Trial Outcomes & Findings for A Study on Rituximab (MabThera) in Participants With Chronic Lymphocytic Leukemia (CLL) (NCT NCT01178086)
NCT ID: NCT01178086
Last Updated: 2018-10-05
Results Overview
PFS was defined as the time from initiation of treatment with rituximab in combination with chemotherapy to disease progression or death due to any cause, whichever occurred first. Disease progression was defined as the occurrence of at least one of the following: greater than or equal to (\>/=) 50 percent (%) increase in the longest diameter of at least two enlarged lymph nodes, increase in spleen and/or liver size by at least 2 centimeters (cm) from Baseline as determined by measurement below the costal margin, or \>/=50% increase in the number of circulating lymphocytes. Participants without disease progression or death at the time of analysis were censored at the last date of tumor evaluation in terms of PFS.
Recruitment status
COMPLETED
Target enrollment
681 participants
Primary outcome timeframe
From initiation of treatment up to disease progression or death due to any cause, whichever occurred first (assessed up to 24 months)
Results posted on
2018-10-05
Participant Flow
This single arm study had baseline and analysis reported per 2 arms (Unselected Population and "Slow Go" Subpopulation).
Participant milestones
| Measure |
Participants With Chonic Lymphatic Leukemia (CLL)
Participants with CLL who were treated with intravenous (IV) rituximab in combination with chemotherapy, were observed for 24 months including 6-month treatment period.
|
|---|---|
|
Overall Study
STARTED
|
681
|
|
Overall Study
Effectiveness Analysis Set (EAS)
|
661
|
|
Overall Study
COMPLETED
|
349
|
|
Overall Study
NOT COMPLETED
|
332
|
Reasons for withdrawal
| Measure |
Participants With Chonic Lymphatic Leukemia (CLL)
Participants with CLL who were treated with intravenous (IV) rituximab in combination with chemotherapy, were observed for 24 months including 6-month treatment period.
|
|---|---|
|
Overall Study
Participant refusal
|
7
|
|
Overall Study
Physician Decision
|
44
|
|
Overall Study
Switch to other CLL therapy
|
113
|
|
Overall Study
Death
|
59
|
|
Overall Study
Other unspecified
|
89
|
|
Overall Study
Excluded from EAS
|
20
|
Baseline Characteristics
A Study on Rituximab (MabThera) in Participants With Chronic Lymphocytic Leukemia (CLL)
Baseline characteristics by cohort
| Measure |
Unselected Population (Participants With Any Comorbidity)
n=472 Participants
Unselected population (participants with any comorbidity) who were treated with IV rituximab in combination with chemotherapy, were observed for 24 months including 6-month treatment period.
|
"Slow Go" Subpopulation
n=189 Participants
"Slow go" subpopulation (participants with cumulative illness rating scale for geriatrics \[CIRS-G\] score greater than \[\>\] 6 and/or creatinine clearance less than \[\<\] 70 milliliters per minute \[mL/min\]) who were treated with IV rituximab in combination with chemotherapy, were observed for 24 months including 6-month treatment period.
|
Total
n=661 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
68.9 years
STANDARD_DEVIATION 9.0 • n=5 Participants
|
74.2 years
STANDARD_DEVIATION 7.9 • n=7 Participants
|
70.5 years
STANDARD_DEVIATION 9.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
160 Participants
n=5 Participants
|
84 Participants
n=7 Participants
|
244 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
312 Participants
n=5 Participants
|
105 Participants
n=7 Participants
|
417 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From initiation of treatment up to disease progression or death due to any cause, whichever occurred first (assessed up to 24 months)Population: Analysis was performed on EAS.
PFS was defined as the time from initiation of treatment with rituximab in combination with chemotherapy to disease progression or death due to any cause, whichever occurred first. Disease progression was defined as the occurrence of at least one of the following: greater than or equal to (\>/=) 50 percent (%) increase in the longest diameter of at least two enlarged lymph nodes, increase in spleen and/or liver size by at least 2 centimeters (cm) from Baseline as determined by measurement below the costal margin, or \>/=50% increase in the number of circulating lymphocytes. Participants without disease progression or death at the time of analysis were censored at the last date of tumor evaluation in terms of PFS.
Outcome measures
| Measure |
Unselected Population (Participants With Any Comorbidity)
n=472 Participants
Unselected population (participants with any comorbidity) who were treated with IV rituximab in combination with chemotherapy, were observed for 24 months including 6-month treatment period.
|
"Slow Go" Subpopulation
n=189 Participants
"Slow go" subpopulation (participants with CIRS-G score \>6 and/or creatinine clearance \<70 mL/min) who were treated with IV rituximab in combination with chemotherapy, were observed for 24 months including 6-month treatment period.
|
|---|---|---|
|
Progression-Free Survival (PFS) as Assessed Using Kaplan-Meier Estimate
|
50.6 months
Interval 42.4 to 59.6
|
33.7 months
Interval 26.2 to
Data 'not estimable' due to insufficient events since follow-up period was too short.
|
PRIMARY outcome
Timeframe: From initiation of treatment up to disease progression or death due to any cause, whichever occurred first (assessed up to 24 months)Population: Analysis was performed on EAS.
Disease progression was defined as the occurrence of at least one of the following: \>/=50% increase in the longest diameter of at least two enlarged lymph nodes, increase in spleen and/or liver size by at least 2 cm from Baseline as determined by measurement below the costal margin, or \>/=50% increase in the number of circulating lymphocytes.
