/153 • From Screening (Day -28 to -1) up to 52 weeks
The SAF include all participants who have received at least 1 dose of study drug and will be used for safety analysis. The number of participants analyzed for safety analysis is different from ITT analysis population (ITT population was defined as all patients randomized). Two participants were randomized but did not receive the treatment with MabThera and therefore were not included in the SAF but included in ITT.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/162 • From Screening (Day -28 to -1) up to 52 weeks
The SAF include all participants who have received at least 1 dose of study drug and will be used for safety analysis. The number of participants analyzed for safety analysis is different from ITT analysis population (ITT population was defined as all patients randomized). Two participants were randomized but did not receive the treatment with MabThera and therefore were not included in the SAF but included in ITT.
|
0.65%
1/153 • Number of events 1 • From Screening (Day -28 to -1) up to 52 weeks
The SAF include all participants who have received at least 1 dose of study drug and will be used for safety analysis. The number of participants analyzed for safety analysis is different from ITT analysis population (ITT population was defined as all patients randomized). Two participants were randomized but did not receive the treatment with MabThera and therefore were not included in the SAF but included in ITT.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/162 • From Screening (Day -28 to -1) up to 52 weeks
The SAF include all participants who have received at least 1 dose of study drug and will be used for safety analysis. The number of participants analyzed for safety analysis is different from ITT analysis population (ITT population was defined as all patients randomized). Two participants were randomized but did not receive the treatment with MabThera and therefore were not included in the SAF but included in ITT.
|
0.65%
1/153 • Number of events 1 • From Screening (Day -28 to -1) up to 52 weeks
The SAF include all participants who have received at least 1 dose of study drug and will be used for safety analysis. The number of participants analyzed for safety analysis is different from ITT analysis population (ITT population was defined as all patients randomized). Two participants were randomized but did not receive the treatment with MabThera and therefore were not included in the SAF but included in ITT.
|
|
Infections and infestations
Oral fungal infection
|
0.00%
0/162 • From Screening (Day -28 to -1) up to 52 weeks
The SAF include all participants who have received at least 1 dose of study drug and will be used for safety analysis. The number of participants analyzed for safety analysis is different from ITT analysis population (ITT population was defined as all patients randomized). Two participants were randomized but did not receive the treatment with MabThera and therefore were not included in the SAF but included in ITT.
|
0.65%
1/153 • Number of events 1 • From Screening (Day -28 to -1) up to 52 weeks
The SAF include all participants who have received at least 1 dose of study drug and will be used for safety analysis. The number of participants analyzed for safety analysis is different from ITT analysis population (ITT population was defined as all patients randomized). Two participants were randomized but did not receive the treatment with MabThera and therefore were not included in the SAF but included in ITT.
|
|
Gastrointestinal disorders
Lumbar hernia
|
0.00%
0/162 • From Screening (Day -28 to -1) up to 52 weeks
The SAF include all participants who have received at least 1 dose of study drug and will be used for safety analysis. The number of participants analyzed for safety analysis is different from ITT analysis population (ITT population was defined as all patients randomized). Two participants were randomized but did not receive the treatment with MabThera and therefore were not included in the SAF but included in ITT.
|
0.65%
1/153 • Number of events 1 • From Screening (Day -28 to -1) up to 52 weeks
The SAF include all participants who have received at least 1 dose of study drug and will be used for safety analysis. The number of participants analyzed for safety analysis is different from ITT analysis population (ITT population was defined as all patients randomized). Two participants were randomized but did not receive the treatment with MabThera and therefore were not included in the SAF but included in ITT.
|
|
Infections and infestations
COVID-19 pneumonia
|
6.2%
10/162 • Number of events 10 • From Screening (Day -28 to -1) up to 52 weeks
The SAF include all participants who have received at least 1 dose of study drug and will be used for safety analysis. The number of participants analyzed for safety analysis is different from ITT analysis population (ITT population was defined as all patients randomized). Two participants were randomized but did not receive the treatment with MabThera and therefore were not included in the SAF but included in ITT.
|
3.3%
5/153 • Number of events 5 • From Screening (Day -28 to -1) up to 52 weeks
The SAF include all participants who have received at least 1 dose of study drug and will be used for safety analysis. The number of participants analyzed for safety analysis is different from ITT analysis population (ITT population was defined as all patients randomized). Two participants were randomized but did not receive the treatment with MabThera and therefore were not included in the SAF but included in ITT.
