Trial Outcomes & Findings for Selinexor and Ibrutinib in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia or Aggressive Non-Hodgkin Lymphoma (NCT NCT02303392)

Last Updated: 2025-06-10

Results Overview

To determine the maximum tolerated dose for the combination of selinexor and ibrutinib in patients with relapsed or refractory chronic lymphocytic leukemia (CLL)/small lymphocytic leukemia(SLL)/B-cell prolymphocytic leukemia (PLL) or aggressive non-Hodgkin lymphoma (NHL).

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

34 participants

Primary outcome timeframe

Day 28

Results posted on

2025-06-10

Participant Flow

Patients were recruited from June 2015 until July 2019

Patients with diagnoses with chronic lymphocytic leukemia (CLL) or non-Hodgkin Lymphoma (NHL) (the NHL arm comprises of diagnoses of Richter transformation (RT), diffuse B-cell lymphoma (DBCL), and mantle cell lymphoma (MCL)) were enrolled

Participant milestones

Participant milestones
Measure	Chronic Lymphocytic Leukemia (CLL) Patients receive ibrutinib PO on days 8-28 of course 1 and on days 1-28 on subsequent courses and selinexor PO BID weekly on day 1 or bi-weekly on days 1 and 3. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Selinexor: Given PO Ibrutinib: Given PO Pharmacological Study: Correlative studies Laboratory Biomarker Analysis: Correlative studies	Non-Hodgkin Lymphoma (NHL) Patients receive ibrutinib PO on days 8-28 of course 1 and on days 1-28 on subsequent courses and selinexor PO BID weekly on day 1 or bi-weekly on days 1 and 3. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Selinexor: Given PO Ibrutinib: Given PO
Overall Study STARTED	16	18
Overall Study COMPLETED	16	18
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Selinexor and Ibrutinib in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia or Aggressive Non-Hodgkin Lymphoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Chronic Lymphocytic Leukemia (CLL) n=16 Participants Patients receive ibrutinib PO on days 8-28 of course 1 and on days 1-28 on subsequent courses and selinexor PO BID weekly on day 1 or bi-weekly on days 1 and 3. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Selinexor: Given PO Ibrutinib: Given PO Pharmacological Study: Correlative studies Laboratory Biomarker Analysis: Correlative studies	Non-Hodgkin Lymphoma (NHL) n=18 Participants Patients receive ibrutinib PO on days 8-28 of course 1 and on days 1-28 on subsequent courses and selinexor PO BID weekly on day 1 or bi-weekly on days 1 and 3. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Selinexor: Given PO Ibrutinib: Given PO	Total n=34 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Categorical Between 18 and 65 years	11 Participants n=99 Participants	6 Participants n=107 Participants	17 Participants n=206 Participants
Age, Categorical >=65 years	5 Participants n=99 Participants	12 Participants n=107 Participants	17 Participants n=206 Participants
Sex: Female, Male Female	5 Participants n=99 Participants	6 Participants n=107 Participants	11 Participants n=206 Participants
Sex: Female, Male Male	11 Participants n=99 Participants	12 Participants n=107 Participants	23 Participants n=206 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Black or African American	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) White	16 Participants n=99 Participants	18 Participants n=107 Participants	34 Participants n=206 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Region of Enrollment United States	16 participants n=99 Participants	18 participants n=107 Participants	34 participants n=206 Participants
Number of prior therapies 1	3 Participants n=99 Participants	2 Participants n=107 Participants	5 Participants n=206 Participants
Number of prior therapies 2	2 Participants n=99 Participants	1 Participants n=107 Participants	3 Participants n=206 Participants
Number of prior therapies 3-8	11 Participants n=99 Participants	10 Participants n=107 Participants	21 Participants n=206 Participants
Number of prior therapies 10-14	0 Participants n=99 Participants	5 Participants n=107 Participants	5 Participants n=206 Participants

PRIMARY outcome

Timeframe: Day 28

Outcome measures

Outcome measures
Measure	Treatment (Selinexor, Ibrutinib) n=34 Participants Patients receive ibrutinib PO on days 8-28 of course 1 and on days 1-28 on subsequent courses and selinexor PO BID weekly on day 1 or bi-weekly on days 1 and 3. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Selinexor: Given PO Ibrutinib: Given PO Pharmacological Study: Correlative studies Laboratory Biomarker Analysis: Correlative studies	Non-Hodgkin Lymphoma (NHL) Patients receive ibrutinib PO on days 8-28 of course 1 and on days 1-28 on subsequent courses and selinexor PO BID weekly on day 1 or bi-weekly on days 1 and 3. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Selinexor: Given PO Ibrutinib: Given PO Pharmacological Study: Correlative studies Laboratory Biomarker Analysis: Correlative studies
Maximum Tolerated Dose for Selinexor	40 mg	—

PRIMARY outcome

Timeframe: Day 28

Outcome measures

Outcome measures
Measure	Treatment (Selinexor, Ibrutinib) n=34 Participants Patients receive ibrutinib PO on days 8-28 of course 1 and on days 1-28 on subsequent courses and selinexor PO BID weekly on day 1 or bi-weekly on days 1 and 3. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Selinexor: Given PO Ibrutinib: Given PO Pharmacological Study: Correlative studies Laboratory Biomarker Analysis: Correlative studies	Non-Hodgkin Lymphoma (NHL) Patients receive ibrutinib PO on days 8-28 of course 1 and on days 1-28 on subsequent courses and selinexor PO BID weekly on day 1 or bi-weekly on days 1 and 3. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Selinexor: Given PO Ibrutinib: Given PO Pharmacological Study: Correlative studies Laboratory Biomarker Analysis: Correlative studies
Maximum Tolerated Dose for Ibrutinib	420 mg	—

SECONDARY outcome

Timeframe: Up to 4 years

Toxicities will be tabulated by type and grade and displayed in summary form. In addition, the number of courses started/completed, number of patients requiring dose reductions, and the reason for going off treatment may be summarized to assess treatment tolerability.

Outcome measures

Outcome measures
Measure	Treatment (Selinexor, Ibrutinib) n=16 Participants Patients receive ibrutinib PO on days 8-28 of course 1 and on days 1-28 on subsequent courses and selinexor PO BID weekly on day 1 or bi-weekly on days 1 and 3. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Selinexor: Given PO Ibrutinib: Given PO Pharmacological Study: Correlative studies Laboratory Biomarker Analysis: Correlative studies	Non-Hodgkin Lymphoma (NHL) n=18 Participants Patients receive ibrutinib PO on days 8-28 of course 1 and on days 1-28 on subsequent courses and selinexor PO BID weekly on day 1 or bi-weekly on days 1 and 3. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Selinexor: Given PO Ibrutinib: Given PO Pharmacological Study: Correlative studies Laboratory Biomarker Analysis: Correlative studies
Number of Participants With Toxicities Graded by CTCAE V4 That Are Grade 3 or Higher Anemia	2 Participants	4 Participants
Number of Participants With Toxicities Graded by CTCAE V4 That Are Grade 3 or Higher Neutropenia	4 Participants	1 Participants
Number of Participants With Toxicities Graded by CTCAE V4 That Are Grade 3 or Higher Lymphocyte count increased	3 Participants	1 Participants
Number of Participants With Toxicities Graded by CTCAE V4 That Are Grade 3 or Higher Lymphopenia	1 Participants	6 Participants
Number of Participants With Toxicities Graded by CTCAE V4 That Are Grade 3 or Higher Nausea	1 Participants	0 Participants
Number of Participants With Toxicities Graded by CTCAE V4 That Are Grade 3 or Higher Diarrhea	1 Participants	1 Participants
Number of Participants With Toxicities Graded by CTCAE V4 That Are Grade 3 or Higher Hypertension	5 Participants	4 Participants
Number of Participants With Toxicities Graded by CTCAE V4 That Are Grade 3 or Higher Joint/Bone Pain	1 Participants	0 Participants
Number of Participants With Toxicities Graded by CTCAE V4 That Are Grade 3 or Higher Hyponatremia	3 Participants	2 Participants
Number of Participants With Toxicities Graded by CTCAE V4 That Are Grade 3 or Higher Pneumonia	1 Participants	2 Participants
Number of Participants With Toxicities Graded by CTCAE V4 That Are Grade 3 or Higher Hyperglycemia	1 Participants	1 Participants
Number of Participants With Toxicities Graded by CTCAE V4 That Are Grade 3 or Higher Hypoxia	0 Participants	2 Participants
Number of Participants With Toxicities Graded by CTCAE V4 That Are Grade 3 or Higher Thrombocytopenia	6 Participants	2 Participants
Number of Participants With Toxicities Graded by CTCAE V4 That Are Grade 3 or Higher Fall	2 Participants	0 Participants
Number of Participants With Toxicities Graded by CTCAE V4 That Are Grade 3 or Higher Cataract	1 Participants	1 Participants
Number of Participants With Toxicities Graded by CTCAE V4 That Are Grade 3 or Higher Cognitive Disturbance	1 Participants	0 Participants
Number of Participants With Toxicities Graded by CTCAE V4 That Are Grade 3 or Higher Hypophosphatemia	1 Participants	2 Participants
Number of Participants With Toxicities Graded by CTCAE V4 That Are Grade 3 or Higher Death	1 Participants	2 Participants

SECONDARY outcome

Timeframe: Up to 4 years

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Outcome measures

Outcome measures
Measure	Treatment (Selinexor, Ibrutinib) n=16 Participants Patients receive ibrutinib PO on days 8-28 of course 1 and on days 1-28 on subsequent courses and selinexor PO BID weekly on day 1 or bi-weekly on days 1 and 3. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Selinexor: Given PO Ibrutinib: Given PO Pharmacological Study: Correlative studies Laboratory Biomarker Analysis: Correlative studies	Non-Hodgkin Lymphoma (NHL) n=18 Participants Patients receive ibrutinib PO on days 8-28 of course 1 and on days 1-28 on subsequent courses and selinexor PO BID weekly on day 1 or bi-weekly on days 1 and 3. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Selinexor: Given PO Ibrutinib: Given PO Pharmacological Study: Correlative studies Laboratory Biomarker Analysis: Correlative studies
Clinical Response Defined as Those With CR or PR	44 percentage of patients	22 percentage of patients

SECONDARY outcome

Timeframe: Date of study enrollment to disease progression or death, whichever occurs first assessed up to 4 years

Progression Free Survival (PFS): PFS calculated from the date of study enrollment to disease progression or death, whichever occurs first. Patients who do not progress or die will be censored at the time of last contact with response assessment by physical exam and laboratory studies.

