Trial Outcomes & Findings for A Study of MabThera (Rituximab) Plus Chlorambucil in Patients With Previously Untreated Chronic Lymphocytic Leukemia. (NCT NCT00738374)
NCT ID: NCT00738374
Last Updated: 2017-08-15
Results Overview
CR defined as: 1) laboratory CR: peripheral blood lymphocytes (PBL) less than (\<) 4000/microliter (μL), neutrophils (PMN) greater than (\>) 1500/μL, platelets \>100,000/μL, and hemoglobin (Hb) \>11 grams per deciliter (g/dL); 2) clinical CR: lymph nodes (LN) \<1.5 centimeter (cm), and no constitutional symptoms, hepatomegaly (HM) or splenomegaly (SM); 3) instrumental CR: LN \<1.5 cm and no HM/SM, and 4) bone marrow (BM) CR: normocellular aspirate/biopsy for participant age \<30 percent (%) lymphocytes, and no B cell lymphoid nodules. CRi was defined as CR with anemia, thrombocytopenia, or neutropenia not related to chronic lymphocytic leukemia (CLL), with no clonal infiltrate in aspirate or biopsy. PR defined as: a 50% decrease in PBL, a 50% decrease in LN size, no increase in LN size, no new enlarged LN, a 50% reduction from baseline (BL) in the HM/SM, and 1 of the following: PMN \>1500/μL, platelets \>100,000/μL or \>50% improvement from BL, and Hb \>11.0 g/dL or \>50% improvement from BL.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
97 participants
Primary outcome timeframe
Month 10
Results posted on
2017-08-15
Participant Flow
Participant milestones
| Measure |
Chlorambucil (CLB) Plus (+) Rituximab (R): Induction Treatment
Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 milligrams per square meter (mg/m\^2), orally (PO) as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m\^2, intravenously (IV), on Day 1 of Course 3, and 500 mg/m\^2, IV, on Day 1 of Courses 4-8. Participants with complete response (CR), complete response with incomplete bone marrow recovery (CRi), or partial response (PR) were randomized to receive either rituximab, 375 mg/m\^2, IV, every 8 weeks for up to 24 months, or to be observed for up to 24 months with no further treatment.
|
CLB + R: Completed Induction Treament But Not Randomized
Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m\^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m\^2, IV, on Day 1 of Course 3, and 500 mg/m\^2, IV, on Day 1 of Courses 4-8. Participants were not randomized to receive further treatment or observation.
|
CLB + R: Maintenance Treatment
Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m\^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m\^2, IV, on Day 1 of Course 3, and 500 mg/m\^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to receive rituximab, 375 mg/m\^2, IV, once every 8 weeks for a total of 12 infusions for up to 24 months.
|
CLB + R: Observation
Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m\^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m\^2, IV, on Day 1 of Course 3, and 500 mg/m\^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to be observed for up to 24 months and received no further treatment.
|
|---|---|---|---|---|
|
Induction Treatment Phase
STARTED
|
97
|
0
|
0
|
0
|
|
Induction Treatment Phase
COMPLETED
|
73
|
0
|
0
|
0
|
|
Induction Treatment Phase
NOT COMPLETED
|
24
|
0
|
0
|
0
|
|
Maintenance Treatment/Observation Phase
STARTED
|
0
|
7
|
34
|
32
|
|
Maintenance Treatment/Observation Phase
COMPLETED
|
0
|
0
|
27
|
20
|
|
Maintenance Treatment/Observation Phase
NOT COMPLETED
|
0
|
7
|
7
|
12
|
Reasons for withdrawal
| Measure |
Chlorambucil (CLB) Plus (+) Rituximab (R): Induction Treatment
Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 milligrams per square meter (mg/m\^2), orally (PO) as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m\^2, intravenously (IV), on Day 1 of Course 3, and 500 mg/m\^2, IV, on Day 1 of Courses 4-8. Participants with complete response (CR), complete response with incomplete bone marrow recovery (CRi), or partial response (PR) were randomized to receive either rituximab, 375 mg/m\^2, IV, every 8 weeks for up to 24 months, or to be observed for up to 24 months with no further treatment.
|
CLB + R: Completed Induction Treament But Not Randomized
Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m\^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m\^2, IV, on Day 1 of Course 3, and 500 mg/m\^2, IV, on Day 1 of Courses 4-8. Participants were not randomized to receive further treatment or observation.
|
CLB + R: Maintenance Treatment
Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m\^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m\^2, IV, on Day 1 of Course 3, and 500 mg/m\^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to receive rituximab, 375 mg/m\^2, IV, once every 8 weeks for a total of 12 infusions for up to 24 months.
|
CLB + R: Observation
Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m\^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m\^2, IV, on Day 1 of Course 3, and 500 mg/m\^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to be observed for up to 24 months and received no further treatment.
|
|---|---|---|---|---|
|
Induction Treatment Phase
Adverse Event
|
14
|
0
|
0
|
0
|
|
Induction Treatment Phase
Disease progression/relapse/stable
|
4
|
0
|
0
|
0
|
|
Induction Treatment Phase
Physician Decision
|
2
|
0
|
0
|
0
|
|
Induction Treatment Phase
Protocol Violation
|
2
|
0
|
0
|
0
|
|
Induction Treatment Phase
Non-compliance
|
1
|
0
|
0
|
0
|
|
Induction Treatment Phase
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
|
Maintenance Treatment/Observation Phase
Adverse Event
|
0
|
1
|
2
|
0
|
|
Maintenance Treatment/Observation Phase
Disease progression/relapse/stable
|
0
|
4
|
5
|
11
|
|
Maintenance Treatment/Observation Phase
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
|
Maintenance Treatment/Observation Phase
Protocol Violation
|
0
|
1
|
0
|
0
|
|
Maintenance Treatment/Observation Phase
Other
|
0
|
1
|
0
|
0
|
Baseline Characteristics
A Study of MabThera (Rituximab) Plus Chlorambucil in Patients With Previously Untreated Chronic Lymphocytic Leukemia.