Outcome measures
| Measure |
Unselected Population (Participants With Any Comorbidity)
n=472 Participants
Unselected population (participants with any comorbidity) who were treated with IV rituximab in combination with chemotherapy, were observed for 24 months including 6-month treatment period.
|
"Slow Go" Subpopulation
n=189 Participants
"Slow go" subpopulation (participants with CIRS-G score \>6 and/or creatinine clearance \<70 mL/min) who were treated with IV rituximab in combination with chemotherapy, were observed for 24 months including 6-month treatment period.
|
|---|---|---|
|
Percentage of Participants Without Progression or Death
|
71.1 percentage of participants
Interval 66.1 to 75.5
|
62.7 percentage of participants
Interval 53.9 to 70.3
|
SECONDARY outcome
Timeframe: From initiation of treatment up to disease progression or death due to any cause, whichever occurred first (assessed up to 24 months)Population: Analysis was performed on EAS with events.
Percentage of participants with an event (progression or death) was reported. Disease progression was defined as the occurrence of at least one of the following: \>/=50% increase in the longest diameter of at least two enlarged lymph nodes, increase in spleen and/or liver size by at least 2 cm from Baseline as determined by measurement below the costal margin, or \>/=50% increase in the number of circulating lymphocytes.
Outcome measures
| Measure |
Unselected Population (Participants With Any Comorbidity)
n=106 Participants
Unselected population (participants with any comorbidity) who were treated with IV rituximab in combination with chemotherapy, were observed for 24 months including 6-month treatment period.
|
"Slow Go" Subpopulation
n=51 Participants
"Slow go" subpopulation (participants with CIRS-G score \>6 and/or creatinine clearance \<70 mL/min) who were treated with IV rituximab in combination with chemotherapy, were observed for 24 months including 6-month treatment period.
|
|---|---|---|
|
Percentage of Participants With Progression and Death
Progression
|
68.9 percentage of participants
|
66.7 percentage of participants
|
|
Percentage of Participants With Progression and Death
Death
|
31.1 percentage of participants
|
33.3 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Cycle 1, 2, 3, 4, 5, 6, 7, 8, last Cycle (Cycle 18) (each cycle=1 month)Population: Analysis was performed on EAS.
The chemotherapeutic regimen administereted during the course of study were: Rituximab-Bendamustine (R-Benda), Rituximab-Fludarabine-Cyclophosphamide (R-FC), Rituximab-Clorambucil (R-Clb), R-Other and Rituximab mono.
Outcome measures
| Measure |
Unselected Population (Participants With Any Comorbidity)
n=472 Participants
Unselected population (participants with any comorbidity) who were treated with IV rituximab in combination with chemotherapy, were observed for 24 months including 6-month treatment period.
|
"Slow Go" Subpopulation
n=189 Participants
"Slow go" subpopulation (participants with CIRS-G score \>6 and/or creatinine clearance \<70 mL/min) who were treated with IV rituximab in combination with chemotherapy, were observed for 24 months including 6-month treatment period.
|
|---|---|---|
|
Percentage of Participants Who Received Each Treatment During the Course of Study
R-Benda at Baseline
|
58.5 percentage of participants
|
64.0 percentage of participants
|
|
Percentage of Participants Who Received Each Treatment During the Course of Study
R-Benda at Cycle 1
|
56.8 percentage of participants
|
60.3 percentage of participants
|
|
Percentage of Participants Who Received Each Treatment During the Course of Study
R-Benda at Cycle 2
|
60.0 percentage of participants
|
67.8 percentage of participants
|
|
Percentage of Participants Who Received Each Treatment During the Course of Study
R-Benda at Cycle 3
|
58.8 percentage of participants
|
64.8 percentage of participants
|
|
Percentage of Participants Who Received Each Treatment During the Course of Study
R-Benda at Cycle 4
|
57.9 percentage of participants
|
62.3 percentage of participants
|
|
Percentage of Participants Who Received Each Treatment During the Course of Study
R-Benda at Cycle 5
|
56.5 percentage of participants
|
58.3 percentage of participants
|
|
Percentage of Participants Who Received Each Treatment During the Course of Study
R-Benda at Cycle 6
|
55.3 percentage of participants
|
60.6 percentage of participants
|
|
Percentage of Participants Who Received Each Treatment During the Course of Study
R-Benda at Cycle 7
|
44.7 percentage of participants
|
29.4 percentage of participants
|
|
Percentage of Participants Who Received Each Treatment During the Course of Study
R-Benda at Cycle 8
|
61.5 percentage of participants
|
10.0 percentage of participants
|
|
Percentage of Participants Who Received Each Treatment During the Course of Study
R-Benda at Last Cycle
|
55.7 percentage of participants
|
62.4 percentage of participants
|
|
Percentage of Participants Who Received Each Treatment During the Course of Study
R-FC at Baseline
|
23.3 percentage of participants
|
8.5 percentage of participants
|
|
Percentage of Participants Who Received Each Treatment During the Course of Study
R-FC at Cycle 1
|
22.0 percentage of participants
|
7.9 percentage of participants
|
|
Percentage of Participants Who Received Each Treatment During the Course of Study
R-FC at Cycle 2
|
24.0 percentage of participants
|
9.3 percentage of participants
|
|
Percentage of Participants Who Received Each Treatment During the Course of Study
R-FC at Cycle 3
|
23.5 percentage of participants
|
10.9 percentage of participants
|
|
Percentage of Participants Who Received Each Treatment During the Course of Study
R-FC at Cycle 4
|
24.4 percentage of participants
|
10.3 percentage of participants
|
|
Percentage of Participants Who Received Each Treatment During the Course of Study
R-FC at Cycle 5
|
23.4 percentage of participants
|
10.8 percentage of participants
|
|
Percentage of Participants Who Received Each Treatment During the Course of Study