Outcome measures

Outcome measures
Measure	Treatment (Selinexor, Ibrutinib) n=16 Participants Patients receive ibrutinib PO on days 8-28 of course 1 and on days 1-28 on subsequent courses and selinexor PO BID weekly on day 1 or bi-weekly on days 1 and 3. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Selinexor: Given PO Ibrutinib: Given PO Pharmacological Study: Correlative studies Laboratory Biomarker Analysis: Correlative studies	Non-Hodgkin Lymphoma (NHL) n=18 Participants Patients receive ibrutinib PO on days 8-28 of course 1 and on days 1-28 on subsequent courses and selinexor PO BID weekly on day 1 or bi-weekly on days 1 and 3. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Selinexor: Given PO Ibrutinib: Given PO Pharmacological Study: Correlative studies Laboratory Biomarker Analysis: Correlative studies
Progression Free Survival (PFS)	8.9 months Interval 3.9 to 16.1	2.7 months Interval 0.7 to 5.4

SECONDARY outcome

Timeframe: Date of study enrollment to death assessed up to 5 years

Overall Survival (OS) calculated from the date of study enrollment to death. Patients who do not die will be censored at the time of last contact. This will be analyzed in each cohort independently

Outcome measures

Outcome measures
Measure	Treatment (Selinexor, Ibrutinib) n=16 Participants Patients receive ibrutinib PO on days 8-28 of course 1 and on days 1-28 on subsequent courses and selinexor PO BID weekly on day 1 or bi-weekly on days 1 and 3. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Selinexor: Given PO Ibrutinib: Given PO Pharmacological Study: Correlative studies Laboratory Biomarker Analysis: Correlative studies	Non-Hodgkin Lymphoma (NHL) n=18 Participants Patients receive ibrutinib PO on days 8-28 of course 1 and on days 1-28 on subsequent courses and selinexor PO BID weekly on day 1 or bi-weekly on days 1 and 3. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Selinexor: Given PO Ibrutinib: Given PO Pharmacological Study: Correlative studies Laboratory Biomarker Analysis: Correlative studies
Overall Survival (OS)	58.9 months Interval 19.6 to 58.9	5.1 months Interval 3.0 to 14.8

Adverse Events

Chronic Lymphocytic Leukemia (CLL)

Serious events: 6 serious events

Other events: 16 other events

Deaths: 1 deaths

Non-Hodgkin Lymphoma (NHL)

