Trial Outcomes & Findings for Nivolumab and Yttrium Y 90 Glass Microspheres in Treating Patients With Advanced Liver Cancer (NCT NCT02837029)

NCT ID: NCT02837029

Last Updated: 2022-01-25

Results Overview

To identify maximum tolerated dose (MTD) of nivolumab for combination treatment of nivolumab following Y-90 in patients with advanced hepatocellular carcinoma. The MTD will be defined as the highest dose of nivolumab that causes dose limiting toxicities (DLTs) in \<2 of 6 patients. The Phase I portion of the study follows a 3+3 dose escalation design. Nivolumab has two dose levels: Level 1: 80mg IV every 2 weeks, Level 2: 240mg IV every 2 weeks. Toxicity will be assessed using the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE), version 4.03. A DLT is defined as an Adverse Event (AE) or abnormal laboratory value assessed as at least possibly related to the study medication, occurs ≤ 28 days (1 cycle) following the first dose of nivolumab and meets any of the criteria listed in the Protocol (Section 4.3.1).

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 27 participants
• Primary outcome timeframe: The first cycle of treatment with nivolumab (28 days)
• Results posted on: 2022-01-25

Participant Flow

The study opened for accrual on July 25th, 2016 with goal of 40 patients. The first patient started treatment Sep. 12, 2016. The study design for Phase 1 was 3 + 3 dose escalation. Accrual was suspended on June 7, 2019 for review of DLT data for dose Level 2 of Phase 1. The study closed Jun. 2, 2020 due to funding issues and Phase 1b never opened.

Participant milestones

Measure	Phase I, Nivolumab Dose Lvl 1 (80mg IV Every 2 Weeks) Nivolumab was administered at 80mg as an intravenous infusion over 30 minutes (-5 minutes / +15 minutes) every 2 weeks (Day 1 \& 15 of each cycle, 1 Cycle = 28 days). Courses repeated every cycle in the absence of disease progression or unacceptable toxicity. Correlatives studies: Peripheral lymphocyte analysis, and analysis for PD-K1, PD-1, CD8+, and CD4+ tumor infiltrating lymphocytes.	Phase I, Nivolumab Dose Lvl 2 (240mg IV Every 2 Weeks) Nivolumab was administered at 240mg as an intravenous infusion over 30 minutes (-5 minutes / +15 minutes) every 2 weeks (Day 1 \& 15 of each cycle, 1 Cycle = 28 days). Courses repeated every cycle in the absence of disease progression or unacceptable toxicity. Correlatives studies: Peripheral lymphocyte analysis, and analysis for PD-K1, PD-1, CD8+, and CD4+ tumor infiltrating lymphocytes.	Phase 1b at Nivolumab MTD (240mg IV, Every 2 Weeks) The maximum tolerated dose of nivolumab was planned to be administered in patients recruited to Phase 1b, as an intravenous infusion over 30 minutes (-5 minutes / +15 minutes) every 2 weeks (Day 1 \& 15 of each cycle, 1 Cycle = 28 days). Courses would repeat every cycle in the absence of disease progression or unacceptable toxicity. Correlatives studies: Peripheral lymphocyte analysis, and analysis for PD-K1, PD-1, CD8+, and CD4+ tumor infiltrating lymphocytes. Phase 1b never opened to accrual due to funding issues.
Screening STARTED	15	12	0
Screening COMPLETED	8	9	0
Screening NOT COMPLETED	7	3	0
Induction Treatment With Y90 STARTED	8	9	0
Induction Treatment With Y90 COMPLETED	8	9	0
Induction Treatment With Y90 NOT COMPLETED	0	0	0
Cycle 1 (DLT Monitoring Period) STARTED	8	9	0
Cycle 1 (DLT Monitoring Period) Received Nivolumab Dose	6	7	0
Cycle 1 (DLT Monitoring Period) COMPLETED	6	6	0
Cycle 1 (DLT Monitoring Period) NOT COMPLETED	2	3	0
Cycle 2 and Beyond STARTED	6	6	0
Cycle 2 and Beyond COMPLETED	5	6	0
Cycle 2 and Beyond NOT COMPLETED	1	0	0
2 Year Follow-up STARTED	6	7	0
2 Year Follow-up COMPLETED	0	0	0
2 Year Follow-up NOT COMPLETED	6	7	0

