Trial Outcomes & Findings for Alisertib in Treating Patients With Myelofibrosis or Relapsed or Refractory Acute Megakaryoblastic Leukemia (NCT NCT02530619)

NCT ID: NCT02530619

Last Updated: 2021-05-26

Results Overview

Adverse events will be defined as those included in CTCAE v 4.0. The AEs that were determined to be at least possibly related to study drug and graded 3, 4, 5 are included here. Grade 1 (mild): the event causes discomfort without disruption of normal daily activities. Grade 2 (moderate): the event causes discomfort that affects normal daily activities. Grade 3 (severe): the event makes the patient unable to perform normal daily activities or significantly affects his/her clinical status. Grade 4 (Life-threatening): the patient was at risk of death at the time of the event. Grade 5 (fatal): the event caused death. All patients who received at least 1 dose of alisertib were considered evaluable for this endpoint.

• Recruitment status: UNKNOWN
• Study phase: NA
• Target enrollment: 26 participants
• Primary outcome timeframe: From time of treatment to 6 months post discontinuation (range of cycles attempted 1 to 29, median 7.5 cycles, 1 Cycle = 21 days)
• Results posted on: 2021-05-26

Participant Flow

The study opened for accrual on October 09, 2015 with an accrual goal of 24 patients. The first patient started treatment July 05, 2016. The study closed to further accrual on November 02, 2017 with total accrual having been met.

Participant milestones

Measure	Alisertib 50 mg BID Patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Alisertib: Administered orally 50 mg BID on days 1-7 of each cycle; one cycle is defined as 21 days (days 8-21 will be rest days). Patients may continue to receive cycles of alisertib until progression of disease or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies
Registered for Study STARTED	26
Registered for Study Registered	26
Registered for Study Received 1st Dose of Alisertib	24
Registered for Study COMPLETED	24
Registered for Study NOT COMPLETED	2
Completed 1st Cycle of Treatment STARTED	24
Completed 1st Cycle of Treatment COMPLETED	24
Completed 1st Cycle of Treatment NOT COMPLETED	0
Continued Treatment Cycles 2 Through 6 STARTED	24
Continued Treatment Cycles 2 Through 6 COMPLETED	14
Continued Treatment Cycles 2 Through 6 NOT COMPLETED	10
Continued Treatment Cycle 7+ STARTED	14
Continued Treatment Cycle 7+ COMPLETED	14
Continued Treatment Cycle 7+ NOT COMPLETED	0
Follow-up Period (6 Months) STARTED	21
Follow-up Period (6 Months) COMPLETED	10
Follow-up Period (6 Months) NOT COMPLETED	11

Reasons for withdrawal

Measure	Alisertib 50 mg BID Patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Alisertib: Administered orally 50 mg BID on days 1-7 of each cycle; one cycle is defined as 21 days (days 8-21 will be rest days). Patients may continue to receive cycles of alisertib until progression of disease or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies
Registered for Study Withdrawal by Subject	2
Continued Treatment Cycles 2 Through 6 Adverse Event	2
Continued Treatment Cycles 2 Through 6 Withdrawal by Subject	2
Continued Treatment Cycles 2 Through 6 Progressive Disease	4
Continued Treatment Cycles 2 Through 6 Lack of Efficacy	2
Follow-up Period (6 Months) Death	4
Follow-up Period (6 Months) Lost to Follow-up	2
Follow-up Period (6 Months) Withdrawal by Subject	5

Baseline Characteristics

Alisertib in Treating Patients With Myelofibrosis or Relapsed or Refractory Acute Megakaryoblastic Leukemia

Baseline characteristics by cohort

Measure	Alisertib 50 mg BID n=24 Participants Patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Alisertib: Administered orally 50 mg BID on days 1-7 of each cycle; one cycle is defined as 21 days (days 8-21 will be rest days). Patients may continue to receive cycles of alisertib until progression of disease or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants
Age, Categorical >=65 years	18 Participants n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	23 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	22 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	24 participants n=5 Participants
Refractory Acute Megakaryoblastic Leukemia or Myelofibrosis Myelofibrosis	24 Participants n=5 Participants
Refractory Acute Megakaryoblastic Leukemia or Myelofibrosis Refractory Acute Megakaryoblastic Leukemia	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: From time of treatment to 6 months post discontinuation (range of cycles attempted 1 to 29, median 7.5 cycles, 1 Cycle = 21 days)

Population: Data was collected from all patients for the primary endpoint until May 2018 when it was determined there was sufficient data collected for primary endpoint analysis and primary endpoint was determined to be met. At the time of data cut off, 7 patients remained on active treatment and range of cycles completed by patients was 1-29 (median 7.5 cycles). No further data was collected after May 2018 for primary outcome measure purposes.

Adverse events will be defined as those included in CTCAE v 4.0. The AEs that were determined to be at least possibly related to study drug and graded 3, 4, 5 are included here. Grade 1 (mild): the event causes discomfort without disruption of normal daily activities. Grade 2 (moderate): the event causes discomfort that affects normal daily activities. Grade 3 (severe): the event makes the patient unable to perform normal daily activities or significantly affects his/her clinical status. Grade 4 (Life-threatening): the patient was at risk of death at the time of the event. Grade 5 (fatal): the event caused death. All patients who received at least 1 dose of alisertib were considered evaluable for this endpoint.

Outcome measures

Measure	Alisertib 50 mg BID n=24 Participants Patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Alisertib: Administered orally 50 mg BID on days 1-7 of each cycle; one cycle is defined as 21 days (days 8-21 will be rest days). Patients may continue to receive cycles of alisertib until progression of disease or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies
Safety Profile of Alisertib Per NCI's Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0. Neutropenia Grade 3	5 Participants
Safety Profile of Alisertib Per NCI's Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0. Neutropenia Grade 4	5 Participants
Safety Profile of Alisertib Per NCI's Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0. Febrile Neutropenia Grade 3	1 Participants
Safety Profile of Alisertib Per NCI's Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0. Lymphocytopenia Grade 3	9 Participants
Safety Profile of Alisertib Per NCI's Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0. Thrombocytopenia Grade 3	5 Participants
Safety Profile of Alisertib Per NCI's Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0. Thrombocytopenia Grade 4	2 Participants
Safety Profile of Alisertib Per NCI's Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0. Anemia Grade 3	5 Participants
Safety Profile of Alisertib Per NCI's Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0. Vertigo Grade 3	1 Participants
Safety Profile of Alisertib Per NCI's Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0. Diarrhea Grade 3	1 Participants
Safety Profile of Alisertib Per NCI's Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0. Alanine aminotransferase increased Grade 3	1 Participants
Safety Profile of Alisertib Per NCI's Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0. Creatinine increased Grade 3	1 Participants

SECONDARY outcome

Timeframe: Baseline to up to 6 months after the last dose of treatment

Serial blood and/or bone marrow samples will be collected at specific timepoints for each disease to determine response to alisertib treatment.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to up to 6 months after the last dose of treatment

To evaluate the relationship between biomarker expression levels and response. Biomarkers will include a) genes encoding key enzymes in Aurora kinase signaling, b) markers of cellular aneuploidy and apoptosis, and c) markers of megakaryocytic differentiation.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Once per cycle (1 cycle=21 days)

To evaluate improvement in MF symptoms in the MF arm, changes in symptom scores over time will be calculated.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to up to 6 months after the last dose of treatment

Serial blood and/or bone marrow samples will be collected at specific timepoints. Flow cytometry, colony forming assays, AURKA autophosphorylation assays, and in vitro cultures of patient specimens to assess the effect of MLN8237 on megakaryocytes and other hematopoietic cells will be measured.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to up to 6 months after the last dose of treatment

To evaluate reduction in splenomegaly by palpation in the MF arm. Patients will be examined for splenomegaly by palpation once per cycle and change from baseline will be calculated over time.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Screening and up to 54 weeks

Assess change in bone marrow fibrosis in patients in the MF arm. Bone marrow will be assessed at screening and after cycle 6 in this population.