R-FC at Cycle 6
|
23.4 percentage of participants
|
9.2 percentage of participants
|
|
Percentage of Participants Who Received Each Treatment During the Course of Study
R-FC at Cycle 7
|
10.5 percentage of participants
|
5.9 percentage of participants
|
|
Percentage of Participants Who Received Each Treatment During the Course of Study
R-FC at Cycle 8
|
3.8 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants Who Received Each Treatment During the Course of Study
R-FC at Last Cycle
|
23.7 percentage of participants
|
8.5 percentage of participants
|
|
Percentage of Participants Who Received Each Treatment During the Course of Study
R-Clb at Baseline
|
5.5 percentage of participants
|
11.1 percentage of participants
|
|
Percentage of Participants Who Received Each Treatment During the Course of Study
R-Clb at Cycle 1
|
5.5 percentage of participants
|
11.1 percentage of participants
|
|
Percentage of Participants Who Received Each Treatment During the Course of Study
R-Clb at Cycle 2
|
5.7 percentage of participants
|
9.8 percentage of participants
|
|
Percentage of Participants Who Received Each Treatment During the Course of Study
R-Clb at Cycle 3
|
5.8 percentage of participants
|
10.3 percentage of participants
|
|
Percentage of Participants Who Received Each Treatment During the Course of Study
R-Clb at Cycle 4
|
6.4 percentage of participants
|
11.0 percentage of participants
|
|
Percentage of Participants Who Received Each Treatment During the Course of Study
R-Clb at Cycle 5
|
6.4 percentage of participants
|
11.7 percentage of participants
|
|
Percentage of Participants Who Received Each Treatment During the Course of Study
R-Clb at Cycle 6
|
6.2 percentage of participants
|
12.8 percentage of participants
|
|
Percentage of Participants Who Received Each Treatment During the Course of Study
R-Clb at Cycle 7
|
5.3 percentage of participants
|
11.8 percentage of participants
|
|
Percentage of Participants Who Received Each Treatment During the Course of Study
R-Clb at Cycle 8
|
7.7 percentage of participants
|
20.0 percentage of participants
|
|
Percentage of Participants Who Received Each Treatment During the Course of Study
R-Clb at Last Cycle
|
5.5 percentage of participants
|
10.6 percentage of participants
|
|
Percentage of Participants Who Received Each Treatment During the Course of Study
R-Other at Baseline
|
9.7 percentage of participants
|
11.1 percentage of participants
|
|
Percentage of Participants Who Received Each Treatment During the Course of Study
R-Other at Cycle 1
|
9.5 percentage of participants
|
9.5 percentage of participants
|
|
Percentage of Participants Who Received Each Treatment During the Course of Study
R-Other at Cycle 2
|
9.3 percentage of participants
|
10.9 percentage of participants
|
|
Percentage of Participants Who Received Each Treatment During the Course of Study
R-Other at Cycle 3
|
9.0 percentage of participants
|
10.9 percentage of participants
|
|
Percentage of Participants Who Received Each Treatment During the Course of Study
R-Other at Cycle 4
|
8.3 percentage of participants
|
10.3 percentage of participants
|
|
Percentage of Participants Who Received Each Treatment During the Course of Study
R-Other at Cycle 5
|
8.8 percentage of participants
|
10.8 percentage of participants
|
|
Percentage of Participants Who Received Each Treatment During the Course of Study
R-Other at Cycle 6
|
8.6 percentage of participants
|
10.1 percentage of participants
|
|
Percentage of Participants Who Received Each Treatment During the Course of Study
R-Other at Cycle 7
|
10.5 percentage of participants
|
5.9 percentage of participants
|
|
Percentage of Participants Who Received Each Treatment During the Course of Study
R-Other at Cycle 8
|
0.0 percentage of participants
|
10.0 percentage of participants
|
|
Percentage of Participants Who Received Each Treatment During the Course of Study
R-Other at Last Cycle
|
8.9 percentage of participants
|
8.5 percentage of participants
|
|
Percentage of Participants Who Received Each Treatment During the Course of Study
Rituximab Mono at Baseline
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants Who Received Each Treatment During the Course of Study
Rituximab Mono at Cycle 1
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants Who Received Each Treatment During the Course of Study
Rituximab Mono at Cycle 2
|
0.7 percentage of participants
|
2.2 percentage of participants
|
|
Percentage of Participants Who Received Each Treatment During the Course of Study
Rituximab Mono at Cycle 3
|
2.4 percentage of participants
|
3.0 percentage of participants
|
|
Percentage of Participants Who Received Each Treatment During the Course of Study
Rituximab Mono at Cycle 4
|
2.4 percentage of participants
|
6.2 percentage of participants
|
|
Percentage of Participants Who Received Each Treatment During the Course of Study
Rituximab Mono at Cycle 5
|
4.6 percentage of participants
|
7.5 percentage of participants
|
|
Percentage of Participants Who Received Each Treatment During the Course of Study
Rituximab Mono at Cycle 6
|
6.2 percentage of participants
|
7.3 percentage of participants
|
|
Percentage of Participants Who Received Each Treatment During the Course of Study
Rituximab Mono at Cycle 7
|
28.9 percentage of participants
|
47.1 percentage of participants
|
|
Percentage of Participants Who Received Each Treatment During the Course of Study
Rituximab Mono at Cycle 8
|
26.9 percentage of participants
|
60.0 percentage of participants
|
|
Percentage of Participants Who Received Each Treatment During the Course of Study
Rituximab Mono at Last Cycle
|
5.7 percentage of participants
|
9.5 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, last cycle (Cycle 18) (each cycle=1 month), last visit (follow-up) (24 months)Population: Analysis was performed on EAS. Overall number of participants analyzed=participants analyzed for this outcome. Here, number analyzed=participants evaluable at specified time-point.