Baseline characteristics by cohort
| Measure |
CLB + R: Not Randomized
n=31 Participants
Participants began a 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m\^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m\^2, IV, on Day 1 of Course 3, and 500 mg/m\^2, IV, on Day 1 of Courses 4-8. Participants who completed the induction treatment with CR, CRi, or PR were randomized to receive either rituximab, 375 mg/m\^2, IV, every 8 weeks for up to 24 months, or to be observed for up to 24 months with no further treatment.
|
CLB + R: Maintenance Treatment
n=34 Participants
Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m\^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m\^2, IV, on Day 1 of Course 3, and 500 mg/m\^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to receive rituximab, 375 mg/m\^2, IV, once every 8 weeks for a total of 12 infusions for up to 24 months.
|
CLB + R: Observation
n=32 Participants
Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m\^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m\^2, IV, on Day 1 of Course 3, and 500 mg/m\^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to be observed for up to 24 months and received no further treatment.
|
Total
n=97 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
74.7 years
STANDARD_DEVIATION 6.5 • n=5 Participants
|
69.8 years
STANDARD_DEVIATION 5.4 • n=7 Participants
|
70.2 years
STANDARD_DEVIATION 5.1 • n=5 Participants
|
71.7 years
STANDARD_DEVIATION 6.1 • n=4 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
65 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Month 10Population: Intent to treat (ITT) population: all consented participants who received at least 1 dose of rituximab.
CR defined as: 1) laboratory CR: peripheral blood lymphocytes (PBL) less than (\<) 4000/microliter (μL), neutrophils (PMN) greater than (\>) 1500/μL, platelets \>100,000/μL, and hemoglobin (Hb) \>11 grams per deciliter (g/dL); 2) clinical CR: lymph nodes (LN) \<1.5 centimeter (cm), and no constitutional symptoms, hepatomegaly (HM) or splenomegaly (SM); 3) instrumental CR: LN \<1.5 cm and no HM/SM, and 4) bone marrow (BM) CR: normocellular aspirate/biopsy for participant age \<30 percent (%) lymphocytes, and no B cell lymphoid nodules. CRi was defined as CR with anemia, thrombocytopenia, or neutropenia not related to chronic lymphocytic leukemia (CLL), with no clonal infiltrate in aspirate or biopsy. PR defined as: a 50% decrease in PBL, a 50% decrease in LN size, no increase in LN size, no new enlarged LN, a 50% reduction from baseline (BL) in the HM/SM, and 1 of the following: PMN \>1500/μL, platelets \>100,000/μL or \>50% improvement from BL, and Hb \>11.0 g/dL or \>50% improvement from BL.
Outcome measures
| Measure |
CLB + R: All Participants
n=85 Participants
Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m\^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m\^2, IV, on Day 1 of Course 3, and 500 mg/m\^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to receive either rituximab, 375 mg/m\^2, IV, once every 8 weeks for up to 24 months (up to 12 infusions), or to be observed for up to 24 months with no further treatment.
|
CLB + R: Observation
Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m\^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m\^2, IV, on Day 1 of Course 3, and 500 mg/m\^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to be observed for up to 24 months and received no further treatment.
|
|---|---|---|
|
Percentage of Participants With Documented CR, CRi, or PR at the End of Induction Treatment
|
82.4 percentage of participants
Interval 74.25 to 90.46
|
—
|
SECONDARY outcome
Timeframe: Month 35Population: All randomized participants.
CR defined as: 1) laboratory CR: PBL \<4000/μL, PMN \> 1500/μL, platelets \> 100,000/μL, and Hb \> 11 g/dL; 2) clinical CR: LN \< 1.5 cm, and no constitutional symptoms, HM or SM; 3) instrumental CR: LN \< 1.5 cm and no HM/SM, and 4) bone marrow CR: normocellular aspirate/biopsy for participant age \< 30% lymphocytes, and no B cell lymphoid nodules. CRi was defined as CR with anemia, thrombocytopenia, or neutropenia not related to CLL, with no clonal infiltrate in aspirate or biopsy. PR defined as: a 50% decrease in PBL, a 50% decrease in LN size, no increase in LN size, no new enlarged LN, a 50% reduction from BL in the HM/SM, and 1 of the following: PMN \> 1500/μL, platelets \> 100,000/μL or \> 50% improvement from BL, and Hb \>11.0 g/dL or \> 50% improvement from BL.
Outcome measures
| Measure |
CLB + R: All Participants
n=34 Participants
Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m\^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m\^2, IV, on Day 1 of Course 3, and 500 mg/m\^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to receive either rituximab, 375 mg/m\^2, IV, once every 8 weeks for up to 24 months (up to 12 infusions), or to be observed for up to 24 months with no further treatment.
|
CLB + R: Observation
n=32 Participants
Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m\^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m\^2, IV, on Day 1 of Course 3, and 500 mg/m\^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to be observed for up to 24 months and received no further treatment.
|
|---|---|---|
|
Percentage of Participants With Documented CR, CRi, or PR at the End of Study
|
55.9 percentage of participants
Interval 39.19 to 72.57
|
34.4 percentage of participants
Interval 17.92 to 50.83
|
SECONDARY outcome
Timeframe: Month 10Population: ITT population
CR, CRi, and PR as previously defined. PD was defined by 1 of the following: 1) lymphadenopathy: any new lesion, HM/SM, or other organ infiltrates, or a greater than or equal to (≥) 50% increase in greatest diameter of any previously noted lesion; 2) a ≥ 50% increase in previously noted HM/SM, or new appearance of HM/SM; 3) a ≥ 50% increase in blood lymphocyte count with at least 5000 B lymphocytes/μL; 4) transformation to a more aggressive histology, e.g., Richter's syndrome; or 5) occurrence of cytopenia attributable to CLL. SD was defined by the absence of necessary criteria to achieve CR or PR, but no advancement to PD. Relapse was defined by a previously noted CR or PR with advancement to PD after a period of ≥ 6 months. Nodular PR was defined by the presence of residual lymphoid nodules.