Outcome measures

Outcome data not reported

Adverse Events

Alisertib 50 mg BID

Serious events: 8 serious events

Other events: 24 other events

Deaths: 5 deaths

Serious adverse events

Measure	Alisertib 50 mg BID n=24 participants at risk Patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Alisertib: Administered orally 50 mg BID on days 1-7 of each cycle; one cycle is defined as 21 days (days 8-21 will be rest days). Patients may continue to receive cycles of alisertib until progression of disease or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies
Infections and infestations Upper Respiratory Infection - parainfluenza	4.2% 1/24 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 6 months post last treatment. 1 cycle = 21 days. Serious Adverse Events (SAEs) are reported from the time of treatment initiation. The range of cycles attempted was 1-38. At the time of reporting this data, 3 patients remain on treatment.
Respiratory, thoracic and mediastinal disorders pneumonia	4.2% 1/24 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 6 months post last treatment. 1 cycle = 21 days. Serious Adverse Events (SAEs) are reported from the time of treatment initiation. The range of cycles attempted was 1-38. At the time of reporting this data, 3 patients remain on treatment.
Infections and infestations Lung infection	4.2% 1/24 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 6 months post last treatment. 1 cycle = 21 days. Serious Adverse Events (SAEs) are reported from the time of treatment initiation. The range of cycles attempted was 1-38. At the time of reporting this data, 3 patients remain on treatment.
Blood and lymphatic system disorders Febrile neutropenia	4.2% 1/24 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 6 months post last treatment. 1 cycle = 21 days. Serious Adverse Events (SAEs) are reported from the time of treatment initiation. The range of cycles attempted was 1-38. At the time of reporting this data, 3 patients remain on treatment.
Infections and infestations Cellulitis	4.2% 1/24 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 6 months post last treatment. 1 cycle = 21 days. Serious Adverse Events (SAEs) are reported from the time of treatment initiation. The range of cycles attempted was 1-38. At the time of reporting this data, 3 patients remain on treatment.
Respiratory, thoracic and mediastinal disorders Pneumonitis	4.2% 1/24 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 6 months post last treatment. 1 cycle = 21 days. Serious Adverse Events (SAEs) are reported from the time of treatment initiation. The range of cycles attempted was 1-38. At the time of reporting this data, 3 patients remain on treatment.
Cardiac disorders Non- ST Myocardial Infarction (NSTEMI)	4.2% 1/24 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 6 months post last treatment. 1 cycle = 21 days. Serious Adverse Events (SAEs) are reported from the time of treatment initiation. The range of cycles attempted was 1-38. At the time of reporting this data, 3 patients remain on treatment.
Vascular disorders pulmonary embolism	4.2% 1/24 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 6 months post last treatment. 1 cycle = 21 days. Serious Adverse Events (SAEs) are reported from the time of treatment initiation. The range of cycles attempted was 1-38. At the time of reporting this data, 3 patients remain on treatment.
Blood and lymphatic system disorders Anemia	4.2% 1/24 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 6 months post last treatment. 1 cycle = 21 days. Serious Adverse Events (SAEs) are reported from the time of treatment initiation. The range of cycles attempted was 1-38. At the time of reporting this data, 3 patients remain on treatment.
Gastrointestinal disorders diarrhea	4.2% 1/24 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 6 months post last treatment. 1 cycle = 21 days. Serious Adverse Events (SAEs) are reported from the time of treatment initiation. The range of cycles attempted was 1-38. At the time of reporting this data, 3 patients remain on treatment.
Blood and lymphatic system disorders Leukocytosis	4.2% 1/24 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 6 months post last treatment. 1 cycle = 21 days. Serious Adverse Events (SAEs) are reported from the time of treatment initiation. The range of cycles attempted was 1-38. At the time of reporting this data, 3 patients remain on treatment.
Blood and lymphatic system disorders Neutropenic fever	4.2% 1/24 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 6 months post last treatment. 1 cycle = 21 days. Serious Adverse Events (SAEs) are reported from the time of treatment initiation. The range of cycles attempted was 1-38. At the time of reporting this data, 3 patients remain on treatment.