Serious events: 7 serious events

Other events: 18 other events

Deaths: 4 deaths

Serious adverse events

Other adverse events

Additional Information

Dr. Jennifer Woyach

The Ohio State University Comprehensive Cancer Center

Phone: 614-293-8165

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Serious adverse events
Measure	Chronic Lymphocytic Leukemia (CLL) n=16 participants at risk Patients receive ibrutinib PO on days 8-28 of course 1 and on days 1-28 on subsequent courses and selinexor PO BID weekly on day 1 or bi-weekly on days 1 and 3. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Selinexor: Given PO Ibrutinib: Given PO Pharmacological Study: Correlative studies Laboratory Biomarker Analysis: Correlative studies	Non-Hodgkin Lymphoma (NHL) n=18 participants at risk Patients receive ibrutinib PO on days 8-28 of course 1 and on days 1-28 on subsequent courses and selinexor PO BID weekly on day 1 or bi-weekly on days 1 and 3. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Selinexor: Given PO Ibrutinib: Given PO Pharmacological Study: Correlative studies Laboratory Biomarker Analysis: Correlative studies
Gastrointestinal disorders Colonic Obstruction	0.00% 0/16 • All patients must be carefully monitored for AEs, including clinical laboratory tests. AEs should be assessed in terms of their seriousness, intensity, and relationship to the study drug. For consistency, events are to be graded using the CTCAE version 4.0 from start of study to completion for up to 4 years. CTCAE version 4.0 is used to grade all adverse events and to provide management guidelines for administrational toxicity. Adverse events from all arms are reported together as participants on all arms received the same treatment regimen.	5.6% 1/18 • Number of events 1 • All patients must be carefully monitored for AEs, including clinical laboratory tests. AEs should be assessed in terms of their seriousness, intensity, and relationship to the study drug. For consistency, events are to be graded using the CTCAE version 4.0 from start of study to completion for up to 4 years. CTCAE version 4.0 is used to grade all adverse events and to provide management guidelines for administrational toxicity. Adverse events from all arms are reported together as participants on all arms received the same treatment regimen.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/16 • All patients must be carefully monitored for AEs, including clinical laboratory tests. AEs should be assessed in terms of their seriousness, intensity, and relationship to the study drug. For consistency, events are to be graded using the CTCAE version 4.0 from start of study to completion for up to 4 years. CTCAE version 4.0 is used to grade all adverse events and to provide management guidelines for administrational toxicity. Adverse events from all arms are reported together as participants on all arms received the same treatment regimen.	5.6% 1/18 • Number of events 1 • All patients must be carefully monitored for AEs, including clinical laboratory tests. AEs should be assessed in terms of their seriousness, intensity, and relationship to the study drug. For consistency, events are to be graded using the CTCAE version 4.0 from start of study to completion for up to 4 years. CTCAE version 4.0 is used to grade all adverse events and to provide management guidelines for administrational toxicity. Adverse events from all arms are reported together as participants on all arms received the same treatment regimen.
Infections and infestations Lung Infection	6.2% 1/16 • Number of events 2 • All patients must be carefully monitored for AEs, including clinical laboratory tests. AEs should be assessed in terms of their seriousness, intensity, and relationship to the study drug. For consistency, events are to be graded using the CTCAE version 4.0 from start of study to completion for up to 4 years. CTCAE version 4.0 is used to grade all adverse events and to provide management guidelines for administrational toxicity. Adverse events from all arms are reported together as participants on all arms received the same treatment regimen.	11.1% 2/18 • Number of events 2 • All patients must be carefully monitored for AEs, including clinical laboratory tests. AEs should be assessed in terms of their seriousness, intensity, and relationship to the study drug. For consistency, events are to be graded using the CTCAE version 4.0 from start of study to completion for up to 4 years. CTCAE version 4.0 is used to grade all adverse events and to provide management guidelines for administrational toxicity. Adverse events from all arms are reported together as participants on all arms received the same treatment regimen.
Injury, poisoning and procedural complications Fall	12.5% 2/16 • Number of events 2 • All patients must be carefully monitored for AEs, including clinical laboratory tests. AEs should be assessed in terms of their seriousness, intensity, and relationship to the study drug. For consistency, events are to be graded using the CTCAE version 4.0 from start of study to completion for up to 4 years. CTCAE version 4.0 is used to grade all adverse events and to provide management guidelines for administrational toxicity. Adverse events from all arms are reported together as participants on all arms received the same treatment regimen.	0.00% 0/18 • All patients must be carefully monitored for AEs, including clinical laboratory tests. AEs should be assessed in terms of their seriousness, intensity, and relationship to the study drug. For consistency, events are to be graded using the CTCAE version 4.0 from start of study to completion for up to 4 years. CTCAE version 4.0 is used to grade all adverse events and to provide management guidelines for administrational toxicity. Adverse events from all arms are reported together as participants on all arms received the same treatment regimen.
General disorders Death, NOS	6.2% 1/16 • Number of events 1 • All patients must be carefully monitored for AEs, including clinical laboratory tests. AEs should be assessed in terms of their seriousness, intensity, and relationship to the study drug. For consistency, events are to be graded using the CTCAE version 4.0 from start of study to completion for up to 4 years. CTCAE version 4.0 is used to grade all adverse events and to provide management guidelines for administrational toxicity. Adverse events from all arms are reported together as participants on all arms received the same treatment regimen.	11.1% 2/18 • Number of events 2 • All patients must be carefully monitored for AEs, including clinical laboratory tests. AEs should be assessed in terms of their seriousness, intensity, and relationship to the study drug. For consistency, events are to be graded using the CTCAE version 4.0 from start of study to completion for up to 4 years. CTCAE version 4.0 is used to grade all adverse events and to provide management guidelines for administrational toxicity. Adverse events from all arms are reported together as participants on all arms received the same treatment regimen.
Metabolism and nutrition disorders Hypercalcemia	0.00% 0/16 • All patients must be carefully monitored for AEs, including clinical laboratory tests. AEs should be assessed in terms of their seriousness, intensity, and relationship to the study drug. For consistency, events are to be graded using the CTCAE version 4.0 from start of study to completion for up to 4 years. CTCAE version 4.0 is used to grade all adverse events and to provide management guidelines for administrational toxicity. Adverse events from all arms are reported together as participants on all arms received the same treatment regimen.	11.1% 2/18 • Number of events 2 • All patients must be carefully monitored for AEs, including clinical laboratory tests. AEs should be assessed in terms of their seriousness, intensity, and relationship to the study drug. For consistency, events are to be graded using the CTCAE version 4.0 from start of study to completion for up to 4 years. CTCAE version 4.0 is used to grade all adverse events and to provide management guidelines for administrational toxicity. Adverse events from all arms are reported together as participants on all arms received the same treatment regimen.
Blood and lymphatic system disorders Anemia	0.00% 0/16 • All patients must be carefully monitored for AEs, including clinical laboratory tests. AEs should be assessed in terms of their seriousness, intensity, and relationship to the study drug. For consistency, events are to be graded using the CTCAE version 4.0 from start of study to completion for up to 4 years. CTCAE version 4.0 is used to grade all adverse events and to provide management guidelines for administrational toxicity. Adverse events from all arms are reported together as participants on all arms received the same treatment regimen.	5.6% 1/18 • Number of events 1 • All patients must be carefully monitored for AEs, including clinical laboratory tests. AEs should be assessed in terms of their seriousness, intensity, and relationship to the study drug. For consistency, events are to be graded using the CTCAE version 4.0 from start of study to completion for up to 4 years. CTCAE version 4.0 is used to grade all adverse events and to provide management guidelines for administrational toxicity. Adverse events from all arms are reported together as participants on all arms received the same treatment regimen.
Psychiatric disorders Confusion	0.00% 0/16 • All patients must be carefully monitored for AEs, including clinical laboratory tests. AEs should be assessed in terms of their seriousness, intensity, and relationship to the study drug. For consistency, events are to be graded using the CTCAE version 4.0 from start of study to completion for up to 4 years. CTCAE version 4.0 is used to grade all adverse events and to provide management guidelines for administrational toxicity. Adverse events from all arms are reported together as participants on all arms received the same treatment regimen.	5.6% 1/18 • Number of events 1 • All patients must be carefully monitored for AEs, including clinical laboratory tests. AEs should be assessed in terms of their seriousness, intensity, and relationship to the study drug. For consistency, events are to be graded using the CTCAE version 4.0 from start of study to completion for up to 4 years. CTCAE version 4.0 is used to grade all adverse events and to provide management guidelines for administrational toxicity. Adverse events from all arms are reported together as participants on all arms received the same treatment regimen.
Nervous system disorders Encephalopathy	0.00% 0/16 • All patients must be carefully monitored for AEs, including clinical laboratory tests. AEs should be assessed in terms of their seriousness, intensity, and relationship to the study drug. For consistency, events are to be graded using the CTCAE version 4.0 from start of study to completion for up to 4 years. CTCAE version 4.0 is used to grade all adverse events and to provide management guidelines for administrational toxicity. Adverse events from all arms are reported together as participants on all arms received the same treatment regimen.	5.6% 1/18 • Number of events 1 • All patients must be carefully monitored for AEs, including clinical laboratory tests. AEs should be assessed in terms of their seriousness, intensity, and relationship to the study drug. For consistency, events are to be graded using the CTCAE version 4.0 from start of study to completion for up to 4 years. CTCAE version 4.0 is used to grade all adverse events and to provide management guidelines for administrational toxicity. Adverse events from all arms are reported together as participants on all arms received the same treatment regimen.
Blood and lymphatic system disorders Febrile Neutropenia	0.00% 0/16 • All patients must be carefully monitored for AEs, including clinical laboratory tests. AEs should be assessed in terms of their seriousness, intensity, and relationship to the study drug. For consistency, events are to be graded using the CTCAE version 4.0 from start of study to completion for up to 4 years. CTCAE version 4.0 is used to grade all adverse events and to provide management guidelines for administrational toxicity. Adverse events from all arms are reported together as participants on all arms received the same treatment regimen.	5.6% 1/18 • Number of events 2 • All patients must be carefully monitored for AEs, including clinical laboratory tests. AEs should be assessed in terms of their seriousness, intensity, and relationship to the study drug. For consistency, events are to be graded using the CTCAE version 4.0 from start of study to completion for up to 4 years. CTCAE version 4.0 is used to grade all adverse events and to provide management guidelines for administrational toxicity. Adverse events from all arms are reported together as participants on all arms received the same treatment regimen.
Infections and infestations Infections and Infestations-other	0.00% 0/16 • All patients must be carefully monitored for AEs, including clinical laboratory tests. AEs should be assessed in terms of their seriousness, intensity, and relationship to the study drug. For consistency, events are to be graded using the CTCAE version 4.0 from start of study to completion for up to 4 years. CTCAE version 4.0 is used to grade all adverse events and to provide management guidelines for administrational toxicity. Adverse events from all arms are reported together as participants on all arms received the same treatment regimen.	5.6% 1/18 • Number of events 1 • All patients must be carefully monitored for AEs, including clinical laboratory tests. AEs should be assessed in terms of their seriousness, intensity, and relationship to the study drug. For consistency, events are to be graded using the CTCAE version 4.0 from start of study to completion for up to 4 years. CTCAE version 4.0 is used to grade all adverse events and to provide management guidelines for administrational toxicity. Adverse events from all arms are reported together as participants on all arms received the same treatment regimen.
Investigations Platelet Count Decreased	0.00% 0/16 • All patients must be carefully monitored for AEs, including clinical laboratory tests. AEs should be assessed in terms of their seriousness, intensity, and relationship to the study drug. For consistency, events are to be graded using the CTCAE version 4.0 from start of study to completion for up to 4 years. CTCAE version 4.0 is used to grade all adverse events and to provide management guidelines for administrational toxicity. Adverse events from all arms are reported together as participants on all arms received the same treatment regimen.	5.6% 1/18 • Number of events 1 • All patients must be carefully monitored for AEs, including clinical laboratory tests. AEs should be assessed in terms of their seriousness, intensity, and relationship to the study drug. For consistency, events are to be graded using the CTCAE version 4.0 from start of study to completion for up to 4 years. CTCAE version 4.0 is used to grade all adverse events and to provide management guidelines for administrational toxicity. Adverse events from all arms are reported together as participants on all arms received the same treatment regimen.