Outcome measures
| Measure |
CLB + R: All Participants
n=85 Participants
Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m\^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m\^2, IV, on Day 1 of Course 3, and 500 mg/m\^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to receive either rituximab, 375 mg/m\^2, IV, once every 8 weeks for up to 24 months (up to 12 infusions), or to be observed for up to 24 months with no further treatment.
|
CLB + R: Observation
Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m\^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m\^2, IV, on Day 1 of Course 3, and 500 mg/m\^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to be observed for up to 24 months and received no further treatment.
|
|---|---|---|
|
Percentage of Participants With CR, CRi, PR, Stable Disease (SD), Progressive Disease (PD), Relapse, or Nodular PR at the End of Induction Treatment
CR
|
16.5 percentage of participants
|
—
|
|
Percentage of Participants With CR, CRi, PR, Stable Disease (SD), Progressive Disease (PD), Relapse, or Nodular PR at the End of Induction Treatment
CRi
|
2.4 percentage of participants
|
—
|
|
Percentage of Participants With CR, CRi, PR, Stable Disease (SD), Progressive Disease (PD), Relapse, or Nodular PR at the End of Induction Treatment
PR
|
60.0 percentage of participants
|
—
|
|
Percentage of Participants With CR, CRi, PR, Stable Disease (SD), Progressive Disease (PD), Relapse, or Nodular PR at the End of Induction Treatment
SD
|
4.7 percentage of participants
|
—
|
|
Percentage of Participants With CR, CRi, PR, Stable Disease (SD), Progressive Disease (PD), Relapse, or Nodular PR at the End of Induction Treatment
PD
|
3.5 percentage of participants
|
—
|
|
Percentage of Participants With CR, CRi, PR, Stable Disease (SD), Progressive Disease (PD), Relapse, or Nodular PR at the End of Induction Treatment
Relapse
|
0.0 percentage of participants
|
—
|
|
Percentage of Participants With CR, CRi, PR, Stable Disease (SD), Progressive Disease (PD), Relapse, or Nodular PR at the End of Induction Treatment
Nodular PR
|
3.5 percentage of participants
|
—
|
|
Percentage of Participants With CR, CRi, PR, Stable Disease (SD), Progressive Disease (PD), Relapse, or Nodular PR at the End of Induction Treatment
Unknown
|
9.4 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Month 35Population: All randomized participants who were assessed at Month 35 were included in the analysis.
CR, and PR as previously defined. PD was defined by 1 of the following: 1) lymphadenopathy: any new lesion, HM/SM, or other organ infiltrates, or a ≥ 50% increase in greatest diameter of any previously noted lesion; 2) a ≥50% increase in previously noted HM/SM, or new appearance of HM/SM; 3) a ≥50% increase in blood lymphocyte count with at least 5000 B lymphocytes/μL; 4) transformation to a more aggressive histology, e.g., Richter's syndrome; or 5) occurrence of cytopenia attributable to CLL. SD was defined by the absence of necessary criteria to achieve CR or PR, but no advancement to PD. Relapse was defined by a previously noted CR or PR with advancement to PD after a period of ≥6 months. Nodular PR was defined by the presence of residual lymphoid nodules.
Outcome measures
| Measure |
CLB + R: All Participants
n=31 Participants
Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m\^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m\^2, IV, on Day 1 of Course 3, and 500 mg/m\^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to receive either rituximab, 375 mg/m\^2, IV, once every 8 weeks for up to 24 months (up to 12 infusions), or to be observed for up to 24 months with no further treatment.
|
CLB + R: Observation
n=28 Participants
Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m\^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m\^2, IV, on Day 1 of Course 3, and 500 mg/m\^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to be observed for up to 24 months and received no further treatment.
|
|---|---|---|
|
Percentage of Participants With CR, PR, SD, PD, Relapse, or Nodular PR at the End of Study
CR
|
32.3 percentage of participants
|
21.4 percentage of participants
|
|
Percentage of Participants With CR, PR, SD, PD, Relapse, or Nodular PR at the End of Study
PR
|
29.0 percentage of participants
|
14.3 percentage of participants
|
|
Percentage of Participants With CR, PR, SD, PD, Relapse, or Nodular PR at the End of Study
SD
|
3.2 percentage of participants
|
7.1 percentage of participants
|
|
Percentage of Participants With CR, PR, SD, PD, Relapse, or Nodular PR at the End of Study
PD
|
29.0 percentage of participants
|
39.3 percentage of participants
|
|
Percentage of Participants With CR, PR, SD, PD, Relapse, or Nodular PR at the End of Study
Relapse
|
6.5 percentage of participants
|
14.3 percentage of participants
|
|
Percentage of Participants With CR, PR, SD, PD, Relapse, or Nodular PR at the End of Study
Nodular PR
|
0.0 percentage of participants
|
3.6 percentage of participants
|
SECONDARY outcome
Timeframe: Month 10Population: ITT population
Immunophenotypic CR was defined as the absence of minimal residual disease (MRD) evaluated in participants with CR by 4-color flow cytometry of PB and BM B cells to confirm that tissue was comprised of non-CLL cells. Molecular CR was defined as the absence of MRD evaluated in participants with CR by quantitative polymerase chain reaction (PCR) in PB and BM B cells to confirm that tissue was comprised of non-CLL cells.
Outcome measures
| Measure |
CLB + R: All Participants
n=85 Participants
Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m\^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m\^2, IV, on Day 1 of Course 3, and 500 mg/m\^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to receive either rituximab, 375 mg/m\^2, IV, once every 8 weeks for up to 24 months (up to 12 infusions), or to be observed for up to 24 months with no further treatment.
|
CLB + R: Observation
Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m\^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m\^2, IV, on Day 1 of Course 3, and 500 mg/m\^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to be observed for up to 24 months and received no further treatment.
|
|---|---|---|
|
Number of Participants With Immunophenotypic CR - BM, Immunophenotypic CR - Peripheral Blood (PB), Molecular CR - BM, or Molecular CR - PB at the End of Induction Treatment
Immunophenotypic CR - BM
|
2 participants
|
—
|
|
Number of Participants With Immunophenotypic CR - BM, Immunophenotypic CR - Peripheral Blood (PB), Molecular CR - BM, or Molecular CR - PB at the End of Induction Treatment
Immunophenotypic CR - PB
|
3 participants
|
—
|
|
Number of Participants With Immunophenotypic CR - BM, Immunophenotypic CR - Peripheral Blood (PB), Molecular CR - BM, or Molecular CR - PB at the End of Induction Treatment
Molecular CR - BM
|
0 participants
|
—
|
|
Number of Participants With Immunophenotypic CR - BM, Immunophenotypic CR - Peripheral Blood (PB), Molecular CR - BM, or Molecular CR - PB at the End of Induction Treatment
Molecular CR - PB
|
0 participants
|
—
|
SECONDARY outcome
Timeframe: Month 35Population: All randomized participants.
CR, CRi, PR, SD, PD, relapse, and nodular PR as previously defined.
