Trial Outcomes & Findings for Fludarabine, Cyclophosphamide, and Rituximab Versus Pentostatin, Cyclophosphamide, and Rituximab in Previously Untreated or Treated B-Cell Chronic Lymphocytic Leukemia Patients (NCT NCT00254163)

NCT ID: NCT00254163

Last Updated: 2016-11-03

Results Overview

infection=febrile events requiring treatment

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 184 participants
• Primary outcome timeframe: 6 cycles of 28-day for FCR and 8 cycles of 21-day for PCR, or until PD, CR, or intolerable toxicity
• Results posted on: 2016-11-03

Participant Flow

Participant milestones

Measure	FCR Arm Fludarabine, Cyclophosphamide, and Rituximab	PCR Arm Pentostatin, Cyclophosphamide, and Rituximab
Overall Study STARTED	92	92
Overall Study COMPLETED	47	46
Overall Study NOT COMPLETED	45	46

Reasons for withdrawal

Measure	FCR Arm Fludarabine, Cyclophosphamide, and Rituximab	PCR Arm Pentostatin, Cyclophosphamide, and Rituximab
Overall Study Adverse Event	29	26
Overall Study Patient request/withdrew consent	6	4
Overall Study Investigator request	1	3
Overall Study Failed entry	1	3
Overall Study Progressive disease	0	1
Overall Study Death	0	1
Overall Study Other	8	8

Baseline Characteristics

Fludarabine, Cyclophosphamide, and Rituximab Versus Pentostatin, Cyclophosphamide, and Rituximab in Previously Untreated or Treated B-Cell Chronic Lymphocytic Leukemia Patients

Baseline characteristics by cohort

Measure	FCR Arm n=92 Participants Fludarabine, Cyclophosphamide, and Rituximab	PCR Arm n=92 Participants Pentostatin, Cyclophosphamide, and Rituximab	Total n=184 Participants Total of all reporting groups
Age, Continuous	63.3 years STANDARD_DEVIATION 10.2 • n=5 Participants	63.6 years STANDARD_DEVIATION 9.9 • n=7 Participants	63.5 years STANDARD_DEVIATION 10.0 • n=5 Participants
Sex: Female, Male Female	27 Participants n=5 Participants	22 Participants n=7 Participants	49 Participants n=5 Participants
Sex: Female, Male Male	65 Participants n=5 Participants	70 Participants n=7 Participants	135 Participants n=5 Participants
Race/Ethnicity, Customized Caucasion	81 participants n=5 Participants	84 participants n=7 Participants	165 participants n=5 Participants
Race/Ethnicity, Customized Black	7 participants n=5 Participants	5 participants n=7 Participants	12 participants n=5 Participants
Race/Ethnicity, Customized Hispanic	2 participants n=5 Participants	3 participants n=7 Participants	5 participants n=5 Participants
Race/Ethnicity, Customized Mixed: Black/Indian	2 participants n=5 Participants	0 participants n=7 Participants	2 participants n=5 Participants
Region of Enrollment United States	92 participants n=5 Participants	92 participants n=7 Participants	184 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 cycles of 28-day for FCR and 8 cycles of 21-day for PCR, or until PD, CR, or intolerable toxicity

Population: Per protocol population

infection=febrile events requiring treatment

Outcome measures

Measure	FCR Arm n=86 Participants Fludarabine, Cyclophosphamide, and Rituximab	PCR Arm n=85 Participants Pentostatin, Cyclophosphamide, and Rituximab
Infection Rate	31.4 percentage of participants Interval 21.8 to 42.3	36.5 percentage of participants Interval 26.3 to 47.6

SECONDARY outcome

Timeframe: 6 cycles of 28-day for FCR and 8 cycles of 21-day for PCR, or until PD, CR, or intolerable toxicity

Population: Per protocol population

infective events=temperature >101 without symptoms or temp <101 with symptoms

Outcome measures

Measure	FCR Arm n=86 Participants Fludarabine, Cyclophosphamide, and Rituximab	PCR Arm n=85 Participants Pentostatin, Cyclophosphamide, and Rituximab
Infective Event Rate	38 percentage of infective events	45 percentage of infective events

SECONDARY outcome

Timeframe: 6 cycles of 28-day for FCR and 8 cycles of 21-day for PCR, or until PD, CR, or intolerable toxicity

Population: Per protocol population

Percentage of patients who were hospitalized due to any reasons during the study period.

Outcome measures

Measure	FCR Arm n=86 Participants Fludarabine, Cyclophosphamide, and Rituximab	PCR Arm n=85 Participants Pentostatin, Cyclophosphamide, and Rituximab
Percentage of Patients Hospitalized	35 percentage of participants	43.5 percentage of participants

SECONDARY outcome

Timeframe: 2 months post-treatment

Population: Per protocol population

defined as Hb >11g/dL and a platelet count >100 × 10^3/mm^3

Outcome measures

Measure	FCR Arm n=86 Participants Fludarabine, Cyclophosphamide, and Rituximab	PCR Arm n=85 Participants Pentostatin, Cyclophosphamide, and Rituximab
Hematologic Recovery	3.5 percentage of participants Interval 0.7 to 9.9	14.1 percentage of participants Interval 7.5 to 23.4

SECONDARY outcome

Timeframe: 2 months post-treatment

Population: Per protocol population

mean Absolute Neutrophil Count (ANC) measured 2 months (8-10 weeks) following the last dose of study treatment

Outcome measures

Measure	FCR Arm n=86 Participants Fludarabine, Cyclophosphamide, and Rituximab	PCR Arm n=85 Participants Pentostatin, Cyclophosphamide, and Rituximab
Mean Absolute Neutrophil Count (ANC) at Post-treatment	1.7 10^3 cells/mm^3 Standard Deviation 0.9	2.2 10^3 cells/mm^3 Standard Deviation 1.6

SECONDARY outcome

Timeframe: 6 cycles of 28-day for FCR and 8 cycles of 21-day for PCR, or until PD, CR, or intolerable toxicity

Population: Per protocol population

Definitions of response is evaluated using guidelines proposed by the National Cancer Institute-Sponsored Working Group for Chronic Lymphocytic Leukemia.

Complete remission (CR) requires all of the following for a period of at least 2 months:

1. Absence of lymphadenopathy by physical examination and appropriate radiographic techniques. Lymph nodes must be <1 cm.