|
|
Infections and infestations
COVID-19
|
1.9%
3/162 • Number of events 3 • From Screening (Day -28 to -1) up to 52 weeks
The SAF include all participants who have received at least 1 dose of study drug and will be used for safety analysis. The number of participants analyzed for safety analysis is different from ITT analysis population (ITT population was defined as all patients randomized). Two participants were randomized but did not receive the treatment with MabThera and therefore were not included in the SAF but included in ITT.
|
2.6%
4/153 • Number of events 4 • From Screening (Day -28 to -1) up to 52 weeks
The SAF include all participants who have received at least 1 dose of study drug and will be used for safety analysis. The number of participants analyzed for safety analysis is different from ITT analysis population (ITT population was defined as all patients randomized). Two participants were randomized but did not receive the treatment with MabThera and therefore were not included in the SAF but included in ITT.
|
|
Infections and infestations
Anal abscess
|
0.62%
1/162 • Number of events 1 • From Screening (Day -28 to -1) up to 52 weeks
The SAF include all participants who have received at least 1 dose of study drug and will be used for safety analysis. The number of participants analyzed for safety analysis is different from ITT analysis population (ITT population was defined as all patients randomized). Two participants were randomized but did not receive the treatment with MabThera and therefore were not included in the SAF but included in ITT.
|
0.65%
1/153 • Number of events 1 • From Screening (Day -28 to -1) up to 52 weeks
The SAF include all participants who have received at least 1 dose of study drug and will be used for safety analysis. The number of participants analyzed for safety analysis is different from ITT analysis population (ITT population was defined as all patients randomized). Two participants were randomized but did not receive the treatment with MabThera and therefore were not included in the SAF but included in ITT.
|
|
Infections and infestations
Appendicitis
|
0.62%
1/162 • Number of events 1 • From Screening (Day -28 to -1) up to 52 weeks
The SAF include all participants who have received at least 1 dose of study drug and will be used for safety analysis. The number of participants analyzed for safety analysis is different from ITT analysis population (ITT population was defined as all patients randomized). Two participants were randomized but did not receive the treatment with MabThera and therefore were not included in the SAF but included in ITT.
|
0.00%
0/153 • From Screening (Day -28 to -1) up to 52 weeks
The SAF include all participants who have received at least 1 dose of study drug and will be used for safety analysis. The number of participants analyzed for safety analysis is different from ITT analysis population (ITT population was defined as all patients randomized). Two participants were randomized but did not receive the treatment with MabThera and therefore were not included in the SAF but included in ITT.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/162 • From Screening (Day -28 to -1) up to 52 weeks
The SAF include all participants who have received at least 1 dose of study drug and will be used for safety analysis. The number of participants analyzed for safety analysis is different from ITT analysis population (ITT population was defined as all patients randomized). Two participants were randomized but did not receive the treatment with MabThera and therefore were not included in the SAF but included in ITT.
|
0.65%
1/153 • Number of events 1 • From Screening (Day -28 to -1) up to 52 weeks
The SAF include all participants who have received at least 1 dose of study drug and will be used for safety analysis. The number of participants analyzed for safety analysis is different from ITT analysis population (ITT population was defined as all patients randomized). Two participants were randomized but did not receive the treatment with MabThera and therefore were not included in the SAF but included in ITT.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/162 • From Screening (Day -28 to -1) up to 52 weeks
The SAF include all participants who have received at least 1 dose of study drug and will be used for safety analysis. The number of participants analyzed for safety analysis is different from ITT analysis population (ITT population was defined as all patients randomized). Two participants were randomized but did not receive the treatment with MabThera and therefore were not included in the SAF but included in ITT.
|
0.65%
1/153 • Number of events 1 • From Screening (Day -28 to -1) up to 52 weeks
The SAF include all participants who have received at least 1 dose of study drug and will be used for safety analysis. The number of participants analyzed for safety analysis is different from ITT analysis population (ITT population was defined as all patients randomized). Two participants were randomized but did not receive the treatment with MabThera and therefore were not included in the SAF but included in ITT.
|
|
Infections and infestations
Infection
|
0.00%
0/162 • From Screening (Day -28 to -1) up to 52 weeks
The SAF include all participants who have received at least 1 dose of study drug and will be used for safety analysis. The number of participants analyzed for safety analysis is different from ITT analysis population (ITT population was defined as all patients randomized). Two participants were randomized but did not receive the treatment with MabThera and therefore were not included in the SAF but included in ITT.