Reasons for withdrawal

Measure	Phase I, Nivolumab Dose Lvl 1 (80mg IV Every 2 Weeks) Nivolumab was administered at 80mg as an intravenous infusion over 30 minutes (-5 minutes / +15 minutes) every 2 weeks (Day 1 \& 15 of each cycle, 1 Cycle = 28 days). Courses repeated every cycle in the absence of disease progression or unacceptable toxicity. Correlatives studies: Peripheral lymphocyte analysis, and analysis for PD-K1, PD-1, CD8+, and CD4+ tumor infiltrating lymphocytes.	Phase I, Nivolumab Dose Lvl 2 (240mg IV Every 2 Weeks) Nivolumab was administered at 240mg as an intravenous infusion over 30 minutes (-5 minutes / +15 minutes) every 2 weeks (Day 1 \& 15 of each cycle, 1 Cycle = 28 days). Courses repeated every cycle in the absence of disease progression or unacceptable toxicity. Correlatives studies: Peripheral lymphocyte analysis, and analysis for PD-K1, PD-1, CD8+, and CD4+ tumor infiltrating lymphocytes.	Phase 1b at Nivolumab MTD (240mg IV, Every 2 Weeks) The maximum tolerated dose of nivolumab was planned to be administered in patients recruited to Phase 1b, as an intravenous infusion over 30 minutes (-5 minutes / +15 minutes) every 2 weeks (Day 1 \& 15 of each cycle, 1 Cycle = 28 days). Courses would repeat every cycle in the absence of disease progression or unacceptable toxicity. Correlatives studies: Peripheral lymphocyte analysis, and analysis for PD-K1, PD-1, CD8+, and CD4+ tumor infiltrating lymphocytes. Phase 1b never opened to accrual due to funding issues.
Screening Failed to meet screening requirements.	7	3	0
Cycle 1 (DLT Monitoring Period) Progressive Disease	2	0	0
Cycle 1 (DLT Monitoring Period) Adverse Event	0	2	0
Cycle 1 (DLT Monitoring Period) Withdrawal by Subject	0	1	0
Cycle 2 and Beyond Adverse Event	1	0	0
2 Year Follow-up Death	6	7	0

Baseline Characteristics

Nivolumab and Yttrium Y 90 Glass Microspheres in Treating Patients With Advanced Liver Cancer

Baseline characteristics by cohort

Measure	Phase I, Nivolumab Dose Lvl 1 (80mg IV Every 2 Weeks) n=8 Participants Nivolumab was administered at 80mg as an intravenous infusion over 30 minutes (-5 minutes / +15 minutes) every 2 weeks (Day 1 \& 15 of each cycle, 1 Cycle = 28 days). Courses repeated every cycle in the absence of disease progression or unacceptable toxicity. Correlatives studies: Peripheral lymphocyte analysis, and analysis for PD-K1, PD-1, CD8+, and CD4+ tumor infiltrating lymphocytes.	Phase I, Nivolumab Dose Lvl 2 (240mg IV Every 2 Weeks) n=9 Participants Nivolumab was administered at 240mg as an intravenous infusion over 30 minutes (-5 minutes / +15 minutes) every 2 weeks (Day 1 \& 15 of each cycle, 1 Cycle = 28 days). Courses repeated every cycle in the absence of disease progression or unacceptable toxicity. Correlatives studies: Peripheral lymphocyte analysis, and analysis for PD-K1, PD-1, CD8+, and CD4+ tumor infiltrating lymphocytes.	Phase 1b at Nivolumab MTD (240mg IV, Every 2 Weeks) The maximum tolerated dose of nivolumab was planned to be administered in patients recruited to Phase 1b, as an intravenous infusion over 30 minutes (-5 minutes / +15 minutes) every 2 weeks (Day 1 \& 15 of each cycle, 1 Cycle = 28 days). Courses would repeat every cycle in the absence of disease progression or unacceptable toxicity. Correlatives studies: Peripheral lymphocyte analysis, and analysis for PD-K1, PD-1, CD8+, and CD4+ tumor infiltrating lymphocytes. Phase 1b never opened to accrual due to funding issues.	Total n=17 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants	6 Participants n=7 Participants	0 Participants n=5 Participants	10 Participants n=4 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants	3 Participants n=7 Participants	0 Participants n=5 Participants	7 Participants n=4 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	5 Participants n=7 Participants	0 Participants n=5 Participants	7 Participants n=4 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	4 Participants n=7 Participants	0 Participants n=5 Participants	10 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	7 Participants n=5 Participants	8 Participants n=7 Participants	0 Participants n=5 Participants	15 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) White	8 Participants n=5 Participants	6 Participants n=7 Participants	0 Participants n=5 Participants	14 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Region of Enrollment United States	8 participants n=5 Participants	9 participants n=7 Participants	—	17 participants n=4 Participants

PRIMARY outcome

Timeframe: The first cycle of treatment with nivolumab (28 days)

To identify maximum tolerated dose (MTD) of nivolumab for combination treatment of nivolumab following Y-90 in patients with advanced hepatocellular carcinoma. The MTD will be defined as the highest dose of nivolumab that causes dose limiting toxicities (DLTs) in <2 of 6 patients. The Phase I portion of the study follows a 3+3 dose escalation design. Nivolumab has two dose levels: Level 1: 80mg IV every 2 weeks, Level 2: 240mg IV every 2 weeks. Toxicity will be assessed using the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE), version 4.03. A DLT is defined as an Adverse Event (AE) or abnormal laboratory value assessed as at least possibly related to the study medication, occurs ≤ 28 days (1 cycle) following the first dose of nivolumab and meets any of the criteria listed in the Protocol (Section 4.3.1).