Outcome measures
| Measure |
Unselected Population (Participants With Any Comorbidity)
n=471 Participants
Unselected population (participants with any comorbidity) who were treated with IV rituximab in combination with chemotherapy, were observed for 24 months including 6-month treatment period.
|
"Slow Go" Subpopulation
n=189 Participants
"Slow go" subpopulation (participants with CIRS-G score \>6 and/or creatinine clearance \<70 mL/min) who were treated with IV rituximab in combination with chemotherapy, were observed for 24 months including 6-month treatment period.
|
|---|---|---|
|
Mean Body Weight
Baseline
|
77.4 kilograms (kg)
Standard Deviation 14.1
|
75.0 kilograms (kg)
Standard Deviation 14.2
|
|
Mean Body Weight
Last Cycle
|
77.4 kilograms (kg)
Standard Deviation 15.2
|
73.7 kilograms (kg)
Standard Deviation 13.9
|
|
Mean Body Weight
Last Visit
|
77.0 kilograms (kg)
Standard Deviation 15.3
|
73.3 kilograms (kg)
Standard Deviation 14.2
|
SECONDARY outcome
Timeframe: Baseline, last cycle (Cycle 18) (each cycle=1 month), last visit (follow-up) (24 months)Population: Analysis was performed on EAS. Here, number analyzed=participants evaluable at specified time-point.
ECOG performance status was measured on a 4 point scale to assess participant's performance status. 0=Fully active, able to carry on all pre-disease activities without restriction; 1=Restricted in physically strenuous activity, ambulatory and able to carry out light or sedentary work; 2=Ambulatory (\>50% of waking hours), capable of all self-care, unable to carry out any work activities; 3=Capable of only limited self-care, confined to bed/chair \>50% of waking hours.
Outcome measures
| Measure |
Unselected Population (Participants With Any Comorbidity)
n=472 Participants
Unselected population (participants with any comorbidity) who were treated with IV rituximab in combination with chemotherapy, were observed for 24 months including 6-month treatment period.
|
"Slow Go" Subpopulation
n=189 Participants
"Slow go" subpopulation (participants with CIRS-G score \>6 and/or creatinine clearance \<70 mL/min) who were treated with IV rituximab in combination with chemotherapy, were observed for 24 months including 6-month treatment period.
|
|---|---|---|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
Grade 0 at Baseline
|
36.4 percentage of participants
|
23.8 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
Grade 0 at Last Cycle
|
23.9 percentage of participants
|
19.0 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
Grade 0 at Last Visit
|
34.0 percentage of participants
|
26.2 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
Grade 1 at Baseline
|
40.5 percentage of participants
|
45.0 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
Grade 1 at Last Cycle
|
33.5 percentage of participants
|
35.4 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
Grade 1 at Last Visit
|
28.0 percentage of participants
|
22.1 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
Grade 2 at Baseline
|
4.9 percentage of participants
|
6.3 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
Grade 2 at Last Cycle
|
3.4 percentage of participants
|
4.8 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
Grade 2 at Last Visit
|
3.8 percentage of participants
|
6.9 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
Grade 3 at Baseline
|
0.4 percentage of participants
|
2.1 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
Grade 3 at Last Cycle
|
1.3 percentage of participants
|
1.6 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
Grade 3 at Last Visit
|
1.6 percentage of participants
|
2.1 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
Missing at Baseline
|
17.8 percentage of participants
|
22.8 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
Missing at Last Cycle
|
37.9 percentage of participants
|
39.2 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
Missing at Last Visit
|
32.6 percentage of participants
|
42.8 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, last cycle (Cycle 18) (each cycle=1 month), last visit (follow-up) (24 months)Population: Analysis was performed on EAS. Here, number analyzed=participants evaluable at specified time-point.
Performance status was reflected by the Karnofsky index. Karnofsky performance status index ranges from 0-100% with higher scores indicating better functional status. An index between 90% and 100% corresponds to ECOG grade 0, index between 70% and 80% corresponds to ECOG grade 1, index between 50% and 60% corresponds to ECOG grade 2, index 40% corresponds to ECOG grade 3. ECOG grade 0=Fully active, able to carry on all pre-disease activities without restriction; grade 1=Restricted in physically strenuous activity, ambulatory and able to carry out light or sedentary work; grade 2=Ambulatory (\>50% of waking hours), capable of all self-care, unable to carry out any work activities; grade 3=Capable of only limited self-care, confined to bed/chair \>50% of waking hours.
Outcome measures
| Measure |
Unselected Population (Participants With Any Comorbidity)
n=472 Participants
Unselected population (participants with any comorbidity) who were treated with IV rituximab in combination with chemotherapy, were observed for 24 months including 6-month treatment period.
|
"Slow Go" Subpopulation
n=189 Participants
"Slow go" subpopulation (participants with CIRS-G score \>6 and/or creatinine clearance \<70 mL/min) who were treated with IV rituximab in combination with chemotherapy, were observed for 24 months including 6-month treatment period.