|
0.65%
1/153 • Number of events 1 • From Screening (Day -28 to -1) up to 52 weeks
The SAF include all participants who have received at least 1 dose of study drug and will be used for safety analysis. The number of participants analyzed for safety analysis is different from ITT analysis population (ITT population was defined as all patients randomized). Two participants were randomized but did not receive the treatment with MabThera and therefore were not included in the SAF but included in ITT.
|
|
Infections and infestations
Influenza
|
0.62%
1/162 • Number of events 1 • From Screening (Day -28 to -1) up to 52 weeks
The SAF include all participants who have received at least 1 dose of study drug and will be used for safety analysis. The number of participants analyzed for safety analysis is different from ITT analysis population (ITT population was defined as all patients randomized). Two participants were randomized but did not receive the treatment with MabThera and therefore were not included in the SAF but included in ITT.
|
0.00%
0/153 • From Screening (Day -28 to -1) up to 52 weeks
The SAF include all participants who have received at least 1 dose of study drug and will be used for safety analysis. The number of participants analyzed for safety analysis is different from ITT analysis population (ITT population was defined as all patients randomized). Two participants were randomized but did not receive the treatment with MabThera and therefore were not included in the SAF but included in ITT.
|
|
Infections and infestations
Otitis externa
|
0.62%
1/162 • Number of events 2 • From Screening (Day -28 to -1) up to 52 weeks
The SAF include all participants who have received at least 1 dose of study drug and will be used for safety analysis. The number of participants analyzed for safety analysis is different from ITT analysis population (ITT population was defined as all patients randomized). Two participants were randomized but did not receive the treatment with MabThera and therefore were not included in the SAF but included in ITT.
|
0.00%
0/153 • From Screening (Day -28 to -1) up to 52 weeks
The SAF include all participants who have received at least 1 dose of study drug and will be used for safety analysis. The number of participants analyzed for safety analysis is different from ITT analysis population (ITT population was defined as all patients randomized). Two participants were randomized but did not receive the treatment with MabThera and therefore were not included in the SAF but included in ITT.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/162 • From Screening (Day -28 to -1) up to 52 weeks
The SAF include all participants who have received at least 1 dose of study drug and will be used for safety analysis. The number of participants analyzed for safety analysis is different from ITT analysis population (ITT population was defined as all patients randomized). Two participants were randomized but did not receive the treatment with MabThera and therefore were not included in the SAF but included in ITT.
|
0.65%
1/153 • Number of events 1 • From Screening (Day -28 to -1) up to 52 weeks
The SAF include all participants who have received at least 1 dose of study drug and will be used for safety analysis. The number of participants analyzed for safety analysis is different from ITT analysis population (ITT population was defined as all patients randomized). Two participants were randomized but did not receive the treatment with MabThera and therefore were not included in the SAF but included in ITT.
|
|
Investigations
Infusion-related reaction
|
0.62%
1/162 • Number of events 1 • From Screening (Day -28 to -1) up to 52 weeks
The SAF include all participants who have received at least 1 dose of study drug and will be used for safety analysis. The number of participants analyzed for safety analysis is different from ITT analysis population (ITT population was defined as all patients randomized). Two participants were randomized but did not receive the treatment with MabThera and therefore were not included in the SAF but included in ITT.
|
0.00%
0/153 • From Screening (Day -28 to -1) up to 52 weeks
The SAF include all participants who have received at least 1 dose of study drug and will be used for safety analysis. The number of participants analyzed for safety analysis is different from ITT analysis population (ITT population was defined as all patients randomized). Two participants were randomized but did not receive the treatment with MabThera and therefore were not included in the SAF but included in ITT.
|
|
Musculoskeletal and connective tissue disorders
Haematoma muscle
|
0.62%
1/162 • Number of events 1 • From Screening (Day -28 to -1) up to 52 weeks
The SAF include all participants who have received at least 1 dose of study drug and will be used for safety analysis. The number of participants analyzed for safety analysis is different from ITT analysis population (ITT population was defined as all patients randomized). Two participants were randomized but did not receive the treatment with MabThera and therefore were not included in the SAF but included in ITT.