Outcome measures

Measure	Phase I (Yttrium Y 90 Glass Microspheres, Nivolumab) n=12 Participants Patients in Phase I receive yttrium Y 90 glass microspheres IA. Approximately 4 weeks after yttrium Y 90 glass microspheres treatment, patients receive nivolumab IV over 30-60 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Phase I follows a 3+3 dose escalation design. There are two dose levels of nivolumab, Level 1: 80mg IV every 2 weeks, and Level 2: 240mg IV every 2 weeks. Laboratory Biomarker Analysis: Correlative studies Nivolumab: Given IV Yttrium Y 90 Glass Microspheres: Given IA	Phase I, Nivolumab Dose Lvl 2 (240mg IV Every 2 Weeks) Nivolumab was administered at 240mg as an intravenous infusion over 30 minutes (-5 minutes / +15 minutes) every 2 weeks (Day 1 \& 15 of each cycle, 1 Cycle = 28 days). Courses repeated every cycle in the absence of disease progression or unacceptable toxicity. Correlatives studies: Peripheral lymphocyte analysis, and analysis for PD-K1, PD-1, CD8+, and CD4+ tumor infiltrating lymphocytes.
Maximum Tolerated Dose (MTD)	240 mg of nivolumab, IV	—

PRIMARY outcome

Timeframe: At baseline and every 8 weeks for the first 13 months and then every 12 weeks up to 2 years

Population: Due to funding issues, Phase 1b of the study never opened to accrual.

Evaluate tumor response by assessing the proportion of patients with Objective response rate (ORR) (according to RECIST v. 1.1 criteria) to the combination treatment of nivolumab with Y-90 by examining imaging scans. Per RECIST v. 1.1: Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10mm. Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: During treatment where (1 Cycle = 28 days) the range of cycles attempted was 1-14 and up to 100 days following the last administration of study drug

Safety and tolerability of toxicities (according to the NCCN CTCAE v4.03) and tolerability of nivolumab and y-90 in patients with advanced hepatocellular carcinoma as graded using CTCAE 4.03 that are grade 3 - 5 for patients determined to be evaluable for other endpoints. In general the following severity definitions are true:

Mild (grade 1): the event causes discomfort without disruption of normal daily activities.

Moderate (grade 2): the event causes discomfort that affects normal daily activities.

Severe (grade 3): the event makes the patient unable to perform normal daily activities or significantly affects his/her clinical status.

Life-threatening (grade 4): the patient was at risk of death at the time of the event. Fatal (grade 5): the event caused death.

Outcome measures

Measure	Phase I (Yttrium Y 90 Glass Microspheres, Nivolumab) n=5 Participants Patients in Phase I receive yttrium Y 90 glass microspheres IA. Approximately 4 weeks after yttrium Y 90 glass microspheres treatment, patients receive nivolumab IV over 30-60 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Phase I follows a 3+3 dose escalation design. There are two dose levels of nivolumab, Level 1: 80mg IV every 2 weeks, and Level 2: 240mg IV every 2 weeks. Laboratory Biomarker Analysis: Correlative studies Nivolumab: Given IV Yttrium Y 90 Glass Microspheres: Given IA	Phase I, Nivolumab Dose Lvl 2 (240mg IV Every 2 Weeks) n=5 Participants Nivolumab was administered at 240mg as an intravenous infusion over 30 minutes (-5 minutes / +15 minutes) every 2 weeks (Day 1 \& 15 of each cycle, 1 Cycle = 28 days). Courses repeated every cycle in the absence of disease progression or unacceptable toxicity. Correlatives studies: Peripheral lymphocyte analysis, and analysis for PD-K1, PD-1, CD8+, and CD4+ tumor infiltrating lymphocytes.
Number of Patients Who Experience Adverse Events Alkaline phosphatase increased	1 Participants	0 Participants
Number of Patients Who Experience Adverse Events Keratitis	1 Participants	0 Participants
Number of Patients Who Experience Adverse Events Thromboembolic event	1 Participants	0 Participants
Number of Patients Who Experience Adverse Events Aspartate aminotransferase increased	0 Participants	1 Participants
Number of Patients Who Experience Adverse Events Hyperglycemia	0 Participants	2 Participants
Number of Patients Who Experience Adverse Events Creatinine increased	0 Participants	1 Participants
Number of Patients Who Experience Adverse Events Investigations (other)	1 Participants	0 Participants
Number of Patients Who Experience Adverse Events Lymphocyte count decreased	2 Participants	1 Participants
Number of Patients Who Experience Adverse Events Abdominal pain	1 Participants	0 Participants
Number of Patients Who Experience Adverse Events Blood bilirubin increased	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to 24 weeks (6 months)

Evaluate the percentage of patients alive and progression free at 24 weeks. PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first. Progression assessment will be performed by investigator each time the patients has a radiologic evaluation after 8 weeks of treatment. In general Progressive Disease (PD) will be assessed using RECIST v1.1 and defined as: At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm (0.5 cm). (Note: the appearance of one or more new lesions is also considered progression).