Other adverse events

Measure	Alisertib 50 mg BID n=24 participants at risk Patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Alisertib: Administered orally 50 mg BID on days 1-7 of each cycle; one cycle is defined as 21 days (days 8-21 will be rest days). Patients may continue to receive cycles of alisertib until progression of disease or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies
Investigations Activated partial thromboplastin time prolonged	20.8% 5/24 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 6 months post last treatment. 1 cycle = 21 days. Serious Adverse Events (SAEs) are reported from the time of treatment initiation. The range of cycles attempted was 1-38. At the time of reporting this data, 3 patients remain on treatment.
Investigations Alanine aminotransferase increased	37.5% 9/24 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 6 months post last treatment. 1 cycle = 21 days. Serious Adverse Events (SAEs) are reported from the time of treatment initiation. The range of cycles attempted was 1-38. At the time of reporting this data, 3 patients remain on treatment.
Investigations Alkaline phosphatase increased	41.7% 10/24 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 6 months post last treatment. 1 cycle = 21 days. Serious Adverse Events (SAEs) are reported from the time of treatment initiation. The range of cycles attempted was 1-38. At the time of reporting this data, 3 patients remain on treatment.
Investigations Aspartate aminotransferase increased	37.5% 9/24 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 6 months post last treatment. 1 cycle = 21 days. Serious Adverse Events (SAEs) are reported from the time of treatment initiation. The range of cycles attempted was 1-38. At the time of reporting this data, 3 patients remain on treatment.
Investigations Blood bilirubin increased	25.0% 6/24 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 6 months post last treatment. 1 cycle = 21 days. Serious Adverse Events (SAEs) are reported from the time of treatment initiation. The range of cycles attempted was 1-38. At the time of reporting this data, 3 patients remain on treatment.
Investigations Creatinine increased	37.5% 9/24 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 6 months post last treatment. 1 cycle = 21 days. Serious Adverse Events (SAEs) are reported from the time of treatment initiation. The range of cycles attempted was 1-38. At the time of reporting this data, 3 patients remain on treatment.
Investigations Electrocardiogram QT corrected interval prolonged	4.2% 1/24 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 6 months post last treatment. 1 cycle = 21 days. Serious Adverse Events (SAEs) are reported from the time of treatment initiation. The range of cycles attempted was 1-38. At the time of reporting this data, 3 patients remain on treatment.
Investigations INR increased	16.7% 4/24 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 6 months post last treatment. 1 cycle = 21 days. Serious Adverse Events (SAEs) are reported from the time of treatment initiation. The range of cycles attempted was 1-38. At the time of reporting this data, 3 patients remain on treatment.
Investigations Lymphocyte count decreased	70.8% 17/24 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 6 months post last treatment. 1 cycle = 21 days. Serious Adverse Events (SAEs) are reported from the time of treatment initiation. The range of cycles attempted was 1-38. At the time of reporting this data, 3 patients remain on treatment.
Musculoskeletal and connective tissue disorders Back pain	8.3% 2/24 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 6 months post last treatment. 1 cycle = 21 days. Serious Adverse Events (SAEs) are reported from the time of treatment initiation. The range of cycles attempted was 1-38. At the time of reporting this data, 3 patients remain on treatment.
Investigations Neutrophil count decreased	58.3% 14/24 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 6 months post last treatment. 1 cycle = 21 days. Serious Adverse Events (SAEs) are reported from the time of treatment initiation. The range of cycles attempted was 1-38. At the time of reporting this data, 3 patients remain on treatment.
Investigations Platelet count decreased	66.7% 16/24 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 6 months post last treatment. 1 cycle = 21 days. Serious Adverse Events (SAEs) are reported from the time of treatment initiation. The range of cycles attempted was 1-38. At the time of reporting this data, 3 patients remain on treatment.
Investigations White blood cell decreased	58.3% 14/24 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 6 months post last treatment. 1 cycle = 21 days. Serious Adverse Events (SAEs) are reported from the time of treatment initiation. The range of cycles attempted was 1-38. At the time of reporting this data, 3 patients remain on treatment.
Metabolism and nutrition disorders Anorexia	29.2% 7/24 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 6 months post last treatment. 1 cycle = 21 days. Serious Adverse Events (SAEs) are reported from the time of treatment initiation. The range of cycles attempted was 1-38. At the time of reporting this data, 3 patients remain on treatment.
Metabolism and nutrition disorders Dehydration	4.2% 1/24 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 6 months post last treatment. 1 cycle = 21 days. Serious Adverse Events (SAEs) are reported from the time of treatment initiation. The range of cycles attempted was 1-38. At the time of reporting this data, 3 patients remain on treatment.
Metabolism and nutrition disorders Hypercalcemia	4.2% 1/24 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 6 months post last treatment. 1 cycle = 21 days. Serious Adverse Events (SAEs) are reported from the time of treatment initiation. The range of cycles attempted was 1-38. At the time of reporting this data, 3 patients remain on treatment.
Metabolism and nutrition disorders Hyperglycemia	66.7% 16/24 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 6 months post last treatment. 1 cycle = 21 days. Serious Adverse Events (SAEs) are reported from the time of treatment initiation. The range of cycles attempted was 1-38. At the time of reporting this data, 3 patients remain on treatment.
Metabolism and nutrition disorders Hyperkalemia	20.8% 5/24 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 6 months post last treatment. 1 cycle = 21 days. Serious Adverse Events (SAEs) are reported from the time of treatment initiation. The range of cycles attempted was 1-38. At the time of reporting this data, 3 patients remain on treatment.
Metabolism and nutrition disorders Hypermagnesemia	4.2% 1/24 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 6 months post last treatment. 1 cycle = 21 days. Serious Adverse Events (SAEs) are reported from the time of treatment initiation. The range of cycles attempted was 1-38. At the time of reporting this data, 3 patients remain on treatment.
Metabolism and nutrition disorders Hypernatremia	4.2% 1/24 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 6 months post last treatment. 1 cycle = 21 days. Serious Adverse Events (SAEs) are reported from the time of treatment initiation. The range of cycles attempted was 1-38. At the time of reporting this data, 3 patients remain on treatment.
Metabolism and nutrition disorders Hyperuricemia	29.2% 7/24 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 6 months post last treatment. 1 cycle = 21 days. Serious Adverse Events (SAEs) are reported from the time of treatment initiation. The range of cycles attempted was 1-38. At the time of reporting this data, 3 patients remain on treatment.
Metabolism and nutrition disorders Hypoalbuminemia	45.8% 11/24 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 6 months post last treatment. 1 cycle = 21 days. Serious Adverse Events (SAEs) are reported from the time of treatment initiation. The range of cycles attempted was 1-38. At the time of reporting this data, 3 patients remain on treatment.
Metabolism and nutrition disorders Hypocalcemia	54.2% 13/24 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 6 months post last treatment. 1 cycle = 21 days. Serious Adverse Events (SAEs) are reported from the time of treatment initiation. The range of cycles attempted was 1-38. At the time of reporting this data, 3 patients remain on treatment.
Metabolism and nutrition disorders Hypoglycemia	4.2% 1/24 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 6 months post last treatment. 1 cycle = 21 days. Serious Adverse Events (SAEs) are reported from the time of treatment initiation. The range of cycles attempted was 1-38. At the time of reporting this data, 3 patients remain on treatment.