Outcome measures
| Measure |
CLB + R: All Participants
n=34 Participants
Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m\^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m\^2, IV, on Day 1 of Course 3, and 500 mg/m\^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to receive either rituximab, 375 mg/m\^2, IV, once every 8 weeks for up to 24 months (up to 12 infusions), or to be observed for up to 24 months with no further treatment.
|
CLB + R: Observation
n=32 Participants
Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m\^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m\^2, IV, on Day 1 of Course 3, and 500 mg/m\^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to be observed for up to 24 months and received no further treatment.
|
|---|---|---|
|
Percentage of Participants With CR, CRi, PR, SD, PD, or Relapse at the End of Study
CR
|
29.4 percentage of participants
|
18.7 percentage of participants
|
|
Percentage of Participants With CR, CRi, PR, SD, PD, or Relapse at the End of Study
CRi
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With CR, CRi, PR, SD, PD, or Relapse at the End of Study
PR
|
26.4 percentage of participants
|
12.5 percentage of participants
|
SECONDARY outcome
Timeframe: Month 35Population: All randomized participants, only participants with a confirmed CR were included in the analysis.
Immunophenotypic CR was defined as the absence of MRD evaluated in participants who achieved CR by 4-color flow cytometry of PB and BM B cells to confirm that tissue was comprised of non-CLL cells.
Outcome measures
| Measure |
CLB + R: All Participants
n=10 Participants
Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m\^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m\^2, IV, on Day 1 of Course 3, and 500 mg/m\^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to receive either rituximab, 375 mg/m\^2, IV, once every 8 weeks for up to 24 months (up to 12 infusions), or to be observed for up to 24 months with no further treatment.
|
CLB + R: Observation
Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m\^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m\^2, IV, on Day 1 of Course 3, and 500 mg/m\^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to be observed for up to 24 months and received no further treatment.
|
|---|---|---|
|
Percentage of Participants With Immunophenotypic CR - BM or Immunophenotypic CR - PB at the End of Study
Immunophenotypic CR - BM
|
10.0 percentage of participants
|
—
|
|
Percentage of Participants With Immunophenotypic CR - BM or Immunophenotypic CR - PB at the End of Study
Immunophenotypic CR - PB
|
30.0 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Month 35Population: All randomized participants analyzed for the given parameter at the specified timepoint.
Molecular CR was defined as the absence of MRD evaluated in participants who achieved CR by quantitative PCR in PB and BM B cells to confirm that tissue was comprised of non-CLL cells.
Outcome measures
| Measure |
CLB + R: All Participants
n=3 Participants
Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m\^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m\^2, IV, on Day 1 of Course 3, and 500 mg/m\^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to receive either rituximab, 375 mg/m\^2, IV, once every 8 weeks for up to 24 months (up to 12 infusions), or to be observed for up to 24 months with no further treatment.
|
CLB + R: Observation
Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m\^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m\^2, IV, on Day 1 of Course 3, and 500 mg/m\^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to be observed for up to 24 months and received no further treatment.
|
|---|---|---|
|
Percentage of Participants With Molecular CR - BM or Molecular CR - PB at the End of Study
Molecular CR - BM
|
100.0 percentage of participants
|
—
|
|
Percentage of Participants With Molecular CR - BM or Molecular CR - PB at the End of Study
Molecular CR - PB
|
33.3 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Screening, Days 1 and 15 of Courses 1-8 (4-week courses) and Day 1 of Courses 10-35 (4-week courses) for up to 35 months.Population: ITT population
Event-free Survival (EFS) was defined as the time from the first dose of study treatment to the date of first documentation of disease progression, relapse for participants with previous CR, death due to any cause, withdrawal due to AE, or beginning new CLL treatment. CR and PD as previously defined. Participants were censored at the time of data cut-off to the most recent date of disease assessment. Participants without a post-BL disease assessment were censored at the time of first dose of study treatment.
Outcome measures
| Measure |
CLB + R: All Participants
n=85 Participants
Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m\^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m\^2, IV, on Day 1 of Course 3, and 500 mg/m\^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to receive either rituximab, 375 mg/m\^2, IV, once every 8 weeks for up to 24 months (up to 12 infusions), or to be observed for up to 24 months with no further treatment.
|
CLB + R: Observation
Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m\^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m\^2, IV, on Day 1 of Course 3, and 500 mg/m\^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to be observed for up to 24 months and received no further treatment.
|
|---|---|---|
|
Number of Participants With Disease Progression, Relapse, Death, Withdrawal Because of an Adverse Event (AE), or New CLL Treatment
|
43 participants
|
—
|
SECONDARY outcome
Timeframe: Screening, Days 1 and 15 of Courses 1-8 (4-week courses) and Day 1 of Courses 10-35 (4-week courses) for up to 35 months.Population: ITT population
The median time, in days, from the the date of first dose of study treatment to the date of first documentation of disease progression, relapse for participants with CR, death due to any cause, withdrawal due to AE, or new CLL treatment. CR and PD as previously defined. Participants were censored at the time of data cut-off to the most recent date of disease assessment. Participants without a post-BL disease assessment were censored at the time of first dose if study treatment. The 95% CI was determined using Kaplan-Meier methodology.
Outcome measures
| Measure |
CLB + R: All Participants
n=85 Participants
Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m\^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m\^2, IV, on Day 1 of Course 3, and 500 mg/m\^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to receive either rituximab, 375 mg/m\^2, IV, once every 8 weeks for up to 24 months (up to 12 infusions), or to be observed for up to 24 months with no further treatment.
|
CLB + R: Observation
Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m\^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m\^2, IV, on Day 1 of Course 3, and 500 mg/m\^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to be observed for up to 24 months and received no further treatment.
|
|---|---|---|
|
EFS
|
1051 days
Interval 768.0 to 1164.0
|
—
|
SECONDARY outcome
Timeframe: Screening, Day 1 Courses 1-8 (4-week courses) and Day 1 of Courses 10-35 (4-week courses) for up to 35 months.Population: ITT population
Progression-free survival (PFS) was defined as the time from the first dose of study treatment to the first documentation of disease progression or death. PD as previously defined. Participants who were withdrawn from the study without documented disease progression were censored at the date of the last tumor assessment when the participant was known to be progression-free. Participants without a post-BL tumor assessment, but known to be alive, were censored at the time of the first dose of study treatment.