Outcome measures

Measure	Phase I (Yttrium Y 90 Glass Microspheres, Nivolumab) n=5 Participants Patients in Phase I receive yttrium Y 90 glass microspheres IA. Approximately 4 weeks after yttrium Y 90 glass microspheres treatment, patients receive nivolumab IV over 30-60 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Phase I follows a 3+3 dose escalation design. There are two dose levels of nivolumab, Level 1: 80mg IV every 2 weeks, and Level 2: 240mg IV every 2 weeks. Laboratory Biomarker Analysis: Correlative studies Nivolumab: Given IV Yttrium Y 90 Glass Microspheres: Given IA	Phase I, Nivolumab Dose Lvl 2 (240mg IV Every 2 Weeks) n=5 Participants Nivolumab was administered at 240mg as an intravenous infusion over 30 minutes (-5 minutes / +15 minutes) every 2 weeks (Day 1 \& 15 of each cycle, 1 Cycle = 28 days). Courses repeated every cycle in the absence of disease progression or unacceptable toxicity. Correlatives studies: Peripheral lymphocyte analysis, and analysis for PD-K1, PD-1, CD8+, and CD4+ tumor infiltrating lymphocytes.
Progression Free Survival (PFS) at 24 Weeks (6 Months)	40 percentage of patients	40 percentage of patients

SECONDARY outcome

Timeframe: At 24 weeks (6 months)

DCR will be determined at 24 weeks from the start of nivolumab treatment by the sum of complete response (CR), partial response (PR) and stable disease (SD) according to measurement of target and non-target lesions as assessed by RECIST v1.1 where generally the following definitions are true:

CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10mm.

PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.

SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study.

Outcome measures

Measure	Phase I (Yttrium Y 90 Glass Microspheres, Nivolumab) n=5 Participants Patients in Phase I receive yttrium Y 90 glass microspheres IA. Approximately 4 weeks after yttrium Y 90 glass microspheres treatment, patients receive nivolumab IV over 30-60 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Phase I follows a 3+3 dose escalation design. There are two dose levels of nivolumab, Level 1: 80mg IV every 2 weeks, and Level 2: 240mg IV every 2 weeks. Laboratory Biomarker Analysis: Correlative studies Nivolumab: Given IV Yttrium Y 90 Glass Microspheres: Given IA	Phase I, Nivolumab Dose Lvl 2 (240mg IV Every 2 Weeks) n=5 Participants Nivolumab was administered at 240mg as an intravenous infusion over 30 minutes (-5 minutes / +15 minutes) every 2 weeks (Day 1 \& 15 of each cycle, 1 Cycle = 28 days). Courses repeated every cycle in the absence of disease progression or unacceptable toxicity. Correlatives studies: Peripheral lymphocyte analysis, and analysis for PD-K1, PD-1, CD8+, and CD4+ tumor infiltrating lymphocytes.
Disease Control Rate (DCR)	4 Participants	4 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: At baseline

Tumor tissue will be used to examine expression of PD-L1 protein on tumor cells.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 2 years

Evaluate biomarker expression level using immunohistochemistry or flow cytometry.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Every 8 weeks for the first 24 weeks then every 16 weeks up to 2 years

Change in clonal burden landscape will be analyzed to investigate its correlation with treatment response or development of resistance to treatment.

Outcome measures

Outcome data not reported

POST_HOC outcome

Timeframe: Followed during treatment (1 Cycle = 28 days the range of cycles attempted was 1-14) and for up to 2 years during follow up

OS is defined as the duration of time from start of treatment to time of death and is summarized using Kaplan-Meier product limit curve and estimates.

Outcome measures

Measure	Phase I (Yttrium Y 90 Glass Microspheres, Nivolumab) n=5 Participants Patients in Phase I receive yttrium Y 90 glass microspheres IA. Approximately 4 weeks after yttrium Y 90 glass microspheres treatment, patients receive nivolumab IV over 30-60 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Phase I follows a 3+3 dose escalation design. There are two dose levels of nivolumab, Level 1: 80mg IV every 2 weeks, and Level 2: 240mg IV every 2 weeks. Laboratory Biomarker Analysis: Correlative studies Nivolumab: Given IV Yttrium Y 90 Glass Microspheres: Given IA	Phase I, Nivolumab Dose Lvl 2 (240mg IV Every 2 Weeks) n=5 Participants Nivolumab was administered at 240mg as an intravenous infusion over 30 minutes (-5 minutes / +15 minutes) every 2 weeks (Day 1 \& 15 of each cycle, 1 Cycle = 28 days). Courses repeated every cycle in the absence of disease progression or unacceptable toxicity. Correlatives studies: Peripheral lymphocyte analysis, and analysis for PD-K1, PD-1, CD8+, and CD4+ tumor infiltrating lymphocytes.
Overall Survival (OS)	14.65 months Interval 8.77 to 14.65	4.50 months Interval 2.3 to 9.36

Adverse Events

Phase I, Nivolumab Dose Lvl 1 (80mg IV Every 2 Weeks)