|
|---|---|---|
|
Percentage of Participants With Karnofsky Performance Status Index
Karnofsky index 100% at Baseline
|
25.4 percentage of participants
|
7.4 percentage of participants
|
|
Percentage of Participants With Karnofsky Performance Status Index
Karnofsky index 100% at Last Cycle
|
14.8 percentage of participants
|
7.9 percentage of participants
|
|
Percentage of Participants With Karnofsky Performance Status Index
Karnofsky index 100% at Last Visit
|
17.5 percentage of participants
|
11.0 percentage of participants
|
|
Percentage of Participants With Karnofsky Performance Status Index
Karnofsky index 90% at Baseline
|
24.4 percentage of participants
|
25.4 percentage of participants
|
|
Percentage of Participants With Karnofsky Performance Status Index
Karnofsky index 90% at Last Cycle
|
17.4 percentage of participants
|
18.5 percentage of participants
|
|
Percentage of Participants With Karnofsky Performance Status Index
Karnofsky index 90% at Last Visit
|
14.6 percentage of participants
|
11.7 percentage of participants
|
|
Percentage of Participants With Karnofsky Performance Status Index
Karnofsky index 80% at Baseline
|
14.2 percentage of participants
|
16.9 percentage of participants
|
|
Percentage of Participants With Karnofsky Performance Status Index
Karnofsky index 80% at Last Cycle
|
7.4 percentage of participants
|
8.5 percentage of participants
|
|
Percentage of Participants With Karnofsky Performance Status Index
Karnofsky index 80% at Last Visit
|
7.3 percentage of participants
|
9.0 percentage of participants
|
|
Percentage of Participants With Karnofsky Performance Status Index
Karnofsky index 70% at Baseline
|
3.4 percentage of participants
|
5.8 percentage of participants
|
|
Percentage of Participants With Karnofsky Performance Status Index
Karnofsky index 70% at Last Cycle
|
3.0 percentage of participants
|
4.2 percentage of participants
|
|
Percentage of Participants With Karnofsky Performance Status Index
Karnofsky index 70% at Last Visit
|
2.4 percentage of participants
|
2.8 percentage of participants
|
|
Percentage of Participants With Karnofsky Performance Status Index
Karnofsky index 60% at Baseline
|
0.6 percentage of participants
|
1.1 percentage of participants
|
|
Percentage of Participants With Karnofsky Performance Status Index
Karnofsky index 60% at Last Cycle
|
0.2 percentage of participants
|
1.6 percentage of participants
|
|
Percentage of Participants With Karnofsky Performance Status Index
Karnofsky index 60% at Last Visit
|
0.3 percentage of participants
|
0.7 percentage of participants
|
|
Percentage of Participants With Karnofsky Performance Status Index
Karnofsky index 50% at Baseline
|
0.2 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With Karnofsky Performance Status Index
Karnofsky index 50% at Last Cycle
|
0.2 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With Karnofsky Performance Status Index
Karnofsky index 50% at Last Visit
|
0.3 percentage of participants
|
0.7 percentage of participants
|
|
Percentage of Participants With Karnofsky Performance Status Index
Karnofsky index 40% at Baseline
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With Karnofsky Performance Status Index
Karnofsky index 40% at Last Cycle
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With Karnofsky Performance Status Index
Karnofsky index 40% at Last Visit
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With Karnofsky Performance Status Index
Missing at Baseline
|
31.8 percentage of participants
|
43.4 percentage of participants
|
|
Percentage of Participants With Karnofsky Performance Status Index
Missing at Last Cycle
|
57.0 percentage of participants
|
59.3 percentage of participants
|
|
Percentage of Participants With Karnofsky Performance Status Index
Missing at Last Visit
|
57.7 percentage of participants
|
64.1 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, last cycle (Cycle 18) (each cycle=1 month), last visit (follow-up) (24 months)Population: Analysis was performed on EAS. Here, number analyzed=participants evaluable at specified time-point.
General symptoms included fatigue, reduced performance, frequent infections, abdominal pain and exhaustion.
Outcome measures
| Measure |
Unselected Population (Participants With Any Comorbidity)
n=472 Participants
Unselected population (participants with any comorbidity) who were treated with IV rituximab in combination with chemotherapy, were observed for 24 months including 6-month treatment period.
|
"Slow Go" Subpopulation
n=189 Participants
"Slow go" subpopulation (participants with CIRS-G score \>6 and/or creatinine clearance \<70 mL/min) who were treated with IV rituximab in combination with chemotherapy, were observed for 24 months including 6-month treatment period.
|
|---|---|---|
|
Percentage of Participants With General Symptoms
Fatigue at Baseline
|
38.1 percentage of participants
|
45.0 percentage of participants
|
|
Percentage of Participants With General Symptoms
Fatigue at Last Cycle
|
23.5 percentage of participants
|
22.8 percentage of participants
|
|
Percentage of Participants With General Symptoms
Fatigue at Last Visit
|
17.8 percentage of participants
|
14.5 percentage of participants
|
|
Percentage of Participants With General Symptoms
Reduced Performance at Baseline
|
46.0 percentage of participants
|
49.2 percentage of participants
|
|
Percentage of Participants With General Symptoms
Reduced Performance at Last Cycle
|
24.2 percentage of participants
|
20.6 percentage of participants
|
|
Percentage of Participants With General Symptoms
Reduced Performance at Last Visit
|
21.3 percentage of participants
|
22.1 percentage of participants
|
|
Percentage of Participants With General Symptoms
Frequent Infections at Baseline
|
13.8 percentage of participants
|
15.9 percentage of participants
|
|
Percentage of Participants With General Symptoms
Frequent Infections at Last Cycle
|
5.5 percentage of participants
|
4.2 percentage of participants
|
|
Percentage of Participants With General Symptoms
Frequent Infections at Last Visit
|
7.5 percentage of participants
|
6.9 percentage of participants
|
|
Percentage of Participants With General Symptoms
Abdominal Pain at Baseline
|
8.3 percentage of participants
|
7.9 percentage of participants
|
|
Percentage of Participants With General Symptoms
Abdominal Pain at Last Cycle
|
1.9 percentage of participants
|
3.2 percentage of participants
|
|
Percentage of Participants With General Symptoms
Abdominal Pain at Last Visit
|
4.9 percentage of participants
|
2.8 percentage of participants
|
|
Percentage of Participants With General Symptoms
Exhaustion at Baseline
|
35.8 percentage of participants
|
40.2 percentage of participants
|
|
Percentage of Participants With General Symptoms
Exhaustion at Last Cycle
|
19.5 percentage of participants
|
15.9 percentage of participants
|
|
Percentage of Participants With General Symptoms
Exhaustion at Last Visit
|
14.6 percentage of participants
|
17.2 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, last cycle (Cycle 18) (each cycle=1 month), last visit (follow-up) (24 months)Population: Analysis was performed on EAS. Here, number analyzed=participants evaluable at specified time-point.