Outcome measures
| Measure |
CLB + R: All Participants
n=85 Participants
Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m\^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m\^2, IV, on Day 1 of Course 3, and 500 mg/m\^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to receive either rituximab, 375 mg/m\^2, IV, once every 8 weeks for up to 24 months (up to 12 infusions), or to be observed for up to 24 months with no further treatment.
|
CLB + R: Observation
Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m\^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m\^2, IV, on Day 1 of Course 3, and 500 mg/m\^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to be observed for up to 24 months and received no further treatment.
|
|---|---|---|
|
Number of Participants With Disease Progression or Death
|
35 participants
|
—
|
SECONDARY outcome
Timeframe: Screening, Day 1 Courses 1-8 (4-week courses) and Day 1 of Courses 10-35 (4-week courses) for up to 35 months.Population: ITT population
The median time, in days, from the date of the first dose of study treatment to the date of first documentation of disease progression or death. CR and PD as previously defined. Participants who were withdrawn from the study without documented disease progression were censored at the date of the last tumor assessment when the participant was known to be progression-free. Participants without a post-BL tumor assessment, but known to be alive, were censored at the time of the first dose of study treatment. The 95% CI was determined using Kaplan-Meier methodology.
Outcome measures
| Measure |
CLB + R: All Participants
n=85 Participants
Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m\^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m\^2, IV, on Day 1 of Course 3, and 500 mg/m\^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to receive either rituximab, 375 mg/m\^2, IV, once every 8 weeks for up to 24 months (up to 12 infusions), or to be observed for up to 24 months with no further treatment.
|
CLB + R: Observation
Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m\^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m\^2, IV, on Day 1 of Course 3, and 500 mg/m\^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to be observed for up to 24 months and received no further treatment.
|
|---|---|---|
|
PFS
|
1059 days
Interval 1010.0 to 1205.0
|
—
|
SECONDARY outcome
Timeframe: Screening, Day 1 Courses 1-8 (4-week courses) and Day 1 of Courses 10-35 (4-week courses) for up to 35 months.Population: ITT population
Time to new CLL treatment (TTNT) was defined as the time from the first dose of study treatment to the date of new CLL treatment received or the date of death from any cause. Participants who did not receive new CLL treatment and were alive at the time of the analysis were censored at the date of the last follow-up assessment. Participants without a follow-up assessment were censored at the day of last dose of study treatment.
Outcome measures
| Measure |
CLB + R: All Participants
n=85 Participants
Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m\^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m\^2, IV, on Day 1 of Course 3, and 500 mg/m\^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to receive either rituximab, 375 mg/m\^2, IV, once every 8 weeks for up to 24 months (up to 12 infusions), or to be observed for up to 24 months with no further treatment.
|
CLB + R: Observation
Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m\^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m\^2, IV, on Day 1 of Course 3, and 500 mg/m\^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to be observed for up to 24 months and received no further treatment.
|
|---|---|---|
|
Number of Participants With New CLL Treatment or Death
|
22 participants
|
—
|
SECONDARY outcome
Timeframe: Screening, Day 1 Courses 1-8 (4-week courses) and Day 1 of Courses 10-35 (4-week courses) for up to 35 months.Population: ITT population
The mean time, in days, from the date of the first dose of study treatment to the date of new CLL treatment or the date of death from any cause. Participants who did not receive new CLL treatment and were alive at the time of the analysis were censored at the date of the last follow-up assessment. Participants without a follow-up assessment were censored at the day of last dose of study treatment. Mean survival time and it's standard error (SE) were underestimated because the largest observation was censored and the estimation was restricted to the largest event time.
Outcome measures
| Measure |
CLB + R: All Participants
n=85 Participants
Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m\^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m\^2, IV, on Day 1 of Course 3, and 500 mg/m\^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to receive either rituximab, 375 mg/m\^2, IV, once every 8 weeks for up to 24 months (up to 12 infusions), or to be observed for up to 24 months with no further treatment.
|
CLB + R: Observation
Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m\^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m\^2, IV, on Day 1 of Course 3, and 500 mg/m\^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to be observed for up to 24 months and received no further treatment.
|
|---|---|---|
|
Time to Next Treatment (TTNT)
|
1048.19 days
Standard Error 31.86
|
—
|
SECONDARY outcome
Timeframe: Screening, Day 1 Courses 1-8 (4-week courses) and Day 1 of Courses 10-35 (4-week courses) for up to 35 months.Population: ITT population
Overall Survival (OS) was defined as the time from the date of the first dose of study treatment to the date of death due to any cause. Participants were censored at the date of the last follow-up assessment. Participants without a follow-up assessment were censored at the day of last dose of study treatment.
Outcome measures
| Measure |
CLB + R: All Participants
n=85 Participants
Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m\^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m\^2, IV, on Day 1 of Course 3, and 500 mg/m\^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to receive either rituximab, 375 mg/m\^2, IV, once every 8 weeks for up to 24 months (up to 12 infusions), or to be observed for up to 24 months with no further treatment.
|
CLB + R: Observation
Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m\^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m\^2, IV, on Day 1 of Course 3, and 500 mg/m\^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to be observed for up to 24 months and received no further treatment.
|
|---|---|---|
|
Number of Participants Who Died
|
8 participants
|
—
|
SECONDARY outcome
Timeframe: Screening, Day 1 Courses 1-8 (4-week courses) and Day 1 of Courses 10-35 (4-week courses) for up to 35 months.Population: ITT population
The mean time, in days, from the date of the first dose of study treatment to the date of death due to any cause. Participants were censored at the date of the last follow-up assessment. Participants without a follow-up assessment were censored at the day of last dose of study treatment. The mean survival time and it's SE were underestimated because the largest observation was censored and the estimation was restricted to the largest event time.
Outcome measures
| Measure |
CLB + R: All Participants
n=85 Participants
Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m\^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m\^2, IV, on Day 1 of Course 3, and 500 mg/m\^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to receive either rituximab, 375 mg/m\^2, IV, once every 8 weeks for up to 24 months (up to 12 infusions), or to be observed for up to 24 months with no further treatment.
|
CLB + R: Observation
Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m\^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m\^2, IV, on Day 1 of Course 3, and 500 mg/m\^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to be observed for up to 24 months and received no further treatment.
|
|---|---|---|
|
OS
|
1135.04 days
Standard Error 24.25
|
—
|
SECONDARY outcome
Timeframe: Screening, Day 1 Courses 1-8 (4-week courses) and Day 1 of Courses 10-35 (4-week courses) for up to 35 months.Population: All randomized participants.