Metabolism and nutrition disorders Hypomagnesemia	8.3% 2/24 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 6 months post last treatment. 1 cycle = 21 days. Serious Adverse Events (SAEs) are reported from the time of treatment initiation. The range of cycles attempted was 1-38. At the time of reporting this data, 3 patients remain on treatment.
Metabolism and nutrition disorders Hyponatremia	33.3% 8/24 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 6 months post last treatment. 1 cycle = 21 days. Serious Adverse Events (SAEs) are reported from the time of treatment initiation. The range of cycles attempted was 1-38. At the time of reporting this data, 3 patients remain on treatment.
Metabolism and nutrition disorders Hypophosphatemia	4.2% 1/24 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 6 months post last treatment. 1 cycle = 21 days. Serious Adverse Events (SAEs) are reported from the time of treatment initiation. The range of cycles attempted was 1-38. At the time of reporting this data, 3 patients remain on treatment.
Musculoskeletal and connective tissue disorders Arthritis	8.3% 2/24 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 6 months post last treatment. 1 cycle = 21 days. Serious Adverse Events (SAEs) are reported from the time of treatment initiation. The range of cycles attempted was 1-38. At the time of reporting this data, 3 patients remain on treatment.
Musculoskeletal and connective tissue disorders Bone pain	16.7% 4/24 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 6 months post last treatment. 1 cycle = 21 days. Serious Adverse Events (SAEs) are reported from the time of treatment initiation. The range of cycles attempted was 1-38. At the time of reporting this data, 3 patients remain on treatment.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	16.7% 4/24 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 6 months post last treatment. 1 cycle = 21 days. Serious Adverse Events (SAEs) are reported from the time of treatment initiation. The range of cycles attempted was 1-38. At the time of reporting this data, 3 patients remain on treatment.
Musculoskeletal and connective tissue disorders Myalgia	8.3% 2/24 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 6 months post last treatment. 1 cycle = 21 days. Serious Adverse Events (SAEs) are reported from the time of treatment initiation. The range of cycles attempted was 1-38. At the time of reporting this data, 3 patients remain on treatment.
Musculoskeletal and connective tissue disorders Myositis	4.2% 1/24 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 6 months post last treatment. 1 cycle = 21 days. Serious Adverse Events (SAEs) are reported from the time of treatment initiation. The range of cycles attempted was 1-38. At the time of reporting this data, 3 patients remain on treatment.
Musculoskeletal and connective tissue disorders Neck pain	8.3% 2/24 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 6 months post last treatment. 1 cycle = 21 days. Serious Adverse Events (SAEs) are reported from the time of treatment initiation. The range of cycles attempted was 1-38. At the time of reporting this data, 3 patients remain on treatment.
Musculoskeletal and connective tissue disorders Osteoporosis	4.2% 1/24 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 6 months post last treatment. 1 cycle = 21 days. Serious Adverse Events (SAEs) are reported from the time of treatment initiation. The range of cycles attempted was 1-38. At the time of reporting this data, 3 patients remain on treatment.
Musculoskeletal and connective tissue disorders Pain in extremity	25.0% 6/24 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 6 months post last treatment. 1 cycle = 21 days. Serious Adverse Events (SAEs) are reported from the time of treatment initiation. The range of cycles attempted was 1-38. At the time of reporting this data, 3 patients remain on treatment.
Nervous system disorders Concentration impairment	4.2% 1/24 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 6 months post last treatment. 1 cycle = 21 days. Serious Adverse Events (SAEs) are reported from the time of treatment initiation. The range of cycles attempted was 1-38. At the time of reporting this data, 3 patients remain on treatment.
Nervous system disorders Dizziness	29.2% 7/24 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 6 months post last treatment. 1 cycle = 21 days. Serious Adverse Events (SAEs) are reported from the time of treatment initiation. The range of cycles attempted was 1-38. At the time of reporting this data, 3 patients remain on treatment.
Nervous system disorders Encephalopathy	4.2% 1/24 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 6 months post last treatment. 1 cycle = 21 days. Serious Adverse Events (SAEs) are reported from the time of treatment initiation. The range of cycles attempted was 1-38. At the time of reporting this data, 3 patients remain on treatment.
Nervous system disorders Headache	16.7% 4/24 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 6 months post last treatment. 1 cycle = 21 days. Serious Adverse Events (SAEs) are reported from the time of treatment initiation. The range of cycles attempted was 1-38. At the time of reporting this data, 3 patients remain on treatment.
Nervous system disorders Memory impairment	4.2% 1/24 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 6 months post last treatment. 1 cycle = 21 days. Serious Adverse Events (SAEs) are reported from the time of treatment initiation. The range of cycles attempted was 1-38. At the time of reporting this data, 3 patients remain on treatment.
Nervous system disorders Paresthesia	4.2% 1/24 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 6 months post last treatment. 1 cycle = 21 days. Serious Adverse Events (SAEs) are reported from the time of treatment initiation. The range of cycles attempted was 1-38. At the time of reporting this data, 3 patients remain on treatment.
Nervous system disorders Peripheral motor neuropathy	8.3% 2/24 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 6 months post last treatment. 1 cycle = 21 days. Serious Adverse Events (SAEs) are reported from the time of treatment initiation. The range of cycles attempted was 1-38. At the time of reporting this data, 3 patients remain on treatment.
Nervous system disorders Presyncope	8.3% 2/24 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 6 months post last treatment. 1 cycle = 21 days. Serious Adverse Events (SAEs) are reported from the time of treatment initiation. The range of cycles attempted was 1-38. At the time of reporting this data, 3 patients remain on treatment.
Nervous system disorders Tremor	8.3% 2/24 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 6 months post last treatment. 1 cycle = 21 days. Serious Adverse Events (SAEs) are reported from the time of treatment initiation. The range of cycles attempted was 1-38. At the time of reporting this data, 3 patients remain on treatment.
Psychiatric disorders Anxiety	4.2% 1/24 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 6 months post last treatment. 1 cycle = 21 days. Serious Adverse Events (SAEs) are reported from the time of treatment initiation. The range of cycles attempted was 1-38. At the time of reporting this data, 3 patients remain on treatment.
Psychiatric disorders Depression	4.2% 1/24 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 6 months post last treatment. 1 cycle = 21 days. Serious Adverse Events (SAEs) are reported from the time of treatment initiation. The range of cycles attempted was 1-38. At the time of reporting this data, 3 patients remain on treatment.
Psychiatric disorders Insomnia	16.7% 4/24 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 6 months post last treatment. 1 cycle = 21 days. Serious Adverse Events (SAEs) are reported from the time of treatment initiation. The range of cycles attempted was 1-38. At the time of reporting this data, 3 patients remain on treatment.
Renal and urinary disorders Chronic kidney disease	4.2% 1/24 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 6 months post last treatment. 1 cycle = 21 days. Serious Adverse Events (SAEs) are reported from the time of treatment initiation. The range of cycles attempted was 1-38. At the time of reporting this data, 3 patients remain on treatment.
Renal and urinary disorders Urinary retention	4.2% 1/24 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 6 months post last treatment. 1 cycle = 21 days. Serious Adverse Events (SAEs) are reported from the time of treatment initiation. The range of cycles attempted was 1-38. At the time of reporting this data, 3 patients remain on treatment.
