Trial Outcomes & Findings for Epigenetic Modulation in Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL) (NCT NCT00978432)

Last Updated: 2016-11-25

Results Overview

Overall Response Rate is the number of participants with a partial and complete response assessed by the Updated Cheson criteria for lymphoma. A complete response is complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy and normalization of those biochemical abnormalities. If a subject has residual lesions on CT scan and the disease was fluorodeoxyglucose (FDG) avid pre-treatment, then that subject will be considered to be in a complete response. Partial response is a greater than or equal to 50% decrease in the sum of the products of the greatest diameters of 6 largest dominant nodes or nodal masses. No increase in size of nodes, liver or spleen and no new sites of disease

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

50 participants

Primary outcome timeframe

after 2 cycles of each study drug or after 2 cycles of doublet, up to 24 weeks

Results posted on

2016-11-25

Participant Flow

The study opened to enrollment in October, 2009. 50 subjects were consented until enrollment closure in April 2015. Patients were recruited at the Duke Cancer Center Hematology clinic.

Fifty (50) participants signed consent. Eleven subjects were screen failures. The PI removed three subjects prior to treatment to receive alternate therapy. Three subjects chose to withdraw from the study prior to treatment.

Participant milestones

Participant milestones
Measure	Arm 1a (RAD001 Followed by LBH589) Part 1a: Sequential single agent therapy with RAD001 and LBH589. Each agent will be given for four-six 28-day cycles. Subjects with less than a CR after 4 cycles of study drug should proceed to the next study drug(s) after the prescribed washout period. Subjects with a CR may receive up to 6 cycles of study drug and will not receive the next study drug(s) until there is evidence of progressive disease. There will be a 1-6 week 'washout' period between stopping and starting each agent in Part 1, unless rapid progression suggests holding therapy would not be in the patient's best interest. RAD001: 10 mg/day for Part 1 of the trial LBH589: 40 mg on Monday, Wednesday and Friday weekly for Part 1 of the trial	Arm 1b (LBH589 Followed by RAD001) Part 1b: Sequential single agent therapy with LBH589 and RAD001 . Each agent will be given for four-six 28-day cycles. Subjects with less than a CR after 4 cycles of study drug should proceed to the next study drug(s) after the prescribed washout period. Subjects with a CR may receive up to 6 cycles of study drug and will not receive the next study drug(s) until there is evidence of progressive disease. There will be a 1-6 week 'washout' period between stopping and starting each agent in Part 1, unless rapid progression suggests holding therapy would not be in the patient's best interest. RAD001: 10 mg/day for Part 1 of the trial LBH589: 40 mg on Monday, Wednesday and Friday weekly for Part 1 of the trial	Doublet (Combination RAD001 and LBH589) Subjects will receive the doublet of RAD001 and LBH589 given in two to thirteen, 28-day cycles. Subjects will be evaluated for the disease status after completion of cycle two and then after every 4 cycles. Subjects with progressive disease will stop after 2 cycles. Subjects with stable disease or better may receive up to 13 cycles. LBH589 will start at 15mg po three days a week at least 2 days apart such as on days M/W/F or T/Th/Sat and RAD001 will start at 7.5mg po daily. Doublet (RAD001 and LBH589): RAD001 7.5 mg by mouth daily and LBH589 15 mg by mouth on Monday/Wednesday/Friday during Part 2.
Overall Study STARTED	10	5	18
Overall Study COMPLETED	7	4	13
Overall Study NOT COMPLETED	3	1	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm 1a (RAD001 Followed by LBH589) Part 1a: Sequential single agent therapy with RAD001 and LBH589. Each agent will be given for four-six 28-day cycles. Subjects with less than a CR after 4 cycles of study drug should proceed to the next study drug(s) after the prescribed washout period. Subjects with a CR may receive up to 6 cycles of study drug and will not receive the next study drug(s) until there is evidence of progressive disease. There will be a 1-6 week 'washout' period between stopping and starting each agent in Part 1, unless rapid progression suggests holding therapy would not be in the patient's best interest. RAD001: 10 mg/day for Part 1 of the trial LBH589: 40 mg on Monday, Wednesday and Friday weekly for Part 1 of the trial	Arm 1b (LBH589 Followed by RAD001) Part 1b: Sequential single agent therapy with LBH589 and RAD001 . Each agent will be given for four-six 28-day cycles. Subjects with less than a CR after 4 cycles of study drug should proceed to the next study drug(s) after the prescribed washout period. Subjects with a CR may receive up to 6 cycles of study drug and will not receive the next study drug(s) until there is evidence of progressive disease. There will be a 1-6 week 'washout' period between stopping and starting each agent in Part 1, unless rapid progression suggests holding therapy would not be in the patient's best interest. RAD001: 10 mg/day for Part 1 of the trial LBH589: 40 mg on Monday, Wednesday and Friday weekly for Part 1 of the trial	Doublet (Combination RAD001 and LBH589) Subjects will receive the doublet of RAD001 and LBH589 given in two to thirteen, 28-day cycles. Subjects will be evaluated for the disease status after completion of cycle two and then after every 4 cycles. Subjects with progressive disease will stop after 2 cycles. Subjects with stable disease or better may receive up to 13 cycles. LBH589 will start at 15mg po three days a week at least 2 days apart such as on days M/W/F or T/Th/Sat and RAD001 will start at 7.5mg po daily. Doublet (RAD001 and LBH589): RAD001 7.5 mg by mouth daily and LBH589 15 mg by mouth on Monday/Wednesday/Friday during Part 2.
Overall Study Withdrawal by Subject	0	0	1
Overall Study Lack of Efficacy	1	1	3
Overall Study Adverse Event	2	0	1