Duration of response was defined as the time from the date of the first documented CR, CRi, or PR to the date of disease progression or death. CR, CRi, PR, and PD as previously defined. Participants with no documented PD after CR, CRi, or PR were censored at the last date at which they were known to have had CR, CRi, or PR, respectively.
Outcome measures
| Measure |
CLB + R: All Participants
n=34 Participants
Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m\^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m\^2, IV, on Day 1 of Course 3, and 500 mg/m\^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to receive either rituximab, 375 mg/m\^2, IV, once every 8 weeks for up to 24 months (up to 12 infusions), or to be observed for up to 24 months with no further treatment.
|
CLB + R: Observation
n=32 Participants
Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m\^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m\^2, IV, on Day 1 of Course 3, and 500 mg/m\^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to be observed for up to 24 months and received no further treatment.
|
|---|---|---|
|
Number of Participants With PD or Death After a Confirmed CR, CRi, or PR
|
11 participants
|
15 participants
|
SECONDARY outcome
Timeframe: Screening, Day 1 Courses 1-8 (4-week courses) and Day 1 of Courses 10-35 (4-week courses) for up to 35 months.Population: All randomized participants.
The mean time, in days, from the date of first documented CR, CRi or PR to the date disease progression or death. CR, CRi, PR, and PD as previously defined. Participants with no documented PD after CR, CRi, or PR were censored at the last date at which they were known to have had CR, CRi, or PR, respectively.
Outcome measures
| Measure |
CLB + R: All Participants
n=34 Participants
Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m\^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m\^2, IV, on Day 1 of Course 3, and 500 mg/m\^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to receive either rituximab, 375 mg/m\^2, IV, once every 8 weeks for up to 24 months (up to 12 infusions), or to be observed for up to 24 months with no further treatment.
|
CLB + R: Observation
n=32 Participants
Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m\^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m\^2, IV, on Day 1 of Course 3, and 500 mg/m\^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to be observed for up to 24 months and received no further treatment.
|
|---|---|---|
|
Duration of Response
|
840.87 days
Standard Error 29.71
|
747.82 days
Standard Error 55.77
|
SECONDARY outcome
Timeframe: Screening, Day 1 Courses 1-8 (4-week courses) and Day 1 of Courses 10-35 (4-week courses) for up to 35 months.Population: All randomized participants with a confirmed CR or CRi were included in the analysis.
Disease-free survival was defined at the time from the date of first documented CR or CRi to the date of disease progression or death. CR, CRi, and PD as previously defined. Participants with no documented PD after CR or CRi were censored on the last date at which they were known to have had CR or CRi.
Outcome measures
| Measure |
CLB + R: All Participants
n=16 Participants
Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m\^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m\^2, IV, on Day 1 of Course 3, and 500 mg/m\^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to receive either rituximab, 375 mg/m\^2, IV, once every 8 weeks for up to 24 months (up to 12 infusions), or to be observed for up to 24 months with no further treatment.
|
CLB + R: Observation
n=15 Participants
Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m\^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m\^2, IV, on Day 1 of Course 3, and 500 mg/m\^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to be observed for up to 24 months and received no further treatment.
|
|---|---|---|
|
Number of Participants With PD or Death After a Confirmed CR/CRi
|
2 participants
|
8 participants
|
SECONDARY outcome
Timeframe: Screening, Day 1 Courses 1-8 (4-week courses) and Day 1 of Courses 10-35 (4-week courses) for up to 35 months.Population: All randomized participants.
The mean time, in days, from the date of first documented CR or CRi to the date of disease progression or death. CR, CRi, and PD as previously defined. Participants with no documented PD after CR or CRi were censored on the last date at which they were known to have had CR or CRi. In both groups, the mean survival time and its standard error were underestimated because the largest observation was censored and the estimation was restricted to the largest event time.
Outcome measures
| Measure |
CLB + R: All Participants
n=34 Participants
Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m\^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m\^2, IV, on Day 1 of Course 3, and 500 mg/m\^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to receive either rituximab, 375 mg/m\^2, IV, once every 8 weeks for up to 24 months (up to 12 infusions), or to be observed for up to 24 months with no further treatment.
|
CLB + R: Observation
n=32 Participants
Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m\^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m\^2, IV, on Day 1 of Course 3, and 500 mg/m\^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to be observed for up to 24 months and received no further treatment.
|
|---|---|---|
|
Disease-Free Survival
|
699.91 days
Standard Error 68.89
|
732.28 days
Standard Error 63.37
|
Adverse Events
CLB + R: Induction Treatment
Serious events: 17 serious events
Other events: 73 other events
Deaths: 0 deaths
CLB + R: Maintenance Treatment
Serious events: 4 serious events
Other events: 25 other events
Deaths: 0 deaths
CLB + R: Observation
Serious events: 4 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CLB + R: Induction Treatment
n=97 participants at risk
Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m\^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m\^2, IV, on Day 1 of Course 3, and 500 mg/m\^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to receive either rituximab, 375 mg/m\^2, IV, once every 8 weeks for up to 24 months (up to 12 infusions), or to be observed for up to 24 months with no further treatment.
|
CLB + R: Maintenance Treatment
n=34 participants at risk
Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m\^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m\^2, IV, on Day 1 of Course 3, and 500 mg/m\^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to receive rituximab, 375 mg/m\^2, IV, once every 8 weeks for a total of 12 infusions for up to 24 months.
|
CLB + R: Observation
n=32 participants at risk
Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m\^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m\^2, IV, on Day 1 of Course 3, and 500 mg/m\^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to be observed for up to 24 months and received no further treatment.