Renal and urinary disorders Urinary urgency	4.2% 1/24 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 6 months post last treatment. 1 cycle = 21 days. Serious Adverse Events (SAEs) are reported from the time of treatment initiation. The range of cycles attempted was 1-38. At the time of reporting this data, 3 patients remain on treatment.
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	4.2% 1/24 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 6 months post last treatment. 1 cycle = 21 days. Serious Adverse Events (SAEs) are reported from the time of treatment initiation. The range of cycles attempted was 1-38. At the time of reporting this data, 3 patients remain on treatment.
Respiratory, thoracic and mediastinal disorders Aspiration	4.2% 1/24 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 6 months post last treatment. 1 cycle = 21 days. Serious Adverse Events (SAEs) are reported from the time of treatment initiation. The range of cycles attempted was 1-38. At the time of reporting this data, 3 patients remain on treatment.
Respiratory, thoracic and mediastinal disorders Atelectasis	4.2% 1/24 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 6 months post last treatment. 1 cycle = 21 days. Serious Adverse Events (SAEs) are reported from the time of treatment initiation. The range of cycles attempted was 1-38. At the time of reporting this data, 3 patients remain on treatment.
Respiratory, thoracic and mediastinal disorders Cough	16.7% 4/24 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 6 months post last treatment. 1 cycle = 21 days. Serious Adverse Events (SAEs) are reported from the time of treatment initiation. The range of cycles attempted was 1-38. At the time of reporting this data, 3 patients remain on treatment.
Respiratory, thoracic and mediastinal disorders Dyspnea	16.7% 4/24 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 6 months post last treatment. 1 cycle = 21 days. Serious Adverse Events (SAEs) are reported from the time of treatment initiation. The range of cycles attempted was 1-38. At the time of reporting this data, 3 patients remain on treatment.
Respiratory, thoracic and mediastinal disorders Epistaxis	4.2% 1/24 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 6 months post last treatment. 1 cycle = 21 days. Serious Adverse Events (SAEs) are reported from the time of treatment initiation. The range of cycles attempted was 1-38. At the time of reporting this data, 3 patients remain on treatment.
Respiratory, thoracic and mediastinal disorders Laryngeal edema	4.2% 1/24 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 6 months post last treatment. 1 cycle = 21 days. Serious Adverse Events (SAEs) are reported from the time of treatment initiation. The range of cycles attempted was 1-38. At the time of reporting this data, 3 patients remain on treatment.
Respiratory, thoracic and mediastinal disorders Nasal congestion	8.3% 2/24 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 6 months post last treatment. 1 cycle = 21 days. Serious Adverse Events (SAEs) are reported from the time of treatment initiation. The range of cycles attempted was 1-38. At the time of reporting this data, 3 patients remain on treatment.
Respiratory, thoracic and mediastinal disorders Pleural effusion	12.5% 3/24 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 6 months post last treatment. 1 cycle = 21 days. Serious Adverse Events (SAEs) are reported from the time of treatment initiation. The range of cycles attempted was 1-38. At the time of reporting this data, 3 patients remain on treatment.
Respiratory, thoracic and mediastinal disorders Pneumonitis	4.2% 1/24 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 6 months post last treatment. 1 cycle = 21 days. Serious Adverse Events (SAEs) are reported from the time of treatment initiation. The range of cycles attempted was 1-38. At the time of reporting this data, 3 patients remain on treatment.
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	4.2% 1/24 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 6 months post last treatment. 1 cycle = 21 days. Serious Adverse Events (SAEs) are reported from the time of treatment initiation. The range of cycles attempted was 1-38. At the time of reporting this data, 3 patients remain on treatment.
Skin and subcutaneous tissue disorders Alopecia	54.2% 13/24 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 6 months post last treatment. 1 cycle = 21 days. Serious Adverse Events (SAEs) are reported from the time of treatment initiation. The range of cycles attempted was 1-38. At the time of reporting this data, 3 patients remain on treatment.
Skin and subcutaneous tissue disorders Dry skin	4.2% 1/24 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 6 months post last treatment. 1 cycle = 21 days. Serious Adverse Events (SAEs) are reported from the time of treatment initiation. The range of cycles attempted was 1-38. At the time of reporting this data, 3 patients remain on treatment.
Skin and subcutaneous tissue disorders Erythema multiforme	4.2% 1/24 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 6 months post last treatment. 1 cycle = 21 days. Serious Adverse Events (SAEs) are reported from the time of treatment initiation. The range of cycles attempted was 1-38. At the time of reporting this data, 3 patients remain on treatment.
Skin and subcutaneous tissue disorders Nail loss	4.2% 1/24 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 6 months post last treatment. 1 cycle = 21 days. Serious Adverse Events (SAEs) are reported from the time of treatment initiation. The range of cycles attempted was 1-38. At the time of reporting this data, 3 patients remain on treatment.
Skin and subcutaneous tissue disorders Pain of skin	4.2% 1/24 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 6 months post last treatment. 1 cycle = 21 days. Serious Adverse Events (SAEs) are reported from the time of treatment initiation. The range of cycles attempted was 1-38. At the time of reporting this data, 3 patients remain on treatment.
Skin and subcutaneous tissue disorders Pruritus	16.7% 4/24 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 6 months post last treatment. 1 cycle = 21 days. Serious Adverse Events (SAEs) are reported from the time of treatment initiation. The range of cycles attempted was 1-38. At the time of reporting this data, 3 patients remain on treatment.
Skin and subcutaneous tissue disorders Rash acneiform	8.3% 2/24 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 6 months post last treatment. 1 cycle = 21 days. Serious Adverse Events (SAEs) are reported from the time of treatment initiation. The range of cycles attempted was 1-38. At the time of reporting this data, 3 patients remain on treatment.
Skin and subcutaneous tissue disorders Rash maculo-papular	16.7% 4/24 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 6 months post last treatment. 1 cycle = 21 days. Serious Adverse Events (SAEs) are reported from the time of treatment initiation. The range of cycles attempted was 1-38. At the time of reporting this data, 3 patients remain on treatment.
Vascular disorders Hot flashes	4.2% 1/24 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 6 months post last treatment. 1 cycle = 21 days. Serious Adverse Events (SAEs) are reported from the time of treatment initiation. The range of cycles attempted was 1-38. At the time of reporting this data, 3 patients remain on treatment.
Vascular disorders Hypertension	37.5% 9/24 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 6 months post last treatment. 1 cycle = 21 days. Serious Adverse Events (SAEs) are reported from the time of treatment initiation. The range of cycles attempted was 1-38. At the time of reporting this data, 3 patients remain on treatment.
Vascular disorders Thromboembolic event	4.2% 1/24 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 6 months post last treatment. 1 cycle = 21 days. Serious Adverse Events (SAEs) are reported from the time of treatment initiation. The range of cycles attempted was 1-38. At the time of reporting this data, 3 patients remain on treatment.
Blood and lymphatic system disorders Raynaud Syndrome	4.2% 1/24 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 6 months post last treatment. 1 cycle = 21 days. Serious Adverse Events (SAEs) are reported from the time of treatment initiation. The range of cycles attempted was 1-38. At the time of reporting this data, 3 patients remain on treatment.