2. No evidence of hepatomegaly or splenomegaly.

3. Absence of constitutional symptoms.

4. Normal CBC as exhibited by:

• Polymorphonuclear leukocytes ≥ 1,500/mm^3
• Platelets > 100,000/mm^3
• Hemoglobin > 11.0 g/dL (untransfused)

5. Bone marrow aspirate and biopsy should be performed 2 months after clinical and laboratory results demonstrate that all of the requirements listed in 1-4 have been met to demonstrate that a CR has been achieved. The marrow sample must be at least normocellular for age, with less than 30% of the nucleated cells being lymphocytes.

Lymphoid nodules should be absent.

Outcome measures

Measure	FCR Arm n=86 Participants Fludarabine, Cyclophosphamide, and Rituximab	PCR Arm n=85 Participants Pentostatin, Cyclophosphamide, and Rituximab
Complete Remission (CR)	14.0 percentage of participants Interval 7.4 to 23.1	7.1 percentage of participants Interval 2.6 to 14.7

SECONDARY outcome

Timeframe: 6 cycles of 28-day for FCR and 8 cycles of 21-day for PCR, or until PD, CR, or intolerable toxicity

Population: Per protocol population

Complete remission (CR) see Outcome Measure 6. Partial remission (PR) must exhibit criteria 1 and 2 as well as one or more of the remaining features for at least 2 months.

1. ≥50% decrease in peripheral blood lymphocyte count from the pretreatment baseline value.

2. ≥50% reduction in lymphadenopathy.

3. ≥50% reduction in the size of the liver and/or spleen.

4. Polymorphonuclear leukocytes ≥ 1,500/mm^3 or 50% improvement over baseline.

5. Platelets >100,000/mm^3 or 50% improvement over baseline.

6. Hemoglobin >11.0 g/dL or 50% improvement over baseline without transfusions. Nodular partial remission (nPR) is defined as a CR with persistent bone marrow nodules; Objective Remission (OR) = CR + PR + nPR.

Outcome measures

Measure	FCR Arm n=86 Participants Fludarabine, Cyclophosphamide, and Rituximab	PCR Arm n=85 Participants Pentostatin, Cyclophosphamide, and Rituximab
Objective Remission Rate (ORR)	59.3 percentage of participants Interval 48.2 to 69.8	49.4 percentage of participants Interval 38.4 to 60.5

SECONDARY outcome

Timeframe: 12 months after registered.

Population: Per protocol population

PFS is measured from the date of randomization to the date of first documented disease progression or date of death, whichever comes first. If a patient neither progresses nor dies, this patient will be censored at last contact date

Outcome measures

Measure	FCR Arm n=86 Participants Fludarabine, Cyclophosphamide, and Rituximab	PCR Arm n=85 Participants Pentostatin, Cyclophosphamide, and Rituximab
Progression-free Survival (PFS) Rate at 1-year	0.86 probability of Progression-free Survival Interval 0.76 to 0.92	0.84 probability of Progression-free Survival Interval 0.74 to 0.9

SECONDARY outcome

Timeframe: 24 months after registered.

Population: Per protocol population

PFS is measured from the date of randomization to the date of first documented disease progression or date of death, whichever comes first. If a patient neither progresses nor dies, this patient will be censored at last contact date.

Outcome measures

Measure	FCR Arm n=86 Participants Fludarabine, Cyclophosphamide, and Rituximab	PCR Arm n=85 Participants Pentostatin, Cyclophosphamide, and Rituximab
Progression-free Survival (PFS) Rate at 2-year	0.72 Probability of Progression-free Survival Interval 0.6 to 0.81	0.63 Probability of Progression-free Survival Interval 0.51 to 0.73