|
0.00%
0/153 • From Screening (Day -28 to -1) up to 52 weeks
The SAF include all participants who have received at least 1 dose of study drug and will be used for safety analysis. The number of participants analyzed for safety analysis is different from ITT analysis population (ITT population was defined as all patients randomized). Two participants were randomized but did not receive the treatment with MabThera and therefore were not included in the SAF but included in ITT.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/162 • From Screening (Day -28 to -1) up to 52 weeks
The SAF include all participants who have received at least 1 dose of study drug and will be used for safety analysis. The number of participants analyzed for safety analysis is different from ITT analysis population (ITT population was defined as all patients randomized). Two participants were randomized but did not receive the treatment with MabThera and therefore were not included in the SAF but included in ITT.
|
0.65%
1/153 • Number of events 1 • From Screening (Day -28 to -1) up to 52 weeks
The SAF include all participants who have received at least 1 dose of study drug and will be used for safety analysis. The number of participants analyzed for safety analysis is different from ITT analysis population (ITT population was defined as all patients randomized). Two participants were randomized but did not receive the treatment with MabThera and therefore were not included in the SAF but included in ITT.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/162 • From Screening (Day -28 to -1) up to 52 weeks
The SAF include all participants who have received at least 1 dose of study drug and will be used for safety analysis. The number of participants analyzed for safety analysis is different from ITT analysis population (ITT population was defined as all patients randomized). Two participants were randomized but did not receive the treatment with MabThera and therefore were not included in the SAF but included in ITT.
|
0.65%
1/153 • Number of events 1 • From Screening (Day -28 to -1) up to 52 weeks
The SAF include all participants who have received at least 1 dose of study drug and will be used for safety analysis. The number of participants analyzed for safety analysis is different from ITT analysis population (ITT population was defined as all patients randomized). Two participants were randomized but did not receive the treatment with MabThera and therefore were not included in the SAF but included in ITT.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.00%
0/162 • From Screening (Day -28 to -1) up to 52 weeks
The SAF include all participants who have received at least 1 dose of study drug and will be used for safety analysis. The number of participants analyzed for safety analysis is different from ITT analysis population (ITT population was defined as all patients randomized). Two participants were randomized but did not receive the treatment with MabThera and therefore were not included in the SAF but included in ITT.
|
0.65%
1/153 • Number of events 1 • From Screening (Day -28 to -1) up to 52 weeks
The SAF include all participants who have received at least 1 dose of study drug and will be used for safety analysis. The number of participants analyzed for safety analysis is different from ITT analysis population (ITT population was defined as all patients randomized). Two participants were randomized but did not receive the treatment with MabThera and therefore were not included in the SAF but included in ITT.
|
|
Nervous system disorders
Facial paralysis
|
0.62%
1/162 • Number of events 1 • From Screening (Day -28 to -1) up to 52 weeks
The SAF include all participants who have received at least 1 dose of study drug and will be used for safety analysis. The number of participants analyzed for safety analysis is different from ITT analysis population (ITT population was defined as all patients randomized). Two participants were randomized but did not receive the treatment with MabThera and therefore were not included in the SAF but included in ITT.
|
0.00%
0/153 • From Screening (Day -28 to -1) up to 52 weeks
The SAF include all participants who have received at least 1 dose of study drug and will be used for safety analysis. The number of participants analyzed for safety analysis is different from ITT analysis population (ITT population was defined as all patients randomized). Two participants were randomized but did not receive the treatment with MabThera and therefore were not included in the SAF but included in ITT.
|
|
Nervous system disorders
Psychomotor hyperactivity
|
0.00%
0/162 • From Screening (Day -28 to -1) up to 52 weeks
The SAF include all participants who have received at least 1 dose of study drug and will be used for safety analysis. The number of participants analyzed for safety analysis is different from ITT analysis population (ITT population was defined as all patients randomized). Two participants were randomized but did not receive the treatment with MabThera and therefore were not included in the SAF but included in ITT.
|
0.65%
1/153 • Number of events 1 • From Screening (Day -28 to -1) up to 52 weeks
The SAF include all participants who have received at least 1 dose of study drug and will be used for safety analysis. The number of participants analyzed for safety analysis is different from ITT analysis population (ITT population was defined as all patients randomized). Two participants were randomized but did not receive the treatment with MabThera and therefore were not included in the SAF but included in ITT.