Blood and lymphatic system disorders Hematoma	4.2% 1/24 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 6 months post last treatment. 1 cycle = 21 days. Serious Adverse Events (SAEs) are reported from the time of treatment initiation. The range of cycles attempted was 1-38. At the time of reporting this data, 3 patients remain on treatment.
Cardiac disorders Systolic murmur	4.2% 1/24 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 6 months post last treatment. 1 cycle = 21 days. Serious Adverse Events (SAEs) are reported from the time of treatment initiation. The range of cycles attempted was 1-38. At the time of reporting this data, 3 patients remain on treatment.
Cardiac disorders cardiomegaly	4.2% 1/24 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 6 months post last treatment. 1 cycle = 21 days. Serious Adverse Events (SAEs) are reported from the time of treatment initiation. The range of cycles attempted was 1-38. At the time of reporting this data, 3 patients remain on treatment.
Cardiac disorders Murmur	4.2% 1/24 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 6 months post last treatment. 1 cycle = 21 days. Serious Adverse Events (SAEs) are reported from the time of treatment initiation. The range of cycles attempted was 1-38. At the time of reporting this data, 3 patients remain on treatment.
Ear and labyrinth disorders Decreased Hearing	4.2% 1/24 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 6 months post last treatment. 1 cycle = 21 days. Serious Adverse Events (SAEs) are reported from the time of treatment initiation. The range of cycles attempted was 1-38. At the time of reporting this data, 3 patients remain on treatment.
Eye disorders conjunctivae erythema	4.2% 1/24 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 6 months post last treatment. 1 cycle = 21 days. Serious Adverse Events (SAEs) are reported from the time of treatment initiation. The range of cycles attempted was 1-38. At the time of reporting this data, 3 patients remain on treatment.
Eye disorders eye bruising and edema	4.2% 1/24 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 6 months post last treatment. 1 cycle = 21 days. Serious Adverse Events (SAEs) are reported from the time of treatment initiation. The range of cycles attempted was 1-38. At the time of reporting this data, 3 patients remain on treatment.
Eye disorders Retinal Hemmorhage	4.2% 1/24 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 6 months post last treatment. 1 cycle = 21 days. Serious Adverse Events (SAEs) are reported from the time of treatment initiation. The range of cycles attempted was 1-38. At the time of reporting this data, 3 patients remain on treatment.
Eye disorders eye redness	4.2% 1/24 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 6 months post last treatment. 1 cycle = 21 days. Serious Adverse Events (SAEs) are reported from the time of treatment initiation. The range of cycles attempted was 1-38. At the time of reporting this data, 3 patients remain on treatment.
Eye disorders periorbital bruising	4.2% 1/24 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 6 months post last treatment. 1 cycle = 21 days. Serious Adverse Events (SAEs) are reported from the time of treatment initiation. The range of cycles attempted was 1-38. At the time of reporting this data, 3 patients remain on treatment.
Gastrointestinal disorders Blood in stool	4.2% 1/24 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 6 months post last treatment. 1 cycle = 21 days. Serious Adverse Events (SAEs) are reported from the time of treatment initiation. The range of cycles attempted was 1-38. At the time of reporting this data, 3 patients remain on treatment.
General disorders polydipsia	4.2% 1/24 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 6 months post last treatment. 1 cycle = 21 days. Serious Adverse Events (SAEs) are reported from the time of treatment initiation. The range of cycles attempted was 1-38. At the time of reporting this data, 3 patients remain on treatment.
General disorders prostatomegaly	4.2% 1/24 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 6 months post last treatment. 1 cycle = 21 days. Serious Adverse Events (SAEs) are reported from the time of treatment initiation. The range of cycles attempted was 1-38. At the time of reporting this data, 3 patients remain on treatment.
General disorders Popliteal fossa cysts	4.2% 1/24 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 6 months post last treatment. 1 cycle = 21 days. Serious Adverse Events (SAEs) are reported from the time of treatment initiation. The range of cycles attempted was 1-38. At the time of reporting this data, 3 patients remain on treatment.
Hepatobiliary disorders Gallstones	4.2% 1/24 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 6 months post last treatment. 1 cycle = 21 days. Serious Adverse Events (SAEs) are reported from the time of treatment initiation. The range of cycles attempted was 1-38. At the time of reporting this data, 3 patients remain on treatment.
Infections and infestations rhinorrhea	4.2% 1/24 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 6 months post last treatment. 1 cycle = 21 days. Serious Adverse Events (SAEs) are reported from the time of treatment initiation. The range of cycles attempted was 1-38. At the time of reporting this data, 3 patients remain on treatment.
Infections and infestations C difficile positive	4.2% 1/24 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 6 months post last treatment. 1 cycle = 21 days. Serious Adverse Events (SAEs) are reported from the time of treatment initiation. The range of cycles attempted was 1-38. At the time of reporting this data, 3 patients remain on treatment.
Infections and infestations Cellulitis	4.2% 1/24 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 6 months post last treatment. 1 cycle = 21 days. Serious Adverse Events (SAEs) are reported from the time of treatment initiation. The range of cycles attempted was 1-38. At the time of reporting this data, 3 patients remain on treatment.
Infections and infestations tinea pedis	4.2% 1/24 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 6 months post last treatment. 1 cycle = 21 days. Serious Adverse Events (SAEs) are reported from the time of treatment initiation. The range of cycles attempted was 1-38. At the time of reporting this data, 3 patients remain on treatment.
Investigations Night Sweats	4.2% 1/24 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 6 months post last treatment. 1 cycle = 21 days. Serious Adverse Events (SAEs) are reported from the time of treatment initiation. The range of cycles attempted was 1-38. At the time of reporting this data, 3 patients remain on treatment.
Injury, poisoning and procedural complications Pain in the bone marrow site	4.2% 1/24 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 6 months post last treatment. 1 cycle = 21 days. Serious Adverse Events (SAEs) are reported from the time of treatment initiation. The range of cycles attempted was 1-38. At the time of reporting this data, 3 patients remain on treatment.
Metabolism and nutrition disorders Appetite increased	4.2% 1/24 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 6 months post last treatment. 1 cycle = 21 days. Serious Adverse Events (SAEs) are reported from the time of treatment initiation. The range of cycles attempted was 1-38. At the time of reporting this data, 3 patients remain on treatment.
Musculoskeletal and connective tissue disorders metatarsalgia	4.2% 1/24 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 6 months post last treatment. 1 cycle = 21 days. Serious Adverse Events (SAEs) are reported from the time of treatment initiation. The range of cycles attempted was 1-38. At the time of reporting this data, 3 patients remain on treatment.
Musculoskeletal and connective tissue disorders Leg cramps	4.2% 1/24 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 6 months post last treatment. 1 cycle = 21 days. Serious Adverse Events (SAEs) are reported from the time of treatment initiation. The range of cycles attempted was 1-38. At the time of reporting this data, 3 patients remain on treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small Squamous cell carcinoma	4.2% 1/24 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 6 months post last treatment. 1 cycle = 21 days. Serious Adverse Events (SAEs) are reported from the time of treatment initiation. The range of cycles attempted was 1-38. At the time of reporting this data, 3 patients remain on treatment.
Psychiatric disorders Mood Swings	8.3% 2/24 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 6 months post last treatment. 1 cycle = 21 days. Serious Adverse Events (SAEs) are reported from the time of treatment initiation. The range of cycles attempted was 1-38. At the time of reporting this data, 3 patients remain on treatment.