Adverse Events

FCR Arm

Serious events: 18 serious events

Other events: 86 other events

Deaths: 0 deaths

PCR Arm

Serious events: 22 serious events

Other events: 87 other events

Deaths: 0 deaths

Serious adverse events

Measure	FCR Arm n=88 participants at risk Fludarabine, Cyclophosphamide, and Rituximab	PCR Arm n=89 participants at risk Pentostatin, Cyclophosphamide, and Rituximab
Gastrointestinal disorders ABDO ENLARGE	1.1% 1/88 • Number of events 1 • During the whole treatment period, up to 30 days following last dose. The safety population, which received at least one of study treatment, was included in the analysis of adverse event. Patients included in this study were 88 and 89 in FCR arm and PCR arm, respectively.	0.00% 0/89 • During the whole treatment period, up to 30 days following last dose. The safety population, which received at least one of study treatment, was included in the analysis of adverse event. Patients included in this study were 88 and 89 in FCR arm and PCR arm, respectively.
Metabolism and nutrition disorders ACIDOSIS	0.00% 0/88 • During the whole treatment period, up to 30 days following last dose. The safety population, which received at least one of study treatment, was included in the analysis of adverse event. Patients included in this study were 88 and 89 in FCR arm and PCR arm, respectively.	1.1% 1/89 • Number of events 1 • During the whole treatment period, up to 30 days following last dose. The safety population, which received at least one of study treatment, was included in the analysis of adverse event. Patients included in this study were 88 and 89 in FCR arm and PCR arm, respectively.
Immune system disorders ALLERG REACT	1.1% 1/88 • Number of events 1 • During the whole treatment period, up to 30 days following last dose. The safety population, which received at least one of study treatment, was included in the analysis of adverse event. Patients included in this study were 88 and 89 in FCR arm and PCR arm, respectively.	0.00% 0/89 • During the whole treatment period, up to 30 days following last dose. The safety population, which received at least one of study treatment, was included in the analysis of adverse event. Patients included in this study were 88 and 89 in FCR arm and PCR arm, respectively.
Blood and lymphatic system disorders ANEMIA	1.1% 1/88 • Number of events 1 • During the whole treatment period, up to 30 days following last dose. The safety population, which received at least one of study treatment, was included in the analysis of adverse event. Patients included in this study were 88 and 89 in FCR arm and PCR arm, respectively.	1.1% 1/89 • Number of events 1 • During the whole treatment period, up to 30 days following last dose. The safety population, which received at least one of study treatment, was included in the analysis of adverse event. Patients included in this study were 88 and 89 in FCR arm and PCR arm, respectively.
Cardiac disorders CARDIOVASC DIS	0.00% 0/88 • During the whole treatment period, up to 30 days following last dose. The safety population, which received at least one of study treatment, was included in the analysis of adverse event. Patients included in this study were 88 and 89 in FCR arm and PCR arm, respectively.	1.1% 1/89 • Number of events 1 • During the whole treatment period, up to 30 days following last dose. The safety population, which received at least one of study treatment, was included in the analysis of adverse event. Patients included in this study were 88 and 89 in FCR arm and PCR arm, respectively.
Infections and infestations CELLULITIS	1.1% 1/88 • Number of events 1 • During the whole treatment period, up to 30 days following last dose. The safety population, which received at least one of study treatment, was included in the analysis of adverse event. Patients included in this study were 88 and 89 in FCR arm and PCR arm, respectively.	0.00% 0/89 • During the whole treatment period, up to 30 days following last dose. The safety population, which received at least one of study treatment, was included in the analysis of adverse event. Patients included in this study were 88 and 89 in FCR arm and PCR arm, respectively.
Gastrointestinal disorders COLITIS	0.00% 0/88 • During the whole treatment period, up to 30 days following last dose. The safety population, which received at least one of study treatment, was included in the analysis of adverse event. Patients included in this study were 88 and 89 in FCR arm and PCR arm, respectively.	1.1% 1/89 • Number of events 1 • During the whole treatment period, up to 30 days following last dose. The safety population, which received at least one of study treatment, was included in the analysis of adverse event. Patients included in this study were 88 and 89 in FCR arm and PCR arm, respectively.
General disorders CHEST PAIN	0.00% 0/88 • During the whole treatment period, up to 30 days following last dose. The safety population, which received at least one of study treatment, was included in the analysis of adverse event. Patients included in this study were 88 and 89 in FCR arm and PCR arm, respectively.	2.2% 2/89 • Number of events 2 • During the whole treatment period, up to 30 days following last dose. The safety population, which received at least one of study treatment, was included in the analysis of adverse event. Patients included in this study were 88 and 89 in FCR arm and PCR arm, respectively.
General disorders CONFUS	0.00% 0/88 • During the whole treatment period, up to 30 days following last dose. The safety population, which received at least one of study treatment, was included in the analysis of adverse event. Patients included in this study were 88 and 89 in FCR arm and PCR arm, respectively.	1.1% 1/89 • Number of events 1 • During the whole treatment period, up to 30 days following last dose. The safety population, which received at least one of study treatment, was included in the analysis of adverse event. Patients included in this study were 88 and 89 in FCR arm and PCR arm, respectively.
Respiratory, thoracic and mediastinal disorders COUGH INC	0.00% 0/88 • During the whole treatment period, up to 30 days following last dose. The safety population, which received at least one of study treatment, was included in the analysis of adverse event. Patients included in this study were 88 and 89 in FCR arm and PCR arm, respectively.	1.1% 1/89 • Number of events 1 • During the whole treatment period, up to 30 days following last dose. The safety population, which received at least one of study treatment, was included in the analysis of adverse event. Patients included in this study were 88 and 89 in FCR arm and PCR arm, respectively.
Gastrointestinal disorders DEHYDRAT	0.00% 0/88 • During the whole treatment period, up to 30 days following last dose. The safety population, which received at least one of study treatment, was included in the analysis of adverse event. Patients included in this study were 88 and 89 in FCR arm and PCR arm, respectively.	3.4% 3/89 • Number of events 3 • During the whole treatment period, up to 30 days following last dose. The safety population, which received at least one of study treatment, was included in the analysis of adverse event. Patients included in this study were 88 and 89 in FCR arm and PCR arm, respectively.
Gastrointestinal disorders DIARRHEA	1.1% 1/88 • Number of events 1 • During the whole treatment period, up to 30 days following last dose. The safety population, which received at least one of study treatment, was included in the analysis of adverse event. Patients included in this study were 88 and 89 in FCR arm and PCR arm, respectively.	0.00% 0/89 • During the whole treatment period, up to 30 days following last dose. The safety population, which received at least one of study treatment, was included in the analysis of adverse event. Patients included in this study were 88 and 89 in FCR arm and PCR arm, respectively.