|
|
Nervous system disorders
Syncope
|
0.62%
1/162 • Number of events 1 • From Screening (Day -28 to -1) up to 52 weeks
The SAF include all participants who have received at least 1 dose of study drug and will be used for safety analysis. The number of participants analyzed for safety analysis is different from ITT analysis population (ITT population was defined as all patients randomized). Two participants were randomized but did not receive the treatment with MabThera and therefore were not included in the SAF but included in ITT.
|
0.00%
0/153 • From Screening (Day -28 to -1) up to 52 weeks
The SAF include all participants who have received at least 1 dose of study drug and will be used for safety analysis. The number of participants analyzed for safety analysis is different from ITT analysis population (ITT population was defined as all patients randomized). Two participants were randomized but did not receive the treatment with MabThera and therefore were not included in the SAF but included in ITT.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/162 • From Screening (Day -28 to -1) up to 52 weeks
The SAF include all participants who have received at least 1 dose of study drug and will be used for safety analysis. The number of participants analyzed for safety analysis is different from ITT analysis population (ITT population was defined as all patients randomized). Two participants were randomized but did not receive the treatment with MabThera and therefore were not included in the SAF but included in ITT.
|
0.65%
1/153 • Number of events 1 • From Screening (Day -28 to -1) up to 52 weeks
The SAF include all participants who have received at least 1 dose of study drug and will be used for safety analysis. The number of participants analyzed for safety analysis is different from ITT analysis population (ITT population was defined as all patients randomized). Two participants were randomized but did not receive the treatment with MabThera and therefore were not included in the SAF but included in ITT.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.62%
1/162 • Number of events 1 • From Screening (Day -28 to -1) up to 52 weeks
The SAF include all participants who have received at least 1 dose of study drug and will be used for safety analysis. The number of participants analyzed for safety analysis is different from ITT analysis population (ITT population was defined as all patients randomized). Two participants were randomized but did not receive the treatment with MabThera and therefore were not included in the SAF but included in ITT.
|
0.00%
0/153 • From Screening (Day -28 to -1) up to 52 weeks
The SAF include all participants who have received at least 1 dose of study drug and will be used for safety analysis. The number of participants analyzed for safety analysis is different from ITT analysis population (ITT population was defined as all patients randomized). Two participants were randomized but did not receive the treatment with MabThera and therefore were not included in the SAF but included in ITT.
|
|
Vascular disorders
Hypertension
|
0.62%
1/162 • Number of events 1 • From Screening (Day -28 to -1) up to 52 weeks
The SAF include all participants who have received at least 1 dose of study drug and will be used for safety analysis. The number of participants analyzed for safety analysis is different from ITT analysis population (ITT population was defined as all patients randomized). Two participants were randomized but did not receive the treatment with MabThera and therefore were not included in the SAF but included in ITT.
|
0.00%
0/153 • From Screening (Day -28 to -1) up to 52 weeks
The SAF include all participants who have received at least 1 dose of study drug and will be used for safety analysis. The number of participants analyzed for safety analysis is different from ITT analysis population (ITT population was defined as all patients randomized). Two participants were randomized but did not receive the treatment with MabThera and therefore were not included in the SAF but included in ITT.
|
Other adverse events
| Measure |
Arm A: DRL_RI
n=162 participants at risk
Randomized participants were administered DRL\_RI 375mg/m\^2 via IV infusion on Days 1, 8, 15, 22 and Weeks 12, 20, 28 and 36.
|
Arm B: MabThera®
n=153 participants at risk
Randomized participants were administered MabThera® 375 mg/m\^2 via IV infusion on Days 1, 8, 15, 22 and Weeks 12, 20, 28 and 36.
|
|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
8.0%
13/162 • Number of events 14 • From Screening (Day -28 to -1) up to 52 weeks
The SAF include all participants who have received at least 1 dose of study drug and will be used for safety analysis. The number of participants analyzed for safety analysis is different from ITT analysis population (ITT population was defined as all patients randomized). Two participants were randomized but did not receive the treatment with MabThera and therefore were not included in the SAF but included in ITT.
|
1.3%
2/153 • Number of events 3 • From Screening (Day -28 to -1) up to 52 weeks
The SAF include all participants who have received at least 1 dose of study drug and will be used for safety analysis. The number of participants analyzed for safety analysis is different from ITT analysis population (ITT population was defined as all patients randomized). Two participants were randomized but did not receive the treatment with MabThera and therefore were not included in the SAF but included in ITT.