|
|---|---|---|---|
|
Infections and infestations
Pneumonia
|
0.00%
0/97 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
2.9%
1/34 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/32 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/97 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/34 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
3.1%
1/32 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
|
Blood and lymphatic system disorders
Anaemia
|
2.1%
2/97 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/34 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/32 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
|
Blood and lymphatic system disorders
Haemorrhagic anaemia
|
1.0%
1/97 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/34 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
3.1%
1/32 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
|
Cardiac disorders
Atrial fibrillation
|
1.0%
1/97 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/34 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/32 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
|
Cardiac disorders
Cardiac failure
|
1.0%
1/97 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/34 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/32 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.0%
1/97 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/34 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/32 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
|
General disorders
Death
|
1.0%
1/97 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/34 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/32 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
|
General disorders
Pyrexia
|
1.0%
1/97 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/34 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
3.1%
1/32 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
|
Infections and infestations
Herpes zoster oticus
|
1.0%
1/97 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/34 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/32 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
1.0%
1/97 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/34 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/32 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.0%
1/97 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/34 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/32 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer
|
1.0%
1/97 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/34 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/32 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mixed oligo-astrocytoma
|
1.0%
1/97 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/34 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/32 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
|
Nervous system disorders
Epilepsy
|
1.0%
1/97 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/34 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/32 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
|
Nervous system disorders
Transient ischaemic attack
|
1.0%
1/97 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/34 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/32 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.0%
1/97 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/34 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/32 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
1.0%
1/97 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/34 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/32 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
|
Skin and subcutaneous tissue disorders
Toxic skin eruption
|
1.0%
1/97 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/34 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/32 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
|
Blood and lymphatic system disorders
Neutropenia
|
1.0%
1/97 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
2.9%
1/34 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/32 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/97 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/34 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
3.1%
1/32 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/97 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
2.9%
1/34 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
3.1%
1/32 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Porocarcinoma
|
0.00%
0/97 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
2.9%
1/34 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/32 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.00%
0/97 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
2.9%
1/34 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/32 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
|
Blood and lymphatic system disorders
Haemolytic anaemia
|
0.00%
0/97 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/34 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
3.1%
1/32 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
Other adverse events
| Measure |
CLB + R: Induction Treatment
n=97 participants at risk
Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m\^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m\^2, IV, on Day 1 of Course 3, and 500 mg/m\^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to receive either rituximab, 375 mg/m\^2, IV, once every 8 weeks for up to 24 months (up to 12 infusions), or to be observed for up to 24 months with no further treatment.
|
CLB + R: Maintenance Treatment
n=34 participants at risk
Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m\^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m\^2, IV, on Day 1 of Course 3, and 500 mg/m\^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to receive rituximab, 375 mg/m\^2, IV, once every 8 weeks for a total of 12 infusions for up to 24 months.
|
CLB + R: Observation
n=32 participants at risk
Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m\^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m\^2, IV, on Day 1 of Course 3, and 500 mg/m\^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to be observed for up to 24 months and received no further treatment.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
14.4%
14/97 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/34 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
3.1%
1/32 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
|
Blood and lymphatic system disorders
Leukopenia
|
5.2%
5/97 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
2.9%
1/34 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/32 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
2.1%
2/97 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
5.9%
2/34 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
12.5%
4/32 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
|
Blood and lymphatic system disorders
Neutropenia
|
32.0%
31/97 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
14.7%
5/34 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
3.1%
1/32 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
|
Blood and lymphatic system disorders
Splenomegaly
|
1.0%
1/97 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/34 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
6.2%
2/32 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
16.5%
16/97 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
2.9%
1/34 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
3.1%
1/32 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
|
Blood and lymphatic system disorders
Lymphocytosis
|
0.00%
0/97 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/34 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
6.2%
2/32 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/97 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
2.9%
1/34 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/32 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
|
Cardiac disorders
Angina pectoris
|
1.0%
1/97 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/34 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/32 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
|
Cardiac disorders
Atrial fibrillation
|
1.0%
1/97 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/34 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
3.1%
1/32 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
|
Cardiac disorders
Hypertensive cardiomyopathy
|
1.0%
1/97 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/34 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/32 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
|
Cardiac disorders
Sinus tachycardia
|
1.0%
1/97 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/34 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/32 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
|
Cardiac disorders
Tachycardia
|
1.0%
1/97 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/34 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
3.1%
1/32 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
|
Ear and labyrinth disorders
Vertigo
|
1.0%
1/97 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/34 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/32 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/97 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
2.9%
1/34 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/32 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
|
Gastrointestinal disorders
Abdominal distension
|
1.0%
1/97 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/34 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/32 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
|
Gastrointestinal disorders
Abdominal pain
|
3.1%
3/97 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/34 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/32 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.0%
1/97 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
2.9%
1/34 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/32 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
|
Gastrointestinal disorders
Constipation
|
2.1%
2/97 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/34 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/32 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
|
Gastrointestinal disorders
Diarrhoea
|
4.1%
4/97 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/34 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/32 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
|
Gastrointestinal disorders
Dyskinesia oesophageal
|
1.0%
1/97 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/34 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/32 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
|
Gastrointestinal disorders
Dyspepsia
|
1.0%
1/97 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/34 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/32 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
|
Gastrointestinal disorders
Hiatus hernia
|
1.0%
1/97 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/34 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/32 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
|
Gastrointestinal disorders
Nausea
|
7.2%
7/97 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/34 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
3.1%
1/32 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
|
Gastrointestinal disorders
Reflux oesophagitis
|
1.0%
1/97 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/34 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/32 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
|
Gastrointestinal disorders
Vomiting
|
4.1%
4/97 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/34 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/32 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
|
General disorders
Asthenia
|
4.1%
4/97 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
2.9%
1/34 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/32 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
|
General disorders
Chest pain
|
3.1%
3/97 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/34 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/32 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
|
General disorders
Chills
|
2.1%
2/97 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/34 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/32 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
|
General disorders
Face oedema
|
1.0%
1/97 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/34 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/32 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
|
General disorders
Fatigue
|
5.2%
5/97 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/34 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
9.4%
3/32 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
|
General disorders
Hyperpyrexia
|
1.0%
1/97 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/34 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/32 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
|
General disorders
Influenza like illness
|
3.1%
3/97 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/34 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
3.1%
1/32 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
|
General disorders
Infusion related reaction
|
6.2%
6/97 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/34 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/32 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
|
General disorders
Mucosal inflammation
|
1.0%
1/97 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/34 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/32 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
|
General disorders
Oedema peripheral
|
2.1%
2/97 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
5.9%
2/34 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/32 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
|
General disorders
Pyrexia
|
11.3%
11/97 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/34 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
6.2%
2/32 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
|
Hepatobiliary disorders
Hepatomegaly
|
1.0%
1/97 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/34 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
3.1%
1/32 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
|
Immune system disorders
Hypersensitivity
|
1.0%
1/97 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
2.9%
1/34 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/32 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
|
Immune system disorders
Multiple allergies
|
1.0%
1/97 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/34 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/32 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
|
Infections and infestations
Cellulitis
|
1.0%
1/97 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/34 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/32 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
|
Infections and infestations
Conjunctivitis bacterial
|
1.0%
1/97 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
5.9%
2/34 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/32 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
|
Infections and infestations