Serious events: 5 serious events

Other events: 8 other events

Deaths: 7 deaths

Phase I, Nivolumab Dose Lvl 2 (240mg IV Every 2 Weeks)

Serious events: 9 serious events

Other events: 9 other events

Deaths: 9 deaths

Phase 1b at Nivolumab MTD (240mg IV, Every 2 Weeks)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Phase I, Nivolumab Dose Lvl 1 (80mg IV Every 2 Weeks) n=8 participants at risk；n=15 participants at risk Nivolumab was administered at 80mg as an intravenous infusion over 30 minutes (-5 minutes / +15 minutes) every 2 weeks (Day 1 \& 15 of each cycle, 1 Cycle = 28 days). Courses repeated every cycle in the absence of disease progression or unacceptable toxicity. Correlatives studies: Peripheral lymphocyte analysis, and analysis for PD-K1, PD-1, CD8+, and CD4+ tumor infiltrating lymphocytes.	Phase I, Nivolumab Dose Lvl 2 (240mg IV Every 2 Weeks) n=9 participants at risk；n=12 participants at risk Nivolumab was administered at 240mg as an intravenous infusion over 30 minutes (-5 minutes / +15 minutes) every 2 weeks (Day 1 \& 15 of each cycle, 1 Cycle = 28 days). Courses repeated every cycle in the absence of disease progression or unacceptable toxicity. Correlatives studies: Peripheral lymphocyte analysis, and analysis for PD-K1, PD-1, CD8+, and CD4+ tumor infiltrating lymphocytes.	Phase 1b at Nivolumab MTD (240mg IV, Every 2 Weeks) The maximum tolerated dose of nivolumab was planned to be administered in patients recruited to Phase 1b, as an intravenous infusion over 30 minutes (-5 minutes / +15 minutes) every 2 weeks (Day 1 \& 15 of each cycle, 1 Cycle = 28 days). Courses would repeat every cycle in the absence of disease progression or unacceptable toxicity. Correlatives studies: Peripheral lymphocyte analysis, and analysis for PD-K1, PD-1, CD8+, and CD4+ tumor infiltrating lymphocytes. Phase 1b never opened to accrual due to funding issues.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatocellular carcinoma	6.7% 1/15 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	25.0% 3/12 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	— 0/0 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
Vascular disorders Thromboembolic event	13.3% 2/15 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	0.00% 0/12 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	— 0/0 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
Hepatobiliary disorders Hepatic Failure	6.7% 1/15 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	0.00% 0/12 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	— 0/0 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
Hepatobiliary disorders Hepatic Encephalopathy	13.3% 2/15 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	0.00% 0/12 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	— 0/0 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
Infections and infestations Spontaneous Bacterial Peritonitis	6.7% 1/15 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	8.3% 1/12 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	— 0/0 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
Infections and infestations Sepsis	6.7% 1/15 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	8.3% 1/12 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	— 0/0 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
Gastrointestinal disorders Abdominal Distention	6.7% 1/15 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	0.00% 0/12 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	— 0/0 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
General disorders Fever	6.7% 1/15 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	0.00% 0/12 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	— 0/0 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
Nervous system disorders Intracranial Hemorrhage	6.7% 1/15 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	0.00% 0/12 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	— 0/0 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
Respiratory, thoracic and mediastinal disorders Respiratory Failure	0.00% 0/15 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	8.3% 1/12 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	— 0/0 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
Gastrointestinal disorders Abdominal Pain	0.00% 0/15 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	8.3% 1/12 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	— 0/0 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
Infections and infestations Urinary tract infection	0.00% 0/15 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	8.3% 1/12 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	— 0/0 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
Nervous system disorders Dizziness	0.00% 0/15 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	8.3% 1/12 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	— 0/0 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
General disorders Death NOS	0.00% 0/15 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	8.3% 1/12 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	— 0/0 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
Gastrointestinal disorders Ascites	0.00% 0/15 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	8.3% 1/12 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	— 0/0 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
Investigations Blood Bilirubin Increased	0.00% 0/15 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	8.3% 1/12 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	— 0/0 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
Metabolism and nutrition disorders Hyponatremia	6.7% 1/15 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	0.00% 0/12 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	— 0/0 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.