B-symptoms included fever, night sweats, weight loss.
Outcome measures
| Measure |
Unselected Population (Participants With Any Comorbidity)
n=472 Participants
Unselected population (participants with any comorbidity) who were treated with IV rituximab in combination with chemotherapy, were observed for 24 months including 6-month treatment period.
|
"Slow Go" Subpopulation
n=189 Participants
"Slow go" subpopulation (participants with CIRS-G score \>6 and/or creatinine clearance \<70 mL/min) who were treated with IV rituximab in combination with chemotherapy, were observed for 24 months including 6-month treatment period.
|
|---|---|---|
|
Percentage of Participants With B-Symptoms
Fever at Baseline
|
4.0 percentage of participants
|
4.8 percentage of participants
|
|
Percentage of Participants With B-Symptoms
Fever at Last Cycle
|
3.4 percentage of participants
|
2.6 percentage of participants
|
|
Percentage of Participants With B-Symptoms
Fever at Last Visit
|
2.2 percentage of participants
|
0.7 percentage of participants
|
|
Percentage of Participants With B-Symptoms
Night Sweats at Baseline
|
29.0 percentage of participants
|
25.4 percentage of participants
|
|
Percentage of Participants With B-Symptoms
Night Sweats at Last Cycle
|
3.2 percentage of participants
|
2.6 percentage of participants
|
|
Percentage of Participants With B-Symptoms
Night Sweats at Last Visit
|
7.0 percentage of participants
|
6.9 percentage of participants
|
|
Percentage of Participants With B-Symptoms
Weight Loss at Baseline
|
21.8 percentage of participants
|
21.2 percentage of participants
|
|
Percentage of Participants With B-Symptoms
Weight Loss at Last Cycle
|
4.2 percentage of participants
|
3.7 percentage of participants
|
|
Percentage of Participants With B-Symptoms
Weight Loss at Last Visit
|
5.7 percentage of participants
|
4.1 percentage of participants
|
SECONDARY outcome
Timeframe: From initiation of treatment up to disease progression or death due to any cause, whichever occurred first (assessed up to 24 months)Population: Analysis was performed on EAS.
Response to treatment was assessed as per clinical routine. BOR included complete response(CR or CR with incomplete hematopoietic regeneration),partial response(PR or nodular PR),stable disease(SD),progressive disease(PD). CR:hemoglobin\>/=11 grams/deciliter(g/dL), lymphocytes\<4000 cells/cubic millimeter(cells/mm\^3), neutrophils\>5000 cells/mm\^3,platelets\>100,000 cells/mm\^3,bone marrow biopsy with \<30% lymphocytes with no lymphocytic infiltrates, no evidence of lymphoid nodules on physical exam, performance status of 0. PR:\>50% decrease in size of enlarged lymph nodes, hepatomegaly, splenomegaly, with peripheral counts meeting same criteria as CR or \>/=50% improvement from pre-treatment values.PD:occurrence of at least one of following: \>/=50% increase in longest diameter of at least 2 enlarged lymph nodes, increase in spleen and liver size by at least 2 cm from Baseline, or \>/=50% increase in number of circulating lymphocytes. Participants without CR/PR or PD were considered having SD.
Outcome measures
| Measure |
Unselected Population (Participants With Any Comorbidity)
n=472 Participants
Unselected population (participants with any comorbidity) who were treated with IV rituximab in combination with chemotherapy, were observed for 24 months including 6-month treatment period.
|
"Slow Go" Subpopulation
n=189 Participants
"Slow go" subpopulation (participants with CIRS-G score \>6 and/or creatinine clearance \<70 mL/min) who were treated with IV rituximab in combination with chemotherapy, were observed for 24 months including 6-month treatment period.
|
|---|---|---|
|
Percentage of Participants With Best Overall Response (BOR)
CR
|
37.9 percentage of participants
|
32.8 percentage of participants
|
|
Percentage of Participants With Best Overall Response (BOR)
PR
|
37.3 percentage of participants
|
39.2 percentage of participants
|
|
Percentage of Participants With Best Overall Response (BOR)
SD
|
8.1 percentage of participants
|
8.5 percentage of participants
|
|
Percentage of Participants With Best Overall Response (BOR)
PD
|
2.8 percentage of participants
|
2.1 percentage of participants
|
|
Percentage of Participants With Best Overall Response (BOR)
Not assessable
|
4.9 percentage of participants
|
5.3 percentage of participants
|
|
Percentage of Participants With Best Overall Response (BOR)
Not assessed / Missing
|
9.1 percentage of participants
|
12.2 percentage of participants
|
Adverse Events
Unselected Population (Participants With Any Comorbidity)
Serious events: 85 serious events
Other events: 259 other events
Deaths: 0 deaths
"Slow Go" Subpopulation
Serious events: 44 serious events
Other events: 98 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Unselected Population (Participants With Any Comorbidity)
n=485 participants at risk
Unselected population (participants with any comorbidity) who were treated with IV rituximab in combination with chemotherapy, were observed for 24 months including 6-month treatment period.