Respiratory, thoracic and mediastinal disorders DYSPNEA	0.00% 0/88 • During the whole treatment period, up to 30 days following last dose. The safety population, which received at least one of study treatment, was included in the analysis of adverse event. Patients included in this study were 88 and 89 in FCR arm and PCR arm, respectively.	4.5% 4/89 • Number of events 4 • During the whole treatment period, up to 30 days following last dose. The safety population, which received at least one of study treatment, was included in the analysis of adverse event. Patients included in this study were 88 and 89 in FCR arm and PCR arm, respectively.
Blood and lymphatic system disorders EDEMA	0.00% 0/88 • During the whole treatment period, up to 30 days following last dose. The safety population, which received at least one of study treatment, was included in the analysis of adverse event. Patients included in this study were 88 and 89 in FCR arm and PCR arm, respectively.	1.1% 1/89 • Number of events 1 • During the whole treatment period, up to 30 days following last dose. The safety population, which received at least one of study treatment, was included in the analysis of adverse event. Patients included in this study were 88 and 89 in FCR arm and PCR arm, respectively.
Respiratory, thoracic and mediastinal disorders EDEMA LUNG	1.1% 1/88 • Number of events 1 • During the whole treatment period, up to 30 days following last dose. The safety population, which received at least one of study treatment, was included in the analysis of adverse event. Patients included in this study were 88 and 89 in FCR arm and PCR arm, respectively.	0.00% 0/89 • During the whole treatment period, up to 30 days following last dose. The safety population, which received at least one of study treatment, was included in the analysis of adverse event. Patients included in this study were 88 and 89 in FCR arm and PCR arm, respectively.
Respiratory, thoracic and mediastinal disorders EFFUS PLEURAL	0.00% 0/88 • During the whole treatment period, up to 30 days following last dose. The safety population, which received at least one of study treatment, was included in the analysis of adverse event. Patients included in this study were 88 and 89 in FCR arm and PCR arm, respectively.	1.1% 1/89 • Number of events 1 • During the whole treatment period, up to 30 days following last dose. The safety population, which received at least one of study treatment, was included in the analysis of adverse event. Patients included in this study were 88 and 89 in FCR arm and PCR arm, respectively.
Blood and lymphatic system disorders FEBRILE NEUTROPENIA	5.7% 5/88 • Number of events 5 • During the whole treatment period, up to 30 days following last dose. The safety population, which received at least one of study treatment, was included in the analysis of adverse event. Patients included in this study were 88 and 89 in FCR arm and PCR arm, respectively.	5.6% 5/89 • Number of events 5 • During the whole treatment period, up to 30 days following last dose. The safety population, which received at least one of study treatment, was included in the analysis of adverse event. Patients included in this study were 88 and 89 in FCR arm and PCR arm, respectively.
General disorders FEVER	6.8% 6/88 • Number of events 7 • During the whole treatment period, up to 30 days following last dose. The safety population, which received at least one of study treatment, was included in the analysis of adverse event. Patients included in this study were 88 and 89 in FCR arm and PCR arm, respectively.	5.6% 5/89 • Number of events 7 • During the whole treatment period, up to 30 days following last dose. The safety population, which received at least one of study treatment, was included in the analysis of adverse event. Patients included in this study were 88 and 89 in FCR arm and PCR arm, respectively.
Cardiac disorders HEART FAIL RIGHT	0.00% 0/88 • During the whole treatment period, up to 30 days following last dose. The safety population, which received at least one of study treatment, was included in the analysis of adverse event. Patients included in this study were 88 and 89 in FCR arm and PCR arm, respectively.	1.1% 1/89 • Number of events 1 • During the whole treatment period, up to 30 days following last dose. The safety population, which received at least one of study treatment, was included in the analysis of adverse event. Patients included in this study were 88 and 89 in FCR arm and PCR arm, respectively.
Skin and subcutaneous tissue disorders HYPOXIA	1.1% 1/88 • Number of events 1 • During the whole treatment period, up to 30 days following last dose. The safety population, which received at least one of study treatment, was included in the analysis of adverse event. Patients included in this study were 88 and 89 in FCR arm and PCR arm, respectively.	1.1% 1/89 • Number of events 1 • During the whole treatment period, up to 30 days following last dose. The safety population, which received at least one of study treatment, was included in the analysis of adverse event. Patients included in this study were 88 and 89 in FCR arm and PCR arm, respectively.
Immune system disorders IMMUNOGLOBUL DEC	1.1% 1/88 • Number of events 1 • During the whole treatment period, up to 30 days following last dose. The safety population, which received at least one of study treatment, was included in the analysis of adverse event. Patients included in this study were 88 and 89 in FCR arm and PCR arm, respectively.	0.00% 0/89 • During the whole treatment period, up to 30 days following last dose. The safety population, which received at least one of study treatment, was included in the analysis of adverse event. Patients included in this study were 88 and 89 in FCR arm and PCR arm, respectively.
Infections and infestations INFECT	1.1% 1/88 • Number of events 1 • During the whole treatment period, up to 30 days following last dose. The safety population, which received at least one of study treatment, was included in the analysis of adverse event. Patients included in this study were 88 and 89 in FCR arm and PCR arm, respectively.	2.2% 2/89 • Number of events 2 • During the whole treatment period, up to 30 days following last dose. The safety population, which received at least one of study treatment, was included in the analysis of adverse event. Patients included in this study were 88 and 89 in FCR arm and PCR arm, respectively.
Renal and urinary disorders KIDNEY FAIL	0.00% 0/88 • During the whole treatment period, up to 30 days following last dose. The safety population, which received at least one of study treatment, was included in the analysis of adverse event. Patients included in this study were 88 and 89 in FCR arm and PCR arm, respectively.	3.4% 3/89 • Number of events 3 • During the whole treatment period, up to 30 days following last dose. The safety population, which received at least one of study treatment, was included in the analysis of adverse event. Patients included in this study were 88 and 89 in FCR arm and PCR arm, respectively.
Hepatobiliary disorders LIVER FAIL	0.00% 0/88 • During the whole treatment period, up to 30 days following last dose. The safety population, which received at least one of study treatment, was included in the analysis of adverse event. Patients included in this study were 88 and 89 in FCR arm and PCR arm, respectively.	1.1% 1/89 • Number of events 1 • During the whole treatment period, up to 30 days following last dose. The safety population, which received at least one of study treatment, was included in the analysis of adverse event. Patients included in this study were 88 and 89 in FCR arm and PCR arm, respectively.
Respiratory, thoracic and mediastinal disorders LUNG DIS	1.1% 1/88 • Number of events 2 • During the whole treatment period, up to 30 days following last dose. The safety population, which received at least one of study treatment, was included in the analysis of adverse event. Patients included in this study were 88 and 89 in FCR arm and PCR arm, respectively.	0.00% 0/89 • During the whole treatment period, up to 30 days following last dose. The safety population, which received at least one of study treatment, was included in the analysis of adverse event. Patients included in this study were 88 and 89 in FCR arm and PCR arm, respectively.