Baseline Characteristics

Epigenetic Modulation in Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm 1a (RAD001 Followed by LBH589) n=10 Participants Part 1a: Sequential single agent therapy with RAD001 and LBH589. Each agent will be given for four-six 28-day cycles. Subjects with less than a CR after 4 cycles of study drug should proceed to the next study drug(s) after the prescribed washout period. Subjects with a CR may receive up to 6 cycles of study drug and will not receive the next study drug(s) until there is evidence of progressive disease. There will be a 1-6 week 'washout' period between stopping and starting each agent in Part 1, unless rapid progression suggests holding therapy would not be in the patient's best interest. RAD001: 10 mg/day for Part 1 of the trial LBH589: 40 mg on Monday, Wednesday and Friday weekly for Part 1 of the trial	Arm 1b (LBH589 Followed by RAD001) n=5 Participants Part 1b: Sequential single agent therapy with LBH589 and RAD001 . Each agent will be given for four-six 28-day cycles. Subjects with less than a CR after 4 cycles of study drug should proceed to the next study drug(s) after the prescribed washout period. Subjects with a CR may receive up to 6 cycles of study drug and will not receive the next study drug(s) until there is evidence of progressive disease. There will be a 1-6 week 'washout' period between stopping and starting each agent in Part 1, unless rapid progression suggests holding therapy would not be in the patient's best interest. RAD001: 10 mg/day for Part 1 of the trial LBH589: 40 mg on Monday, Wednesday and Friday weekly for Part 1 of the trial	Doublet (Combination RAD001 and LBH589) n=18 Participants Subjects will receive the doublet of RAD001 and LBH589 given in two to thirteen, 28-day cycles. Subjects will be evaluated for the disease status after completion of cycle two and then after every 4 cycles. Subjects with progressive disease will stop after 2 cycles. Subjects with stable disease or better may receive up to 13 cycles. LBH589 will start at 15mg po three days a week at least 2 days apart such as on days M/W/F or T/Th/Sat and RAD001 will start at 7.5mg po daily. Doublet (RAD001 and LBH589): RAD001 7.5 mg by mouth daily and LBH589 15 mg by mouth on Monday/Wednesday/Friday during Part 2.	Total n=33 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants	2 Participants n=7 Participants	9 Participants n=5 Participants	16 Participants n=4 Participants
Age, Categorical >=65 years	5 Participants n=5 Participants	3 Participants n=7 Participants	9 Participants n=5 Participants	17 Participants n=4 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants	10 Participants n=4 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	4 Participants n=7 Participants	15 Participants n=5 Participants	23 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	10 Participants n=5 Participants	5 Participants n=7 Participants	18 Participants n=5 Participants	33 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants
Race (NIH/OMB) White	9 Participants n=5 Participants	5 Participants n=7 Participants	17 Participants n=5 Participants	31 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment United States	10 participants n=5 Participants	5 participants n=7 Participants	18 participants n=5 Participants	33 participants n=4 Participants

PRIMARY outcome

Timeframe: after 2 cycles of each study drug or after 2 cycles of doublet, up to 24 weeks

Population: Patients have to be on each drug for at least 2 cycles to be evaluable for response.