Renal and urinary disorders Dysuria	4.2% 1/24 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 6 months post last treatment. 1 cycle = 21 days. Serious Adverse Events (SAEs) are reported from the time of treatment initiation. The range of cycles attempted was 1-38. At the time of reporting this data, 3 patients remain on treatment.
Renal and urinary disorders renal cysts	4.2% 1/24 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 6 months post last treatment. 1 cycle = 21 days. Serious Adverse Events (SAEs) are reported from the time of treatment initiation. The range of cycles attempted was 1-38. At the time of reporting this data, 3 patients remain on treatment.
Respiratory, thoracic and mediastinal disorders Respiratory synctial virus	4.2% 1/24 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 6 months post last treatment. 1 cycle = 21 days. Serious Adverse Events (SAEs) are reported from the time of treatment initiation. The range of cycles attempted was 1-38. At the time of reporting this data, 3 patients remain on treatment.
Respiratory, thoracic and mediastinal disorders Rhinitis	4.2% 1/24 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 6 months post last treatment. 1 cycle = 21 days. Serious Adverse Events (SAEs) are reported from the time of treatment initiation. The range of cycles attempted was 1-38. At the time of reporting this data, 3 patients remain on treatment.
Skin and subcutaneous tissue disorders Tear	4.2% 1/24 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 6 months post last treatment. 1 cycle = 21 days. Serious Adverse Events (SAEs) are reported from the time of treatment initiation. The range of cycles attempted was 1-38. At the time of reporting this data, 3 patients remain on treatment.
Skin and subcutaneous tissue disorders skin nodules	4.2% 1/24 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 6 months post last treatment. 1 cycle = 21 days. Serious Adverse Events (SAEs) are reported from the time of treatment initiation. The range of cycles attempted was 1-38. At the time of reporting this data, 3 patients remain on treatment.
Skin and subcutaneous tissue disorders Rash	4.2% 1/24 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 6 months post last treatment. 1 cycle = 21 days. Serious Adverse Events (SAEs) are reported from the time of treatment initiation. The range of cycles attempted was 1-38. At the time of reporting this data, 3 patients remain on treatment.
Skin and subcutaneous tissue disorders facial hair loss	4.2% 1/24 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 6 months post last treatment. 1 cycle = 21 days. Serious Adverse Events (SAEs) are reported from the time of treatment initiation. The range of cycles attempted was 1-38. At the time of reporting this data, 3 patients remain on treatment.
Skin and subcutaneous tissue disorders shoulder cyst	4.2% 1/24 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 6 months post last treatment. 1 cycle = 21 days. Serious Adverse Events (SAEs) are reported from the time of treatment initiation. The range of cycles attempted was 1-38. At the time of reporting this data, 3 patients remain on treatment.
Vascular disorders calcifications	4.2% 1/24 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 6 months post last treatment. 1 cycle = 21 days. Serious Adverse Events (SAEs) are reported from the time of treatment initiation. The range of cycles attempted was 1-38. At the time of reporting this data, 3 patients remain on treatment.
Blood and lymphatic system disorders Anemia	45.8% 11/24 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 6 months post last treatment. 1 cycle = 21 days. Serious Adverse Events (SAEs) are reported from the time of treatment initiation. The range of cycles attempted was 1-38. At the time of reporting this data, 3 patients remain on treatment.
Blood and lymphatic system disorders Febrile neutropenia	8.3% 2/24 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 6 months post last treatment. 1 cycle = 21 days. Serious Adverse Events (SAEs) are reported from the time of treatment initiation. The range of cycles attempted was 1-38. At the time of reporting this data, 3 patients remain on treatment.
Cardiac disorders Atrial fibrillation	4.2% 1/24 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 6 months post last treatment. 1 cycle = 21 days. Serious Adverse Events (SAEs) are reported from the time of treatment initiation. The range of cycles attempted was 1-38. At the time of reporting this data, 3 patients remain on treatment.
Cardiac disorders Chest pain - cardiac	4.2% 1/24 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 6 months post last treatment. 1 cycle = 21 days. Serious Adverse Events (SAEs) are reported from the time of treatment initiation. The range of cycles attempted was 1-38. At the time of reporting this data, 3 patients remain on treatment.
Cardiac disorders Myocardial infarction	4.2% 1/24 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 6 months post last treatment. 1 cycle = 21 days. Serious Adverse Events (SAEs) are reported from the time of treatment initiation. The range of cycles attempted was 1-38. At the time of reporting this data, 3 patients remain on treatment.
Cardiac disorders Palpitations	4.2% 1/24 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 6 months post last treatment. 1 cycle = 21 days. Serious Adverse Events (SAEs) are reported from the time of treatment initiation. The range of cycles attempted was 1-38. At the time of reporting this data, 3 patients remain on treatment.
Cardiac disorders Sinus bradycardia	8.3% 2/24 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 6 months post last treatment. 1 cycle = 21 days. Serious Adverse Events (SAEs) are reported from the time of treatment initiation. The range of cycles attempted was 1-38. At the time of reporting this data, 3 patients remain on treatment.
Cardiac disorders Sinus tachycardia	4.2% 1/24 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 6 months post last treatment. 1 cycle = 21 days. Serious Adverse Events (SAEs) are reported from the time of treatment initiation. The range of cycles attempted was 1-38. At the time of reporting this data, 3 patients remain on treatment.
Cardiac disorders Ventricular arrhythmia	4.2% 1/24 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 6 months post last treatment. 1 cycle = 21 days. Serious Adverse Events (SAEs) are reported from the time of treatment initiation. The range of cycles attempted was 1-38. At the time of reporting this data, 3 patients remain on treatment.
Ear and labyrinth disorders Ear pain	4.2% 1/24 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 6 months post last treatment. 1 cycle = 21 days. Serious Adverse Events (SAEs) are reported from the time of treatment initiation. The range of cycles attempted was 1-38. At the time of reporting this data, 3 patients remain on treatment.
Ear and labyrinth disorders Vertigo	8.3% 2/24 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 6 months post last treatment. 1 cycle = 21 days. Serious Adverse Events (SAEs) are reported from the time of treatment initiation. The range of cycles attempted was 1-38. At the time of reporting this data, 3 patients remain on treatment.
Eye disorders Blurred vision	4.2% 1/24 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 6 months post last treatment. 1 cycle = 21 days. Serious Adverse Events (SAEs) are reported from the time of treatment initiation. The range of cycles attempted was 1-38. At the time of reporting this data, 3 patients remain on treatment.
Gastrointestinal disorders Abdominal pain	33.3% 8/24 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 6 months post last treatment. 1 cycle = 21 days. Serious Adverse Events (SAEs) are reported from the time of treatment initiation. The range of cycles attempted was 1-38. At the time of reporting this data, 3 patients remain on treatment.
Gastrointestinal disorders Constipation	29.2% 7/24 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 6 months post last treatment. 1 cycle = 21 days. Serious Adverse Events (SAEs) are reported from the time of treatment initiation. The range of cycles attempted was 1-38. At the time of reporting this data, 3 patients remain on treatment.
Gastrointestinal disorders Diarrhea	45.8% 11/24 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 6 months post last treatment. 1 cycle = 21 days. Serious Adverse Events (SAEs) are reported from the time of treatment initiation. The range of cycles attempted was 1-38. At the time of reporting this data, 3 patients remain on treatment.