Musculoskeletal and connective tissue disorders MYASTHENIA	0.00% 0/88 • During the whole treatment period, up to 30 days following last dose. The safety population, which received at least one of study treatment, was included in the analysis of adverse event. Patients included in this study were 88 and 89 in FCR arm and PCR arm, respectively.	1.1% 1/89 • Number of events 1 • During the whole treatment period, up to 30 days following last dose. The safety population, which received at least one of study treatment, was included in the analysis of adverse event. Patients included in this study were 88 and 89 in FCR arm and PCR arm, respectively.
Blood and lymphatic system disorders NEUTROPENIA	4.5% 4/88 • Number of events 4 • During the whole treatment period, up to 30 days following last dose. The safety population, which received at least one of study treatment, was included in the analysis of adverse event. Patients included in this study were 88 and 89 in FCR arm and PCR arm, respectively.	4.5% 4/89 • Number of events 4 • During the whole treatment period, up to 30 days following last dose. The safety population, which received at least one of study treatment, was included in the analysis of adverse event. Patients included in this study were 88 and 89 in FCR arm and PCR arm, respectively.
General disorders PAIN	0.00% 0/88 • During the whole treatment period, up to 30 days following last dose. The safety population, which received at least one of study treatment, was included in the analysis of adverse event. Patients included in this study were 88 and 89 in FCR arm and PCR arm, respectively.	1.1% 1/89 • Number of events 2 • During the whole treatment period, up to 30 days following last dose. The safety population, which received at least one of study treatment, was included in the analysis of adverse event. Patients included in this study were 88 and 89 in FCR arm and PCR arm, respectively.
Gastrointestinal disorders PAIN ABDO	0.00% 0/88 • During the whole treatment period, up to 30 days following last dose. The safety population, which received at least one of study treatment, was included in the analysis of adverse event. Patients included in this study were 88 and 89 in FCR arm and PCR arm, respectively.	1.1% 1/89 • Number of events 1 • During the whole treatment period, up to 30 days following last dose. The safety population, which received at least one of study treatment, was included in the analysis of adverse event. Patients included in this study were 88 and 89 in FCR arm and PCR arm, respectively.
Blood and lymphatic system disorders PANCYTOPENIA	0.00% 0/88 • During the whole treatment period, up to 30 days following last dose. The safety population, which received at least one of study treatment, was included in the analysis of adverse event. Patients included in this study were 88 and 89 in FCR arm and PCR arm, respectively.	1.1% 1/89 • Number of events 1 • During the whole treatment period, up to 30 days following last dose. The safety population, which received at least one of study treatment, was included in the analysis of adverse event. Patients included in this study were 88 and 89 in FCR arm and PCR arm, respectively.
Respiratory, thoracic and mediastinal disorders PNEUMONIA	2.3% 2/88 • Number of events 2 • During the whole treatment period, up to 30 days following last dose. The safety population, which received at least one of study treatment, was included in the analysis of adverse event. Patients included in this study were 88 and 89 in FCR arm and PCR arm, respectively.	2.2% 2/89 • Number of events 2 • During the whole treatment period, up to 30 days following last dose. The safety population, which received at least one of study treatment, was included in the analysis of adverse event. Patients included in this study were 88 and 89 in FCR arm and PCR arm, respectively.
Respiratory, thoracic and mediastinal disorders RESPIRAT DIS	0.00% 0/88 • During the whole treatment period, up to 30 days following last dose. The safety population, which received at least one of study treatment, was included in the analysis of adverse event. Patients included in this study were 88 and 89 in FCR arm and PCR arm, respectively.	1.1% 1/89 • Number of events 1 • During the whole treatment period, up to 30 days following last dose. The safety population, which received at least one of study treatment, was included in the analysis of adverse event. Patients included in this study were 88 and 89 in FCR arm and PCR arm, respectively.
Infections and infestations SEPSIS	2.3% 2/88 • Number of events 2 • During the whole treatment period, up to 30 days following last dose. The safety population, which received at least one of study treatment, was included in the analysis of adverse event. Patients included in this study were 88 and 89 in FCR arm and PCR arm, respectively.	2.2% 2/89 • Number of events 2 • During the whole treatment period, up to 30 days following last dose. The safety population, which received at least one of study treatment, was included in the analysis of adverse event. Patients included in this study were 88 and 89 in FCR arm and PCR arm, respectively.
Respiratory, thoracic and mediastinal disorders SINUSITIS	1.1% 1/88 • Number of events 1 • During the whole treatment period, up to 30 days following last dose. The safety population, which received at least one of study treatment, was included in the analysis of adverse event. Patients included in this study were 88 and 89 in FCR arm and PCR arm, respectively.	0.00% 0/89 • During the whole treatment period, up to 30 days following last dose. The safety population, which received at least one of study treatment, was included in the analysis of adverse event. Patients included in this study were 88 and 89 in FCR arm and PCR arm, respectively.
Gastrointestinal disorders STOMATITIS	1.1% 1/88 • Number of events 1 • During the whole treatment period, up to 30 days following last dose. The safety population, which received at least one of study treatment, was included in the analysis of adverse event. Patients included in this study were 88 and 89 in FCR arm and PCR arm, respectively.	0.00% 0/89 • During the whole treatment period, up to 30 days following last dose. The safety population, which received at least one of study treatment, was included in the analysis of adverse event. Patients included in this study were 88 and 89 in FCR arm and PCR arm, respectively.
Cardiac disorders TACHYCARDIA	0.00% 0/88 • During the whole treatment period, up to 30 days following last dose. The safety population, which received at least one of study treatment, was included in the analysis of adverse event. Patients included in this study were 88 and 89 in FCR arm and PCR arm, respectively.	1.1% 1/89 • Number of events 1 • During the whole treatment period, up to 30 days following last dose. The safety population, which received at least one of study treatment, was included in the analysis of adverse event. Patients included in this study were 88 and 89 in FCR arm and PCR arm, respectively.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) TUMOR LYSIS SYNDROME	1.1% 1/88 • Number of events 1 • During the whole treatment period, up to 30 days following last dose. The safety population, which received at least one of study treatment, was included in the analysis of adverse event. Patients included in this study were 88 and 89 in FCR arm and PCR arm, respectively.	0.00% 0/89 • During the whole treatment period, up to 30 days following last dose. The safety population, which received at least one of study treatment, was included in the analysis of adverse event. Patients included in this study were 88 and 89 in FCR arm and PCR arm, respectively.
Gastrointestinal disorders VOMIT	1.1% 1/88 • Number of events 1 • During the whole treatment period, up to 30 days following last dose. The safety population, which received at least one of study treatment, was included in the analysis of adverse event. Patients included in this study were 88 and 89 in FCR arm and PCR arm, respectively.	0.00% 0/89 • During the whole treatment period, up to 30 days following last dose. The safety population, which received at least one of study treatment, was included in the analysis of adverse event. Patients included in this study were 88 and 89 in FCR arm and PCR arm, respectively.