Outcome measures

Outcome measures
Measure	Arm 1a (RAD001 Followed by LBH589) n=10 Participants Part 1a: Sequential single agent therapy with RAD001 and LBH589. Each agent will be given for four-six 28-day cycles. Subjects with less than a CR after 4 cycles of study drug should proceed to the next study drug(s) after the prescribed washout period. Subjects with a CR may receive up to 6 cycles of study drug and will not receive the next study drug(s) until there is evidence of progressive disease. There will be a 1-6 week 'washout' period between stopping and starting each agent in Part 1, unless rapid progression suggests holding therapy would not be in the patient's best interest. RAD001: 10 mg/day for Part 1 of the trial LBH589: 40 mg on Monday, Wednesday and Friday weekly for Part 1 of the trial	Arm 1b (LBH589 Followed by RAD001) n=5 Participants Part 1b: Sequential single agent therapy with LBH589 and RAD001 . Each agent will be given for four-six 28-day cycles. Subjects with less than a CR after 4 cycles of study drug should proceed to the next study drug(s) after the prescribed washout period. Subjects with a CR may receive up to 6 cycles of study drug and will not receive the next study drug(s) until there is evidence of progressive disease. There will be a 1-6 week 'washout' period between stopping and starting each agent in Part 1, unless rapid progression suggests holding therapy would not be in the patient's best interest. RAD001: 10 mg/day for Part 1 of the trial LBH589: 40 mg on Monday, Wednesday and Friday weekly for Part 1 of the trial	Doublet (Combination RAD001 and LBH589) n=18 Participants Subjects will receive the doublet of RAD001 and LBH589 given in two to thirteen, 28-day cycles. Subjects will be evaluated for the disease status after completion of cycle two and then after every 4 cycles. Subjects with progressive disease will stop after 2 cycles. Subjects with stable disease or better may receive up to 13 cycles. LBH589 will start at 15mg po three days a week at least 2 days apart such as on days M/W/F or T/Th/Sat and RAD001 will start at 7.5mg po daily. Doublet (RAD001 and LBH589): RAD001 7.5 mg by mouth daily and LBH589 15 mg by mouth on Monday/Wednesday/Friday during Part 2.
Overall Response Rate	1 participants	0 participants	4 participants

PRIMARY outcome

Timeframe: From the start of combination therapy until a maximum of 2 years after completion of therapy

Population: The number of responses to treatment were so few that we did not think we could get enough meaningful data for analysis. Therefore, molecular analysis was not performed and no results are available.

We will estimate the association of the molecular signature-predicted response to the doublet (CR+PR) with the observed response. All evaluable patients will be used in estimating response. The chi-square test with one-sided alpha of 0.10 will be used to test for the association between predicted and observed responses. Contingency tables will be used to present these associations.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From the time of first dose of study drug until 4 weeks after participant has stopped study drug; up to 1 year

Population: Participants who consented to the study and took study drug were analyzed for this outcome measure. Total number of events per CTCAE v4 category per arm are reported if more than one event occurred.

Counts of adverse events or treatment-emergent adverse events (TEAE, defined as newly occurring or worsening after first dose) experienced by patients on study drug(s). National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version 3.0) is used to assess severity. Relatedness to study drug is assessed by the investigator.

Outcome measures

Outcome measures
Measure	Arm 1a (RAD001 Followed by LBH589) n=10 Participants Part 1a: Sequential single agent therapy with RAD001 and LBH589. Each agent will be given for four-six 28-day cycles. Subjects with less than a CR after 4 cycles of study drug should proceed to the next study drug(s) after the prescribed washout period. Subjects with a CR may receive up to 6 cycles of study drug and will not receive the next study drug(s) until there is evidence of progressive disease. There will be a 1-6 week 'washout' period between stopping and starting each agent in Part 1, unless rapid progression suggests holding therapy would not be in the patient's best interest. RAD001: 10 mg/day for Part 1 of the trial LBH589: 40 mg on Monday, Wednesday and Friday weekly for Part 1 of the trial	Arm 1b (LBH589 Followed by RAD001) n=5 Participants Part 1b: Sequential single agent therapy with LBH589 and RAD001 . Each agent will be given for four-six 28-day cycles. Subjects with less than a CR after 4 cycles of study drug should proceed to the next study drug(s) after the prescribed washout period. Subjects with a CR may receive up to 6 cycles of study drug and will not receive the next study drug(s) until there is evidence of progressive disease. There will be a 1-6 week 'washout' period between stopping and starting each agent in Part 1, unless rapid progression suggests holding therapy would not be in the patient's best interest. RAD001: 10 mg/day for Part 1 of the trial LBH589: 40 mg on Monday, Wednesday and Friday weekly for Part 1 of the trial	Doublet (Combination RAD001 and LBH589) n=18 Participants Subjects will receive the doublet of RAD001 and LBH589 given in two to thirteen, 28-day cycles. Subjects will be evaluated for the disease status after completion of cycle two and then after every 4 cycles. Subjects with progressive disease will stop after 2 cycles. Subjects with stable disease or better may receive up to 13 cycles. LBH589 will start at 15mg po three days a week at least 2 days apart such as on days M/W/F or T/Th/Sat and RAD001 will start at 7.5mg po daily. Doublet (RAD001 and LBH589): RAD001 7.5 mg by mouth daily and LBH589 15 mg by mouth on Monday/Wednesday/Friday during Part 2.
Summary of Adverse Events (AEs) Blood and lymphatic AEs	18 events	6 events	42 events
Summary of Adverse Events (AEs) Gastrointestinal AEs	30 events	10 events	39 events
Summary of Adverse Events (AEs) General Disorder AEs	6 events	5 events	19 events
Summary of Adverse Events (AEs) Investigation (Lab) AEs	6 events	3 events	23 events
Summary of Adverse Events (AEs) Metabolism and Nutrition AEs	5 events	2 events	45 events
Summary of Adverse Events (AEs) Musculoskeletal and Connective Tissue AEs	4 events	1 events	2 events
Summary of Adverse Events (AEs) Nervous System AEs	13 events	3 events	5 events
Summary of Adverse Events (AEs) Renal and Urinary AEs	0 events	1 events	4 events
Summary of Adverse Events (AEs) Reproductive System AEs	0 events	1 events	1 events
Summary of Adverse Events (AEs) Respiratory, thoracic and mediastinal AEs	10 events	4 events	15 events
Summary of Adverse Events (AEs) Skin and Subcutaneous Tissue AEs	8 events	2 events	3 events
Summary of Adverse Events (AEs) Vascular AEs	2 events	1 events	1 events