|
|
Gastrointestinal disorders
Nausea
|
3.7%
6/162 • Number of events 8 • From Screening (Day -28 to -1) up to 52 weeks
The SAF include all participants who have received at least 1 dose of study drug and will be used for safety analysis. The number of participants analyzed for safety analysis is different from ITT analysis population (ITT population was defined as all patients randomized). Two participants were randomized but did not receive the treatment with MabThera and therefore were not included in the SAF but included in ITT.
|
6.5%
10/153 • Number of events 11 • From Screening (Day -28 to -1) up to 52 weeks
The SAF include all participants who have received at least 1 dose of study drug and will be used for safety analysis. The number of participants analyzed for safety analysis is different from ITT analysis population (ITT population was defined as all patients randomized). Two participants were randomized but did not receive the treatment with MabThera and therefore were not included in the SAF but included in ITT.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.9%
3/162 • Number of events 4 • From Screening (Day -28 to -1) up to 52 weeks
The SAF include all participants who have received at least 1 dose of study drug and will be used for safety analysis. The number of participants analyzed for safety analysis is different from ITT analysis population (ITT population was defined as all patients randomized). Two participants were randomized but did not receive the treatment with MabThera and therefore were not included in the SAF but included in ITT.
|
5.2%
8/153 • Number of events 10 • From Screening (Day -28 to -1) up to 52 weeks
The SAF include all participants who have received at least 1 dose of study drug and will be used for safety analysis. The number of participants analyzed for safety analysis is different from ITT analysis population (ITT population was defined as all patients randomized). Two participants were randomized but did not receive the treatment with MabThera and therefore were not included in the SAF but included in ITT.
|
|
General disorders
Pyrexia
|
0.62%
1/162 • Number of events 1 • From Screening (Day -28 to -1) up to 52 weeks
The SAF include all participants who have received at least 1 dose of study drug and will be used for safety analysis. The number of participants analyzed for safety analysis is different from ITT analysis population (ITT population was defined as all patients randomized). Two participants were randomized but did not receive the treatment with MabThera and therefore were not included in the SAF but included in ITT.
|
6.5%
10/153 • Number of events 10 • From Screening (Day -28 to -1) up to 52 weeks
The SAF include all participants who have received at least 1 dose of study drug and will be used for safety analysis. The number of participants analyzed for safety analysis is different from ITT analysis population (ITT population was defined as all patients randomized). Two participants were randomized but did not receive the treatment with MabThera and therefore were not included in the SAF but included in ITT.
|
|
Infections and infestations
COVID-19
|
11.7%
19/162 • Number of events 20 • From Screening (Day -28 to -1) up to 52 weeks
The SAF include all participants who have received at least 1 dose of study drug and will be used for safety analysis. The number of participants analyzed for safety analysis is different from ITT analysis population (ITT population was defined as all patients randomized). Two participants were randomized but did not receive the treatment with MabThera and therefore were not included in the SAF but included in ITT.
|
11.1%
17/153 • Number of events 19 • From Screening (Day -28 to -1) up to 52 weeks
The SAF include all participants who have received at least 1 dose of study drug and will be used for safety analysis. The number of participants analyzed for safety analysis is different from ITT analysis population (ITT population was defined as all patients randomized). Two participants were randomized but did not receive the treatment with MabThera and therefore were not included in the SAF but included in ITT.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.8%
11/162 • Number of events 14 • From Screening (Day -28 to -1) up to 52 weeks
The SAF include all participants who have received at least 1 dose of study drug and will be used for safety analysis. The number of participants analyzed for safety analysis is different from ITT analysis population (ITT population was defined as all patients randomized). Two participants were randomized but did not receive the treatment with MabThera and therefore were not included in the SAF but included in ITT.
|
6.5%
10/153 • Number of events 10 • From Screening (Day -28 to -1) up to 52 weeks
The SAF include all participants who have received at least 1 dose of study drug and will be used for safety analysis. The number of participants analyzed for safety analysis is different from ITT analysis population (ITT population was defined as all patients randomized). Two participants were randomized but did not receive the treatment with MabThera and therefore were not included in the SAF but included in ITT.
|
Additional Information
Head - Clinical Development
Dr. Reddy's Laboratories Ltd.
Phone: 91-40-4464-4000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60