|
"Slow Go" Subpopulation
n=196 participants at risk
"Slow go" subpopulation (participants with CIRS-G score \>6 and/or creatinine clearance \<70 mL/min) who were treated with IV rituximab in combination with chemotherapy, were observed for 24 months including 6-month treatment period.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
1.0%
5/485 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
3.1%
6/196 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
|
Blood and lymphatic system disorders
Autoimmune hemolytic anemia
|
0.21%
1/485 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
0.00%
0/196 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
|
Blood and lymphatic system disorders
Bone marrow toxicity
|
0.21%
1/485 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
0.00%
0/196 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
|
Blood and lymphatic system disorders
Cytopenia
|
0.21%
1/485 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
0.00%
0/196 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
1.0%
5/485 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
0.51%
1/196 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
|
Blood and lymphatic system disorders
Leukopenia
|
2.3%
11/485 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
2.6%
5/196 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
|
Blood and lymphatic system disorders
Neutropenia
|
3.5%
17/485 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
2.6%
5/196 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.21%
1/485 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
0.00%
0/196 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.6%
8/485 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
1.0%
2/196 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.21%
1/485 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
0.00%
0/196 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
|
Cardiac disorders
Arrhythmia
|
0.21%
1/485 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
0.00%
0/196 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
|
Cardiac disorders
Cardiac disorder
|
0.21%
1/485 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
0.00%
0/196 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
|
Cardiac disorders
Cardiac failure
|
0.21%
1/485 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
0.00%
0/196 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
|
Endocrine disorders
Adrenal mass
|
0.21%
1/485 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
0.00%
0/196 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.41%
2/485 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
0.51%
1/196 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.21%
1/485 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
0.00%
0/196 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
|
Gastrointestinal disorders
Gastrointestinal hemorrhage
|
0.41%
2/485 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
0.00%
0/196 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
|
Gastrointestinal disorders
Ileus
|
0.21%
1/485 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
0.00%
0/196 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
|
Gastrointestinal disorders
Melena
|
0.21%
1/485 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
0.00%
0/196 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
|
Gastrointestinal disorders
Mouth hemorrhage
|
0.21%
1/485 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
0.00%
0/196 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
|
Gastrointestinal disorders
Nausea
|
0.21%
1/485 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
0.51%
1/196 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
|
Gastrointestinal disorders
Vomiting
|
0.62%
3/485 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
0.00%
0/196 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
|
General disorders
Asthenia
|
0.21%
1/485 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
0.00%
0/196 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
|
General disorders
Chills
|
0.82%
4/485 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
0.51%
1/196 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
|
General disorders
Death
|
0.21%
1/485 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
0.00%
0/196 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
|
General disorders
Disease progression
|
0.41%
2/485 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
0.51%
1/196 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
|
General disorders
Effusion
|
0.21%
1/485 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
0.00%
0/196 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
|
General disorders
General physical health deterioration
|
1.0%
5/485 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
1.5%
3/196 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
|
General disorders
Pyrexia
|
2.7%
13/485 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
0.51%
1/196 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
|
Immune system disorders
Hypersensitivity
|
0.41%
2/485 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
1.0%
2/196 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
|
Immune system disorders
Secondary immunodeficiency
|
0.21%
1/485 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
0.51%
1/196 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
|
Infections and infestations
Atypical Pneumonia
|
0.21%
1/485 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
0.00%
0/196 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
|
Infections and infestations
Bacterial infection
|
2.1%
10/485 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
1.5%
3/196 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
|
Infections and infestations
Bronchitis
|
0.41%
2/485 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
0.00%
0/196 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
|
Infections and infestations
Device related infection
|
0.21%
1/485 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
0.00%
0/196 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
|
Infections and infestations
Fungal infection
|
0.21%
1/485 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
0.00%
0/196 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
|
Infections and infestations
Herpes zoster
|
0.62%
3/485 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
0.00%
0/196 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
|
Infections and infestations
Klebsiella bacteraemia
|
0.21%
1/485 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
0.00%
0/196 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
|
Infections and infestations
Meningitis
|
0.21%
1/485 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
0.00%
0/196 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
|
Infections and infestations
Necrotizing fasciitis
|
0.21%
1/485 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
0.00%
0/196 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
|
Infections and infestations
Pneumonia viral
|
0.21%
1/485 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
0.00%
0/196 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
|
Infections and infestations
Sepsis
|
0.62%
3/485 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
1.5%
3/196 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
|
Infections and infestations
Staphylococcal sepsis
|
0.21%
1/485 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
0.00%
0/196 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
|
Infections and infestations
Viral infection
|
0.21%
1/485 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
0.00%
0/196 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
|
Injury, poisoning and procedural complications
Injury
|
0.21%
1/485 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
0.00%
0/196 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
|
Injury, poisoning and procedural complications
Splenic rupture
|
0.21%
1/485 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
0.00%
0/196 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
|
Investigations
Blood pressure increased
|
0.21%
1/485 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
0.00%
0/196 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
|
Investigations
Body temperature increased
|
0.21%
1/485 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
0.00%
0/196 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
|
Investigations
White blood cell count increased
|
0.21%
1/485 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
0.00%
0/196 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.21%
1/485 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
0.00%
0/196 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
|
Metabolism and nutrition disorders
Tumour lysis syndrome
|
0.21%
1/485 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
0.00%
0/196 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.21%
1/485 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
0.00%
0/196 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.21%
1/485 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
0.00%
0/196 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.21%
1/485 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
0.00%
0/196 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
0.82%
4/485 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
0.00%
0/196 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.21%
1/485 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
0.00%
0/196 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.21%
1/485 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
0.00%
0/196 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lung
|
0.21%
1/485 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
0.00%
0/196 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic neoplasm
|
0.21%
1/485 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
0.00%
0/196 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.21%