Other adverse events

Measure	FCR Arm n=88 participants at risk Fludarabine, Cyclophosphamide, and Rituximab	PCR Arm n=89 participants at risk Pentostatin, Cyclophosphamide, and Rituximab
Immune system disorders ALLERG REACT	2.3% 2/88 • Number of events 2 • During the whole treatment period, up to 30 days following last dose. The safety population, which received at least one of study treatment, was included in the analysis of adverse event. Patients included in this study were 88 and 89 in FCR arm and PCR arm, respectively.	6.7% 6/89 • Number of events 7 • During the whole treatment period, up to 30 days following last dose. The safety population, which received at least one of study treatment, was included in the analysis of adverse event. Patients included in this study were 88 and 89 in FCR arm and PCR arm, respectively.
Skin and subcutaneous tissue disorders ALOPECIA	4.5% 4/88 • Number of events 4 • During the whole treatment period, up to 30 days following last dose. The safety population, which received at least one of study treatment, was included in the analysis of adverse event. Patients included in this study were 88 and 89 in FCR arm and PCR arm, respectively.	6.7% 6/89 • Number of events 6 • During the whole treatment period, up to 30 days following last dose. The safety population, which received at least one of study treatment, was included in the analysis of adverse event. Patients included in this study were 88 and 89 in FCR arm and PCR arm, respectively.
Blood and lymphatic system disorders ANEMIA	51.1% 45/88 • Number of events 126 • During the whole treatment period, up to 30 days following last dose. The safety population, which received at least one of study treatment, was included in the analysis of adverse event. Patients included in this study were 88 and 89 in FCR arm and PCR arm, respectively.	38.2% 34/89 • Number of events 82 • During the whole treatment period, up to 30 days following last dose. The safety population, which received at least one of study treatment, was included in the analysis of adverse event. Patients included in this study were 88 and 89 in FCR arm and PCR arm, respectively.
Gastrointestinal disorders ANOREXIA	15.9% 14/88 • Number of events 20 • During the whole treatment period, up to 30 days following last dose. The safety population, which received at least one of study treatment, was included in the analysis of adverse event. Patients included in this study were 88 and 89 in FCR arm and PCR arm, respectively.	25.8% 23/89 • Number of events 31 • During the whole treatment period, up to 30 days following last dose. The safety population, which received at least one of study treatment, was included in the analysis of adverse event. Patients included in this study were 88 and 89 in FCR arm and PCR arm, respectively.
Nervous system disorders ANXIETY	2.3% 2/88 • Number of events 2 • During the whole treatment period, up to 30 days following last dose. The safety population, which received at least one of study treatment, was included in the analysis of adverse event. Patients included in this study were 88 and 89 in FCR arm and PCR arm, respectively.	5.6% 5/89 • Number of events 5 • During the whole treatment period, up to 30 days following last dose. The safety population, which received at least one of study treatment, was included in the analysis of adverse event. Patients included in this study were 88 and 89 in FCR arm and PCR arm, respectively.
Musculoskeletal and connective tissue disorders ARTHRALGIA	3.4% 3/88 • Number of events 3 • During the whole treatment period, up to 30 days following last dose. The safety population, which received at least one of study treatment, was included in the analysis of adverse event. Patients included in this study were 88 and 89 in FCR arm and PCR arm, respectively.	7.9% 7/89 • Number of events 8 • During the whole treatment period, up to 30 days following last dose. The safety population, which received at least one of study treatment, was included in the analysis of adverse event. Patients included in this study were 88 and 89 in FCR arm and PCR arm, respectively.
General disorders ASTHENIA	54.5% 48/88 • Number of events 99 • During the whole treatment period, up to 30 days following last dose. The safety population, which received at least one of study treatment, was included in the analysis of adverse event. Patients included in this study were 88 and 89 in FCR arm and PCR arm, respectively.	59.6% 53/89 • Number of events 97 • During the whole treatment period, up to 30 days following last dose. The safety population, which received at least one of study treatment, was included in the analysis of adverse event. Patients included in this study were 88 and 89 in FCR arm and PCR arm, respectively.
Metabolism and nutrition disorders BILIRUBINEM	6.8% 6/88 • Number of events 7 • During the whole treatment period, up to 30 days following last dose. The safety population, which received at least one of study treatment, was included in the analysis of adverse event. Patients included in this study were 88 and 89 in FCR arm and PCR arm, respectively.	2.2% 2/89 • Number of events 2 • During the whole treatment period, up to 30 days following last dose. The safety population, which received at least one of study treatment, was included in the analysis of adverse event. Patients included in this study were 88 and 89 in FCR arm and PCR arm, respectively.
General disorders CHILLS	20.5% 18/88 • Number of events 21 • During the whole treatment period, up to 30 days following last dose. The safety population, which received at least one of study treatment, was included in the analysis of adverse event. Patients included in this study were 88 and 89 in FCR arm and PCR arm, respectively.	18.0% 16/89 • Number of events 25 • During the whole treatment period, up to 30 days following last dose. The safety population, which received at least one of study treatment, was included in the analysis of adverse event. Patients included in this study were 88 and 89 in FCR arm and PCR arm, respectively.
Gastrointestinal disorders CONSTIP	18.2% 16/88 • Number of events 21 • During the whole treatment period, up to 30 days following last dose. The safety population, which received at least one of study treatment, was included in the analysis of adverse event. Patients included in this study were 88 and 89 in FCR arm and PCR arm, respectively.	10.1% 9/89 • Number of events 16 • During the whole treatment period, up to 30 days following last dose. The safety population, which received at least one of study treatment, was included in the analysis of adverse event. Patients included in this study were 88 and 89 in FCR arm and PCR arm, respectively.
Respiratory, thoracic and mediastinal disorders COUGH INC	9.1% 8/88 • Number of events 9 • During the whole treatment period, up to 30 days following last dose. The safety population, which received at least one of study treatment, was included in the analysis of adverse event. Patients included in this study were 88 and 89 in FCR arm and PCR arm, respectively.	11.2% 10/89 • Number of events 11 • During the whole treatment period, up to 30 days following last dose. The safety population, which received at least one of study treatment, was included in the analysis of adverse event. Patients included in this study were 88 and 89 in FCR arm and PCR arm, respectively.
Metabolism and nutrition disorders CREATININE INC	3.4% 3/88 • Number of events 3 • During the whole treatment period, up to 30 days following last dose. The safety population, which received at least one of study treatment, was included in the analysis of adverse event. Patients included in this study were 88 and 89 in FCR arm and PCR arm, respectively.	7.9% 7/89 • Number of events 10 • During the whole treatment period, up to 30 days following last dose. The safety population, which received at least one of study treatment, was included in the analysis of adverse event. Patients included in this study were 88 and 89 in FCR arm and PCR arm, respectively.
Gastrointestinal disorders DEHYDRAT	2.3% 2/88 • Number of events 2 • During the whole treatment period, up to 30 days following last dose. The safety population, which received at least one of study treatment, was included in the analysis of adverse event. Patients included in this study were 88 and 89 in FCR arm and PCR arm, respectively.	5.6% 5/89 • Number of events 6 • During the whole treatment period, up to 30 days following last dose. The safety population, which received at least one of study treatment, was included in the analysis of adverse event. Patients included in this study were 88 and 89 in FCR arm and PCR arm, respectively.