Infections and infestations Sepsis	0.00% 0/16 • All patients must be carefully monitored for AEs, including clinical laboratory tests. AEs should be assessed in terms of their seriousness, intensity, and relationship to the study drug. For consistency, events are to be graded using the CTCAE version 4.0 from start of study to completion for up to 4 years. CTCAE version 4.0 is used to grade all adverse events and to provide management guidelines for administrational toxicity. Adverse events from all arms are reported together as participants on all arms received the same treatment regimen.	11.1% 2/18 • Number of events 3 • All patients must be carefully monitored for AEs, including clinical laboratory tests. AEs should be assessed in terms of their seriousness, intensity, and relationship to the study drug. For consistency, events are to be graded using the CTCAE version 4.0 from start of study to completion for up to 4 years. CTCAE version 4.0 is used to grade all adverse events and to provide management guidelines for administrational toxicity. Adverse events from all arms are reported together as participants on all arms received the same treatment regimen.
General disorders Multi-organ Failure	0.00% 0/16 • All patients must be carefully monitored for AEs, including clinical laboratory tests. AEs should be assessed in terms of their seriousness, intensity, and relationship to the study drug. For consistency, events are to be graded using the CTCAE version 4.0 from start of study to completion for up to 4 years. CTCAE version 4.0 is used to grade all adverse events and to provide management guidelines for administrational toxicity. Adverse events from all arms are reported together as participants on all arms received the same treatment regimen.	5.6% 1/18 • Number of events 1 • All patients must be carefully monitored for AEs, including clinical laboratory tests. AEs should be assessed in terms of their seriousness, intensity, and relationship to the study drug. For consistency, events are to be graded using the CTCAE version 4.0 from start of study to completion for up to 4 years. CTCAE version 4.0 is used to grade all adverse events and to provide management guidelines for administrational toxicity. Adverse events from all arms are reported together as participants on all arms received the same treatment regimen.
Respiratory, thoracic and mediastinal disorders Respiratory Failure	0.00% 0/16 • All patients must be carefully monitored for AEs, including clinical laboratory tests. AEs should be assessed in terms of their seriousness, intensity, and relationship to the study drug. For consistency, events are to be graded using the CTCAE version 4.0 from start of study to completion for up to 4 years. CTCAE version 4.0 is used to grade all adverse events and to provide management guidelines for administrational toxicity. Adverse events from all arms are reported together as participants on all arms received the same treatment regimen.	5.6% 1/18 • Number of events 1 • All patients must be carefully monitored for AEs, including clinical laboratory tests. AEs should be assessed in terms of their seriousness, intensity, and relationship to the study drug. For consistency, events are to be graded using the CTCAE version 4.0 from start of study to completion for up to 4 years. CTCAE version 4.0 is used to grade all adverse events and to provide management guidelines for administrational toxicity. Adverse events from all arms are reported together as participants on all arms received the same treatment regimen.
Respiratory, thoracic and mediastinal disorders Pneumonitis	6.2% 1/16 • Number of events 1 • All patients must be carefully monitored for AEs, including clinical laboratory tests. AEs should be assessed in terms of their seriousness, intensity, and relationship to the study drug. For consistency, events are to be graded using the CTCAE version 4.0 from start of study to completion for up to 4 years. CTCAE version 4.0 is used to grade all adverse events and to provide management guidelines for administrational toxicity. Adverse events from all arms are reported together as participants on all arms received the same treatment regimen.	0.00% 0/18 • All patients must be carefully monitored for AEs, including clinical laboratory tests. AEs should be assessed in terms of their seriousness, intensity, and relationship to the study drug. For consistency, events are to be graded using the CTCAE version 4.0 from start of study to completion for up to 4 years. CTCAE version 4.0 is used to grade all adverse events and to provide management guidelines for administrational toxicity. Adverse events from all arms are reported together as participants on all arms received the same treatment regimen.
Respiratory, thoracic and mediastinal disorders Upper Respiratory Infection	6.2% 1/16 • Number of events 1 • All patients must be carefully monitored for AEs, including clinical laboratory tests. AEs should be assessed in terms of their seriousness, intensity, and relationship to the study drug. For consistency, events are to be graded using the CTCAE version 4.0 from start of study to completion for up to 4 years. CTCAE version 4.0 is used to grade all adverse events and to provide management guidelines for administrational toxicity. Adverse events from all arms are reported together as participants on all arms received the same treatment regimen.	0.00% 0/18 • All patients must be carefully monitored for AEs, including clinical laboratory tests. AEs should be assessed in terms of their seriousness, intensity, and relationship to the study drug. For consistency, events are to be graded using the CTCAE version 4.0 from start of study to completion for up to 4 years. CTCAE version 4.0 is used to grade all adverse events and to provide management guidelines for administrational toxicity. Adverse events from all arms are reported together as participants on all arms received the same treatment regimen.
Musculoskeletal and connective tissue disorders Back Pain	6.2% 1/16 • Number of events 1 • All patients must be carefully monitored for AEs, including clinical laboratory tests. AEs should be assessed in terms of their seriousness, intensity, and relationship to the study drug. For consistency, events are to be graded using the CTCAE version 4.0 from start of study to completion for up to 4 years. CTCAE version 4.0 is used to grade all adverse events and to provide management guidelines for administrational toxicity. Adverse events from all arms are reported together as participants on all arms received the same treatment regimen.	0.00% 0/18 • All patients must be carefully monitored for AEs, including clinical laboratory tests. AEs should be assessed in terms of their seriousness, intensity, and relationship to the study drug. For consistency, events are to be graded using the CTCAE version 4.0 from start of study to completion for up to 4 years. CTCAE version 4.0 is used to grade all adverse events and to provide management guidelines for administrational toxicity. Adverse events from all arms are reported together as participants on all arms received the same treatment regimen.
Renal and urinary disorders Acute Kidney Injury	6.2% 1/16 • Number of events 1 • All patients must be carefully monitored for AEs, including clinical laboratory tests. AEs should be assessed in terms of their seriousness, intensity, and relationship to the study drug. For consistency, events are to be graded using the CTCAE version 4.0 from start of study to completion for up to 4 years. CTCAE version 4.0 is used to grade all adverse events and to provide management guidelines for administrational toxicity. Adverse events from all arms are reported together as participants on all arms received the same treatment regimen.	0.00% 0/18 • All patients must be carefully monitored for AEs, including clinical laboratory tests. AEs should be assessed in terms of their seriousness, intensity, and relationship to the study drug. For consistency, events are to be graded using the CTCAE version 4.0 from start of study to completion for up to 4 years. CTCAE version 4.0 is used to grade all adverse events and to provide management guidelines for administrational toxicity. Adverse events from all arms are reported together as participants on all arms received the same treatment regimen.
Cardiac disorders Palpitations	6.2% 1/16 • Number of events 1 • All patients must be carefully monitored for AEs, including clinical laboratory tests. AEs should be assessed in terms of their seriousness, intensity, and relationship to the study drug. For consistency, events are to be graded using the CTCAE version 4.0 from start of study to completion for up to 4 years. CTCAE version 4.0 is used to grade all adverse events and to provide management guidelines for administrational toxicity. Adverse events from all arms are reported together as participants on all arms received the same treatment regimen.	0.00% 0/18 • All patients must be carefully monitored for AEs, including clinical laboratory tests. AEs should be assessed in terms of their seriousness, intensity, and relationship to the study drug. For consistency, events are to be graded using the CTCAE version 4.0 from start of study to completion for up to 4 years. CTCAE version 4.0 is used to grade all adverse events and to provide management guidelines for administrational toxicity. Adverse events from all arms are reported together as participants on all arms received the same treatment regimen.
Gastrointestinal disorders Pancreatitis	6.2% 1/16 • Number of events 1 • All patients must be carefully monitored for AEs, including clinical laboratory tests. AEs should be assessed in terms of their seriousness, intensity, and relationship to the study drug. For consistency, events are to be graded using the CTCAE version 4.0 from start of study to completion for up to 4 years. CTCAE version 4.0 is used to grade all adverse events and to provide management guidelines for administrational toxicity. Adverse events from all arms are reported together as participants on all arms received the same treatment regimen.	0.00% 0/18 • All patients must be carefully monitored for AEs, including clinical laboratory tests. AEs should be assessed in terms of their seriousness, intensity, and relationship to the study drug. For consistency, events are to be graded using the CTCAE version 4.0 from start of study to completion for up to 4 years. CTCAE version 4.0 is used to grade all adverse events and to provide management guidelines for administrational toxicity. Adverse events from all arms are reported together as participants on all arms received the same treatment regimen.
Renal and urinary disorders Renal Calculi	0.00% 0/16 • All patients must be carefully monitored for AEs, including clinical laboratory tests. AEs should be assessed in terms of their seriousness, intensity, and relationship to the study drug. For consistency, events are to be graded using the CTCAE version 4.0 from start of study to completion for up to 4 years. CTCAE version 4.0 is used to grade all adverse events and to provide management guidelines for administrational toxicity. Adverse events from all arms are reported together as participants on all arms received the same treatment regimen.	5.6% 1/18 • Number of events 1 • All patients must be carefully monitored for AEs, including clinical laboratory tests. AEs should be assessed in terms of their seriousness, intensity, and relationship to the study drug. For consistency, events are to be graded using the CTCAE version 4.0 from start of study to completion for up to 4 years. CTCAE version 4.0 is used to grade all adverse events and to provide management guidelines for administrational toxicity. Adverse events from all arms are reported together as participants on all arms received the same treatment regimen.
Blood and lymphatic system disorders Blood and lymphatic system disorders, Other	0.00% 0/16 • All patients must be carefully monitored for AEs, including clinical laboratory tests. AEs should be assessed in terms of their seriousness, intensity, and relationship to the study drug. For consistency, events are to be graded using the CTCAE version 4.0 from start of study to completion for up to 4 years. CTCAE version 4.0 is used to grade all adverse events and to provide management guidelines for administrational toxicity. Adverse events from all arms are reported together as participants on all arms received the same treatment regimen.	5.6% 1/18 • Number of events 1 • All patients must be carefully monitored for AEs, including clinical laboratory tests. AEs should be assessed in terms of their seriousness, intensity, and relationship to the study drug. For consistency, events are to be graded using the CTCAE version 4.0 from start of study to completion for up to 4 years. CTCAE version 4.0 is used to grade all adverse events and to provide management guidelines for administrational toxicity. Adverse events from all arms are reported together as participants on all arms received the same treatment regimen.
Infections and infestations E. coli bacteremia	0.00% 0/16 • All patients must be carefully monitored for AEs, including clinical laboratory tests. AEs should be assessed in terms of their seriousness, intensity, and relationship to the study drug. For consistency, events are to be graded using the CTCAE version 4.0 from start of study to completion for up to 4 years. CTCAE version 4.0 is used to grade all adverse events and to provide management guidelines for administrational toxicity. Adverse events from all arms are reported together as participants on all arms received the same treatment regimen.	5.6% 1/18 • Number of events 1 • All patients must be carefully monitored for AEs, including clinical laboratory tests. AEs should be assessed in terms of their seriousness, intensity, and relationship to the study drug. For consistency, events are to be graded using the CTCAE version 4.0 from start of study to completion for up to 4 years. CTCAE version 4.0 is used to grade all adverse events and to provide management guidelines for administrational toxicity. Adverse events from all arms are reported together as participants on all arms received the same treatment regimen.