Cystitis
|
1.0%
1/97 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/34 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/32 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
|
Infections and infestations
Fungal infection
|
2.1%
2/97 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/34 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/32 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
|
Infections and infestations
Herpes simplex
|
3.1%
3/97 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/34 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
3.1%
1/32 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
|
Infections and infestations
Herpes zoster oticus
|
1.0%
1/97 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
2.9%
1/34 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
6.2%
2/32 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
|
Infections and infestations
Nasopharyngitis
|
2.1%
2/97 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
2.9%
1/34 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
3.1%
1/32 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
|
Infections and infestations
Pharyngitis
|
2.1%
2/97 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/34 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
3.1%
1/32 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
|
Infections and infestations
Productive cough
|
1.0%
1/97 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/34 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/32 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
|
Infections and infestations
Pyrexia
|
1.0%
1/97 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/34 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/32 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
1.0%
1/97 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
2.9%
1/34 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/32 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
1.0%
1/97 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/34 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/32 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
|
Investigations
Breath sounds abnormal
|
1.0%
1/97 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/34 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/32 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
|
Investigations
Platelet count decreased
|
1.0%
1/97 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/34 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/32 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
|
Investigations
Transaminases increased
|
1.0%
1/97 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/34 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
3.1%
1/32 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
|
Metabolism and nutrition disorders
Anorexia
|
1.0%
1/97 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/34 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/32 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
2.1%
2/97 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/34 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
3.1%
1/32 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
1.0%
1/97 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/34 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/32 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
1.0%
1/97 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
2.9%
1/34 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
6.2%
2/32 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.1%
2/97 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
2.9%
1/34 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/32 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.1%
4/97 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
5.9%
2/34 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/32 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
1.0%
1/97 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/34 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/32 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.0%
1/97 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/34 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/32 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
|
Nervous system disorders
Headache
|
1.0%
1/97 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/34 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/32 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
|
Nervous system disorders
Memory impairment
|
1.0%
1/97 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/34 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/32 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
|
Nervous system disorders
Neuropathy peripheral
|
1.0%
1/97 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/34 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/32 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
|
Nervous system disorders
Syncope
|
1.0%
1/97 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/34 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/32 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
|
Renal and urinary disorders
Bladder disorder
|
1.0%
1/97 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/34 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/32 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
|
Renal and urinary disorders
Dysuria
|
1.0%
1/97 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/34 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
3.1%
1/32 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.2%
5/97 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
8.8%
3/34 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
3.1%
1/32 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.1%
3/97 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/34 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/32 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal septum perforation
|
1.0%
1/97 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/34 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/32 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal discomfort
|
2.1%
2/97 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/34 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
3.1%
1/32 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillar hypertrophy
|
1.0%
1/97 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/34 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/32 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
2.1%
2/97 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/34 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/32 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
1.0%
1/97 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/34 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
3.1%
1/32 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.2%
5/97 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/34 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/32 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.1%
2/97 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/34 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/32 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
2.1%
2/97 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/34 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/32 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
1.0%
1/97 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/34 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/32 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
|
Vascular disorders
Deep vein thrombosis
|
1.0%
1/97 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/34 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/32 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
|
Vascular disorders
Hypertension
|
2.1%
2/97 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
5.9%
2/34 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
3.1%
1/32 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
|
Vascular disorders
Hypotension
|
3.1%
3/97 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/34 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/32 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
|
Endocrine disorders
Thyroid disorder
|
0.00%
0/97 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
2.9%
1/34 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/32 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
|
Endocrine disorders
Thyroiditis
|
0.00%
0/97 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
2.9%
1/34 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/32 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/97 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/34 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
3.1%
1/32 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/97 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/34 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
3.1%
1/32 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/97 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
2.9%
1/34 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/32 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/97 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
2.9%
1/34 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/32 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
|
Gastrointestinal disorders
Tongue dry
|
0.00%
0/97 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/34 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
3.1%
1/32 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
|
General disorders
Cyst
|
0.00%
0/97 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/34 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
3.1%
1/32 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
|
General disorders
Pain
|
0.00%
0/97 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/34 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
3.1%
1/32 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/97 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
11.8%
4/34 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
3.1%
1/32 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/97 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/34 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
3.1%
1/32 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
|
Infections and infestations
Hepatitis B
|
0.00%
0/97 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/34 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
3.1%
1/32 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/97 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/34 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
3.1%
1/32 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
|
Infections and infestations
Pilonidal cyst
|
0.00%
0/97 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/34 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
3.1%
1/32 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/97 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
2.9%
1/34 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/32 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/97 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
2.9%
1/34 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/32 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
|
Investigations
Blood creatine increased
|
0.00%
0/97 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/34 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
3.1%
1/32 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/97 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
5.9%
2/34 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/32 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
|
Investigations
Weight decreased
|
0.00%
0/97 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/34 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
3.1%
1/32 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/97 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/34 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
6.2%
2/32 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/97 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
2.9%
1/34 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/32 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/97 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
2.9%
1/34 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/32 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/97 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
2.9%
1/34 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/32 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/97 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/34 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
3.1%
1/32 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
|
Renal and urinary disorders
Micturition urgency
|
0.00%
0/97 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/34 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
3.1%
1/32 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/97 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
2.9%
1/34 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/32 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
|
Reproductive system and breast disorders
Gynaecomastia
|
0.00%
0/97 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
2.9%
1/34 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/32 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
|
Reproductive system and breast disorders
Peyronie's disease
|
0.00%
0/97 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
2.9%
1/34 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/32 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/97 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
2.9%
1/34 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/32 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
|
Skin and subcutaneous tissue disorders
Pemphigoid
|
0.00%
0/97 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
2.9%
1/34 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/32 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
|
Surgical and medical procedures
Haemorrhoid operation
|
0.00%
0/97 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/34 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
3.1%
1/32 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
|
Surgical and medical procedures
Knee operation
|
0.00%
0/97 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/34 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
3.1%
1/32 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
|
Vascular disorders
Carotid artery stenosis
|
0.00%
0/97 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
2.9%
1/34 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
3.1%
1/32 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
|
Blood and lymphatic system disorders
Haemolytic anaemia
|
0.00%
0/97 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
0.00%
0/34 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
3.1%
1/32 • Adverse events (AEs) were recorded from Screening through the Final Visit or withdrawal from study, approximately 35 months.
All participants who received at least 1 dose of chlorambucil or rituximab were included in the analysis.
|
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