Gastrointestinal disorders DIARRHEA	14.8% 13/88 • Number of events 18 • During the whole treatment period, up to 30 days following last dose. The safety population, which received at least one of study treatment, was included in the analysis of adverse event. Patients included in this study were 88 and 89 in FCR arm and PCR arm, respectively.	13.5% 12/89 • Number of events 16 • During the whole treatment period, up to 30 days following last dose. The safety population, which received at least one of study treatment, was included in the analysis of adverse event. Patients included in this study were 88 and 89 in FCR arm and PCR arm, respectively.
Nervous system disorders DIZZINESS	8.0% 7/88 • Number of events 8 • During the whole treatment period, up to 30 days following last dose. The safety population, which received at least one of study treatment, was included in the analysis of adverse event. Patients included in this study were 88 and 89 in FCR arm and PCR arm, respectively.	7.9% 7/89 • Number of events 8 • During the whole treatment period, up to 30 days following last dose. The safety population, which received at least one of study treatment, was included in the analysis of adverse event. Patients included in this study were 88 and 89 in FCR arm and PCR arm, respectively.
Gastrointestinal disorders DYSPEPSIA	10.2% 9/88 • Number of events 16 • During the whole treatment period, up to 30 days following last dose. The safety population, which received at least one of study treatment, was included in the analysis of adverse event. Patients included in this study were 88 and 89 in FCR arm and PCR arm, respectively.	3.4% 3/89 • Number of events 3 • During the whole treatment period, up to 30 days following last dose. The safety population, which received at least one of study treatment, was included in the analysis of adverse event. Patients included in this study were 88 and 89 in FCR arm and PCR arm, respectively.
Respiratory, thoracic and mediastinal disorders DYSPNEA	10.2% 9/88 • Number of events 9 • During the whole treatment period, up to 30 days following last dose. The safety population, which received at least one of study treatment, was included in the analysis of adverse event. Patients included in this study were 88 and 89 in FCR arm and PCR arm, respectively.	7.9% 7/89 • Number of events 9 • During the whole treatment period, up to 30 days following last dose. The safety population, which received at least one of study treatment, was included in the analysis of adverse event. Patients included in this study were 88 and 89 in FCR arm and PCR arm, respectively.
Blood and lymphatic system disorders EDEMA	3.4% 3/88 • Number of events 3 • During the whole treatment period, up to 30 days following last dose. The safety population, which received at least one of study treatment, was included in the analysis of adverse event. Patients included in this study were 88 and 89 in FCR arm and PCR arm, respectively.	9.0% 8/89 • Number of events 14 • During the whole treatment period, up to 30 days following last dose. The safety population, which received at least one of study treatment, was included in the analysis of adverse event. Patients included in this study were 88 and 89 in FCR arm and PCR arm, respectively.
Blood and lymphatic system disorders EDEMA PERIPH	6.8% 6/88 • Number of events 6 • During the whole treatment period, up to 30 days following last dose. The safety population, which received at least one of study treatment, was included in the analysis of adverse event. Patients included in this study were 88 and 89 in FCR arm and PCR arm, respectively.	5.6% 5/89 • Number of events 5 • During the whole treatment period, up to 30 days following last dose. The safety population, which received at least one of study treatment, was included in the analysis of adverse event. Patients included in this study were 88 and 89 in FCR arm and PCR arm, respectively.
General disorders FEVER	20.5% 18/88 • Number of events 24 • During the whole treatment period, up to 30 days following last dose. The safety population, which received at least one of study treatment, was included in the analysis of adverse event. Patients included in this study were 88 and 89 in FCR arm and PCR arm, respectively.	33.7% 30/89 • Number of events 45 • During the whole treatment period, up to 30 days following last dose. The safety population, which received at least one of study treatment, was included in the analysis of adverse event. Patients included in this study were 88 and 89 in FCR arm and PCR arm, respectively.
General disorders HEADACHE	11.4% 10/88 • Number of events 15 • During the whole treatment period, up to 30 days following last dose. The safety population, which received at least one of study treatment, was included in the analysis of adverse event. Patients included in this study were 88 and 89 in FCR arm and PCR arm, respectively.	4.5% 4/89 • Number of events 5 • During the whole treatment period, up to 30 days following last dose. The safety population, which received at least one of study treatment, was included in the analysis of adverse event. Patients included in this study were 88 and 89 in FCR arm and PCR arm, respectively.
Metabolism and nutrition disorders HYPERGLYCEM	6.8% 6/88 • Number of events 8 • During the whole treatment period, up to 30 days following last dose. The safety population, which received at least one of study treatment, was included in the analysis of adverse event. Patients included in this study were 88 and 89 in FCR arm and PCR arm, respectively.	6.7% 6/89 • Number of events 7 • During the whole treatment period, up to 30 days following last dose. The safety population, which received at least one of study treatment, was included in the analysis of adverse event. Patients included in this study were 88 and 89 in FCR arm and PCR arm, respectively.
Infections and infestations INFECT	5.7% 5/88 • Number of events 8 • During the whole treatment period, up to 30 days following last dose. The safety population, which received at least one of study treatment, was included in the analysis of adverse event. Patients included in this study were 88 and 89 in FCR arm and PCR arm, respectively.	5.6% 5/89 • Number of events 7 • During the whole treatment period, up to 30 days following last dose. The safety population, which received at least one of study treatment, was included in the analysis of adverse event. Patients included in this study were 88 and 89 in FCR arm and PCR arm, respectively.
General disorders INSOMNIA	9.1% 8/88 • Number of events 10 • During the whole treatment period, up to 30 days following last dose. The safety population, which received at least one of study treatment, was included in the analysis of adverse event. Patients included in this study were 88 and 89 in FCR arm and PCR arm, respectively.	3.4% 3/89 • Number of events 4 • During the whole treatment period, up to 30 days following last dose. The safety population, which received at least one of study treatment, was included in the analysis of adverse event. Patients included in this study were 88 and 89 in FCR arm and PCR arm, respectively.
Metabolism and nutrition disorders LDH INC	5.7% 5/88 • Number of events 5 • During the whole treatment period, up to 30 days following last dose. The safety population, which received at least one of study treatment, was included in the analysis of adverse event. Patients included in this study were 88 and 89 in FCR arm and PCR arm, respectively.	5.6% 5/89 • Number of events 7 • During the whole treatment period, up to 30 days following last dose. The safety population, which received at least one of study treatment, was included in the analysis of adverse event. Patients included in this study were 88 and 89 in FCR arm and PCR arm, respectively.
Blood and lymphatic system disorders LEUKOPENIA	46.6% 41/88 • Number of events 267 • During the whole treatment period, up to 30 days following last dose. The safety population, which received at least one of study treatment, was included in the analysis of adverse event. Patients included in this study were 88 and 89 in FCR arm and PCR arm, respectively.	38.2% 34/89 • Number of events 135 • During the whole treatment period, up to 30 days following last dose. The safety population, which received at least one of study treatment, was included in the analysis of adverse event. Patients included in this study were 88 and 89 in FCR arm and PCR arm, respectively.
Gastrointestinal disorders NAUSEA	53.4% 47/88 • Number of events 81 • During the whole treatment period, up to 30 days following last dose. The safety population, which received at least one of study treatment, was included in the analysis of adverse event. Patients included in this study were 88 and 89 in FCR arm and PCR arm, respectively.	55.1% 49/89 • Number of events 123 • During the whole treatment period, up to 30 days following last dose. The safety population, which received at least one of study treatment, was included in the analysis of adverse event. Patients included in this study were 88 and 89 in FCR arm and PCR arm, respectively.
Nervous system disorders NEUROPATHY	3.4% 3/88 • Number of events 3 • During the whole treatment period, up to 30 days following last dose. The safety population, which received at least one of study treatment, was included in the analysis of adverse event. Patients included in this study were 88 and 89 in FCR arm and PCR arm, respectively.	6.7% 6/89 • Number of events 10 • During the whole treatment period, up to 30 days following last dose. The safety population, which received at least one of study treatment, was included in the analysis of adverse event. Patients included in this study were 88 and 89 in FCR arm and PCR arm, respectively.
Blood and lymphatic system disorders NEUTROPENIA	81.8% 72/88 • Number of events 271 • During the whole treatment period, up to 30 days following last dose. The safety population, which received at least one of study treatment, was included in the analysis of adverse event. Patients included in this study were 88 and 89 in FCR arm and PCR arm, respectively.	76.4% 68/89 • Number of events 185 • During the whole treatment period, up to 30 days following last dose. The safety population, which received at least one of study treatment, was included in the analysis of adverse event. Patients included in this study were 88 and 89 in FCR arm and PCR arm, respectively.
General disorders PAIN	6.8% 6/88 • Number of events 7 • During the whole treatment period, up to 30 days following last dose. The safety population, which received at least one of study treatment, was included in the analysis of adverse event. Patients included in this study were 88 and 89 in FCR arm and PCR arm, respectively.	10.1% 9/89 • Number of events 11 • During the whole treatment period, up to 30 days following last dose. The safety population, which received at least one of study treatment, was included in the analysis of adverse event. Patients included in this study were 88 and 89 in FCR arm and PCR arm, respectively.
Gastrointestinal disorders PAIN ABDO	6.8% 6/88 • Number of events 7 • During the whole treatment period, up to 30 days following last dose. The safety population, which received at least one of study treatment, was included in the analysis of adverse event. Patients included in this study were 88 and 89 in FCR arm and PCR arm, respectively.	5.6% 5/89 • Number of events 9 • During the whole treatment period, up to 30 days following last dose. The safety population, which received at least one of study treatment, was included in the analysis of adverse event. Patients included in this study were 88 and 89 in FCR arm and PCR arm, respectively.
Skin and subcutaneous tissue disorders RASH	12.5% 11/88 • Number of events 16 • During the whole treatment period, up to 30 days following last dose. The safety population, which received at least one of study treatment, was included in the analysis of adverse event. Patients included in this study were 88 and 89 in FCR arm and PCR arm, respectively.	13.5% 12/89 • Number of events 20 • During the whole treatment period, up to 30 days following last dose. The safety population, which received at least one of study treatment, was included in the analysis of adverse event. Patients included in this study were 88 and 89 in FCR arm and PCR arm, respectively.
Metabolism and nutrition disorders SGOT INC	6.8% 6/88 • Number of events 6 • During the whole treatment period, up to 30 days following last dose. The safety population, which received at least one of study treatment, was included in the analysis of adverse event. Patients included in this study were 88 and 89 in FCR arm and PCR arm, respectively.	3.4% 3/89 • Number of events 3 • During the whole treatment period, up to 30 days following last dose. The safety population, which received at least one of study treatment, was included in the analysis of adverse event. Patients included in this study were 88 and 89 in FCR arm and PCR arm, respectively.
Metabolism and nutrition disorders SGPT INC	10.2% 9/88 • Number of events 9 • During the whole treatment period, up to 30 days following last dose. The safety population, which received at least one of study treatment, was included in the analysis of adverse event. Patients included in this study were 88 and 89 in FCR arm and PCR arm, respectively.	2.2% 2/89 • Number of events 2 • During the whole treatment period, up to 30 days following last dose. The safety population, which received at least one of study treatment, was included in the analysis of adverse event. Patients included in this study were 88 and 89 in FCR arm and PCR arm, respectively.
Skin and subcutaneous tissue disorders SKIN DRY	5.7% 5/88 • Number of events 6 • During the whole treatment period, up to 30 days following last dose. The safety population, which received at least one of study treatment, was included in the analysis of adverse event. Patients included in this study were 88 and 89 in FCR arm and PCR arm, respectively.	6.7% 6/89 • Number of events 6 • During the whole treatment period, up to 30 days following last dose. The safety population, which received at least one of study treatment, was included in the analysis of adverse event. Patients included in this study were 88 and 89 in FCR arm and PCR arm, respectively.
Gastrointestinal disorders STOMATITIS	8.0% 7/88 • Number of events 11 • During the whole treatment period, up to 30 days following last dose. The safety population, which received at least one of study treatment, was included in the analysis of adverse event. Patients included in this study were 88 and 89 in FCR arm and PCR arm, respectively.	4.5% 4/89 • Number of events 4 • During the whole treatment period, up to 30 days following last dose. The safety population, which received at least one of study treatment, was included in the analysis of adverse event. Patients included in this study were 88 and 89 in FCR arm and PCR arm, respectively.
Gastrointestinal disorders TASTE PERVERS	8.0% 7/88 • Number of events 9 • During the whole treatment period, up to 30 days following last dose. The safety population, which received at least one of study treatment, was included in the analysis of adverse event. Patients included in this study were 88 and 89 in FCR arm and PCR arm, respectively.	11.2% 10/89 • Number of events 11 • During the whole treatment period, up to 30 days following last dose. The safety population, which received at least one of study treatment, was included in the analysis of adverse event. Patients included in this study were 88 and 89 in FCR arm and PCR arm, respectively.
Blood and lymphatic system disorders THROMBOCYTOPENIA	37.5% 33/88 • Number of events 87 • During the whole treatment period, up to 30 days following last dose. The safety population, which received at least one of study treatment, was included in the analysis of adverse event. Patients included in this study were 88 and 89 in FCR arm and PCR arm, respectively.	27.0% 24/89 • Number of events 44 • During the whole treatment period, up to 30 days following last dose. The safety population, which received at least one of study treatment, was included in the analysis of adverse event. Patients included in this study were 88 and 89 in FCR arm and PCR arm, respectively.
Renal and urinary disorders URIN FREQUENCY	6.8% 6/88 • Number of events 6 • During the whole treatment period, up to 30 days following last dose. The safety population, which received at least one of study treatment, was included in the analysis of adverse event. Patients included in this study were 88 and 89 in FCR arm and PCR arm, respectively.	2.2% 2/89 • Number of events 2 • During the whole treatment period, up to 30 days following last dose. The safety population, which received at least one of study treatment, was included in the analysis of adverse event. Patients included in this study were 88 and 89 in FCR arm and PCR arm, respectively.
Gastrointestinal disorders VOMIT	15.9% 14/88 • Number of events 18 • During the whole treatment period, up to 30 days following last dose. The safety population, which received at least one of study treatment, was included in the analysis of adverse event. Patients included in this study were 88 and 89 in FCR arm and PCR arm, respectively.	28.1% 25/89 • Number of events 44 • During the whole treatment period, up to 30 days following last dose. The safety population, which received at least one of study treatment, was included in the analysis of adverse event. Patients included in this study were 88 and 89 in FCR arm and PCR arm, respectively.

Additional Information

Dr. Craig Reynolds

Ocala Oncology

Phone: (352) 732-4032

Email: Craig.Reynolds@USOncology.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place