Other adverse events
Measure	Chronic Lymphocytic Leukemia (CLL) n=16 participants at risk Patients receive ibrutinib PO on days 8-28 of course 1 and on days 1-28 on subsequent courses and selinexor PO BID weekly on day 1 or bi-weekly on days 1 and 3. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Selinexor: Given PO Ibrutinib: Given PO Pharmacological Study: Correlative studies Laboratory Biomarker Analysis: Correlative studies	Non-Hodgkin Lymphoma (NHL) n=18 participants at risk Patients receive ibrutinib PO on days 8-28 of course 1 and on days 1-28 on subsequent courses and selinexor PO BID weekly on day 1 or bi-weekly on days 1 and 3. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Selinexor: Given PO Ibrutinib: Given PO Pharmacological Study: Correlative studies Laboratory Biomarker Analysis: Correlative studies
Gastrointestinal disorders Abdominal pain	12.5% 2/16 • Number of events 4 • All patients must be carefully monitored for AEs, including clinical laboratory tests. AEs should be assessed in terms of their seriousness, intensity, and relationship to the study drug. For consistency, events are to be graded using the CTCAE version 4.0 from start of study to completion for up to 4 years. CTCAE version 4.0 is used to grade all adverse events and to provide management guidelines for administrational toxicity. Adverse events from all arms are reported together as participants on all arms received the same treatment regimen.	16.7% 3/18 • Number of events 3 • All patients must be carefully monitored for AEs, including clinical laboratory tests. AEs should be assessed in terms of their seriousness, intensity, and relationship to the study drug. For consistency, events are to be graded using the CTCAE version 4.0 from start of study to completion for up to 4 years. CTCAE version 4.0 is used to grade all adverse events and to provide management guidelines for administrational toxicity. Adverse events from all arms are reported together as participants on all arms received the same treatment regimen.
Skin and subcutaneous tissue disorders Actinic Keratosis	6.2% 1/16 • Number of events 1 • All patients must be carefully monitored for AEs, including clinical laboratory tests. AEs should be assessed in terms of their seriousness, intensity, and relationship to the study drug. For consistency, events are to be graded using the CTCAE version 4.0 from start of study to completion for up to 4 years. CTCAE version 4.0 is used to grade all adverse events and to provide management guidelines for administrational toxicity. Adverse events from all arms are reported together as participants on all arms received the same treatment regimen.	0.00% 0/18 • All patients must be carefully monitored for AEs, including clinical laboratory tests. AEs should be assessed in terms of their seriousness, intensity, and relationship to the study drug. For consistency, events are to be graded using the CTCAE version 4.0 from start of study to completion for up to 4 years. CTCAE version 4.0 is used to grade all adverse events and to provide management guidelines for administrational toxicity. Adverse events from all arms are reported together as participants on all arms received the same treatment regimen.
Investigations Activated partial thromboplastin time prolonged	18.8% 3/16 • Number of events 8 • All patients must be carefully monitored for AEs, including clinical laboratory tests. AEs should be assessed in terms of their seriousness, intensity, and relationship to the study drug. For consistency, events are to be graded using the CTCAE version 4.0 from start of study to completion for up to 4 years. CTCAE version 4.0 is used to grade all adverse events and to provide management guidelines for administrational toxicity. Adverse events from all arms are reported together as participants on all arms received the same treatment regimen.	38.9% 7/18 • Number of events 13 • All patients must be carefully monitored for AEs, including clinical laboratory tests. AEs should be assessed in terms of their seriousness, intensity, and relationship to the study drug. For consistency, events are to be graded using the CTCAE version 4.0 from start of study to completion for up to 4 years. CTCAE version 4.0 is used to grade all adverse events and to provide management guidelines for administrational toxicity. Adverse events from all arms are reported together as participants on all arms received the same treatment regimen.
Infections and infestations Otitis media	6.2% 1/16 • Number of events 1 • All patients must be carefully monitored for AEs, including clinical laboratory tests. AEs should be assessed in terms of their seriousness, intensity, and relationship to the study drug. For consistency, events are to be graded using the CTCAE version 4.0 from start of study to completion for up to 4 years. CTCAE version 4.0 is used to grade all adverse events and to provide management guidelines for administrational toxicity. Adverse events from all arms are reported together as participants on all arms received the same treatment regimen.	0.00% 0/18 • All patients must be carefully monitored for AEs, including clinical laboratory tests. AEs should be assessed in terms of their seriousness, intensity, and relationship to the study drug. For consistency, events are to be graded using the CTCAE version 4.0 from start of study to completion for up to 4 years. CTCAE version 4.0 is used to grade all adverse events and to provide management guidelines for administrational toxicity. Adverse events from all arms are reported together as participants on all arms received the same treatment regimen.
Investigations Alkaline Phosphatase increased	31.2% 5/16 • Number of events 10 • All patients must be carefully monitored for AEs, including clinical laboratory tests. AEs should be assessed in terms of their seriousness, intensity, and relationship to the study drug. For consistency, events are to be graded using the CTCAE version 4.0 from start of study to completion for up to 4 years. CTCAE version 4.0 is used to grade all adverse events and to provide management guidelines for administrational toxicity. Adverse events from all arms are reported together as participants on all arms received the same treatment regimen.	22.2% 4/18 • Number of events 5 • All patients must be carefully monitored for AEs, including clinical laboratory tests. AEs should be assessed in terms of their seriousness, intensity, and relationship to the study drug. For consistency, events are to be graded using the CTCAE version 4.0 from start of study to completion for up to 4 years. CTCAE version 4.0 is used to grade all adverse events and to provide management guidelines for administrational toxicity. Adverse events from all arms are reported together as participants on all arms received the same treatment regimen.
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	37.5% 6/16 • Number of events 6 • All patients must be carefully monitored for AEs, including clinical laboratory tests. AEs should be assessed in terms of their seriousness, intensity, and relationship to the study drug. For consistency, events are to be graded using the CTCAE version 4.0 from start of study to completion for up to 4 years. CTCAE version 4.0 is used to grade all adverse events and to provide management guidelines for administrational toxicity. Adverse events from all arms are reported together as participants on all arms received the same treatment regimen.	16.7% 3/18 • Number of events 3 • All patients must be carefully monitored for AEs, including clinical laboratory tests. AEs should be assessed in terms of their seriousness, intensity, and relationship to the study drug. For consistency, events are to be graded using the CTCAE version 4.0 from start of study to completion for up to 4 years. CTCAE version 4.0 is used to grade all adverse events and to provide management guidelines for administrational toxicity. Adverse events from all arms are reported together as participants on all arms received the same treatment regimen.
Investigations Alanine aminotransferase increased	18.8% 3/16 • Number of events 9 • All patients must be carefully monitored for AEs, including clinical laboratory tests. AEs should be assessed in terms of their seriousness, intensity, and relationship to the study drug. For consistency, events are to be graded using the CTCAE version 4.0 from start of study to completion for up to 4 years. CTCAE version 4.0 is used to grade all adverse events and to provide management guidelines for administrational toxicity. Adverse events from all arms are reported together as participants on all arms received the same treatment regimen.	5.6% 1/18 • Number of events 1 • All patients must be carefully monitored for AEs, including clinical laboratory tests. AEs should be assessed in terms of their seriousness, intensity, and relationship to the study drug. For consistency, events are to be graded using the CTCAE version 4.0 from start of study to completion for up to 4 years. CTCAE version 4.0 is used to grade all adverse events and to provide management guidelines for administrational toxicity. Adverse events from all arms are reported together as participants on all arms received the same treatment regimen.
Nervous system disorders Altered Mental Status	6.2% 1/16 • Number of events 1 • All patients must be carefully monitored for AEs, including clinical laboratory tests. AEs should be assessed in terms of their seriousness, intensity, and relationship to the study drug. For consistency, events are to be graded using the CTCAE version 4.0 from start of study to completion for up to 4 years. CTCAE version 4.0 is used to grade all adverse events and to provide management guidelines for administrational toxicity. Adverse events from all arms are reported together as participants on all arms received the same treatment regimen.	0.00% 0/18 • All patients must be carefully monitored for AEs, including clinical laboratory tests. AEs should be assessed in terms of their seriousness, intensity, and relationship to the study drug. For consistency, events are to be graded using the CTCAE version 4.0 from start of study to completion for up to 4 years. CTCAE version 4.0 is used to grade all adverse events and to provide management guidelines for administrational toxicity. Adverse events from all arms are reported together as participants on all arms received the same treatment regimen.
Blood and lymphatic system disorders Anemia	87.5% 14/16 • Number of events 39 • All patients must be carefully monitored for AEs, including clinical laboratory tests. AEs should be assessed in terms of their seriousness, intensity, and relationship to the study drug. For consistency, events are to be graded using the CTCAE version 4.0 from start of study to completion for up to 4 years. CTCAE version 4.0 is used to grade all adverse events and to provide management guidelines for administrational toxicity. Adverse events from all arms are reported together as participants on all arms received the same treatment regimen.	77.8% 14/18 • Number of events 48 • All patients must be carefully monitored for AEs, including clinical laboratory tests. AEs should be assessed in terms of their seriousness, intensity, and relationship to the study drug. For consistency, events are to be graded using the CTCAE version 4.0 from start of study to completion for up to 4 years. CTCAE version 4.0 is used to grade all adverse events and to provide management guidelines for administrational toxicity. Adverse events from all arms are reported together as participants on all arms received the same treatment regimen.