1/485 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
0.00%
0/196 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer
|
0.21%
1/485 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
0.00%
0/196 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.21%
1/485 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
0.00%
0/196 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
|
Nervous system disorders
Depressed level of consciousness
|
0.21%
1/485 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
0.00%
0/196 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
|
Nervous system disorders
Dizziness
|
0.21%
1/485 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
0.00%
0/196 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
|
Nervous system disorders
Syncope
|
0.21%
1/485 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
0.51%
1/196 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.21%
1/485 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
0.00%
0/196 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
|
Renal and urinary disorders
Hematuria
|
0.21%
1/485 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
0.00%
0/196 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.41%
2/485 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
0.51%
1/196 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.21%
1/485 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
0.00%
0/196 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.41%
2/485 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
0.51%
1/196 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.21%
1/485 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
0.51%
1/196 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.21%
1/485 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
0.00%
0/196 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
0.21%
1/485 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
0.00%
0/196 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
|
Surgical and medical procedures
Dental operation
|
0.21%
1/485 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
0.00%
0/196 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
|
Vascular disorders
Circulatory collapse
|
0.21%
1/485 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
0.00%
0/196 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
|
Vascular disorders
Embolism
|
0.21%
1/485 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
0.00%
0/196 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
|
Vascular disorders
Haematoma
|
0.21%
1/485 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
0.00%
0/196 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
|
Vascular disorders
Hot flush
|
0.21%
1/485 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
0.00%
0/196 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
|
Vascular disorders
Thrombosis
|
0.21%
1/485 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
0.00%
0/196 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
|
Blood and lymphatic system disorders
Hematotoxicity
|
0.00%
0/485 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
0.51%
1/196 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/485 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
0.51%
1/196 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/485 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
0.51%
1/196 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
|
Infections and infestations
Endocarditis
|
0.00%
0/485 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
1.0%
2/196 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
|
Infections and infestations
Enterococcal infection
|
0.00%
0/485 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
0.51%
1/196 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
|
Infections and infestations
Febrile infection
|
0.00%
0/485 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
0.51%
1/196 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
|
Infections and infestations
Infection
|
0.00%
0/485 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
0.51%
1/196 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/485 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
1.5%
3/196 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
|
Infections and infestations
Septic shock
|
0.00%
0/485 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
0.51%
1/196 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/485 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
0.51%
1/196 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/485 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
0.51%
1/196 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
|
Investigations
Hemoglobin decreased
|
0.00%
0/485 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
1.0%
2/196 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/485 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
0.51%
1/196 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/485 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
1.5%
3/196 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/485 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
0.51%
1/196 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.00%
0/485 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
0.51%
1/196 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/485 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
0.51%
1/196 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/485 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
0.51%
1/196 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphatic system neoplasm
|
0.00%
0/485 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
0.51%
1/196 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/485 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
0.51%
1/196 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/485 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
0.51%
1/196 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
|
Nervous system disorders
Peroneal nerve palsy
|
0.00%
0/485 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
0.51%
1/196 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/485 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
0.51%
1/196 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
|
Nervous system disorders
Seizure
|
0.00%
0/485 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
0.51%
1/196 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/485 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
0.51%
1/196 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/485 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
0.51%
1/196 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/485 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
0.51%
1/196 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/485 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
0.51%
1/196 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/485 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
0.51%
1/196 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
|
Surgical and medical procedures
Hospitalization
|
0.00%
0/485 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
0.51%
1/196 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/485 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
0.51%
1/196 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/485 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
0.51%
1/196 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
Other adverse events
| Measure |
Unselected Population (Participants With Any Comorbidity)
n=485 participants at risk
Unselected population (participants with any comorbidity) who were treated with IV rituximab in combination with chemotherapy, were observed for 24 months including 6-month treatment period.
|
"Slow Go" Subpopulation
n=196 participants at risk
"Slow go" subpopulation (participants with CIRS-G score \>6 and/or creatinine clearance \<70 mL/min) who were treated with IV rituximab in combination with chemotherapy, were observed for 24 months including 6-month treatment period.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
8.2%
40/485 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
10.7%
21/196 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
|
Blood and lymphatic system disorders
Leukopenia
|
26.6%
129/485 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
24.5%
48/196 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
|
Blood and lymphatic system disorders
Neutropenia
|
6.8%
33/485 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
7.7%
15/196 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
20.4%
99/485 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
15.8%
31/196 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
|
Gastrointestinal disorders
Diarrhoea
|
5.4%
26/485 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
7.1%
14/196 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
|
Gastrointestinal disorders
Nausea
|
13.8%
67/485 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
10.2%
20/196 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
|
General disorders
Chills
|
7.8%
38/485 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
8.7%
17/196 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
|
General disorders
Pyrexia
|
9.5%
46/485 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
7.7%
15/196 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
|
Immune system disorders
Hypersensitivity
|
9.7%
47/485 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
9.7%
19/196 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
|
Infections and infestations
Bacterial infection
|
6.0%
29/485 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
0.00%
0/196 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
|
General disorders
Fatigue
|
0.00%
0/485 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
5.6%
11/196 • Baseline up to 24 months
Analysis was performed on safety analysis set.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER