Trial Outcomes & Findings for A Study to Compare Mabthera (Rituximab), Fludarabine and Cyclophosphamide to Mabthera and Chlorambucil in Participants With Chronic Lymphocytic Leukemia and Unfavorable Somatic Status (NCT NCT01283386)

NCT ID: NCT01283386

Last Updated: 2019-03-14

Results Overview

Complete remission was defined as the disappearance of all signs of disease.

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 26 participants
• Primary outcome timeframe: Up to approximately 5 years
• Results posted on: 2019-03-14

Participant Flow

Participant milestones

Measure	FCR-lite Rituximab 375 milligrams per square meter (mg/m\^2) intravenously (IV) on Day 1 of Cycle 1 (one cycle = 28 days), then 500 mg/m\^2 IV on Day 1 of each subsequent cycle for 6 cycles. When fludarabine / cyclophosphamide IV administered: fludarabine 20 mg/m\^2 IV on Days 1-3; cyclophosphamide 150 mg/m\^2 IV on Days 1-3. When fludarabine / cyclophosphamide orally administered: fludarabine 32 mg/m\^2 orally on Days 1-3; cyclophosphamide 150 mg/m\^2 orally on Days 1-3 for 6 cycles (28 days each).	LR Therapy Rituximab 375 mg/m\^2 IV on Day 1 of Cycle 1, then 500 mg/m\^2 IV on Day 1 of each subsequent cycle for 6 cycles. Chlorambucile 10 mg/m\^2 orally on Days 1-7 for 6 cycles.
Overall Study STARTED	10	16
Overall Study COMPLETED	2	4
Overall Study NOT COMPLETED	8	12

Reasons for withdrawal

Measure	FCR-lite Rituximab 375 milligrams per square meter (mg/m\^2) intravenously (IV) on Day 1 of Cycle 1 (one cycle = 28 days), then 500 mg/m\^2 IV on Day 1 of each subsequent cycle for 6 cycles. When fludarabine / cyclophosphamide IV administered: fludarabine 20 mg/m\^2 IV on Days 1-3; cyclophosphamide 150 mg/m\^2 IV on Days 1-3. When fludarabine / cyclophosphamide orally administered: fludarabine 32 mg/m\^2 orally on Days 1-3; cyclophosphamide 150 mg/m\^2 orally on Days 1-3 for 6 cycles (28 days each).	LR Therapy Rituximab 375 mg/m\^2 IV on Day 1 of Cycle 1, then 500 mg/m\^2 IV on Day 1 of each subsequent cycle for 6 cycles. Chlorambucile 10 mg/m\^2 orally on Days 1-7 for 6 cycles.
Overall Study Death	2	0
Overall Study Withdrawal by Subject	2	1
Overall Study Relapse of underlying disease	1	3
Overall Study Progression of underlying disease	2	7
Overall Study Reason not specified	1	0
Overall Study Protocol Violation	0	1

Baseline Characteristics

A Study to Compare Mabthera (Rituximab), Fludarabine and Cyclophosphamide to Mabthera and Chlorambucil in Participants With Chronic Lymphocytic Leukemia and Unfavorable Somatic Status

Baseline characteristics by cohort

Measure	FCR-lite n=10 Participants Rituximab 375 milligrams per square meter (mg/m\^2) intravenously (IV) on Day 1 of Cycle 1 (one cycle = 28 days), then 500 mg/m\^2 IV on Day 1 of each subsequent cycle for 6 cycles. When fludarabine / cyclophosphamide IV administered: fludarabine 20 mg/m\^2 IV on Days 1-3; cyclophosphamide 150 mg/m\^2 IV on Days 1-3. When fludarabine / cyclophosphamide orally administered: fludarabine 32 mg/m\^2 orally on Days 1-3; cyclophosphamide 150 mg/m\^2 orally on Days 1-3 for 6 cycles (28 days each).	LR Therapy n=16 Participants Rituximab 375 mg/m\^2 IV on Day 1 of Cycle 1, then 500 mg/m\^2 IV on Day 1 of each subsequent cycle for 6 cycles. Chlorambucile 10 mg/m\^2 orally on Days 1-7 for 6 cycles.	Total n=26 Participants Total of all reporting groups
Age, Continuous	68.7 years STANDARD_DEVIATION 7.09 • n=5 Participants	68.6 years STANDARD_DEVIATION 4.95 • n=7 Participants	68.6 years STANDARD_DEVIATION 5.73 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	7 Participants n=7 Participants	10 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	9 Participants n=7 Participants	16 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to approximately 5 years

Population: All enrolled participants who were evaluable for this outcome measure at the end of therapy.

Complete remission was defined as the disappearance of all signs of disease.

Outcome measures

Measure	FCR-lite n=7 Participants Rituximab 375 milligrams per square meter (mg/m\^2) intravenously (IV) on Day 1 of Cycle 1 (one cycle = 28 days), then 500 mg/m\^2 IV on Day 1 of each subsequent cycle for 6 cycles. When fludarabine / cyclophosphamide IV administered: fludarabine 20 mg/m\^2 IV on Days 1-3; cyclophosphamide 150 mg/m\^2 IV on Days 1-3. When fludarabine / cyclophosphamide orally administered: fludarabine 32 mg/m\^2 orally on Days 1-3; cyclophosphamide 150 mg/m\^2 orally on Days 1-3 for 6 cycles (28 days each).	LR Therapy n=16 Participants Rituximab 375 mg/m\^2 IV on Day 1 of Cycle 1, then 500 mg/m\^2 IV on Day 1 of each subsequent cycle for 6 cycles. Chlorambucile 10 mg/m\^2 orally on Days 1-7 for 6 cycles.
Percentage of Participants With Complete Remission	42.9 percentage of participants	18.8 percentage of participants

PRIMARY outcome

Timeframe: Up to approximately 5 years

Population: All enrolled participants who were evaluable for this outcome measure at the end of therapy.

Disease progression was defined as an increase in lymphocytosis, or enlargement of the lymph nodes or spleen.

Outcome measures

Measure	FCR-lite n=7 Participants Rituximab 375 milligrams per square meter (mg/m\^2) intravenously (IV) on Day 1 of Cycle 1 (one cycle = 28 days), then 500 mg/m\^2 IV on Day 1 of each subsequent cycle for 6 cycles. When fludarabine / cyclophosphamide IV administered: fludarabine 20 mg/m\^2 IV on Days 1-3; cyclophosphamide 150 mg/m\^2 IV on Days 1-3. When fludarabine / cyclophosphamide orally administered: fludarabine 32 mg/m\^2 orally on Days 1-3; cyclophosphamide 150 mg/m\^2 orally on Days 1-3 for 6 cycles (28 days each).	LR Therapy n=16 Participants Rituximab 375 mg/m\^2 IV on Day 1 of Cycle 1, then 500 mg/m\^2 IV on Day 1 of each subsequent cycle for 6 cycles. Chlorambucile 10 mg/m\^2 orally on Days 1-7 for 6 cycles.
Percentage of Participants With Disease Progression	0 percentage of participants	6.3 percentage of participants

PRIMARY outcome

Timeframe: Up to approximately 5 years

Population: All enrolled participants who were evaluable for this outcome measure at the end of therapy.

Stable disease was defined as not meeting the criteria for partial remission or disease progression

Outcome measures

Measure	FCR-lite n=7 Participants Rituximab 375 milligrams per square meter (mg/m\^2) intravenously (IV) on Day 1 of Cycle 1 (one cycle = 28 days), then 500 mg/m\^2 IV on Day 1 of each subsequent cycle for 6 cycles. When fludarabine / cyclophosphamide IV administered: fludarabine 20 mg/m\^2 IV on Days 1-3; cyclophosphamide 150 mg/m\^2 IV on Days 1-3. When fludarabine / cyclophosphamide orally administered: fludarabine 32 mg/m\^2 orally on Days 1-3; cyclophosphamide 150 mg/m\^2 orally on Days 1-3 for 6 cycles (28 days each).	LR Therapy n=16 Participants Rituximab 375 mg/m\^2 IV on Day 1 of Cycle 1, then 500 mg/m\^2 IV on Day 1 of each subsequent cycle for 6 cycles. Chlorambucile 10 mg/m\^2 orally on Days 1-7 for 6 cycles.
Percentage of Participants With Stable Disease	14.3 percentage of participants	18.8 percentage of participants

PRIMARY outcome

Timeframe: Up to approximately 5 years

Population: All enrolled participants who were evaluable for this outcome measure at the end of therapy.

Partial remission was defined as a reduction in tumor size by >50%.

Outcome measures

Measure	FCR-lite n=7 Participants Rituximab 375 milligrams per square meter (mg/m\^2) intravenously (IV) on Day 1 of Cycle 1 (one cycle = 28 days), then 500 mg/m\^2 IV on Day 1 of each subsequent cycle for 6 cycles. When fludarabine / cyclophosphamide IV administered: fludarabine 20 mg/m\^2 IV on Days 1-3; cyclophosphamide 150 mg/m\^2 IV on Days 1-3. When fludarabine / cyclophosphamide orally administered: fludarabine 32 mg/m\^2 orally on Days 1-3; cyclophosphamide 150 mg/m\^2 orally on Days 1-3 for 6 cycles (28 days each).	LR Therapy n=16 Participants Rituximab 375 mg/m\^2 IV on Day 1 of Cycle 1, then 500 mg/m\^2 IV on Day 1 of each subsequent cycle for 6 cycles. Chlorambucile 10 mg/m\^2 orally on Days 1-7 for 6 cycles.
Percentage of Participants With Partial Remission	42.9 percentage of participants	56.3 percentage of participants

PRIMARY outcome

Timeframe: Up to approximately 5 years

Population: Enrolled participants who had disease progression after response to therapy.

Duration of Response was defined as the time period from the last day of study treatment to the day when disease progression occurred in participants who previously had complete or partial remission. Disease progression was defined as an increase in lymphocytosis, or enlargement of the lymph nodes or spleen. Complete remission was defined as the disappearance of all signs of disease. Partial remission was defined as a reduction in tumor size by >50%.

Outcome measures

Measure	FCR-lite n=5 Participants Rituximab 375 milligrams per square meter (mg/m\^2) intravenously (IV) on Day 1 of Cycle 1 (one cycle = 28 days), then 500 mg/m\^2 IV on Day 1 of each subsequent cycle for 6 cycles. When fludarabine / cyclophosphamide IV administered: fludarabine 20 mg/m\^2 IV on Days 1-3; cyclophosphamide 150 mg/m\^2 IV on Days 1-3. When fludarabine / cyclophosphamide orally administered: fludarabine 32 mg/m\^2 orally on Days 1-3; cyclophosphamide 150 mg/m\^2 orally on Days 1-3 for 6 cycles (28 days each).	LR Therapy n=12 Participants Rituximab 375 mg/m\^2 IV on Day 1 of Cycle 1, then 500 mg/m\^2 IV on Day 1 of each subsequent cycle for 6 cycles. Chlorambucile 10 mg/m\^2 orally on Days 1-7 for 6 cycles.
Duration of Response	NA days Median and 95% lower and upper confidence interval limits were not calculable due to the low numbers of participants with events.	NA days Median and 95% lower and upper confidence interval limits were not calculable due to the low numbers of participants with events.

PRIMARY outcome

Timeframe: Up to approximately 5 years

Population: Enrolled participants who had disease progression at the end of the study.

Progression-free survival was defined as the time period from the first day of study treatment to the day when disease progression occurred. Disease progression was defined as an increase in lymphocytosis, or enlargement of the lymph nodes or spleen.

Outcome measures

Measure	FCR-lite n=8 Participants Rituximab 375 milligrams per square meter (mg/m\^2) intravenously (IV) on Day 1 of Cycle 1 (one cycle = 28 days), then 500 mg/m\^2 IV on Day 1 of each subsequent cycle for 6 cycles. When fludarabine / cyclophosphamide IV administered: fludarabine 20 mg/m\^2 IV on Days 1-3; cyclophosphamide 150 mg/m\^2 IV on Days 1-3. When fludarabine / cyclophosphamide orally administered: fludarabine 32 mg/m\^2 orally on Days 1-3; cyclophosphamide 150 mg/m\^2 orally on Days 1-3 for 6 cycles (28 days each).	LR Therapy n=16 Participants Rituximab 375 mg/m\^2 IV on Day 1 of Cycle 1, then 500 mg/m\^2 IV on Day 1 of each subsequent cycle for 6 cycles. Chlorambucile 10 mg/m\^2 orally on Days 1-7 for 6 cycles.
Progression-free Survival	NA days Median and 95% lower and upper confidence interval limits were not calculable due to the low numbers of participants with events.	NA days Median and 95% lower and upper confidence interval limits were not calculable due to the low numbers of participants with events.

PRIMARY outcome

Timeframe: Up to approximately 5 years

Population: Enrolled participants who had an event of disease progression, relapse, or death.

Event-free survival was defined as the time period from the first day of study treatment to occurrence of any of the following events: appearance of disease progression or relapse; prescription of a new treatment for disease relapse; death caused by B-cell chronic lymphocytic leukemia (B-CLL); or complications from B-CLL or therapy. Relapse was defined as disease progression in participants with complete or partial remission lasting at least 6 months after treatment completion. Disease progression was defined as an increase in lymphocytosis, or enlargement of the lymph nodes or spleen. Complete remission was defined as the disappearance of all signs of disease. Partial remission was defined as a reduction in tumor size by >50%.

Outcome measures

Measure	FCR-lite n=9 Participants Rituximab 375 milligrams per square meter (mg/m\^2) intravenously (IV) on Day 1 of Cycle 1 (one cycle = 28 days), then 500 mg/m\^2 IV on Day 1 of each subsequent cycle for 6 cycles. When fludarabine / cyclophosphamide IV administered: fludarabine 20 mg/m\^2 IV on Days 1-3; cyclophosphamide 150 mg/m\^2 IV on Days 1-3. When fludarabine / cyclophosphamide orally administered: fludarabine 32 mg/m\^2 orally on Days 1-3; cyclophosphamide 150 mg/m\^2 orally on Days 1-3 for 6 cycles (28 days each).	LR Therapy n=16 Participants Rituximab 375 mg/m\^2 IV on Day 1 of Cycle 1, then 500 mg/m\^2 IV on Day 1 of each subsequent cycle for 6 cycles. Chlorambucile 10 mg/m\^2 orally on Days 1-7 for 6 cycles.
Event-free Survival	679 days Interval 14.0 to 95% upper confidence interval limit was not calculable due to the low numbers of participants with events.	NA days Median and 95% lower and upper confidence interval limits were not calculable due to the low numbers of participants with events.

PRIMARY outcome

Timeframe: Up to approximately 5 years

Population: Enrolled participants who died.

Overall survival was defined as the time period from the first day of study treatment to participant death.

Outcome measures

Measure	FCR-lite n=10 Participants Rituximab 375 milligrams per square meter (mg/m\^2) intravenously (IV) on Day 1 of Cycle 1 (one cycle = 28 days), then 500 mg/m\^2 IV on Day 1 of each subsequent cycle for 6 cycles. When fludarabine / cyclophosphamide IV administered: fludarabine 20 mg/m\^2 IV on Days 1-3; cyclophosphamide 150 mg/m\^2 IV on Days 1-3. When fludarabine / cyclophosphamide orally administered: fludarabine 32 mg/m\^2 orally on Days 1-3; cyclophosphamide 150 mg/m\^2 orally on Days 1-3 for 6 cycles (28 days each).	LR Therapy n=16 Participants Rituximab 375 mg/m\^2 IV on Day 1 of Cycle 1, then 500 mg/m\^2 IV on Day 1 of each subsequent cycle for 6 cycles. Chlorambucile 10 mg/m\^2 orally on Days 1-7 for 6 cycles.
Overall Survival	NA days Median and 95% lower and upper confidence interval limits were not calculable due to the low numbers of participants with events.	NA days Median and 95% lower and upper confidence interval limits were not calculable due to the low numbers of participants with events.

PRIMARY outcome

Timeframe: Up to approximately 5 years

Population: Enrolled participants who were evaluable for this assessment.

Phenotypic remission was considered achieved if a participant had a negative test for minimal residual disease. A negative test for minimal residual disease was defined as tumor cells ≤0.01% of the total number of peripheral leukocytes.

Outcome measures

Measure	FCR-lite n=8 Participants Rituximab 375 milligrams per square meter (mg/m\^2) intravenously (IV) on Day 1 of Cycle 1 (one cycle = 28 days), then 500 mg/m\^2 IV on Day 1 of each subsequent cycle for 6 cycles. When fludarabine / cyclophosphamide IV administered: fludarabine 20 mg/m\^2 IV on Days 1-3; cyclophosphamide 150 mg/m\^2 IV on Days 1-3. When fludarabine / cyclophosphamide orally administered: fludarabine 32 mg/m\^2 orally on Days 1-3; cyclophosphamide 150 mg/m\^2 orally on Days 1-3 for 6 cycles (28 days each).	LR Therapy n=10 Participants Rituximab 375 mg/m\^2 IV on Day 1 of Cycle 1, then 500 mg/m\^2 IV on Day 1 of each subsequent cycle for 6 cycles. Chlorambucile 10 mg/m\^2 orally on Days 1-7 for 6 cycles.
Percentage of Participants With Phenotypic Remission	25.0 percentage of participants	30.0 percentage of participants

PRIMARY outcome

Timeframe: Up to approximately 5 years

Population: All enrolled participants.

An AE was defined as any unfavorable medical occurrence in a participant receiving a study drug, regardless of relationship the study drug. An AE was considered serious if it met any of the following criteria: was fatal or life-threatening; required hospitalization or prolonged hospitalization; led to persistent or significant disability/incapacity; was a congenital anomaly/birth defect; was clinically significant and/or required an intervention to prevent any of the listed criteria.

Outcome measures

Measure	FCR-lite n=10 Participants Rituximab 375 milligrams per square meter (mg/m\^2) intravenously (IV) on Day 1 of Cycle 1 (one cycle = 28 days), then 500 mg/m\^2 IV on Day 1 of each subsequent cycle for 6 cycles. When fludarabine / cyclophosphamide IV administered: fludarabine 20 mg/m\^2 IV on Days 1-3; cyclophosphamide 150 mg/m\^2 IV on Days 1-3. When fludarabine / cyclophosphamide orally administered: fludarabine 32 mg/m\^2 orally on Days 1-3; cyclophosphamide 150 mg/m\^2 orally on Days 1-3 for 6 cycles (28 days each).	LR Therapy n=16 Participants Rituximab 375 mg/m\^2 IV on Day 1 of Cycle 1, then 500 mg/m\^2 IV on Day 1 of each subsequent cycle for 6 cycles. Chlorambucile 10 mg/m\^2 orally on Days 1-7 for 6 cycles.
Percentage of Participants With Adverse Events (AEs) and Serious AEs Non-serious AEs	80.00 percentage of participants	56.25 percentage of participants
Percentage of Participants With Adverse Events (AEs) and Serious AEs Serious AEs	20.00 percentage of participants	18.75 percentage of participants

Adverse Events

FCR-lite

Serious events: 2 serious events

Other events: 8 other events

Deaths: 0 deaths

LR Therapy

Serious events: 3 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Measure	FCR-lite n=10 participants at risk Rituximab 375 milligrams per square meter (mg/m\^2) intravenously (IV) on Day 1 of Cycle 1 (one cycle = 28 days), then 500 mg/m\^2 IV on Day 1 of each subsequent cycle for 6 cycles. When fludarabine / cyclophosphamide IV administered: fludarabine 20 mg/m\^2 IV on Days 1-3; cyclophosphamide 150 mg/m\^2 IV on Days 1-3. When fludarabine / cyclophosphamide orally administered: fludarabine 32 mg/m\^2 orally on Days 1-3; cyclophosphamide 150 mg/m\^2 orally on Days 1-3 for 6 cycles (28 days each).	LR Therapy n=16 participants at risk Rituximab 375 mg/m\^2 IV on Day 1 of Cycle 1, then 500 mg/m\^2 IV on Day 1 of each subsequent cycle for 6 cycles. Chlorambucile 10 mg/m\^2 orally on Days 1-7 for 6 cycles.
General disorders Death	20.0% 2/10 • Up to approximately 5 years	0.00% 0/16 • Up to approximately 5 years
Infections and infestations Retroperitoneal abscess	0.00% 0/10 • Up to approximately 5 years	6.2% 1/16 • Up to approximately 5 years
Reproductive system and breast disorders Benign prostatic hyperplasia	0.00% 0/10 • Up to approximately 5 years	6.2% 1/16 • Up to approximately 5 years
Respiratory, thoracic and mediastinal disorders Pneumonia	0.00% 0/10 • Up to approximately 5 years	6.2% 1/16 • Up to approximately 5 years
Vascular disorders Acute myocardial infarction	10.0% 1/10 • Up to approximately 5 years	0.00% 0/16 • Up to approximately 5 years

Other adverse events

Measure	FCR-lite n=10 participants at risk Rituximab 375 milligrams per square meter (mg/m\^2) intravenously (IV) on Day 1 of Cycle 1 (one cycle = 28 days), then 500 mg/m\^2 IV on Day 1 of each subsequent cycle for 6 cycles. When fludarabine / cyclophosphamide IV administered: fludarabine 20 mg/m\^2 IV on Days 1-3; cyclophosphamide 150 mg/m\^2 IV on Days 1-3. When fludarabine / cyclophosphamide orally administered: fludarabine 32 mg/m\^2 orally on Days 1-3; cyclophosphamide 150 mg/m\^2 orally on Days 1-3 for 6 cycles (28 days each).	LR Therapy n=16 participants at risk Rituximab 375 mg/m\^2 IV on Day 1 of Cycle 1, then 500 mg/m\^2 IV on Day 1 of each subsequent cycle for 6 cycles. Chlorambucile 10 mg/m\^2 orally on Days 1-7 for 6 cycles.
Investigations Neutrophil count decreased	20.0% 2/10 • Up to approximately 5 years	12.5% 2/16 • Up to approximately 5 years
Investigations White blood cell count decreased	10.0% 1/10 • Up to approximately 5 years	12.5% 2/16 • Up to approximately 5 years
Investigations Blood bilirubin increased	10.0% 1/10 • Up to approximately 5 years	0.00% 0/16 • Up to approximately 5 years
Investigations Glomerular filtration rate	10.0% 1/10 • Up to approximately 5 years	0.00% 0/16 • Up to approximately 5 years
Investigations Urea urine increased	0.00% 0/10 • Up to approximately 5 years	6.2% 1/16 • Up to approximately 5 years
Respiratory, thoracic and mediastinal disorders Bronchitis	20.0% 2/10 • Up to approximately 5 years	6.2% 1/16 • Up to approximately 5 years
Respiratory, thoracic and mediastinal disorders Pneumonia	0.00% 0/10 • Up to approximately 5 years	6.2% 1/16 • Up to approximately 5 years
Respiratory, thoracic and mediastinal disorders Sinusitis	0.00% 0/10 • Up to approximately 5 years	6.2% 1/16 • Up to approximately 5 years
Cardiac disorders Angina unstable	0.00% 0/10 • Up to approximately 5 years	6.2% 1/16 • Up to approximately 5 years
Cardiac disorders Cardiac failure acute	10.0% 1/10 • Up to approximately 5 years	0.00% 0/16 • Up to approximately 5 years
Cardiac disorders Extrasystoles	0.00% 0/10 • Up to approximately 5 years	6.2% 1/16 • Up to approximately 5 years
Blood and lymphatic system disorders Anaemia	0.00% 0/10 • Up to approximately 5 years	6.2% 1/16 • Up to approximately 5 years
Blood and lymphatic system disorders Thrombocytopenia	10.0% 1/10 • Up to approximately 5 years	0.00% 0/16 • Up to approximately 5 years
General disorders Pyrexia	20.0% 2/10 • Up to approximately 5 years	0.00% 0/16 • Up to approximately 5 years
Endocrine disorders Hyperglycaemia	0.00% 0/10 • Up to approximately 5 years	6.2% 1/16 • Up to approximately 5 years
Gastrointestinal disorders Nausea	10.0% 1/10 • Up to approximately 5 years	0.00% 0/16 • Up to approximately 5 years
Infections and infestations Respiratory tract infection	0.00% 0/10 • Up to approximately 5 years	6.2% 1/16 • Up to approximately 5 years
Musculoskeletal and connective tissue disorders Chills	0.00% 0/10 • Up to approximately 5 years	6.2% 1/16 • Up to approximately 5 years
Renal and urinary disorders Renal colic	10.0% 1/10 • Up to approximately 5 years	0.00% 0/16 • Up to approximately 5 years
Reproductive system and breast disorders Prostatitis	10.0% 1/10 • Up to approximately 5 years	0.00% 0/16 • Up to approximately 5 years

Additional Information

Medical Communications

Hoffmann-LaRoche

Phone: 1-800-821-8590

Email: genentech@druginfo.com

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