Metabolism and nutrition disorders Anorexia	50.0% 8/16 • Number of events 11 • All patients must be carefully monitored for AEs, including clinical laboratory tests. AEs should be assessed in terms of their seriousness, intensity, and relationship to the study drug. For consistency, events are to be graded using the CTCAE version 4.0 from start of study to completion for up to 4 years. CTCAE version 4.0 is used to grade all adverse events and to provide management guidelines for administrational toxicity. Adverse events from all arms are reported together as participants on all arms received the same treatment regimen.	55.6% 10/18 • Number of events 12 • All patients must be carefully monitored for AEs, including clinical laboratory tests. AEs should be assessed in terms of their seriousness, intensity, and relationship to the study drug. For consistency, events are to be graded using the CTCAE version 4.0 from start of study to completion for up to 4 years. CTCAE version 4.0 is used to grade all adverse events and to provide management guidelines for administrational toxicity. Adverse events from all arms are reported together as participants on all arms received the same treatment regimen.
Psychiatric disorders Anxiety	18.8% 3/16 • Number of events 3 • All patients must be carefully monitored for AEs, including clinical laboratory tests. AEs should be assessed in terms of their seriousness, intensity, and relationship to the study drug. For consistency, events are to be graded using the CTCAE version 4.0 from start of study to completion for up to 4 years. CTCAE version 4.0 is used to grade all adverse events and to provide management guidelines for administrational toxicity. Adverse events from all arms are reported together as participants on all arms received the same treatment regimen.	5.6% 1/18 • Number of events 1 • All patients must be carefully monitored for AEs, including clinical laboratory tests. AEs should be assessed in terms of their seriousness, intensity, and relationship to the study drug. For consistency, events are to be graded using the CTCAE version 4.0 from start of study to completion for up to 4 years. CTCAE version 4.0 is used to grade all adverse events and to provide management guidelines for administrational toxicity. Adverse events from all arms are reported together as participants on all arms received the same treatment regimen.
Musculoskeletal and connective tissue disorders Arthralgia	37.5% 6/16 • Number of events 9 • All patients must be carefully monitored for AEs, including clinical laboratory tests. AEs should be assessed in terms of their seriousness, intensity, and relationship to the study drug. For consistency, events are to be graded using the CTCAE version 4.0 from start of study to completion for up to 4 years. CTCAE version 4.0 is used to grade all adverse events and to provide management guidelines for administrational toxicity. Adverse events from all arms are reported together as participants on all arms received the same treatment regimen.	16.7% 3/18 • Number of events 3 • All patients must be carefully monitored for AEs, including clinical laboratory tests. AEs should be assessed in terms of their seriousness, intensity, and relationship to the study drug. For consistency, events are to be graded using the CTCAE version 4.0 from start of study to completion for up to 4 years. CTCAE version 4.0 is used to grade all adverse events and to provide management guidelines for administrational toxicity. Adverse events from all arms are reported together as participants on all arms received the same treatment regimen.
Musculoskeletal and connective tissue disorders Arthritis	6.2% 1/16 • Number of events 1 • All patients must be carefully monitored for AEs, including clinical laboratory tests. AEs should be assessed in terms of their seriousness, intensity, and relationship to the study drug. For consistency, events are to be graded using the CTCAE version 4.0 from start of study to completion for up to 4 years. CTCAE version 4.0 is used to grade all adverse events and to provide management guidelines for administrational toxicity. Adverse events from all arms are reported together as participants on all arms received the same treatment regimen.	5.6% 1/18 • Number of events 1 • All patients must be carefully monitored for AEs, including clinical laboratory tests. AEs should be assessed in terms of their seriousness, intensity, and relationship to the study drug. For consistency, events are to be graded using the CTCAE version 4.0 from start of study to completion for up to 4 years. CTCAE version 4.0 is used to grade all adverse events and to provide management guidelines for administrational toxicity. Adverse events from all arms are reported together as participants on all arms received the same treatment regimen.
Investigations Aspartate aminotransferase increased	25.0% 4/16 • Number of events 7 • All patients must be carefully monitored for AEs, including clinical laboratory tests. AEs should be assessed in terms of their seriousness, intensity, and relationship to the study drug. For consistency, events are to be graded using the CTCAE version 4.0 from start of study to completion for up to 4 years. CTCAE version 4.0 is used to grade all adverse events and to provide management guidelines for administrational toxicity. Adverse events from all arms are reported together as participants on all arms received the same treatment regimen.	11.1% 2/18 • Number of events 2 • All patients must be carefully monitored for AEs, including clinical laboratory tests. AEs should be assessed in terms of their seriousness, intensity, and relationship to the study drug. For consistency, events are to be graded using the CTCAE version 4.0 from start of study to completion for up to 4 years. CTCAE version 4.0 is used to grade all adverse events and to provide management guidelines for administrational toxicity. Adverse events from all arms are reported together as participants on all arms received the same treatment regimen.
Respiratory, thoracic and mediastinal disorders Asthma	6.2% 1/16 • Number of events 1 • All patients must be carefully monitored for AEs, including clinical laboratory tests. AEs should be assessed in terms of their seriousness, intensity, and relationship to the study drug. For consistency, events are to be graded using the CTCAE version 4.0 from start of study to completion for up to 4 years. CTCAE version 4.0 is used to grade all adverse events and to provide management guidelines for administrational toxicity. Adverse events from all arms are reported together as participants on all arms received the same treatment regimen.	0.00% 0/18 • All patients must be carefully monitored for AEs, including clinical laboratory tests. AEs should be assessed in terms of their seriousness, intensity, and relationship to the study drug. For consistency, events are to be graded using the CTCAE version 4.0 from start of study to completion for up to 4 years. CTCAE version 4.0 is used to grade all adverse events and to provide management guidelines for administrational toxicity. Adverse events from all arms are reported together as participants on all arms received the same treatment regimen.
Respiratory, thoracic and mediastinal disorders Atelectasis	6.2% 1/16 • Number of events 2 • All patients must be carefully monitored for AEs, including clinical laboratory tests. AEs should be assessed in terms of their seriousness, intensity, and relationship to the study drug. For consistency, events are to be graded using the CTCAE version 4.0 from start of study to completion for up to 4 years. CTCAE version 4.0 is used to grade all adverse events and to provide management guidelines for administrational toxicity. Adverse events from all arms are reported together as participants on all arms received the same treatment regimen.	0.00% 0/18 • All patients must be carefully monitored for AEs, including clinical laboratory tests. AEs should be assessed in terms of their seriousness, intensity, and relationship to the study drug. For consistency, events are to be graded using the CTCAE version 4.0 from start of study to completion for up to 4 years. CTCAE version 4.0 is used to grade all adverse events and to provide management guidelines for administrational toxicity. Adverse events from all arms are reported together as participants on all arms received the same treatment regimen.
Cardiac disorders Atrial Flutter	12.5% 2/16 • Number of events 2 • All patients must be carefully monitored for AEs, including clinical laboratory tests. AEs should be assessed in terms of their seriousness, intensity, and relationship to the study drug. For consistency, events are to be graded using the CTCAE version 4.0 from start of study to completion for up to 4 years. CTCAE version 4.0 is used to grade all adverse events and to provide management guidelines for administrational toxicity. Adverse events from all arms are reported together as participants on all arms received the same treatment regimen.	5.6% 1/18 • Number of events 1 • All patients must be carefully monitored for AEs, including clinical laboratory tests. AEs should be assessed in terms of their seriousness, intensity, and relationship to the study drug. For consistency, events are to be graded using the CTCAE version 4.0 from start of study to completion for up to 4 years. CTCAE version 4.0 is used to grade all adverse events and to provide management guidelines for administrational toxicity. Adverse events from all arms are reported together as participants on all arms received the same treatment regimen.
Cardiac disorders Atrial Fibrillation	6.2% 1/16 • Number of events 1 • All patients must be carefully monitored for AEs, including clinical laboratory tests. AEs should be assessed in terms of their seriousness, intensity, and relationship to the study drug. For consistency, events are to be graded using the CTCAE version 4.0 from start of study to completion for up to 4 years. CTCAE version 4.0 is used to grade all adverse events and to provide management guidelines for administrational toxicity. Adverse events from all arms are reported together as participants on all arms received the same treatment regimen.	11.1% 2/18 • Number of events 2 • All patients must be carefully monitored for AEs, including clinical laboratory tests. AEs should be assessed in terms of their seriousness, intensity, and relationship to the study drug. For consistency, events are to be graded using the CTCAE version 4.0 from start of study to completion for up to 4 years. CTCAE version 4.0 is used to grade all adverse events and to provide management guidelines for administrational toxicity. Adverse events from all arms are reported together as participants on all arms received the same treatment regimen.
Immune system disorders Autoimmune disorder (Sjogren's syndrome)	6.2% 1/16 • Number of events 1 • All patients must be carefully monitored for AEs, including clinical laboratory tests. AEs should be assessed in terms of their seriousness, intensity, and relationship to the study drug. For consistency, events are to be graded using the CTCAE version 4.0 from start of study to completion for up to 4 years. CTCAE version 4.0 is used to grade all adverse events and to provide management guidelines for administrational toxicity. Adverse events from all arms are reported together as participants on all arms received the same treatment regimen.	0.00% 0/18 • All patients must be carefully monitored for AEs, including clinical laboratory tests. AEs should be assessed in terms of their seriousness, intensity, and relationship to the study drug. For consistency, events are to be graded using the CTCAE version 4.0 from start of study to completion for up to 4 years. CTCAE version 4.0 is used to grade all adverse events and to provide management guidelines for administrational toxicity. Adverse events from all arms are reported together as participants on all arms received the same treatment regimen.
Musculoskeletal and connective tissue disorders Back pain	31.2% 5/16 • Number of events 5 • All patients must be carefully monitored for AEs, including clinical laboratory tests. AEs should be assessed in terms of their seriousness, intensity, and relationship to the study drug. For consistency, events are to be graded using the CTCAE version 4.0 from start of study to completion for up to 4 years. CTCAE version 4.0 is used to grade all adverse events and to provide management guidelines for administrational toxicity. Adverse events from all arms are reported together as participants on all arms received the same treatment regimen.	16.7% 3/18 • Number of events 3 • All patients must be carefully monitored for AEs, including clinical laboratory tests. AEs should be assessed in terms of their seriousness, intensity, and relationship to the study drug. For consistency, events are to be graded using the CTCAE version 4.0 from start of study to completion for up to 4 years. CTCAE version 4.0 is used to grade all adverse events and to provide management guidelines for administrational toxicity. Adverse events from all arms are reported together as participants on all arms received the same treatment regimen.