Gastrointestinal disorders Dry mouth	4.2% 1/24 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 6 months post last treatment. 1 cycle = 21 days. Serious Adverse Events (SAEs) are reported from the time of treatment initiation. The range of cycles attempted was 1-38. At the time of reporting this data, 3 patients remain on treatment.
Gastrointestinal disorders Dyspepsia	4.2% 1/24 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 6 months post last treatment. 1 cycle = 21 days. Serious Adverse Events (SAEs) are reported from the time of treatment initiation. The range of cycles attempted was 1-38. At the time of reporting this data, 3 patients remain on treatment.
Gastrointestinal disorders Gastroesophageal reflux disease	4.2% 1/24 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 6 months post last treatment. 1 cycle = 21 days. Serious Adverse Events (SAEs) are reported from the time of treatment initiation. The range of cycles attempted was 1-38. At the time of reporting this data, 3 patients remain on treatment.
Gastrointestinal disorders Gastrointestinal pain	4.2% 1/24 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 6 months post last treatment. 1 cycle = 21 days. Serious Adverse Events (SAEs) are reported from the time of treatment initiation. The range of cycles attempted was 1-38. At the time of reporting this data, 3 patients remain on treatment.
Gastrointestinal disorders Mucositis oral	20.8% 5/24 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 6 months post last treatment. 1 cycle = 21 days. Serious Adverse Events (SAEs) are reported from the time of treatment initiation. The range of cycles attempted was 1-38. At the time of reporting this data, 3 patients remain on treatment.
Gastrointestinal disorders Nausea	41.7% 10/24 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 6 months post last treatment. 1 cycle = 21 days. Serious Adverse Events (SAEs) are reported from the time of treatment initiation. The range of cycles attempted was 1-38. At the time of reporting this data, 3 patients remain on treatment.
Gastrointestinal disorders Vomiting	16.7% 4/24 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 6 months post last treatment. 1 cycle = 21 days. Serious Adverse Events (SAEs) are reported from the time of treatment initiation. The range of cycles attempted was 1-38. At the time of reporting this data, 3 patients remain on treatment.
General disorders Chills	12.5% 3/24 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 6 months post last treatment. 1 cycle = 21 days. Serious Adverse Events (SAEs) are reported from the time of treatment initiation. The range of cycles attempted was 1-38. At the time of reporting this data, 3 patients remain on treatment.
General disorders Edema face	4.2% 1/24 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 6 months post last treatment. 1 cycle = 21 days. Serious Adverse Events (SAEs) are reported from the time of treatment initiation. The range of cycles attempted was 1-38. At the time of reporting this data, 3 patients remain on treatment.
General disorders Edema limbs	29.2% 7/24 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 6 months post last treatment. 1 cycle = 21 days. Serious Adverse Events (SAEs) are reported from the time of treatment initiation. The range of cycles attempted was 1-38. At the time of reporting this data, 3 patients remain on treatment.
General disorders Fatigue	37.5% 9/24 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 6 months post last treatment. 1 cycle = 21 days. Serious Adverse Events (SAEs) are reported from the time of treatment initiation. The range of cycles attempted was 1-38. At the time of reporting this data, 3 patients remain on treatment.
General disorders Fever	16.7% 4/24 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 6 months post last treatment. 1 cycle = 21 days. Serious Adverse Events (SAEs) are reported from the time of treatment initiation. The range of cycles attempted was 1-38. At the time of reporting this data, 3 patients remain on treatment.
General disorders Flu like symptoms	8.3% 2/24 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 6 months post last treatment. 1 cycle = 21 days. Serious Adverse Events (SAEs) are reported from the time of treatment initiation. The range of cycles attempted was 1-38. At the time of reporting this data, 3 patients remain on treatment.
General disorders Gait disturbance	4.2% 1/24 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 6 months post last treatment. 1 cycle = 21 days. Serious Adverse Events (SAEs) are reported from the time of treatment initiation. The range of cycles attempted was 1-38. At the time of reporting this data, 3 patients remain on treatment.
General disorders Non-cardiac chest pain	4.2% 1/24 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 6 months post last treatment. 1 cycle = 21 days. Serious Adverse Events (SAEs) are reported from the time of treatment initiation. The range of cycles attempted was 1-38. At the time of reporting this data, 3 patients remain on treatment.
General disorders Pain	20.8% 5/24 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 6 months post last treatment. 1 cycle = 21 days. Serious Adverse Events (SAEs) are reported from the time of treatment initiation. The range of cycles attempted was 1-38. At the time of reporting this data, 3 patients remain on treatment.
Infections and infestations Bronchial infection	4.2% 1/24 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 6 months post last treatment. 1 cycle = 21 days. Serious Adverse Events (SAEs) are reported from the time of treatment initiation. The range of cycles attempted was 1-38. At the time of reporting this data, 3 patients remain on treatment.
Infections and infestations Lung infection	4.2% 1/24 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 6 months post last treatment. 1 cycle = 21 days. Serious Adverse Events (SAEs) are reported from the time of treatment initiation. The range of cycles attempted was 1-38. At the time of reporting this data, 3 patients remain on treatment.
Infections and infestations Rhinitis infective	4.2% 1/24 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 6 months post last treatment. 1 cycle = 21 days. Serious Adverse Events (SAEs) are reported from the time of treatment initiation. The range of cycles attempted was 1-38. At the time of reporting this data, 3 patients remain on treatment.
Infections and infestations Sinusitis	8.3% 2/24 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 6 months post last treatment. 1 cycle = 21 days. Serious Adverse Events (SAEs) are reported from the time of treatment initiation. The range of cycles attempted was 1-38. At the time of reporting this data, 3 patients remain on treatment.
Infections and infestations Upper respiratory infection	12.5% 3/24 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 6 months post last treatment. 1 cycle = 21 days. Serious Adverse Events (SAEs) are reported from the time of treatment initiation. The range of cycles attempted was 1-38. At the time of reporting this data, 3 patients remain on treatment.
Injury, poisoning and procedural complications Bruising	29.2% 7/24 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 6 months post last treatment. 1 cycle = 21 days. Serious Adverse Events (SAEs) are reported from the time of treatment initiation. The range of cycles attempted was 1-38. At the time of reporting this data, 3 patients remain on treatment.
Injury, poisoning and procedural complications Fall	16.7% 4/24 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 6 months post last treatment. 1 cycle = 21 days. Serious Adverse Events (SAEs) are reported from the time of treatment initiation. The range of cycles attempted was 1-38. At the time of reporting this data, 3 patients remain on treatment.
Injury, poisoning and procedural complications Wound complication	4.2% 1/24 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 6 months post last treatment. 1 cycle = 21 days. Serious Adverse Events (SAEs) are reported from the time of treatment initiation. The range of cycles attempted was 1-38. At the time of reporting this data, 3 patients remain on treatment.
Injury, poisoning and procedural complications Wrist fracture	4.2% 1/24 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 6 months post last treatment. 1 cycle = 21 days. Serious Adverse Events (SAEs) are reported from the time of treatment initiation. The range of cycles attempted was 1-38. At the time of reporting this data, 3 patients remain on treatment.

Additional Information

Brady L. Stein, MD

Northwestern University, Feinberg School of Medicine

Phone: 312-695-6832

Email: bstein@nmff.org

Results disclosure agreements

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