SECONDARY outcome

Timeframe: after 2 cycles of study therapy; up to 8 weeks

Population: The number of responses to treatment were so few that we did not think we could get enough meaningful data for analysis. Therefore, serum marker analysis was not performed and no results are available.

Serum markers will be measured on the first day of cycle 1 and on the first day of cycle 3. The distribution of change across time in a marker will be summarized.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 13 cycles of therapy; approximately 1 year

Response rates seen in subjects with activated B cell like DLBCL and for Germinal center B cell like DLBCL will be reported and assessed to see if GCB is associated with improved outcomes compared to ABC in subjects with relapsed disease who have received RAD + LBH. We will estimate the association of the ABC and GCB with the observed response. All evaluable patients will be used in estimating response. The chi-square test with one-sided alpha of 0.10 will be used to test for the association between predicted and observed responses. The number of responses to treatment were so few that we did not think we could get enough meaningful data for analysis.

Outcome measures

Outcome data not reported

Adverse Events

Arm 1a (RAD001 Followed by LBH589)

Serious events: 1 serious events

Other events: 10 other events

Deaths: 0 deaths

Arm 1b (LBH589 Followed by RAD001)

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

Doublet (Combination RAD001 and LBH589)

Serious events: 6 serious events

Other events: 18 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Arm 1a (RAD001 Followed by LBH589) n=10 participants at risk Part 1a: Sequential single agent therapy with RAD001 and LBH589. Each agent will be given for four-six 28-day cycles. Subjects with less than a CR after 4 cycles of study drug should proceed to the next study drug(s) after the prescribed washout period. Subjects with a CR may receive up to 6 cycles of study drug and will not receive the next study drug(s) until there is evidence of progressive disease. There will be a 1-6 week 'washout' period between stopping and starting each agent in Part 1, unless rapid progression suggests holding therapy would not be in the patient's best interest. RAD001: 10 mg/day for Part 1 of the trial LBH589: 40 mg on Monday, Wednesday and Friday weekly for Part 1 of the trial	Arm 1b (LBH589 Followed by RAD001) n=5 participants at risk Part 1b: Sequential single agent therapy with LBH589 and RAD001 . Each agent will be given for four-six 28-day cycles. Subjects with less than a CR after 4 cycles of study drug should proceed to the next study drug(s) after the prescribed washout period. Subjects with a CR may receive up to 6 cycles of study drug and will not receive the next study drug(s) until there is evidence of progressive disease. There will be a 1-6 week 'washout' period between stopping and starting each agent in Part 1, unless rapid progression suggests holding therapy would not be in the patient's best interest. RAD001: 10 mg/day for Part 1 of the trial LBH589: 40 mg on Monday, Wednesday and Friday weekly for Part 1 of the trial	Doublet (Combination RAD001 and LBH589) n=18 participants at risk Subjects will receive the doublet of RAD001 and LBH589 given in two to thirteen, 28-day cycles. Subjects will be evaluated for the disease status after completion of cycle two and then after every 4 cycles. Subjects with progressive disease will stop after 2 cycles. Subjects with stable disease or better may receive up to 13 cycles. LBH589 will start at 15mg po three days a week at least 2 days apart such as on days M/W/F or T/Th/Sat and RAD001 will start at 7.5mg po daily. Doublet (RAD001 and LBH589): RAD001 7.5 mg by mouth daily and LBH589 15 mg by mouth on Monday/Wednesday/Friday during Part 2.