Skin and subcutaneous tissue disorders Basal Cell Carcinoma	6.2% 1/16 • Number of events 3 • All patients must be carefully monitored for AEs, including clinical laboratory tests. AEs should be assessed in terms of their seriousness, intensity, and relationship to the study drug. For consistency, events are to be graded using the CTCAE version 4.0 from start of study to completion for up to 4 years. CTCAE version 4.0 is used to grade all adverse events and to provide management guidelines for administrational toxicity. Adverse events from all arms are reported together as participants on all arms received the same treatment regimen.	0.00% 0/18 • All patients must be carefully monitored for AEs, including clinical laboratory tests. AEs should be assessed in terms of their seriousness, intensity, and relationship to the study drug. For consistency, events are to be graded using the CTCAE version 4.0 from start of study to completion for up to 4 years. CTCAE version 4.0 is used to grade all adverse events and to provide management guidelines for administrational toxicity. Adverse events from all arms are reported together as participants on all arms received the same treatment regimen.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign Polyp	6.2% 1/16 • Number of events 1 • All patients must be carefully monitored for AEs, including clinical laboratory tests. AEs should be assessed in terms of their seriousness, intensity, and relationship to the study drug. For consistency, events are to be graded using the CTCAE version 4.0 from start of study to completion for up to 4 years. CTCAE version 4.0 is used to grade all adverse events and to provide management guidelines for administrational toxicity. Adverse events from all arms are reported together as participants on all arms received the same treatment regimen.	0.00% 0/18 • All patients must be carefully monitored for AEs, including clinical laboratory tests. AEs should be assessed in terms of their seriousness, intensity, and relationship to the study drug. For consistency, events are to be graded using the CTCAE version 4.0 from start of study to completion for up to 4 years. CTCAE version 4.0 is used to grade all adverse events and to provide management guidelines for administrational toxicity. Adverse events from all arms are reported together as participants on all arms received the same treatment regimen.
Reproductive system and breast disorders Benign Prostatic Hypertrophy (BPH)	6.2% 1/16 • Number of events 1 • All patients must be carefully monitored for AEs, including clinical laboratory tests. AEs should be assessed in terms of their seriousness, intensity, and relationship to the study drug. For consistency, events are to be graded using the CTCAE version 4.0 from start of study to completion for up to 4 years. CTCAE version 4.0 is used to grade all adverse events and to provide management guidelines for administrational toxicity. Adverse events from all arms are reported together as participants on all arms received the same treatment regimen.	5.6% 1/18 • Number of events 1 • All patients must be carefully monitored for AEs, including clinical laboratory tests. AEs should be assessed in terms of their seriousness, intensity, and relationship to the study drug. For consistency, events are to be graded using the CTCAE version 4.0 from start of study to completion for up to 4 years. CTCAE version 4.0 is used to grade all adverse events and to provide management guidelines for administrational toxicity. Adverse events from all arms are reported together as participants on all arms received the same treatment regimen.
Blood and lymphatic system disorders Blood Blisters	12.5% 2/16 • Number of events 2 • All patients must be carefully monitored for AEs, including clinical laboratory tests. AEs should be assessed in terms of their seriousness, intensity, and relationship to the study drug. For consistency, events are to be graded using the CTCAE version 4.0 from start of study to completion for up to 4 years. CTCAE version 4.0 is used to grade all adverse events and to provide management guidelines for administrational toxicity. Adverse events from all arms are reported together as participants on all arms received the same treatment regimen.	0.00% 0/18 • All patients must be carefully monitored for AEs, including clinical laboratory tests. AEs should be assessed in terms of their seriousness, intensity, and relationship to the study drug. For consistency, events are to be graded using the CTCAE version 4.0 from start of study to completion for up to 4 years. CTCAE version 4.0 is used to grade all adverse events and to provide management guidelines for administrational toxicity. Adverse events from all arms are reported together as participants on all arms received the same treatment regimen.
Eye disorders Blurry Vision	25.0% 4/16 • Number of events 6 • All patients must be carefully monitored for AEs, including clinical laboratory tests. AEs should be assessed in terms of their seriousness, intensity, and relationship to the study drug. For consistency, events are to be graded using the CTCAE version 4.0 from start of study to completion for up to 4 years. CTCAE version 4.0 is used to grade all adverse events and to provide management guidelines for administrational toxicity. Adverse events from all arms are reported together as participants on all arms received the same treatment regimen.	22.2% 4/18 • Number of events 4 • All patients must be carefully monitored for AEs, including clinical laboratory tests. AEs should be assessed in terms of their seriousness, intensity, and relationship to the study drug. For consistency, events are to be graded using the CTCAE version 4.0 from start of study to completion for up to 4 years. CTCAE version 4.0 is used to grade all adverse events and to provide management guidelines for administrational toxicity. Adverse events from all arms are reported together as participants on all arms received the same treatment regimen.
Musculoskeletal and connective tissue disorders Bone spur	6.2% 1/16 • Number of events 1 • All patients must be carefully monitored for AEs, including clinical laboratory tests. AEs should be assessed in terms of their seriousness, intensity, and relationship to the study drug. For consistency, events are to be graded using the CTCAE version 4.0 from start of study to completion for up to 4 years. CTCAE version 4.0 is used to grade all adverse events and to provide management guidelines for administrational toxicity. Adverse events from all arms are reported together as participants on all arms received the same treatment regimen.	0.00% 0/18 • All patients must be carefully monitored for AEs, including clinical laboratory tests. AEs should be assessed in terms of their seriousness, intensity, and relationship to the study drug. For consistency, events are to be graded using the CTCAE version 4.0 from start of study to completion for up to 4 years. CTCAE version 4.0 is used to grade all adverse events and to provide management guidelines for administrational toxicity. Adverse events from all arms are reported together as participants on all arms received the same treatment regimen.
Gastrointestinal disorders Bowel Obstruction	6.2% 1/16 • Number of events 1 • All patients must be carefully monitored for AEs, including clinical laboratory tests. AEs should be assessed in terms of their seriousness, intensity, and relationship to the study drug. For consistency, events are to be graded using the CTCAE version 4.0 from start of study to completion for up to 4 years. CTCAE version 4.0 is used to grade all adverse events and to provide management guidelines for administrational toxicity. Adverse events from all arms are reported together as participants on all arms received the same treatment regimen.	0.00% 0/18 • All patients must be carefully monitored for AEs, including clinical laboratory tests. AEs should be assessed in terms of their seriousness, intensity, and relationship to the study drug. For consistency, events are to be graded using the CTCAE version 4.0 from start of study to completion for up to 4 years. CTCAE version 4.0 is used to grade all adverse events and to provide management guidelines for administrational toxicity. Adverse events from all arms are reported together as participants on all arms received the same treatment regimen.
Cardiac disorders Bradycardia	6.2% 1/16 • Number of events 1 • All patients must be carefully monitored for AEs, including clinical laboratory tests. AEs should be assessed in terms of their seriousness, intensity, and relationship to the study drug. For consistency, events are to be graded using the CTCAE version 4.0 from start of study to completion for up to 4 years. CTCAE version 4.0 is used to grade all adverse events and to provide management guidelines for administrational toxicity. Adverse events from all arms are reported together as participants on all arms received the same treatment regimen.	0.00% 0/18 • All patients must be carefully monitored for AEs, including clinical laboratory tests. AEs should be assessed in terms of their seriousness, intensity, and relationship to the study drug. For consistency, events are to be graded using the CTCAE version 4.0 from start of study to completion for up to 4 years. CTCAE version 4.0 is used to grade all adverse events and to provide management guidelines for administrational toxicity. Adverse events from all arms are reported together as participants on all arms received the same treatment regimen.
Nervous system disorders Brain fog	6.2% 1/16 • Number of events 1 • All patients must be carefully monitored for AEs, including clinical laboratory tests. AEs should be assessed in terms of their seriousness, intensity, and relationship to the study drug. For consistency, events are to be graded using the CTCAE version 4.0 from start of study to completion for up to 4 years. CTCAE version 4.0 is used to grade all adverse events and to provide management guidelines for administrational toxicity. Adverse events from all arms are reported together as participants on all arms received the same treatment regimen.	0.00% 0/18 • All patients must be carefully monitored for AEs, including clinical laboratory tests. AEs should be assessed in terms of their seriousness, intensity, and relationship to the study drug. For consistency, events are to be graded using the CTCAE version 4.0 from start of study to completion for up to 4 years. CTCAE version 4.0 is used to grade all adverse events and to provide management guidelines for administrational toxicity. Adverse events from all arms are reported together as participants on all arms received the same treatment regimen.
Skin and subcutaneous tissue disorders Brittle nails	12.5% 2/16 • Number of events 3 • All patients must be carefully monitored for AEs, including clinical laboratory tests. AEs should be assessed in terms of their seriousness, intensity, and relationship to the study drug. For consistency, events are to be graded using the CTCAE version 4.0 from start of study to completion for up to 4 years. CTCAE version 4.0 is used to grade all adverse events and to provide management guidelines for administrational toxicity. Adverse events from all arms are reported together as participants on all arms received the same treatment regimen.	0.00% 0/18 • All patients must be carefully monitored for AEs, including clinical laboratory tests. AEs should be assessed in terms of their seriousness, intensity, and relationship to the study drug. For consistency, events are to be graded using the CTCAE version 4.0 from start of study to completion for up to 4 years. CTCAE version 4.0 is used to grade all adverse events and to provide management guidelines for administrational toxicity. Adverse events from all arms are reported together as participants on all arms received the same treatment regimen.