Other adverse events

Measure	Phase I, Nivolumab Dose Lvl 1 (80mg IV Every 2 Weeks) n=8 participants at risk；n=15 participants at risk Nivolumab was administered at 80mg as an intravenous infusion over 30 minutes (-5 minutes / +15 minutes) every 2 weeks (Day 1 \& 15 of each cycle, 1 Cycle = 28 days). Courses repeated every cycle in the absence of disease progression or unacceptable toxicity. Correlatives studies: Peripheral lymphocyte analysis, and analysis for PD-K1, PD-1, CD8+, and CD4+ tumor infiltrating lymphocytes.	Phase I, Nivolumab Dose Lvl 2 (240mg IV Every 2 Weeks) n=9 participants at risk；n=12 participants at risk Nivolumab was administered at 240mg as an intravenous infusion over 30 minutes (-5 minutes / +15 minutes) every 2 weeks (Day 1 \& 15 of each cycle, 1 Cycle = 28 days). Courses repeated every cycle in the absence of disease progression or unacceptable toxicity. Correlatives studies: Peripheral lymphocyte analysis, and analysis for PD-K1, PD-1, CD8+, and CD4+ tumor infiltrating lymphocytes.	Phase 1b at Nivolumab MTD (240mg IV, Every 2 Weeks) The maximum tolerated dose of nivolumab was planned to be administered in patients recruited to Phase 1b, as an intravenous infusion over 30 minutes (-5 minutes / +15 minutes) every 2 weeks (Day 1 \& 15 of each cycle, 1 Cycle = 28 days). Courses would repeat every cycle in the absence of disease progression or unacceptable toxicity. Correlatives studies: Peripheral lymphocyte analysis, and analysis for PD-K1, PD-1, CD8+, and CD4+ tumor infiltrating lymphocytes. Phase 1b never opened to accrual due to funding issues.
Blood and lymphatic system disorders Anemia	50.0% 4/8 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	66.7% 6/9 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	— 0/0 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
Blood and lymphatic system disorders Blood and lymphatic system disorders - Other, specify	0.00% 0/8 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	11.1% 1/9 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	— 0/0 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
Cardiac disorders Cardiac disorders - Other, specify	0.00% 0/8 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	11.1% 1/9 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	— 0/0 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
Cardiac disorders Sinus tachycardia	0.00% 0/8 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	22.2% 2/9 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	— 0/0 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
Ear and labyrinth disorders Tinnitus	0.00% 0/8 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	11.1% 1/9 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	— 0/0 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
Endocrine disorders Hypothyroidism	25.0% 2/8 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	11.1% 1/9 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	— 0/0 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
Eye disorders Blurred vision	0.00% 0/8 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	22.2% 2/9 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	— 0/0 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
Eye disorders Cataract	12.5% 1/8 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	0.00% 0/9 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	— 0/0 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
Eye disorders Conjunctivitis	0.00% 0/8 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	11.1% 1/9 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	— 0/0 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
Eye disorders Keratitis	12.5% 1/8 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	0.00% 0/9 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	— 0/0 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
Gastrointestinal disorders Abdominal distension	37.5% 3/8 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	44.4% 4/9 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	— 0/0 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
Gastrointestinal disorders Abdominal pain	62.5% 5/8 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	44.4% 4/9 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	— 0/0 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
Gastrointestinal disorders Ascites	12.5% 1/8 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	22.2% 2/9 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	— 0/0 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
Gastrointestinal disorders Colitis	0.00% 0/8 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	11.1% 1/9 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	— 0/0 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
Gastrointestinal disorders Constipation	50.0% 4/8 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	33.3% 3/9 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	— 0/0 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
Gastrointestinal disorders Diarrhea	25.0% 2/8 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	22.2% 2/9 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	— 0/0 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
Gastrointestinal disorders Dry mouth	0.00% 0/8 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	11.1% 1/9 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	— 0/0 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
Gastrointestinal disorders Gastric ulcer	12.5% 1/8 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	0.00% 0/9 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	— 0/0 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
Gastrointestinal disorders Gastroesophageal reflux disease	12.5% 1/8 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	11.1% 1/9 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	— 0/0 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
Gastrointestinal disorders Gastrointestinal disorders - Other, specify	12.5% 1/8 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	11.1% 1/9 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	— 0/0 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
Gastrointestinal disorders Gastrointestinal pain	12.5% 1/8 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	0.00% 0/9 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	— 0/0 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
Gastrointestinal disorders Hemorrhoids	0.00% 0/8 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	11.1% 1/9 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	— 0/0 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
Gastrointestinal disorders Nausea	50.0% 4/8 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	44.4% 4/9 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	— 0/0 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
Gastrointestinal disorders Stomach pain	12.5% 1/8 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	0.00% 0/9 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	— 0/0 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
Gastrointestinal disorders Upper gastrointestinal hemorrhage	12.5% 1/8 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	0.00% 0/9 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	— 0/0 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
Gastrointestinal disorders Vomiting	25.0% 2/8 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	33.3% 3/9 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	— 0/0 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
General disorders Edema limbs	37.5% 3/8 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	33.3% 3/9 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	— 0/0 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
General disorders Fatigue	62.5% 5/8 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	55.6% 5/9 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	— 0/0 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
General disorders Fever	25.0% 2/8 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	11.1% 1/9 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	— 0/0 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
General disorders Gait disturbance	12.5% 1/8 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	11.1% 1/9 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	— 0/0 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
General disorders General disorders and administration site conditions - Other, specify	12.5% 1/8 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	11.1% 1/9 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	— 0/0 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
General disorders Injection site reaction	0.00% 0/8 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	11.1% 1/9 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	— 0/0 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
General disorders Localized edema	0.00% 0/8 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	11.1% 1/9 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	— 0/0 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
General disorders Non-cardiac chest pain	0.00% 0/8 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	33.3% 3/9 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	— 0/0 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
General disorders Pain	12.5% 1/8 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	11.1% 1/9 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	— 0/0 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
Hepatobiliary disorders Hepatobiliary disorders - Other, specify	25.0% 2/8 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	11.1% 1/9 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	— 0/0 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
Immune system disorders Immune system disorders - Other, specify	0.00% 0/8 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	11.1% 1/9 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	— 0/0 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
Infections and infestations Infections and infestations - Other, specify	12.5% 1/8 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	33.3% 3/9 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	— 0/0 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
Infections and infestations Lung infection	0.00% 0/8 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	11.1% 1/9 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	— 0/0 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
Infections and infestations Urinary tract infection	0.00% 0/8 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	33.3% 3/9 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	— 0/0 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
Injury, poisoning and procedural complications Burn	0.00% 0/8 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	11.1% 1/9 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	— 0/0 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
Injury, poisoning and procedural complications Fall	12.5% 1/8 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	11.1% 1/9 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	— 0/0 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
Investigations Activated partial thromboplastin time prolonged	25.0% 2/8 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	0.00% 0/9 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	— 0/0 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
Investigations Alanine aminotransferase increased	62.5% 5/8 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	66.7% 6/9 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	— 0/0 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
Investigations Alkaline phosphatase increased	75.0% 6/8 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	66.7% 6/9 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	— 0/0 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
Investigations Aspartate aminotransferase increased	62.5% 5/8 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	77.8% 7/9 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	— 0/0 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
Investigations Blood bilirubin increased	75.0% 6/8 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	100.0% 9/9 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	— 0/0 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
Investigations Creatinine increased	12.5% 1/8 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	22.2% 2/9 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	— 0/0 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
Investigations INR increased	25.0% 2/8 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	44.4% 4/9 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	— 0/0 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
Investigations Investigations - Other, specify	25.0% 2/8 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	0.00% 0/9 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	— 0/0 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
Investigations Lymphocyte count decreased	87.5% 7/8 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	77.8% 7/9 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	— 0/0 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
Investigations Platelet count decreased	50.0% 4/8 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	55.6% 5/9 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	— 0/0 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
Investigations Urine output decreased	0.00% 0/8 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	11.1% 1/9 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	— 0/0 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
Investigations Weight gain	12.5% 1/8 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	0.00% 0/9 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	— 0/0 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
Investigations Weight loss	0.00% 0/8 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	33.3% 3/9 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	— 0/0 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
Investigations White blood cell decreased	0.00% 0/8 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	22.2% 2/9 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	— 0/0 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
Metabolism and nutrition disorders Anorexia	25.0% 2/8 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	55.6% 5/9 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	— 0/0 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
Metabolism and nutrition disorders Hypercalcemia	25.0% 2/8 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	11.1% 1/9 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	— 0/0 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
Metabolism and nutrition disorders Hyperglycemia	87.5% 7/8 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	66.7% 6/9 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	— 0/0 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
Metabolism and nutrition disorders Hyperkalemia	0.00% 0/8 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	44.4% 4/9 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	— 0/0 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
Metabolism and nutrition disorders Hypoalbuminemia	62.5% 5/8 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	77.8% 7/9 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	— 0/0 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
Metabolism and nutrition disorders Hypocalcemia	37.5% 3/8 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	22.2% 2/9 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	— 0/0 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
Metabolism and nutrition disorders Hypoglycemia	12.5% 1/8 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	11.1% 1/9 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	— 0/0 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
Metabolism and nutrition disorders Hypokalemia	50.0% 4/8 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	33.3% 3/9 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	— 0/0 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
Metabolism and nutrition disorders Hyponatremia	62.5% 5/8 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	55.6% 5/9 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	— 0/0 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
Metabolism and nutrition disorders Hypophosphatemia	12.5% 1/8 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	0.00% 0/9 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	— 0/0 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/8 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	55.6% 5/9 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	— 0/0 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/8 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	11.1% 1/9 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	— 0/0 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
Musculoskeletal and connective tissue disorders Buttock pain	0.00% 0/8 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	11.1% 1/9 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	— 0/0 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	12.5% 1/8 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	33.3% 3/9 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	— 0/0 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, specify	0.00% 0/8 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	11.1% 1/9 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	— 0/0 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
Musculoskeletal and connective tissue disorders Myalgia	12.5% 1/8 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	0.00% 0/9 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	— 0/0 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/8 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	22.2% 2/9 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	— 0/0 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify	0.00% 0/8 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	11.1% 1/9 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	— 0/0 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
Nervous system disorders Cognitive disturbance	0.00% 0/8 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	11.1% 1/9 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	— 0/0 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
Nervous system disorders Dizziness	25.0% 2/8 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	44.4% 4/9 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	— 0/0 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
Nervous system disorders Dysarthria	0.00% 0/8 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	11.1% 1/9 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	— 0/0 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
Nervous system disorders Dysgeusia	0.00% 0/8 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	11.1% 1/9 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	— 0/0 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
Nervous system disorders Encephalopathy	12.5% 1/8 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	11.1% 1/9 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	— 0/0 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