Gastrointestinal disorders Diarrhea	10.0% 1/10 • Number of events 1 • From the time of consent until 4 weeks after the last dose of study drug; approximately 1 year.	0.00% 0/5 • From the time of consent until 4 weeks after the last dose of study drug; approximately 1 year.	0.00% 0/18 • From the time of consent until 4 weeks after the last dose of study drug; approximately 1 year.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/10 • From the time of consent until 4 weeks after the last dose of study drug; approximately 1 year.	0.00% 0/5 • From the time of consent until 4 weeks after the last dose of study drug; approximately 1 year.	5.6% 1/18 • Number of events 1 • From the time of consent until 4 weeks after the last dose of study drug; approximately 1 year.
General disorders Fever	0.00% 0/10 • From the time of consent until 4 weeks after the last dose of study drug; approximately 1 year.	0.00% 0/5 • From the time of consent until 4 weeks after the last dose of study drug; approximately 1 year.	11.1% 2/18 • Number of events 2 • From the time of consent until 4 weeks after the last dose of study drug; approximately 1 year.
Cardiac disorders Atrial flutter	0.00% 0/10 • From the time of consent until 4 weeks after the last dose of study drug; approximately 1 year.	0.00% 0/5 • From the time of consent until 4 weeks after the last dose of study drug; approximately 1 year.	5.6% 1/18 • Number of events 1 • From the time of consent until 4 weeks after the last dose of study drug; approximately 1 year.
Cardiac disorders Pericardial effusion	0.00% 0/10 • From the time of consent until 4 weeks after the last dose of study drug; approximately 1 year.	0.00% 0/5 • From the time of consent until 4 weeks after the last dose of study drug; approximately 1 year.	5.6% 1/18 • Number of events 1 • From the time of consent until 4 weeks after the last dose of study drug; approximately 1 year.
Metabolism and nutrition disorders Dehydration	0.00% 0/10 • From the time of consent until 4 weeks after the last dose of study drug; approximately 1 year.	0.00% 0/5 • From the time of consent until 4 weeks after the last dose of study drug; approximately 1 year.	5.6% 1/18 • Number of events 1 • From the time of consent until 4 weeks after the last dose of study drug; approximately 1 year.
Metabolism and nutrition disorders Anorexia	0.00% 0/10 • From the time of consent until 4 weeks after the last dose of study drug; approximately 1 year.	0.00% 0/5 • From the time of consent until 4 weeks after the last dose of study drug; approximately 1 year.	5.6% 1/18 • Number of events 1 • From the time of consent until 4 weeks after the last dose of study drug; approximately 1 year.
General disorders Fatigue	0.00% 0/10 • From the time of consent until 4 weeks after the last dose of study drug; approximately 1 year.	0.00% 0/5 • From the time of consent until 4 weeks after the last dose of study drug; approximately 1 year.	5.6% 1/18 • Number of events 1 • From the time of consent until 4 weeks after the last dose of study drug; approximately 1 year.
Gastrointestinal disorders Colitis	0.00% 0/10 • From the time of consent until 4 weeks after the last dose of study drug; approximately 1 year.	0.00% 0/5 • From the time of consent until 4 weeks after the last dose of study drug; approximately 1 year.	5.6% 1/18 • Number of events 1 • From the time of consent until 4 weeks after the last dose of study drug; approximately 1 year.
Gastrointestinal disorders Ascites	10.0% 1/10 • Number of events 1 • From the time of consent until 4 weeks after the last dose of study drug; approximately 1 year.	0.00% 0/5 • From the time of consent until 4 weeks after the last dose of study drug; approximately 1 year.	0.00% 0/18 • From the time of consent until 4 weeks after the last dose of study drug; approximately 1 year.
Nervous system disorders Cognitive disturbance	0.00% 0/10 • From the time of consent until 4 weeks after the last dose of study drug; approximately 1 year.	20.0% 1/5 • Number of events 1 • From the time of consent until 4 weeks after the last dose of study drug; approximately 1 year.	0.00% 0/18 • From the time of consent until 4 weeks after the last dose of study drug; approximately 1 year.

Other adverse events

Additional Information

Anne Beaven, MD

Duke University Medical Center

Phone: 919-684-8964

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place