Infections and infestations Bronchial infection	6.2% 1/16 • Number of events 1 • All patients must be carefully monitored for AEs, including clinical laboratory tests. AEs should be assessed in terms of their seriousness, intensity, and relationship to the study drug. For consistency, events are to be graded using the CTCAE version 4.0 from start of study to completion for up to 4 years. CTCAE version 4.0 is used to grade all adverse events and to provide management guidelines for administrational toxicity. Adverse events from all arms are reported together as participants on all arms received the same treatment regimen.	5.6% 1/18 • Number of events 1 • All patients must be carefully monitored for AEs, including clinical laboratory tests. AEs should be assessed in terms of their seriousness, intensity, and relationship to the study drug. For consistency, events are to be graded using the CTCAE version 4.0 from start of study to completion for up to 4 years. CTCAE version 4.0 is used to grade all adverse events and to provide management guidelines for administrational toxicity. Adverse events from all arms are reported together as participants on all arms received the same treatment regimen.
Injury, poisoning and procedural complications Bruising	37.5% 6/16 • Number of events 8 • All patients must be carefully monitored for AEs, including clinical laboratory tests. AEs should be assessed in terms of their seriousness, intensity, and relationship to the study drug. For consistency, events are to be graded using the CTCAE version 4.0 from start of study to completion for up to 4 years. CTCAE version 4.0 is used to grade all adverse events and to provide management guidelines for administrational toxicity. Adverse events from all arms are reported together as participants on all arms received the same treatment regimen.	44.4% 8/18 • Number of events 9 • All patients must be carefully monitored for AEs, including clinical laboratory tests. AEs should be assessed in terms of their seriousness, intensity, and relationship to the study drug. For consistency, events are to be graded using the CTCAE version 4.0 from start of study to completion for up to 4 years. CTCAE version 4.0 is used to grade all adverse events and to provide management guidelines for administrational toxicity. Adverse events from all arms are reported together as participants on all arms received the same treatment regimen.
Gastrointestinal disorders Bruxism	6.2% 1/16 • Number of events 1 • All patients must be carefully monitored for AEs, including clinical laboratory tests. AEs should be assessed in terms of their seriousness, intensity, and relationship to the study drug. For consistency, events are to be graded using the CTCAE version 4.0 from start of study to completion for up to 4 years. CTCAE version 4.0 is used to grade all adverse events and to provide management guidelines for administrational toxicity. Adverse events from all arms are reported together as participants on all arms received the same treatment regimen.	0.00% 0/18 • All patients must be carefully monitored for AEs, including clinical laboratory tests. AEs should be assessed in terms of their seriousness, intensity, and relationship to the study drug. For consistency, events are to be graded using the CTCAE version 4.0 from start of study to completion for up to 4 years. CTCAE version 4.0 is used to grade all adverse events and to provide management guidelines for administrational toxicity. Adverse events from all arms are reported together as participants on all arms received the same treatment regimen.
Cardiac disorders Cardiac disorder - other Chest Pressure, intermittent	6.2% 1/16 • Number of events 1 • All patients must be carefully monitored for AEs, including clinical laboratory tests. AEs should be assessed in terms of their seriousness, intensity, and relationship to the study drug. For consistency, events are to be graded using the CTCAE version 4.0 from start of study to completion for up to 4 years. CTCAE version 4.0 is used to grade all adverse events and to provide management guidelines for administrational toxicity. Adverse events from all arms are reported together as participants on all arms received the same treatment regimen.	0.00% 0/18 • All patients must be carefully monitored for AEs, including clinical laboratory tests. AEs should be assessed in terms of their seriousness, intensity, and relationship to the study drug. For consistency, events are to be graded using the CTCAE version 4.0 from start of study to completion for up to 4 years. CTCAE version 4.0 is used to grade all adverse events and to provide management guidelines for administrational toxicity. Adverse events from all arms are reported together as participants on all arms received the same treatment regimen.
Eye disorders Cataract	18.8% 3/16 • Number of events 4 • All patients must be carefully monitored for AEs, including clinical laboratory tests. AEs should be assessed in terms of their seriousness, intensity, and relationship to the study drug. For consistency, events are to be graded using the CTCAE version 4.0 from start of study to completion for up to 4 years. CTCAE version 4.0 is used to grade all adverse events and to provide management guidelines for administrational toxicity. Adverse events from all arms are reported together as participants on all arms received the same treatment regimen.	27.8% 5/18 • Number of events 5 • All patients must be carefully monitored for AEs, including clinical laboratory tests. AEs should be assessed in terms of their seriousness, intensity, and relationship to the study drug. For consistency, events are to be graded using the CTCAE version 4.0 from start of study to completion for up to 4 years. CTCAE version 4.0 is used to grade all adverse events and to provide management guidelines for administrational toxicity. Adverse events from all arms are reported together as participants on all arms received the same treatment regimen.
Infections and infestations Cellulitis	6.2% 1/16 • Number of events 1 • All patients must be carefully monitored for AEs, including clinical laboratory tests. AEs should be assessed in terms of their seriousness, intensity, and relationship to the study drug. For consistency, events are to be graded using the CTCAE version 4.0 from start of study to completion for up to 4 years. CTCAE version 4.0 is used to grade all adverse events and to provide management guidelines for administrational toxicity. Adverse events from all arms are reported together as participants on all arms received the same treatment regimen.	5.6% 1/18 • Number of events 1 • All patients must be carefully monitored for AEs, including clinical laboratory tests. AEs should be assessed in terms of their seriousness, intensity, and relationship to the study drug. For consistency, events are to be graded using the CTCAE version 4.0 from start of study to completion for up to 4 years. CTCAE version 4.0 is used to grade all adverse events and to provide management guidelines for administrational toxicity. Adverse events from all arms are reported together as participants on all arms received the same treatment regimen.
Respiratory, thoracic and mediastinal disorders Chest heaviness	6.2% 1/16 • Number of events 1 • All patients must be carefully monitored for AEs, including clinical laboratory tests. AEs should be assessed in terms of their seriousness, intensity, and relationship to the study drug. For consistency, events are to be graded using the CTCAE version 4.0 from start of study to completion for up to 4 years. CTCAE version 4.0 is used to grade all adverse events and to provide management guidelines for administrational toxicity. Adverse events from all arms are reported together as participants on all arms received the same treatment regimen.	0.00% 0/18 • All patients must be carefully monitored for AEs, including clinical laboratory tests. AEs should be assessed in terms of their seriousness, intensity, and relationship to the study drug. For consistency, events are to be graded using the CTCAE version 4.0 from start of study to completion for up to 4 years. CTCAE version 4.0 is used to grade all adverse events and to provide management guidelines for administrational toxicity. Adverse events from all arms are reported together as participants on all arms received the same treatment regimen.
Cardiac disorders Chest Tightness	6.2% 1/16 • Number of events 1 • All patients must be carefully monitored for AEs, including clinical laboratory tests. AEs should be assessed in terms of their seriousness, intensity, and relationship to the study drug. For consistency, events are to be graded using the CTCAE version 4.0 from start of study to completion for up to 4 years. CTCAE version 4.0 is used to grade all adverse events and to provide management guidelines for administrational toxicity. Adverse events from all arms are reported together as participants on all arms received the same treatment regimen.	0.00% 0/18 • All patients must be carefully monitored for AEs, including clinical laboratory tests. AEs should be assessed in terms of their seriousness, intensity, and relationship to the study drug. For consistency, events are to be graded using the CTCAE version 4.0 from start of study to completion for up to 4 years. CTCAE version 4.0 is used to grade all adverse events and to provide management guidelines for administrational toxicity. Adverse events from all arms are reported together as participants on all arms received the same treatment regimen.
Musculoskeletal and connective tissue disorders Chest wall pain	6.2% 1/16 • Number of events 2 • All patients must be carefully monitored for AEs, including clinical laboratory tests. AEs should be assessed in terms of their seriousness, intensity, and relationship to the study drug. For consistency, events are to be graded using the CTCAE version 4.0 from start of study to completion for up to 4 years. CTCAE version 4.0 is used to grade all adverse events and to provide management guidelines for administrational toxicity. Adverse events from all arms are reported together as participants on all arms received the same treatment regimen.	11.1% 2/18 • Number of events 2 • All patients must be carefully monitored for AEs, including clinical laboratory tests. AEs should be assessed in terms of their seriousness, intensity, and relationship to the study drug. For consistency, events are to be graded using the CTCAE version 4.0 from start of study to completion for up to 4 years. CTCAE version 4.0 is used to grade all adverse events and to provide management guidelines for administrational toxicity. Adverse events from all arms are reported together as participants on all arms received the same treatment regimen.
General disorders Chills (Intermittent)	6.2% 1/16 • Number of events 1 • All patients must be carefully monitored for AEs, including clinical laboratory tests. AEs should be assessed in terms of their seriousness, intensity, and relationship to the study drug. For consistency, events are to be graded using the CTCAE version 4.0 from start of study to completion for up to 4 years. CTCAE version 4.0 is used to grade all adverse events and to provide management guidelines for administrational toxicity. Adverse events from all arms are reported together as participants on all arms received the same treatment regimen.	0.00% 0/18 • All patients must be carefully monitored for AEs, including clinical laboratory tests. AEs should be assessed in terms of their seriousness, intensity, and relationship to the study drug. For consistency, events are to be graded using the CTCAE version 4.0 from start of study to completion for up to 4 years. CTCAE version 4.0 is used to grade all adverse events and to provide management guidelines for administrational toxicity. Adverse events from all arms are reported together as participants on all arms received the same treatment regimen.