Nervous system disorders Headache	12.5% 1/8 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	22.2% 2/9 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	— 0/0 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
Nervous system disorders Lethargy	12.5% 1/8 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	0.00% 0/9 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	— 0/0 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
Nervous system disorders Memory impairment	12.5% 1/8 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	11.1% 1/9 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	— 0/0 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
Nervous system disorders Nervous system disorders - Other, specify	12.5% 1/8 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	22.2% 2/9 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	— 0/0 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
Nervous system disorders Presyncope	0.00% 0/8 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	11.1% 1/9 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	— 0/0 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
Nervous system disorders Somnolence	0.00% 0/8 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	11.1% 1/9 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	— 0/0 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
Nervous system disorders Tremor	12.5% 1/8 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	0.00% 0/9 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	— 0/0 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
Psychiatric disorders Agitation	12.5% 1/8 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	0.00% 0/9 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	— 0/0 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
Psychiatric disorders Anxiety	12.5% 1/8 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	11.1% 1/9 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	— 0/0 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
Psychiatric disorders Confusion	12.5% 1/8 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	11.1% 1/9 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	— 0/0 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
Psychiatric disorders Delirium	0.00% 0/8 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	11.1% 1/9 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	— 0/0 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
Psychiatric disorders Depression	0.00% 0/8 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	11.1% 1/9 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	— 0/0 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
Psychiatric disorders Hallucinations	12.5% 1/8 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	0.00% 0/9 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	— 0/0 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
Psychiatric disorders Insomnia	0.00% 0/8 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	11.1% 1/9 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	— 0/0 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
Psychiatric disorders Personality change	12.5% 1/8 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	0.00% 0/9 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	— 0/0 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
Psychiatric disorders Psychiatric disorders - Other, specify	12.5% 1/8 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	11.1% 1/9 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	— 0/0 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
Renal and urinary disorders Acute kidney injury	12.5% 1/8 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	22.2% 2/9 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	— 0/0 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
Renal and urinary disorders Chronic kidney disease	12.5% 1/8 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	33.3% 3/9 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	— 0/0 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
Renal and urinary disorders Hematuria	12.5% 1/8 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	11.1% 1/9 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	— 0/0 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
Renal and urinary disorders Proteinuria	0.00% 0/8 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	11.1% 1/9 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	— 0/0 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
Renal and urinary disorders Renal and urinary disorders - Other, specify	0.00% 0/8 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	22.2% 2/9 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	— 0/0 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
Renal and urinary disorders Urinary frequency	0.00% 0/8 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	22.2% 2/9 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	— 0/0 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
Renal and urinary disorders Urine discoloration	12.5% 1/8 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	0.00% 0/9 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	— 0/0 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
Reproductive system and breast disorders Reproductive system and breast disorders - Other, specify	12.5% 1/8 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	0.00% 0/9 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	— 0/0 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	12.5% 1/8 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	11.1% 1/9 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	— 0/0 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
Respiratory, thoracic and mediastinal disorders Aspiration	12.5% 1/8 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	0.00% 0/9 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	— 0/0 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
Respiratory, thoracic and mediastinal disorders Cough	37.5% 3/8 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	11.1% 1/9 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	— 0/0 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
Respiratory, thoracic and mediastinal disorders Dyspnea	12.5% 1/8 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	44.4% 4/9 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	— 0/0 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/8 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	11.1% 1/9 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	— 0/0 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
Respiratory, thoracic and mediastinal disorders Pleural effusion	12.5% 1/8 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	11.1% 1/9 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	— 0/0 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
Respiratory, thoracic and mediastinal disorders Productive cough	12.5% 1/8 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	22.2% 2/9 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	— 0/0 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
Respiratory, thoracic and mediastinal disorders Pulmonary edema	0.00% 0/8 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	11.1% 1/9 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	— 0/0 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other, specify	0.00% 0/8 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	44.4% 4/9 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	— 0/0 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
Respiratory, thoracic and mediastinal disorders Wheezing	12.5% 1/8 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	11.1% 1/9 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	— 0/0 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/8 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	11.1% 1/9 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	— 0/0 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysesthesia syndrome	0.00% 0/8 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	11.1% 1/9 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	— 0/0 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
Skin and subcutaneous tissue disorders Pruritus	12.5% 1/8 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	22.2% 2/9 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	— 0/0 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specify	12.5% 1/8 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	22.2% 2/9 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	— 0/0 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
Vascular disorders Hypertension	50.0% 4/8 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	44.4% 4/9 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	— 0/0 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
Vascular disorders Hypotension	12.5% 1/8 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	22.2% 2/9 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	— 0/0 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
Vascular disorders Thromboembolic event	25.0% 2/8 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	0.00% 0/9 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.	— 0/0 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-14. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 1 out of 10 screenfail patients experiencing an SAE. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.

Additional Information

Aparna Kalyan, MBBS, FRACP

Northwestern University, Feinberg School of Medicine

Phone: 312 926 4291

Email: Aparna.kalyan@northwestern.edu

Results disclosure agreements

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